FrancophonIA/ELRC3.0 huggingface dataset:
English: 6.5 Nature and contents of container
Danish: 6,5 Emballagetype og pakningsstørrelser
English: Osteoporosis/osteopenia, arthralgia muscular weakness, muscle spasms, joint swelling/stiffness
Danish: Osteoporose/osteopeni, artralgi, muskelsvaghed, muskelkramper, hævelser/stivhed i leddene
English: 3 vial adapter
Danish: 3 hætteglas adaptere
English: How to store FIRMAGON Contents of the pack and other information
Danish: Pakningsstørrelser og yderligere oplysninger
English: Pack-size of 2 trays containing: 2 vials with 120 mg degarelix (powder) 2 pre-filled syringes with 3 ml solvent 2 plunger rods
Danish: Pakningsstørrelse med 2 bakker indeholdende:2 hætteglas med 120 mg degarelix (pulver) 2 fyldte injektionssprøjter med 3 ml solvens
English: FIRMAGON is for subcutaneous use ONLY, not to be administered intravenously.
Danish: FIRMAGON er kun beregnet til subkutan administration.
English: − skin redness, loss of hair, skin nodule, numbness
Danish: − rødme af huden, hårtab, knuder i huden, følelsesløshed
English: What FIRMAGON is and what it is used for What you need to know before you use FIRMAGON How to use FIRMAGON
Danish: Det skal du vide, før du begynder at bruge FIRMAGON Sådan skal du bruge FIRMAGON Bivirkninger
English: Posology
Danish: Stempelstænger
English: Ferring S.p.A. Tel: +39 02 640 00 11
Danish: Tel: +39 02 640 00 11
English: Always make sure to withdraw the precise volume and adjust for any air bubbles.
Danish: Kontroller altid, at det rigtige volumen er trukket over i sprøjten.
English: − Kidney disease.
Danish: - Du har en nyresygdom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR FIRMAGON 120 mg powder and solvent for solution for injection
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON FOR FIRMAGON 120 mg, pulver og solvens til injektionsvæske, opløsning
English: Pack-size of 3 trays containing 3 vials with 80 mg degarelix (powder) 3 pre-filled syringe with 4.2 ml solvent 3 plunger rod
Danish: Pakningsstørrelse med 3 bakker indeholdende 3 hætteglas med 80 mg degarelix (pulver) 3 fyldte injektionssprøjter med 4,2 ml solvens 3 stempelstænger
English: 2 vials with powder containing 120 mg of degarelix and 2 pre-filled syringes with 3 ml of solvent.
Danish: 2 hætteglas med pulver indeholdende 120 mg degarelix og 2 fyldte injektionssprøjter med 3 ml solvens.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR FIRMAGON 80 mg powder and solvent for solution for injection
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON FOR FIRMAGON 80 mg, pulver og solvens til injektionsvæske, opløsning
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse
English: − The active substance is degarelix, each vial contains 80 mg degarelix (as acetate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 80 mg degarelix (som acetat).
English: 3 vials with powder containing 80 mg of degarelix and 3 pre-filled syringes with 4.2 ml of solvent.
Danish: 3 hætteglas med pulver indeholdende 80 mg degarelix og 3 fyldte injektionssprøjter med 4,2 ml solvens.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL FOR FIRMAGON 120 mg powder for solution for injection
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS TIL FIRMAGON 120 mg, pulver til injektionsvæske, opløsning
English: Mechanism of action
Danish: Virkningsmåde
English: Vial adapter
Danish: Hætteglas adaptere
English: Pack-size of 1 tray containing 1 vial with 80 mg degarelix (powder) 1 pre-filled syringe with 4.2 ml solvent 1 plunger rod
Danish: Pakningsstørrelse med 1 bakke indeholdende 1 hætteglas med 80 mg degarelix (pulver) 1 fyldt injektionssprøjte med 4,2 ml solvens 1 stempelstang
English: 1 vial with powder containing 80 mg of degarelix and 1 pre-filled syringe with 4.2 ml of solvent.
