FrancophonIA/ELRC3.0 huggingface dataset:
English: A small, temporary swelling may occur at the injection site, which will either disappear or reduce in size within two weeks after vaccination.
Danish: Der kan opstå en mindre, midlertidig hævning på injektionsstedet, som enten vil forsvinde eller reducere i størrelse inden for to uger efter vaccinationen.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Nobivac L4 on 16 July 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nobivac L4 den 16/07/2012.
English: The benefit/risk balance can be found in the scientific discussion module of this EPAR.
Danish: Benefit/risk-forholdet fremgår af afsnittet om den videnskabelige drøftelse i denne EPAR.
English: The main infection source is from urine or urine-contaminated water or soil.
Danish: Den største infektionskilde er urin eller vand eller jord, som er forurenet med urin.
English: When puppies are known to have high levels of maternally derived antibodies (special type of proteins, received from the mother in the milk, that help the body to fight infection), it is recommended that the first vaccination is given at
Danish: Når man ved, at hvalpene har store mængder antistoffer erhvervet fra moderen (en særlig type proteiner, der overføres via modermælken, og som hjælper kroppen med at bekæmpe infektioner), anbefales det, at den første vaccination gives i en alder af ni uger.
English: Leptospirosis disease in dogs results in bleeding, hepatitis (infection of the liver) and jaundice (yellowing of the skin and eyes) or nephritis (kidney infection).
Danish: Leptospirose hos hunde medfører blødning, hepatitis (infektion af leveren) og gulsot (gulfarvning af huden og øjnene) eller nephritis (nyreinfektion).
English: A mild and temporary increase in body temperature ( 1°C) may occur for a few days after vaccination, with some puppies showing less activity and/or a reduced appetite.
Danish: Der kan forekomme en mild og midlertidig forhøjelse i kropstemperaturen ( 1 °C) få dage efter vaccinationen, og i visse tilfælde kan hundehvalpe være mindre aktive og/eller vise nedsat ædelyst.
English: The vaccine is given to dogs as two injections, four weeks apart, under the skin.
Danish: Vaccinen gives til hunde som to injektioner under huden med fire ugers mellemrum.
English: The studies showed that the vaccine reduces infection with Leptospira and excretion of the bacteria into the urine.
Danish: Undersøgelserne viste, at vaccinen hæmmer Leptospira-infektionen og bakteriernes udskillelse i urinen.
English: When Nobivac L4 is given to dogs, the immune system recognises the bacteria contained in the vaccine as ‘foreign' and makes defences against them.
Danish: Når Nobivac L4 gives til hunde, opfatter immunsystemet bakterierne i vaccinen som »fremmed« og danner forsvar mod dem.
English: The vaccine also reduces the excretion (shedding) of the virus into the urine by the infected dogs, thereby reducing the risk of transmission.
Danish: Vaccinen nedsætter desuden virusudskillelsen i de inficerede hundes urin og reducerer derved risikoen for overførsel.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobivac L4 exceed the risks and recommended that it be given a marketing authorisation.
Danish: Udvalget for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Nobivac L4 opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Nobivac L4.
English: Nobivac L4 is used to vaccinate dogs from six weeks of age to reduce the risk of developing an infection with certain Leptospira strains.
Danish: Nobivac L4 anvendes til vaccination af hunde i en alder af seks uger og frem for at reducere risikoen for udvikling af en infektion med visse Leptospira-stammer.
English: They also showed that the vaccine is safe to give to pregnant bitches.
Danish: Undersøgelserne viste desuden, at vaccinen er sikker for drægtige tæver.
English: Nobivac L4 is a vaccine.
Danish: Nobivac L4 er en vaccine.
English: Other information about Nobivac L4:
Danish: Andre oplysninger om Nobivac L4:
English: Nobivac L4 is a vaccine available as a suspension for injection.
Danish: Nobivac L4 er en vaccine, der fås som en suspension til injektion.
English: What is the risk associated with Nobivac L4?
Danish: Hvilken risiko er der forbundet med Nobivac L4?
English: Why has Nobivac L4 been approved?
Danish: Hvorfor blev Nobivac L4 godkendt?
English: What is Nobivac L4?
Danish: Hvad er Nobivac L4?
English: How has Nobivac L4 been studied?
Danish: Hvordan blev Nobivac L4 undersøgt?
English: How does Nobivac L4 work?
Danish: Hvordan virker Nobivac L4?
English: What is Nobivac L4 used for?
Danish: Hvad anvendes Nobivac L4 til?
English: What benefit has Nobivac L4 shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Nobivac L4?
