FrancophonIA/ELRC3.0 huggingface dataset:
English: Inactivated Leptospira strains: - L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12
Danish: Inaktiveret Leptospira stammer: - L. interogans serogruppe Canicola serovar Portland-vere
English: STATEMENT OF ACTIVE SUBSTANCES Read the package leaflet before use.
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Læs indlægssedlen inden brug.
English: 3550-7100 U1
Danish: 3550-7100 E1
English: Plastic box with 10, or 50 vials of 1 ml Cardboard box with 1 vial of 10 ml
Danish: Plastikæske med 10 eller 50 hætteglas af 1 ml Karton med 1 hætteglas af 10 ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Canigen L4 suspension for injection for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Canigen L4 injektionsvæske, suspension til hunde
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with vaccines of the Canigen series from the same marketing authorisation holder (or national subsidiary) containing Bordetella bronchiseptica strain B-C2 and/or canine parainfluenza virus strain Cornell components for intranasal administration where authorised.
Danish: Der foreligger oplysninger om sikkerhed og virkning, som viser, at vaccinen kan gives samme dag som, men ikke blandet med Canigen-vacciner, godkendt fra samme markedsføringsindehaver (eller nationalt datterselskab), indeholdende Bordetella bronchiseptica stamme B-C2 og/eller hundeparainfluenzavirus stamme Cornell komponenter til intranasal administration.
English: Plastic box with 10 or 50 vials of 1 ml (1 dose).
Danish: Plastikæske med 10 eller 50 hætteglas af 1 ml (1 dosis).
English: PACKAGE LEAFLET: Canigen L4 suspension for injection for dogs
Danish: INDLÆGSSEDDEL Canigen L4 Injektionsvæske, suspension til hunde
English: MARKETING AUTHORISATION NUMBER(S) EU/2/15/183/001 - 10 vials (1 ml) EU/2/15/183/002 - 50 vials (1 ml) EU/2/15/183/003 - 1 vial (10 ml)
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/15/183/001 - 10 hætteglas (1 ml)
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER FOR MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
English: In vitro and in vivo data in non-target species suggests that the vaccine may provide a degree of cross-protection against L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.
Danish: In vitro og in vivo data fra andre dyrearter end hunde antyder at vaccine kan give nogen grad af krydsbeskyttelse mod L. interrogans serogruppe Icterohaemorrhagiae serovar Icterohaemorrhagiae og L. kirschneri serogruppe Grippotyphosa serovar Grippotyphosa.
English: For simultaneous use with Canigen vaccines where authorised: 1 dose of a Canigen vaccine from the same marketing authorisation holder (or national subsidiary) containing canine distemper virus strain Onderstepoort, canine adenovirus type 2 strain Manhattan LPV3, canine parvovirus strain 154 and/or canine parainfluenza virus strain Cornell components should be reconstituted with 1 dose (1 ml) of Canigen L4.
Danish: Ved samtidig anvendelse af Canigen vacciner, hvor godkendt: 1 dosis Canigen vaccine, fra samme markedsføringsindehaver (eller nationalt datterselskab), indeholdende hundesygevirus virusstamme Onderstepoort, hundens type-2 adenovirus stamme Manhattan LPV3, hundeparvovirus stamme 154 og/eller hundeparainfluenzavirus stamme Cornell komponenter, skal rekonstitueres med 1 dosis (1 ml) Canigen L4.
English: For simultaneous use with Canigen vaccines where authorised: 1 dose of a Canigen vaccine from the same marketing authorisation holder (or national subsidiary) containing canine distemper virus strain Onderstepoort, canine adenovirus type 2 strain Manhattan LPV3, canine parvovirus strain 154, and/or canine parainfluenza virus strain Cornell components should be reconstituted with 1 dose (1 ml) of Canigen L4.
Danish: Ved samtidig anvendelse af Canigen vacciner, hvor godkendt: 1 dosis Canigen vaccine, fra samme markedsføringsindehaver (eller nationalt datterselskab), indeholdende hundesygevirus virus stamme Onderstepoort, hundens type-2 adenovirus stamme Manhattan LPV3, hundeparvovirus stamme 154 og/eller hundeparainfluenzavirus stamme Cornell komponenter, skal rekonstitueres med 1 dosis (1 ml) Canigen L4.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with vaccines of the Canigen series from the same marketing authorisation holder (or national subsidiary) containing canine distemper virus strain Onderstepoort, canine adenovirus type 2 strain Manhattan LPV3, canine parvovirus strain 154 and/or canine parainfluenza virus strain Cornell components for subcutaneous administration where authorised.