Danish: 1 hætteglas med pulver indeholdende 80 mg degarelix og 1 fyldt injektionssprøjte med 4,2 ml solvens.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL FOR FIRMAGON 80 mg powder for solution for injection
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS TIL FIRMAGON 80 mg, pulver til injektionsvæske, opløsning
English: After reconstitution, each ml solution contains 40 mg of degarelix.
Danish: Efter rekonstituering indeholder hver ml opløsning 40 mg degarelix.
English: After reconstitution, each ml of solution contains 20 mg of degarelix.
Danish: Efter rekonstituering indeholder hver ml opløsning 20 mg degarelix.
English: Degarelix 240/80 mg N=207
Danish: Degarelix 240@40/80@20
English: FIRMAGON 120 mg powder and solvent for solution for injection degarelix
Danish: FIRMAGON 120 mg, pulver og solvens til injektionsvæske, opløsning Degarelix
English: FIRMAGON 80 mg powder and solvent for solution for injection degarelix
Danish: FIRMAGON 80 mg, pulver og solvens til injektionsvæske, opløsning Degarelix
English: Prepare the pre-filled syringe by attaching the plunger rod.
Danish: Klargør den fyldte injektionssprøjte med påsætning af stempelstangen.
English: Day 1 Day 3 Day 7
Danish: Dag 7
English: FIRMAGON 120 mg powder and solvent for solution for injection
Danish: LÆGEMIDLETS NAVN FIRMAGON 120 mg, pulver og solvens til injektionsvæske, opløsning
English: Remove the cap of the pre-filled syringe.
Danish: Fjern beskyttelseshætten fra den fyldte injektionssprøjte.
English: − If you get any of the side effects, talk to your doctor.
Danish: - Tal med lægen, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: FIRMAGON 80 mg powder and solvent for solution for injection
Danish: LÆGEMIDLETS NAVN FIRMAGON 80 mg, pulver og solvens til injektionsvæske, opløsning
English: Batch
Danish: Stempelstang
English: 1 injection needle
Danish: 1 injektionskanyle
English: Diarrhoea, nausea
Danish: Nyrer og urinveje
English: 1 ml of the reconstituted solution contains 40 mg degarelix.
Danish: Efter opløsning indeholder 1 ml af den færdigblandede injektionsvæske 40 mg degarelix.
English: Justification for not including Braille accepted.
Danish: INFORMATION I BRAILLESKRIFT Fritaget fra krav om blindeskrift.
English: 1 ml of the reconstituted solution contains 20 mg degarelix.
Danish: Efter opløsning indeholder 1 ml af den færdigblandede injektionsvæske 20 mg degarelix.
English: − blurred vision
Danish: − sløret syn
English: It is recommended that the second vaccination is given at a different site than the first vaccination.
Danish: Det anbefales, at den anden vaccination indgives på et andet sted end den første vaccination.
English: The pigs should be re-vaccinated every 6 months.
Danish: Svinene skal vaccineres hver 6. måned.
English: The import, sale, supply and/or use of Porcilis Pesti is only allowed under the particular conditions established by European Community legislation on the control of CSF (Council Directive 80/217/EEC, as amended).
Danish: Import, salg, levering og/eller anvendelse af Porcilis Pesti er kun tilladt under de særlige betingelser fastsat i den Europæiske Unions lovgivning vedrørende kontrol af CSF (Rådets direktiv 80/217/EØF, med ændringer).
English: The package leaflet should be taken to the doctor.
Danish: Indlægssedlen skal medbringes til lægen.
English: Any person intending to import, sell, supply and/or use the veterinary medicinal product must be authorised by the competent authority of the Member State.
Danish: Enhver person, der påtænker at indføre, sælge, levere og/eller anvende dette veterinærlægemiddel, skal være godkendt af rette myndighed i det pågældende medlemsland.
English: If you need more information about your animal's medical condition or treatment, contact your veterinarian.