English: EU/1/09/601/001 Firdapse
Danish: EU/1/09/601/001
English: Content (concentration)
Danish: <Indhold (Koncentration)>
English: Perforated unit dose thermoformed blisters
Danish: Oral anvendelse Perforerede, termoformede enhedsdosisblistre
English: MA (EU)-number
Danish: <EMA's procedurenr.> <MF (EU)-nummer>
English: Packsize
Danish: Pakningsstørrelse
English: (invented) name Strength Pharmaceutical form
Danish: Styrke Lægemiddelform Administration Emballage
English: Oral use
Danish: Firdapse
English: g n d
Danish: Paknings-størrelse t r
English: Zarzio can be used:
Danish: Zarzio kan anvendes:
English: It is advisable to wait and see how you feel after taking Zarzio and before driving or operating machinery.
Danish: Det er tilrådeligt at vente og se, hvordan du har det, efter du tager Zarzio, og før du fører motorkøretøj eller betjener maskiner.
English: How is Zarzio given and how much should I take?
Danish: Hvordan gives Zarzio, og hvor meget skal jeg tage?
English: This section contains information on how to give yourself an injection of Zarzio.
Danish: Dette afsnit indeholder information om, hvordan du kan give dig selv en indsprøjtning med Zarzio.
English: Zarzio is a biosimilar medicinal product.
Danish: Zarzio er et biosimilært lægemiddel.
English: Accidental freezing will not harm Zarzio.
Danish: Utilsigtet frysning vil ikke ødelægge Zarzio.
English: How long will I have to take Zarzio?
Danish: Hvor længe skal jeg tage Zarzio?
English: Zarzio is a white blood cell growth factor (granulocyte colony stimulating factor) and belongs to a group of proteins called cytokines.
Danish: Zarzio er en vækstfaktor for hvide blodlegemer (granulocytkoloni-stimulerende faktor) og tilhører en gruppe proteiner ved navn cytokiner.
English: Zarzio has not been tested in pregnant or breast-feeding women.
Danish: Zarzio er ikke blevet testet hos gravide eller ammende kvinder.
English: Inject the Zarzio solution as you have been shown by your doctor.
Danish: Indsprøjt opløsningen med Zarzio som din læge har vist dig.
English: You will need to take Zarzio until your white blood cell count is normal.
Danish: Du skal tage Zarzio indtil antallet af dine hvide blodlegemer er normalt.
English: Zarzio is not recommended during pregnancy.
Danish: Zarzio bør ikke anvendes under graviditeten.
English: Randomised, double-blind, single and multiple dose, crossover studies in 204 healthy volunteers showed that the pharmacokinetic profile of Zarzio was comparable to that of the reference product after subcutaneous and intravenous administration.
Danish: Randomiserede, dobbeltblindede overkrydsningsstudier med en enkelt og multiple doser med 204 raske frivillige viste, at Zarzios farmakokinetiske profil var sammenlignelig med referenceproduktets efter subkutan og intravenøs administration.
English: Zarzio is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection).
Danish: Zarzio gives normalt som en daglig indsprøjtning i vævet lige under huden (det kaldes en subkutan indsprøjtning).
English: Your doctor will tell you how much Zarzio you should take.
Danish: Din læge vil fortælle dig, hvor meget Zarzio du skal tage.
English: Contents of the pack and other information What Zarzio contains
Danish: Pakningsstørrelser og yderligere oplysninger Zarzio indeholder
English: Zarzio is provided with or without a needle safety guard and you will be shown how to use this by your doctor or nurse.
Danish: Zarzio leveres med eller uden kanylebeskyttelse, og lægen eller sundhedspersonalet viser dig, hvordan du anvender den.
English: - if you are allergic to filgrastim or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for filgrastim eller et af de øvrige indholdsstoffer i Zarzio (angivet i punkt 6).
English: Talk to your doctor, pharmacist or nurse before using Zarzio.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Zarzio.
English: If you develop or are likely to develop cancers of the blood, you should not use Zarzio unless instructed by your doctor.
Danish: Hvis du udvikler, eller det er sandsynligt, at du vil udvikle leukæmi, bør du ikke anvende Zarzio, medmindre din læge har anvist det.
English: Zarzio is used to treat children who are receiving chemotherapy or who suffer from severe low white blood cell count (neutropenia).
Danish: Zarzio anvendes til at behandle børn, som får kemoterapi, eller som har et meget lavt antal hvide blodlegemer (neutropeni).
English: If you become pregnant during Zarzio treatment, please inform your doctor.
Danish: Hvis du bliver gravid, mens du er i behandling med Zarzio, skal du fortælle det til din læge.