Danish: Der foreligger oplysninger om sikkerhed og virkning, som viser, at vaccinen kan blandes og anvendes med Canigen-vacciner, godkendt fra samme markedsføringsindehaver (eller nationalt datterselskab), indeholdende hundesygevirus virusstamme Onderstepoort, hundens type-2 adenovirus stamme Manhattan LPV3, hundeparvovirus stamme 154 og/eller hundeparainfluenzavirus stamme Cornell komponenter til subkutan anvendelse.
English: Sodium chloride
Danish: Hjælpestof: Thiomersal
English: EXPIRY DATE EXP {month/year} Once broached, use within 10 hours
Danish: Efter anbrud/åbning anvendes inden 10 timer (kun for 10 ml hætteglas)
English: For active immunisation of dogs against: - L. interrogans serogroup Canicola serovar Canicola to reduce infection and urinary excretion - L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni to reduce infection and urinary excretion - L. interrogans serogroup Australis serovar Bratislava to reduce infection - L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang to reduce infection and urinary excretion
Danish: Til aktiv immunisering af hunde mod: - L. interrogans serogruppe Canicola serovar Canicola for at begrænse infektion og udskillelse i urin.
English: FR-06516 Carros, France/ Frankrijk/Frankreich Tel: + 33 (0) 4 92 08 73 00
Danish: 1ère avenue 2065 m - L.I.D., FR-06516 Carros, France/ Frankrijk/Frankreich Tel: + 33 (0) 4 92 08 73 00
English: Infections may be more likely in younger children.
Danish: Infektioner kan være mere hyppige hos mindre børn.
English: Patients should therefore be observed for several hours after at least the first two infusions.
Danish: Patienterne skal derfor observeres i flere timer efter de to første infusioner som minimum.
English: Benlysta received a marketing authorisation valid throughout the European Union on 13 July 2011.
Danish: Benlysta fik en markedsføringstilladelse med gyldighed i hele EU den 13. juli 2011.
English: The first three doses are given at two-week intervals.
Danish: De første tre doser gives med to ugers mellemrum.
English: After this, Benlysta is given once every four weeks.
Danish: Herefter indgives Benlysta én gang hver fjerde uge.
English: The Agency also noted the lack of effective alternative treatments for patients who have already tried standard treatments.
Danish: Agenturet bemærkede også, at der mangler effektive alternative behandlingsmuligheder for patienter, som allerede har prøvet standardbehandlingerne.
English: Further information on Benlysta can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/benlysta.
Danish: Yderligere information om Benlysta findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/benlysta.
English: In SLE, some of these antibodies attack the body's own cells and organs instead (autoantibodies).
Danish: Ved SLE angriber nogle af disse antistoffer kroppens egne celler og organer i stedet (autoantistoffer).
English: As for all medicines, data on the use of Benlysta are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Benlysta løbende overvåget.
English: All infusions with Benlysta, and the first injection under the skin, should be given in a place where these reactions can be managed immediately if they occur.
Danish: Alle infusioner med Benlysta samt den første injektion under huden skal gives i et lokale, hvor sådanne reaktioner kan behandles med det samme, hvis de opstår.
English: Other information about Benlysta
Danish: Andre oplysninger om Benlysta
English: Benlysta is given to patients whose disease is still highly active despite standard treatment.
Danish: Benlysta gives til patienter, hvis sygdom bliver ved med at udvise høj aktivitet, selvom de får standardbehandling.
English: What measures are being taken to ensure the safe and effective use of Benlysta?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Benlysta?
English: The European Medicines Agency decided that Benlysta's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Benlysta opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What is Benlysta and what is it used for?
Danish: Hvad er Benlysta, og hvad anvendes det til?
English: Why is Benlysta authorised in the EU?
Danish: Hvorfor er Benlysta godkendt i EU?
English: Benlysta contains the active substance belimumab.
Danish: Benlysta indeholder det aktive stof belimumab.
English: SLE can affect almost any organ in the body, and is thought to involve a type of white blood cell called B lymphocytes.