Danish: Hvis du ønsker yderligere oplysninger om dit dyrs medicinske tilstand eller behandling, skal du kontakte din dyrlæge.
English: Maternally derived antibodies did not interfere with vaccination.
Danish: Maternelle antistoffer interfererede ikke med vaccinen.
English: If someone is accidentally injected with this product, they must seek immediate medical advice even if only a very small amount is injected.
Danish: Hvis en person ved et uheld får injiceret dette produkt, skal vedkommende søge læge omgående, også selvom der kun er injiceret en meget lille mængde.
English: This first dose is followed by a second injection 4 weeks later.
Danish: Den første dosis følges op med en ny injektion 4 uger senere.
English: When exposed to CSF later in life, the pig will either not become infected or have a much less serious infection.
Danish: Hvis svinet eksponeres for CSF senere i livet, vil det enten ikke blive inficeret eller vil få en langt mindre alvorlig infektion.
English: Protection from CSF starts after 2 weeks and lasts for 6 months.
Danish: Beskyttelsen mod CSF indtræder efter 2 uger og varer i 6 måneder.
English: When this antigen is injected, this small exposure helps the pig's immune system to recognise and attack CSF.
Danish: Når dette antigen er blevet injiceret, hjælper denne lille eksponering svinets immunsystem til at genkende og angribe CSF.
English: Porcilis Pesti contains mineral oil.
Danish: Porcilis Pesti indeholder mineralolie.
English: Viraemia was only prevented by two injections (as recommended in the vaccination schedule for Porcilis Pesti).
Danish: Viræmi blev kun forebygget med to injektioner (som anbefalet i vaccinationsplanen for Porcilis Pesti).
English: Abscesses may be seen at the injection site.
Danish: Der kan muligvis observeres bylder ved injektionsstedet.
English: The piglets were also tested for viraemia (presence of virus in their blood).
Danish: Smågrisene blev også tester for viræmi (tilstedeværelse af virus i blodet).
English: Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger - rarely causing the loss of a finger.
Danish: Uforsætlig injektion/selvinjektion kan medføre alvorlige smerter og hævelser, navnlig ved injektion i led eller fingre, og kan i sjældne tilfælde medføre tab af den pågældende finger.
English: Porcilis Pesti can cause a swelling at the injection site for up to 4 weeks after each injection of the vaccine.
Danish: Porcilis Pesti kan fremkalde en hævelse ved injektionsstedet i op til 4 uger efter hver injektion af vaccinen.
English: The vaccine is shaken before use and an intramuscular (into a muscle) injection of one dose (2 ml) is given in the neck behind the ear.
Danish: Vaccinen omrystes før brug, og én dosis (2 ml) injiceres intramuskulært (i en muskel) på halsen bag øret.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PORCILIS PESTI EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) PORCILIS PESTI EPAR - sammendrag for offentligheden
English: The field trials confirm the results obtained in the laboratory safety experiments and show that the product is safe for the target animal (piglets from 5 weeks of age onwards) and in the most sensitive category of animals (pregnant sows).
Danish: Feltundersøgelserne bekræftede de resultater, der var opnået med eksperimentelle sikkerhedsundersøgelser i laboratorium, og viste, at produktet er sikkert for måldyret (smågrise fra 5 uger og opefter) og for den mest følsomme kategori af dyr (drægtige søer).
English: They recommended that Porcilis Pesti should be given a marketing authorisation.
Danish: Udvalget anbefalede, at Porcilis Pesti fik markedsføringstilladelse.
English: Antibodies to the CSF antigen showed that the piglets developed immunity after 2 weeks, which was maintained for 6 months.
Danish: Antistoffer mod CSF-antigenet viste, at smågrisene efter 2 uger udviklede immunitet, som blev opretholdt i 6 måneder.
English: All the vaccinations prevented death when the piglets were exposed to CSF virus at a later date.
Danish: Alle vaccinationerne forebyggede dødelighed, når smågrisene blev eksponeret for CSF-virus på et senere tidspunkt.