English: In view of the possible risk of microbial contamination, Zarzio syringes are for single use only.
Danish: For at undgå risiko for mikrobiel kontaminering er Zarzio injektionssprøjterne kun til engangsbrug.
English: Zarzio containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Danish: Zarzio indeholder r-metHuG-CSF (filgrastim) og forårsager udtalte stigninger i neutrofiltal i perifert blod inden for 24 timer ledsaget af en mindre stigning i antallet af monocytter.
English: Zarzio may have a minor influence on your ability to drive and use machines.
Danish: Zarzio kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Unless your doctor directs you otherwise, you must stop breast feeding if you use Zarzio.
Danish: Medmindre din læge giver dig andre anvisninger, skal du holde op med at amme, hvis du bruger Zarzio.
English: If you forget to use Zarzio
Danish: Hvis du har glemt at bruge Zarzio
English: You will normally receive your first dose of Zarzio at least 24 hours after your chemotherapy and at least 24 hours after receiving your bone marrow transplant.
Danish: Du vil normalt få din første dosis Zarzio mindst 24 timer efter kemoterapi og mindst 24 timer efter, du har gennemgået din knoglemarvstransplantation.
English: Your doctor will tell you how long you will need to take Zarzio.
Danish: Din læge vil fortælle dig, hvor længe du skal tage Zarzio.
English: Zarzio is one of a group of products that stimulate the production of white blood cells.
Danish: Zarzio tilhører en gruppe lægemidler, der stimulerer produktionen af hvide blodlegemer.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Zarzio therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med Zarzio skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Zarzio contains sorbitol
Danish: Zarzio indeholder sorbitol
English: Zarzio must not be diluted with sodium chloride solutions.
Danish: Zarzio må ikke fortyndes med natriumchloridopløsninger.
English: Zarzio is a clear, colourless to slightly yellowish solution for injection or infusion in pre-filled syringe.
Danish: Zarzio er en klar, farveløs til let gullig opløsning til injektion eller infusion i fyldt injektionssprøjte.
English: What you need to know before you use Zarzio Do not use Zarzio
Danish: Det skal du vide, før du begynder at bruge Zarzio Brug ikke Zarzio
English: Please tell your doctor immediately during treatment with Zarzio, if you: - get left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder [these may be symptoms of an enlarged spleen (splenomegaly), or possibly rupture of the spleen].
Danish: Du skal straks fortælle det til din læge, hvis du i løbet af behandlingen med Zarzio - får smerter i den øverste venstre side af maven (abdomen), smerter under de venstre ribben eller smerter i venstre skulder [det kan være symptomer på en forstørret milt (splenomegali) eller en mulig sprængt milt].
English: Zarzio contains sorbitol (E420).
Danish: Zarzio indeholder sorbitol (E420).
English: Zarzio is available in packs containing 1, 3, 5 or 10 pre-filled syringes with injection needle and with or without a needle safety guard.
Danish: Zarzio fås i pakninger med 1, 3, 5 eller 10 fyldte injektionssprøjter med eller uden kanylebeskyttelse.
English: Permanently discontinue Zarzio in patients with clinically significant hypersensitivity.
Danish: Zarzio skal seponeres permanent hos patienter med klinisk signifikant overfølsomhed.
English: Other medicines and Zarzio
Danish: Brug af anden medicin sammen med Zarzio
English: Zarzio contains no preservative.
Danish: Zarzio indeholder ingen konserveringsmidler.
English: Zarzio 48 MU/0.5 ml
Danish: Zarzio 48 mill. E/0,5 ml
English: Zarzio 30 MU/0.5 ml
Danish: Zarzio 30 mill. E/0,5 ml
English: If required, Zarzio may be diluted in glucose 50 mg/ml (5%) solution.
Danish: Om nødvendigt kan Zarzio fortyndes i 50 mg/ml (5%) glukoseopløsning.
English: Zarzio stimulates the bone marrow to produce new white cells quickly.
Danish: Zarzio stimulerer knoglemarven, så der hurtigt dannes nye hvide blodlegemer.
English: Zarzio works by encouraging the bone marrow to produce more white blood cells.
Danish: Zarzio virker ved at anspore knoglemarven, så den producerer flere hvide blodlegemer.
English: Do not administer Zarzio to patients with a history of hypersensitivity to filgrastim or pegfilgrastim.
Danish: Zarzio må ikke administreres til patienter med overfølsomhed over for filgrastim eller pegfilgrastim i anamnesen.
English: Zarzio must not be diluted with sodium chloride solution.