Danish: SLE kan ramme næsten alle organer i kroppen og menes at involvere en type hvide blodlegemer kaldet B-lymfocytter.
English: An overview of Benlysta and why it is authorised in the EU
Danish: En oversigt over Benlysta, og hvorfor det er godkendt i EU
English: Side effects reported with Benlysta are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Benlysta vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: The company that markets Benlysta will provide further information on the safety of the medicine from a study and from a register of patients being followed up long-term.
Danish: Den virksomhed, der markedsfører Benlysta, vil fremlægge flere data om lægemidlets sikkerhed på baggrund af et studie og et register over patienter under langtidsopfølgning.
English: Usually, B lymphocytes produce antibodies which help to fight infections.
Danish: Normalt producerer B-lymfocytterne antistoffer, som hjælper med at bekæmpe infektioner.
English: Results from a main study involving 93 children aged 5 to 17 years with active SLE showed that Benlysta was distributed in the body in a similar way as in adults and could be expected to have similar benefits.
Danish: Resultaterne fra et hovedstudie, der omfattede 93 børn i alderen 5-17 år med aktiv SLE, viste, at Benlysta blev distribueret i kroppen på samme måde som hos voksne og kunne forventes at have tilsvarende fordele.
English: Patients may inject Benlysta themselves once they have been properly trained, if the doctor considers this appropriate.
Danish: Patienterne kan selv injicere Benlysta, når de har lært at gøre det, hvis lægen finder det hensigtsmæssigt.
English: The medicine may cause infusion and hypersensitivity reactions as well as infections, but is generally well tolerated.
Danish: Lægemidlet kan forårsage infusionsrelaterede reaktioner, overfølsomhedsreaktioner og infektioner, men det tåles generelt godt.
English: The doctor may interrupt or stop treatment if the patient develops reactions linked to the infusion (such as rash, itchiness and difficulty breathing) or hypersensitivity (allergic) reactions which may be severe and life-threatening and can develop several hours after Benlysta is given.
Danish: Behandlingen kan afbrydes eller indstilles af lægen, hvis patienten udvikler infusionsrelaterede reaktioner (f.eks. udslæt, kløe eller vejrtrækningsproblemer) eller overfølsomhedsreaktioner (allergiske reaktioner), som kan være alvorlige og livstruende og kan udvikle sig flere timer efter, at patienten har fået Benlysta.
English: When Benlysta is given as an infusion into a vein, the recommended dose is 10 mg per kilogram body weight given over one hour.
Danish: Når Benlysta gives som infusion (drop) i en vene, er den anbefalede dosis 10 mg pr. kg legemsvægt, der indgives over en time.
English: What are the risks associated with Benlysta?
Danish: Hvilke risici er der forbundet med Benlysta?
English: By blocking the action of BLyS, belimumab reduces the life span of B lymphocytes, thereby reducing the inflammation and organ damage that occur in SLE.
Danish: Ved at blokere funktionen af BLyS reducerer belimumab B-lymfocytternes levetid og reducerer dermed den betændelsestilstand og organskade, der forekommer ved SLE.
English: For more information about using Benlysta, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Benlysta, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: The active substance in Benlysta, belimumab, is a monoclonal antibody, a protein that has been designed to attach to and block a protein called BLyS which helps B lymphocytes to live longer.
Danish: Det aktive stof i Benlysta, belimumab, er et monoklonalt antistof, dvs. et protein, der er designet til at binde til og blokere proteinet BLyS, som hjælper B-lymfocytterne med at leve længere.
English: Another study involved 836 adult patients with active SLE, who received add-on Benlysta as an injection under the skin once a week for a year.
Danish: Et tredje studie omfattede 836 voksne patienter med aktiv SLE, og som fik Benlysta som tillægsbehandling injiceret under huden én gang om ugen i et år.
English: Benlysta is available as a powder (120 mg and 400 mg) that is made up into a solution for infusion (drip) into a vein; it is also available as a pre-filled pen and pre-filled syringe (200 mg) for injection under the skin.
Danish: Benlysta fås som et pulver (120 mg og 400 mg), som opblandes til en væske, der indgives som infusion (drop) i en vene; det fås også i en fyldt pen og en fyldt sprøjte (200 mg) til injektion under huden.