English: Porcilis Pesti contains an antigen - E2 (a substance that stimulates an immune response) to CSF.
Danish: Porcilis Pesti indeholder et antigen - E2 (et stof, som fremkalder en immunrespons) mod CSF.
English: Temporary hyperthermia (increased temperature) may occur after the second injection.
Danish: Efter den anden injektion kan der opstå forbigående hypertermi (forhøjet temperatur).
English: The main measure of effectiveness in a field trial with piglets was the survival of the piglets when exposed to the CSF virus later in life.
Danish: Den vigtigste målestok for virkningen i en feltundersøgelse af smågrise var grisenes overlevelse, når de blev eksponeret for CSF-virus senere i livet.
English: Porcilis Pesti is an emulsion for injection.
Danish: Porcilis Pesti er en injektionsvæske, emulsion.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis Pesti to Intervet International B.V. on 9 February 2000, which was renewed in February
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Porcilis Pesti til Intervet International B.V.
English: Other information about Porcilis Pesti:
Danish: Øvrige oplysninger om Porcilis Pesti:
English: The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Porcilis Pesti are greater than any risks to immunise pigs from the age of 5 weeks onwards to prevent death and to reduce clinical signs of Classical Swine Fever.
Danish: Udvalget for Veterinærlægemidler (CVMP) har konkluderet, at de gavnlige virkninger ved Porcilis Pesti er større end de eventuelle risici ved at immunisere svin fra 5 uger og opefter for at forebygge dødelighed og for at reducere de kliniske symptomer på klassisk svinepest.
English: Porcilis Pesti is used to immunise healthy pigs from the age of 5 weeks onwards to prevent death and to reduce clinical signs of Classical Swine Fever (CSF).
Danish: Porcilis Pesti anvendes til immunisering af raske svin fra 5-ugersalderen for at forebygge dødelighed og reducere de kliniske symptomer ved klassisk svinepest (CSF).
English: Porcilis Pesti contains Classical Swine Fever Virus -E2 subunit antigen.
Danish: Porcilis Pesti indeholder klassisk svinepestvirus (CSFV)-E2 subunit-antigen.
English: It is also used to reduce infection with CSF and excretion of CSF virus into the environment.
Danish: Det anvendes også til at reducere infektion med CSF og udskillelse af klassisk svinepestvirus.
English: What is the risk associated with Porcilis Pesti?
Danish: Hvilken risiko er der forbundet med Porcilis Pesti?
English: Why has Porcilis Pesti been approved?
Danish: Hvorfor blev Porcilis Pesti godkendt?
English: What is Porcilis Pesti?
Danish: Hvad er Porcilis Pesti?
English: How has Porcilis Pesti been studied?
Danish: Hvordan blev Porcilis Pesti undersøgt?
English: The start and length of immunity was measured by antibodies produced by the piglets to the CSF antigen (E2).
Danish: Immunitetens indtræden og varighed blev målt ud fra de antistoffer,
English: Porcilis Pesti has been studied in two safety field trials, one in finishing pigs and one in sows using different vaccination doses.
Danish: Porcilis Pesti blev undersøgt i to feltundersøgelser for så vidt angår sikkerheden.
English: What is Porcilis Pesti used for?
Danish: Hvad anvendes Porcilis Pesti til?
English: What benefit has Porcilis Pesti shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Porcilis Pesti?
English: How does Porcilis Pesti work?
Danish: Hvordan virker Porcilis Pesti?
English: This summary was last updated on 05/09/2006.
Danish: Dette sammendrag blev sidst ajourført den 05/09/2006.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Nobilis Influenza H5N2 to Intervet International BV on 01/09/2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nobilis Influenza H5N2 til Intervet International BV den 01/09/2006.
English: The vaccine was assessed in the context of an emergency situation which means that further studies with Nobilis H5N2 are still ongoing and will be assessed.
Danish: Vaccinen er blevet vurderet i forbindelse med en nødsituation, hvilket betyder, at der stadig pågår yderligere undersøgelser af Nobilis H5N2, som vil blive vurderet.