Danish: Zarzio må ikke fortyndes med natriumchloridholdig opløsning.
English: If you think you have injected more than you should, contact your doctor as soon as possible.
Danish: Hvis du mener, du har indsprøjtet for meget Zarzio, skal du kontakte din læge så snart som muligt.
English: Initial dose adjustment to alternate day dosing with 30 MU/day (300 μg/day) is recommended.
Danish: Initial dosisjustering til en dosis på 30 mill. E/dag (300 μg/dag) hver anden dag anbefales.
English: How to use Zarzio
Danish: Sådan skal du bruge Zarzio
English: Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe EU/1/08/495/001
Danish: Zarzio 30 mill. E/0,5 ml injektions-/infusionsvæske, opløsning i fyldt injektionssprøjte EU/1/08/495/001
English: Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe EU/1/08/495/005
Danish: Zarzio 48 mill. E/0,5 ml injektions-/infusionsvæske, opløsning i fyldt injektionssprøjte EU/1/08/495/005
English: Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe Each ml of solution contains 60 million units (MU) (equivalent to 600 micrograms [μg]) filgrastim*.
Danish: Zarzio 30 mill. E/0,5 ml injektions-/infusionsvæske, opløsning i fyldt injektionssprøjte Hver ml opløsning indeholder 60 millioner enheder (mill. E) (svarende til 600 mikrogram [μg]) filgrastim*.
English: Very commonly seen in normal stem cell donors is increase in white blood cells (leukocytosis) and decrease of platelets which reduces the ability of blood to clot (thrombocytopenia), these will be monitored by your doctor.
Danish: (leukocytose) og en reduktion af blodplader ses meget almindeligt hos normale stamcelledonorer, hvilket sænker blodets evne til at størkne (trombocytopeni).
English: Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe: Each pre-filled syringe contains 30 MU filgrastim in 0.5 ml, corresponding to 60 MU/ml.
Danish: Zarzio 30 mill. E/0,5 ml injektions-/infusionsvæske, opløsning i fyldt injektionssprøjte: Hver fyldt injektionssprøjte indeholder 30 mill. E filgrastim i 0,5 ml svarende til 60 mill. E/ml.
English: Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe
Danish: Zarzio 30 mill. E/0,5 ml injektions-/infusionsvæske, opløsning i fyldt injektionssprøjte Zarzio 48 mill. E/0,5 ml injektions-/infusionsvæske, opløsning i fyldt injektionssprøjte filgrastim
English: In patients undergoing a stem cell or bone marrow transplant, Graft versus Host Disease (GvHD) may occur- this is a reaction of the donor cells against the patient receiving the transplant; signs and symptoms include rash on the palms of your hands or soles of your feet and ulcer and sores in your mouth, gut, liver, skin, or your eyes, lungs, vagina and joints.
Danish: Tegn og symptomer omfatter udslæt på håndfladerne eller fodsålerne samt sår i mund, mave, lever, hud eller dine øjne, lunger, skede og led.
English: Zarzio 30 MU/0.5 ml injection or infusion Filgrastim
Danish: Zarzio 30 mill. E/0,5 ml injektion eller infusion filgrastim s.c./i.v.
English: Zarzio 48 MU/0.5 ml injection or infusion Filgrastim
Danish: Zarzio 48 mill. E/0,5 ml injektion eller infusion filgrastim s.c./i.v.
English: What Zarzio is and what it is used for What you need to know before you use Zarzio How to use Zarzio
Danish: Det skal du vide, før du begynder at bruge Zarzio Sådan skal du bruge Zarzio Bivirkninger
English: Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe: Each pre-filled syringe contains 48 MU filgrastim in 0.5 ml, corresponding to 96 MU/ml - The other ingredients are glutamic acid, sorbitol (E420), polysorbate 80 and water for injections.
Danish: Zarzio 48 mill. E/0,5 ml injektions-/infusionsvæske, opløsning i fyldt injektionssprøjte: Hver fyldt injektionssprøjte indeholder 48 mill. E filgrastim i 0,5 ml svarende til 96 mill. E/ml.
English: If you use more Zarzio than you should
Danish: Hvis du har brugt for meget Zarzio
English: Accidental exposure to freezing temperatures does not adversely affect the stability of Zarzio.
Danish: Zarzios stabilitet ændres ikke, selvom det ved et uheld bliver udsat for temperaturer under frysepunktet.