English: The Agency considered that Benlysta, used as an add-on treatment, reduced disease activity in SLE.
Danish: Agenturet vurderede, at Benlysta som tillægsbehandling reducerer sygdomsaktiviteten ved SLE.
English: For the full list of side effects and restrictions of Benlysta, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Benlysta fremgår af indlægssedlen.
English: In adults, Benlysta can also be given as a 200-mg injection under the skin, once a week.
Danish: Hos voksne kan Benlysta også gives som injektion under huden (200 mg) én gang om ugen.
English: The most common side effects with Benlysta (which may affect more than 1 in 10 people) are bacterial infections, such as bronchitis (infection in the lungs) and infection of the urinary tract (structures that produce or carry urine), diarrhoea and nausea (feeling sick).
Danish: De hyppigste bivirkninger ved Benlysta (som kan forekomme hos mere end 1 ud af 10 personer) er bakterieinfektioner som f.eks. bronkitis og urinvejsinfektion, diarré og kvalme.
English: Benlysta can only be obtained with a prescription and treatment should only be started and supervised by a doctor who has experience in the diagnosis and treatment of SLE.
Danish: Benlysta fås kun på recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i diagnosticering og behandling af systemisk lupus erythematosus (SLE).
English: How is Benlysta used?
Danish: Hvordan anvendes Benlysta?
English: What benefits of Benlysta have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Benlysta?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Benlysta have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Benlysta.
English: In the second study, disease activity decreased in 58% of patients treated with Benlysta, compared with 44% of patients who were given placebo.
Danish: I det andet studie faldt sygdomsaktiviteten hos 58 % af de patienter, der fik Benlysta, sammenholdt med 44 % af de patienter, der fik placebo.
English: In the first study, disease activity decreased in 43% of patients treated with Benlysta, compared with 34% of patients who were given placebo.
Danish: I det første studie faldt sygdomsaktiviteten hos 43 % af de patienter, der fik Benlysta, sammenholdt med 34 % af de patienter, der fik placebo.
English: The study showed that disease activity decreased in 61% of patients treated with Benlysta, compared with 48% of patients given placebo.
Danish: I dette studie faldt sygdomsaktiviteten hos 61 % af de patienter, der fik Benlysta, sammenholdt med 48 % af de patienter, der fik placebo.
English: How does Benlysta work?
Danish: Hvordan virker Benlysta?
English: Benlysta given by infusion was shown to be more effective than placebo (a dummy treatment) in reducing disease activity when used as an add-on treatment for SLE in two main studies involving 1,693 adult patients with active SLE.
Danish: To hovedstudier, der omfattede 1.693 voksne patienter med aktiv SLE, har vist, at infusion af Benlysta som tillægsbehandling er mere effektivt end placebo (et uvirksomt stof) til at reducere sygdomsaktiviteten.
English: Benlysta is a medicine used as an add-on treatment in patients aged 5 years and older with systemic lupus erythematosus (SLE), a disease in which the immune system (the body's natural defences) attacks normal cells and tissues, causing inflammation and organ damage.
Danish: Benlysta er et lægemiddel, der anvendes som tillægsbehandling hos patienter på 5 år og derover med systemisk lupus erythematosus (SLE).
English: This is a procedure when one Member State (the ‘reference Member State', in this instance the UK) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other member states (the ‘concerned Member States', in this instance Germany and Poland).
Danish: Det er en procedure, hvor en medlemsstat ("referencemedlemsstaten", i dette tilfælde Det Forenede Kongerige) vurderer et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, som gælder både nationalt og i andre medlemsstater (de "berørte medlemsstater", i dette tilfælde Tyskland og Polen).
English: What is Pantoprazole Olinka?
Danish: Hvad er Pantoprazol Olinka?
English: The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Pantoprazole Olinka.
Danish: Det Europæiske Lægemiddelagentur (EMA) har afsluttet en voldgiftsprocedure som følge af uenighed blandt Den Europæiske Unions medlemsstater om godkendelsen af lægemidlet Pantoprazole Olinka.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Pantoprazole Olinka outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the European Union, Germany and Poland.
Danish: Agenturets Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Pantoprazole Olinka opvejer risiciene, og at der kan udstedes markedsføringstilladelse i Det Forenede Kongerige og i EU-medlemsstaterne Tyskland og Polen.