English: The virus used for the vaccine carries the H5 (haemagglutinin 5) and N2 (neuramidase 2) antigens.
Danish: Den virus, der anvendes til denne vaccine, bærer antigenerne H5 (hæmagglutinin 5) og N3 (neuraminidase 2).
English: Nobilis Influenza H5N2 is a vaccine containing an inactivated avian influenza virus H5N2 (inactivated means that the virus has been killed so that it cannot cause the disease any more).
Danish: Nobilis Influenza H5N2 er en vaccine, der indeholder en inaktiveret fugleinfluenzavirus H5N2 (inaktiveret vil sige, at virussen er dræbt, så den ikke længere kan forårsage sygdommen).
English: • If the circulating avian influenza field virus has a different N component to the N2 included in the vaccine, it may be possible to differentiate between vaccinated from infected birds by using a diagnostic test to detect Neuraminidase antibodies.
Danish: • Hvis N-komponenten i den fugleinfluenzavirus, der er i omløb, er forskellig fra den N2, der indgår i vaccinen, kan vaccinerede og smittede fugle muligvis skelnes fra hinanden ved en diagnostisk test til påvisning af neuraminidase-antistoffer.
English: Nobilis Influenza H5N2 is a vaccine used in chickens to protect against avian influenza.
Danish: Nobilis Influenza H5N2 er en vaccine, der anvendes til at beskytte kyllinger mod fugleinfluenza.
English: Nobilis Influenza H5N2 has been authorised under “Exceptional Circumstances”.
Danish: Nobilis Influenza H5N2 er godkendt på "særlige vilkår".
English: The company carried out laboratory safety studies using a vaccine very similar to Nobilis Influenza H5N2.
Danish: Firmaet har udført sikkerhedsundersøgelser i laboratoriet med en vaccine, der har stor lighed med Nobilis Influenza H5N2.
English: Vaccinated birds can be differentiated from infected birds by a diagnostic test for antibodies against the N2 component.
Danish: Vaccinerede fugle kan skelnes fra smittede fugle ved, at de har dannet antistoffer mod N2-komponenten.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NOBILIS INFLUENZA H5N2
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) NOBILIS INFLUENZA H5N2 EPAR - sammendrag for offentligheden
English: They also tested the safety of three standard production batches of Nobilis Influenza H5N2.
Danish: Desuden har firmaet undersøgt sikkerheden ved tre standardproducerede batcher af Nobilis Influenza H5N2.
English: Nobilis Influenza H5N2 is a vaccine.
Danish: Nobilis Influenza H5N2 er en vaccine.
English: Other information about Nobilis Influenza H5N2:
Danish: Andre oplysninger om Nobilis Influenza H5N2:
English: What is the risk associated with Nobilis Influenza H5N2?
Danish: Hvilken risiko er der forbundet med Nobilis Influenza H5N2?
English: Why has Nobilis Influenza H5N2 been approved?
Danish: Hvorfor blev Nobilis Influenza H5N2 godkendt?
English: What is Nobilis Influenza H5N2?
Danish: Hvad er Nobilis Influenza H5N2?
English: How has Nobilis Influenza H5N2 been studied?
Danish: Hvordan blev Nobilis Influenza H5N2 undersøgt?
English: What is Nobilis Influenza H5N2 used for?
Danish: Hvad anvendes Nobilis Influenza H5N2 til?
English: How does Nobilis Influenza H5N2 work?
Danish: Hvordan virker Nobilis Influenza H5N2?
English: What benefit has Nobilis Influenza H5N2 shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Nobilis Influenza H5N2?
English: MedDRA Preferred term
Danish: MedDRA Foretrukket term
English: Monitoring is advised when possible.
Danish: Overvågning tilrådes, hvor det er muligt.
English: • Cold hands and feet
Danish: • Kolde hænder og fødder
English: Baseline assessments were obtained on day 0.
Danish: Baseline vurderinger blev opnået på dag 0.