English: Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe Filgrastim
Danish: Zarzio 48 mill. E/0,5 ml injektions-/infusionsvæske, opløsning i fyldt injektionssprøjte filgrastim
English: Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe Filgrastim
Danish: Zarzio 30 mill. E/0,5 ml injektions-/infusionsvæske, opløsning i fyldt injektionssprøjte filgrastim
English: Please tell your doctor before starting treatment if you have: - osteoporosis (bone disease); - sickle cell anaemia, as Zarzio may cause sickle cell crisis.
Danish: Fortæl det til din læge, før du påbegynder behandlingen, hvis du: - har knogleskørhed (knoglesygdom),
English: 84 x 1 capsules (unit dose)
Danish: 84x1 kapsler (enhedsdosis)
English: EMA procedure number
Danish: EMA's procedure nr.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is treating you in the trial.
Danish: Hvis du deltager i et klinisk studie og har behov for mere information om din behandling, kan du kontakte den læge, der behandler dig.
English: What was Exondys expected to be used for?
Danish: Hvad forventedes Exondys anvendt til?
English: The company also compared the results of these studies with those from a variety of historical data.
Danish: Virksomheden sammenlignede også resultaterne fra disse studier med en række historiske data.
English: Exondys is a medicine that contains the active substance eteplirsen.
Danish: Exondys er et lægemiddel, der indeholder det aktive stof eteplirsen.
English: Refusal of the marketing authorisation for Exondys (eteplirsen)
Danish: Afslag på ansøgningen om markedsføringstilladelse for Exondys (eteplirsen)
English: What is Exondys?
Danish: Hvad er Exondys?
English: The company that applied for authorisation, AVI Biopharma International Ltd, requested a re-examination of the CHMP's opinion on 1 June 2018.
Danish: Den virksomhed, der har indgivet ansøgningen, AVI Biopharma International Ltd, anmodede om revurdering af CHMP's udtalelse den 1. juni 2018.
English: The second study, an extension of the first one, involved the same patients who were all treated with Exondys for another 4 years.
Danish: Det andet studie, der var en forlængelse af det første studie, omfattede de samme patienter, der alle blev behandlet med Exondys i yderligere 4 år.
English: Refusal of the marketing authorisation for Exondys (eteplirsen) EMA/621972/2018
Danish: Afslag på ansøgningen om markedsføringstilladelse for Exondys (eteplirsen) EMA/621972/2018
English: The methods for comparing results of the main studies with historical data were not satisfactory for showing that the medicine was effective.
Danish: Metoden, hvor resultaterne fra hovedstudierne sammenholdes med historiske data, er ikke tilfredsstillende til påvisning af lægemidlets virkning.
English: The Committee considered further data were needed to show that the very low amounts of shortened dystrophin produced as a result of Exondys treatment bring lasting benefits relevant to the patient.
Danish: Udvalget vurderer, at der er behov for yderligere data for at kunne påvise, at den meget lille mængde afkortet dystrofin, der produceres ved Exondys-behandling, er til vedvarende gavn for patienten.
English: This shortened protein is expected to act in a similar way to normal dystrophin, helping the body to make up for the lack of dystrophin, and so relieve the symptoms of DMD.
Danish: Dette afkortede protein forventes at virke på samme måde som normalt dystrofin og hjælpe kroppen ved at kompensere for det manglende dystrofin og på den måde lindre DMD-symptomerne.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Exondys.
Danish: Virksomheden har informeret CHMP om, at beslutningen ikke vil få konsekvenser for patienter, der aktuelt deltager i kliniske studier med Exondys.
English: On 31 May 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Exondys, intended for the treatment of Duchenne muscular dystrophy.
Danish: Den 31. maj 2018 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Exondys, der er beregnet til behandling af Duchennes muskeldystrofi.
English: Therefore, the CHMP was of the opinion that the balance of benefits and risks of Exondys in the treatment of DMD could not be established and recommended that the marketing authorisation be refused.
Danish: CHMP er derfor af den opfattelse, at benefit/risk-forholdet for Exondys ved behandling af DMD ikke er klarlagt, og anbefalede afslag på ansøgningen om markedsføringstilladelse.
English: The CHMP was concerned that the main study, which involved just 12 patients, did not compare Exondys with placebo beyond 24 weeks, during which there was no meaningful difference between Exondys and placebo in the 6-minute walking distance.
Danish: CHMP fandt det problematisk, at hovedstudiet, der kun omfattede 12 patienter, ikke sammenlignede Exondys med placebo i mere end 24 uger, da der i denne periode ikke var nogen nævneværdig forskel mellem Exondys og placebo i 6-minutters gangtesten.
English: Exondys was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 3 December 2008 for the treatment of DMD.
Danish: Exondys blev udpeget som "lægemiddel til sjældne sygdomme" den 3. december 2008 til behandling af DMD.