English: Invented name Strength
Danish: EU nummer Særnavn Styrke
English: 10 vials
Danish: Intravenøs anvendelse Hætteglas 50 ml
English: This risk appears to be higher in children.
Danish: Denne risiko synes at være højere hos børn.
English: Therefore this information is of limited value.
Danish: Derfor er disse oplysninger af begrænset værdi.
English: Elderly patients (over 65 years of age)
Danish: Ældre patienter (over 65 år)
English: Children aged less than 18 years should not take this medicine.
Danish: Børn under 18 år bør ikke tage denne medicin.
English: • You feel any change in your mental health and wellbeing.
Danish: • Du føler nogen som helst forandringer i din mentale tilstand og velbefindende.
English: Modafinil was first authorized in the EU in France, in June 1992.
Danish: Modafinil blev først godkendt i EU i Frankrig i juni 1992.
English: Misuse and illicit use accounted for less than 3% of posted messages online.
Danish: Misbrug og ulovlig brug udgjorde mindre end 3 % af onlinemeddelelserne.
English: It is currently licensed in 21 countries in Europe, and the approved indications vary between Member States.
Danish: Det er på nuværende tidspunkt godkendt i 21 lande i Europa, og de godkendte indikationer er forskellige i medlemsstaterne.
English: Improvements were also noted in the subjective measurements.
Danish: Der blev også noteret forbedringer i de subjektive målinger.
English: It is however noted that the dose-response profile does not seem to be linear.
Danish: Det bemærkes dog, at dosisresponsprofilen ikke synes at være lineær.
English: Suicide-related behaviour
Danish: Selvmordsrelateret adfærd
English: Aggressive or hostile behaviour
Danish: Aggressiv eller fjendtlig adfærd
English: Data should be submitted once it is available from the investigators.
Danish: Dataene skal indsendes én gang og er tilgængelige fra investigatorerne.
English: As the Committee's assessment of the safety information did not change following re-examination, the Product Information remained unchanged.
Danish: Da udvalgets vurdering af sikkerhedsoplysningerne ikke ændredes efter revurderingen, forblev produktinformationen uændret.
English: • Awareness of your heart beat, which may be faster than normal.
Danish: • Opmærksomhed på din hjerterytme, hvilken kan være hurtigere end normalt.
English: Overall benefit/risk assessment
Danish: Samlet risk/benefit-vurdering
English: The large number of spontaneous reports seems to support this association.
Danish: Det store antal spontane indberetninger synes at understøtte denne forbindelse.
English: Common: decreased appetite
Danish: Almindelig: nedsat appetit
English: Stop taking this medicine and tell your doctor straight away if
Danish: Stop med at tage medicinen og fortæl straks din læge, hvis
English: The CHMP Scientific Advisory Group (SAG) was also consulted.
Danish: CHMP's videnskabelige rådgivende gruppe (Scientific Advisory Group - SAG) blev også hørt.
English: The efficacy in the long term has also not been demonstrated.
Danish: Virkningen på langt sigt er heller ikke påvist.
English: Three of these had a fatal outcome, and for the majority, causality could not be excluded.
Danish: Tre af disse havde fatalt udfald, og for de fleste kunne kausalitet ikke udelukkes.
English: Statistically significant differences were seen in the subjective parameters (ESS and CGI-C).
Danish: Der sås statistisk signifikante forskelle i de subjektive parametre (ESS og CGI-C).
English: Off label use
Danish: Off label-anvendelse
English: The study is intended to be initiated in September 2010 and the final report will be submitted in 4Q2011.
Danish: Det er meningen, at undersøgelsen indledes i september 2010, og at den endelige rapport indsendes i fjerde kvartal 2011.
English: • Misinterpretation of the risks associated to modafinil
Danish: • Fejlfortolkning af risiciene i forbindelse med modafinil
English: The Committee considered that further risk minimisation measures would not adequately address the concern as the magnitude of the risk is not fully determined.
Danish: Udvalget fandt, at yderligere risikominimeringsforanstaltninger ikke vil afhjælpe denne betænkelighed tilstrækkeligt, da risikoens størrelse ikke er fuldt ud fastlagt.
English: However the effect size is small and does not necessarily reflect a clinically significant benefit.
Danish: Men virkningen er lille og afspejler ikke nødvendigvis en klinisk signifikant fordel.