English: They can present in many locations, therefore the clinical presentation can be varied.
Danish: De kan forekomme mange steder, og derfor kan den kliniske præsentation være forskellig.
English: No specific antidote is known.
Danish: Der er ingen specifik kendt antidot.
English: (1=terrible to 7=delighted).
Danish: (1=forfærdelig til 7=begejstret).
English: Annual reports: as part of the annual re-assessment dossier
Danish: Som en del af det årlige re-assessment-dossier
English: The following side effects have also been reported (frequencies cannot be estimated from the available data):
Danish: Følgende bivirkninger er også set (hyppigheden kan ikke beregnes ud fra de tilgængelige data):
English: Your doctor will also monitor your heart at the start of your treatment and also every year thereafter.
Danish: Din læge vil også holde øje med dit hjerte ved behandlingens begyndelse og derefter hvert år.
English: It is especially important to talk to your doctor if you are taking one of the following medicines or plan to start taking the following medicines:
Danish: Det er særlig vigtigt at tale med din læge, hvis du tager et af følgende lægemidler eller har planer om at tage følgende lægemidler:
English: The clinical relevance of these results is unknown.
Danish: Den kliniske relevans af disse fund er ukendt.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Danish: UNIK IDENTIFIKATOR- MENNESKELIGE LÆSELIGE DATA PC:
English: There is little experience with overdose.
Danish: Der er begrænset erfaring med overdosering.
English: Combinations to be taken into consideration
Danish: Kombinationer, der skal tages i betragtning
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/601/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/09/601/001
English: Summary of Changes in Primary and Secondary Efficacy Endpoints from Baseline
Danish: Oversigt over ændringer i primære og sekundære effektendepunkter fra baseline
English: Most Schwannomas are benign and asymptomatic.
Danish: De fleste schwannomer er benigne og asymptomatiske.
English: Frequencies are defined as: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000) and Unknown (cannot be estimated from available data).
Danish: Hyppighed defineres som: Meget almindelig (≥ 1/10), Almindelig (≥ 1/100 til < 1/10), Ikke almindelig (≥ 1/1.000 til < 1/100), Sjælden (≥ 1/10.000 til < 1/1.000), Meget sjælden (< 1/10.000) og Ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Schwannomas are generally slow-growing and can exist for months to years without producing symptoms.
Danish: Schwannomer er generelt langsomt voksende og kan være tilstede i måneder til år uden at give symptomer.
English: This medicine has been authorised under “Exceptional Circumstances”.
Danish: Dette lægemiddel er godkendt under “særlige omstændigheder”.
English: Supportive care should be given as clinically indicated, including close monitoring of vital signs.
Danish: Understøttende behandling bør gives som klinisk indiceret, herunder nøje monitorering af vitale tegn.
English: No safety margins to human exposure were achieved in the animal studies due to the sensitivity of the animal models used.
Danish: Der kunne ikke udledes nogen sikkerhedsmarginer for eksponeringen hos mennesker på grundlag af dyrestudierne på grund af de anvendte dyremodellers følsomhed.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Danish: UNIK IDENTIFIKATOR - 2D-STREGKODE 2D-stregkode med den unikke identifikator inkluderet.
English: The safety and efficacy of FIRDAPSE in children aged 0 to 17 years has not been established.
Danish: FIRDAPSEs sikkerhed og virkning hos børn i alderen 0-17 år er endnu ikke klarlagt.
English: Amifampridine 20 mg
Danish: Amifampridin 20 mg
English: The following medicines must not be combined with FIRDAPSE:
Danish: Følgende lægemidler må ikke tages samtidig med FIRDAPSE:
English: • Together with medicines with a therapeutic dose close to the maximum safe dose
Danish: • Sammen med lægemidler, som har en terapeutisk dosis, som ligger tæt på den maksimale sikre dosis
English: Stop the treatment and immediately consult your doctor in the event of:
Danish: Stop behandlingen og kontakt straks lægen i tilfælde af: