FrancophonIA/ELRC3.0 huggingface dataset:
English: What measures are being taken to ensure the safe and effective use of Pemetrexed Sandoz?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pemetrexed Sandoz?
English: What are the benefits and risks of Pemetrexed Sandoz?
Danish: Hvilke fordele og risici er der forbundet med Pemetrexed Sandoz?
English: Pemetrexed Sandoz contains the active substance pemetrexed.
Danish: Pemetrexed Sandoz indeholder det aktive stof pemetrexed.
English: It is not intended to provide practical advice on how to use Pemetrexed Sandoz.
Danish: Det er ikke en praktisk vejledning i, hvordan Pemetrexed Sandoz bør anvendes.
English: What is Pemetrexed Sandoz and what is it used for?
Danish: Hvad er Pemetrexed Sandoz, og hvad anvendes det til?
English: For practical information about using Pemetrexed Sandoz, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Pemetrexed Sandoz, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: When Pemetrexed Sandoz is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Danish: Når Pemetrexed Sandoz gives sammen med cisplatin, bør der desuden før og efter cisplatin gives medicin mod kvalme og opkastninger samt væsketilskud for at forhindre udtørring.
English: Why is Pemetrexed Sandoz approved?
Danish: Hvorfor blev Pemetrexed Sandoz godkendt?
English: Pemetrexed Sandoz is available as a powder that is made up into a solution for infusion (drip) into a vein.
Danish: Pemetrexed Sandoz fås som et pulver, der efter opløsning indgives med drop (ved infusion i en vene).
English: How is Pemetrexed Sandoz used?
Danish: Hvordan anvendes Pemetrexed Sandoz?
English: How has Pemetrexed Sandoz been studied?
Danish: Hvordan blev Pemetrexed Sandoz undersøgt?
English: How does Pemetrexed Sandoz work?
Danish: Hvordan virker Pemetrexed Sandoz?
English: Duration of immunity: 12 months.
Danish: Immunitetens varighed: 12 måneder.
English: This swelling normally resolves within 1 to 5 days.
Danish: Denne hævelse vil normalt forsvinde inden for 1 til 5 dage.
English: ATCvet code: QI05AA10.
Danish: QI05AA10.
English: Any person intending to manufacture, import, possess, sell, supply and use Equilis West Nile must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Danish: Enhver, som har til hensigt at fremstille, indføre, besidde, sælge, levere og/eller anvende Equilis West Nile, skal forinden rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik, da disse aktiviteter kan være forbudt i en medlemsstat på hele eller en del af dens område i henhold til nationale lovgivning.
English: Following the administration of a double dose of vaccine, no side-effects other than those described under section 4.6 have been observed.
Danish: Efter administration af en dobbelt dosis vaccine er der ikke observeret andre bivirkninger end dem, der er beskrevet under pkt.
English: Date of last renewal: 16/04/2018
Danish: Dato for seneste fornyelse af markedsføringstilladelsen: 16/04/2018
English: Horses.
Danish: Heste
English: BATCH NUMBER Lot {number}
Danish: BATCHNUMMER Batch {nummer}
English: Opalescent suspension.
Danish: Opaliserende suspension.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/06/2013.
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 06/06/2013
English: Iscom-Matrix containing: Purified saponin
Danish: Iscom-Matrix indeholdende: Renset saponin
English: Primary vaccination: first injection from 6 months of age onwards, second injection 3 to 5 weeks later.
Danish: Grundvaccination: første injektion fra 6-måneders-alderen, anden injektion 3 til 5 uger senere.
English: 250 micrograms
Danish: 250 mikrogram
English: ≥ 492 AU1
Danish: ≥ 492 AE1
English: Major incompatibilities: Do not mix with any other veterinary medicinal product.
Danish: Væsentlige uforligeligheder: Må ikke blandes med andre lægemidler til dyr.
English: Revaccination: a yearly booster injection of one dose (1 ml) should be sufficient to achieve a reduction of fever, lesions in the brain and viraemia.
Danish: Revaccination: en årlig booster-vaccination med en enkelt dosis (1 ml) bør være tilstrækkelig for at opnå reduktion af feber, hjernelæsioner og viræmi.
English: 5831 AN Boxmeer
Danish: NL-5831 AN Boxmeer
English: PHARMACEUTICAL FORM Suspension for injection.
Danish: LÆGEMIDDELFORM Suspension til injektion.
English: 83 micrograms
Danish: 83 mikrogram
English: ≥ 492 AU
Danish: ≥ 492 AE
English: PACKAGE SIZE 10 vials x 1 dose 5 pre-filled syringes x 1 dose 10 pre-filled syringes x 1 dose
Danish: PAKNINGSSTØRRELSE 10 hætteglas x 1 dosis 5 forfyldte sprøjter x 1 dosis 10 forfyldte sprøjter x 1 dosis
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 2 år
English: Antigenic units Opalescent suspension.
Danish: Antigen enheder Opaliserende suspension.
English: The vaccine stimulates active immunity against West Nile virus in horses.
Danish: Vaccinen stimulerer aktiv immunitet mod infektion med vestnilvirus hos heste.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Én dosis a 1 ml indeholder:
English: Disodium hydrogen phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Danish: Dinatriumhydrogenphosphatdihydrat Kaliumdihydrogenphosphat Vand til injektionsvæsker
English: Vaccination schedule: Administer one dose (1 ml) by intramuscular injection, according to the following schedule:
Danish: Vaccinationsprogram: Indgiv en dosis (1 ml) ved intramuskulær injektion i henhold til følgende program:
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED {DD/MM/YYYY}
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN {DD/MM/YYYY}
English: 42 micrograms
Danish: 42 mikrogram
English: A mild body temperature increase (max. 1.5 °C) may very commonly occur for 1 to 2 days.
Danish: 1,5 °C) kan meget almindeligt forekomme i 1 til 2 dage.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis West Nile [a clear pictogram of a horse]
Danish: VETERINÆRLÆGEMIDLETS NAVN Equilis West Nile [piktogram af en hest]
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Danish: Ikke anvendte veterinære lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 1 ml contains:
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Én dosis a 1 ml indeholder:
English: Onset of immunity: 2 weeks after primary vaccination course of two injections.
Danish: Immunitetens indtræden: 2 uger efter basisvaccination bestående af to injektioner.
English: EU/2/13/151/002 (5 pre-filled syringes) EU/2/13/151/003 (10 pre-filled syringes)
Danish: EU/2/13/151/002 (5 forfyldte sprøjter) EU/2/13/151/003 (10 forfyldte sprøjter)
English: Can be used during pregnancy and lactation.
Danish: Kan anvendes under drægtighed og diegivning.
English: After vaccination a mild transient swelling may very commonly develop at the injection site (max. 3 cm in diameter).
Danish: Det er meget almindeligt, at der efter vaccination kan udvikle sig en mild forbigående hævelse på injektionsstedet (maks.
English: 1 ml: Inactivated chimeric flavivirus strain YF-WN
Danish: 1 ml: Inaktiveret kimærisk flavivirus-stamme YF-WN
English: MARKETING AUTHORISATION NUMBER(S) EU/2/13/151/001-003
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/13/151/001-003
English: 1 ml vial, 1 ml pre-filled syringe
Danish: 1 ml hætteglas, 1 ml forfyldte sprøjter
English: - common (more than 1 but less than 10 animals in 100 animals treated ) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling)) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter)
English: Active immunisation of horses against West Nile virus (WNV) to reduce clinical signs of disease and lesions in the brain and to reduce viraemia.
Danish: Aktiv immunisering af heste mod infektion med vestnilvirus for at reducere kliniske tegn på sygdom og læsioner i hjernen og for at reducere viræmi.
English: 4.2 Indications for use, specifying the target species Active immunisation of horses against West Nile virus (WNV) to reduce clinical signs of disease and lesions in the brain and to reduce viraemia.
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Aktiv immunisering af heste mod infektion med vestnilvirus for at reducere kliniske tegn på sygdom og læsioner i hjernen og for at reducere viræmi.
English: Type I glass vials of 1 ml (1 dose) closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
Danish: Type I hætteglas af glas med 1 ml (1 dosis) lukket med en gummiprop af halogenobutyl og forseglet med en aluminiumshætte.
English: Inactivated chimeric flavivirus strain YF-WN
Danish: Inaktiveret kimærisk flavivirus-stamme YF-WN
English: Type I glass pre-filled syringes of 1ml (1 dose), containing a plunger with a halogenobutyl end and closed with a halogenobutyl stopper.
Danish: Præfyldte sprøjter af type I glas med 1 ml (1 dosis), forsynet med et stempel med en top af halogenobutyl og lukket med en prop af halogenobutyl.
English: WITHDRAWAL PERIOD(S) Withdrawal period: Zero days.
Danish: TILBAGEHOLDELSESTID(ER) Tilbageholdelsestid: 0 dage
English: MARKETING AUTHORISATION NUMBER(S) EU/2/13/151/001 (10 vials)
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/13/151/001 (10 hætteglas)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis West Nile suspension for injection for horses
Danish: VETERINÆRLÆGEMIDLETS NAVN Equilis West Nile injektionsvæske, suspension til heste
English: Intervet International B.V. Wim de Körverstraat 35 5831AN Boxmeer The NETHERLANDS
Danish: Wim de Körverstraat 35 5831AN Boxmeer Holland
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS
Danish: Wim de Körverstraat 35 NL-5831 AN Boxmeer Holland
English: 1 Antigenic units determined by ELISA.
Danish: 1 Antigen enheder målt ved ELISA-metoden Alle hjælpestoffer er anført under pkt.
English: PACKAGE LEAFLET: Equilis West Nile suspension for injection for horses
Danish: Equilis West Nile Injektionsvæske, suspension til heste
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only
Danish: TEKSTEN ”TIL DYR” Til dyr.
English: Cardboard box or plastic box with 10 vials of 1 ml, or 5 or 10 pre-filled syringes of 1 ml
Danish: Kartonæske eller plastikæske med 10 hætteglas à 1 ml eller 5 eller 10 forfyldte sprøjter à 1 ml
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 1 ml (1 dose)
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: EXPIRY DATE EXP {month/year}
Danish: UDLØBSDATO Udløbsdato: {måned/år}
English: Plastic box with 5 or 10 pre-filled syringes of 1 ml (1 dose).
Danish: Plastikæske med 5 eller 10 præfyldte sprøjter af 1 ml (1 dosis).
English: Cardboard box with 5 or 10 pre-filled syringes of 1 ml (1 dose).
Danish: Kartonæske med 5 eller 10 præfyldte sprøjter af 1 ml (1 dosis).
English: Cardboard box with 10 glass vials of 1 ml (1 dose).
Danish: Kartonæske med 10 hætteglas af glas af 1 ml (1 dosis).
English: Plastic box with 10 glass vials of 1 ml (1 dose).
Danish: Plastikæske med 10 hætteglas af glas à 1 ml (1 dosis).
English: 4.4 Special warnings for each target species
Danish: 4.4 Særlige advarsler for hver enkelt dyreart, som lægemidlet er beregnet til Kun raske dyr må vaccineres.
English: Pharmacotherapeutic group: Immunologicals for Equidae, inactivated viral vaccines.
Danish: inaktiverede virale vacciner.
English: Capsule, hard blister (alu/PVC) 42 capsules
Danish: Oral anvendelse blister (alu/PVC) 42 kapsler EU/1/99/110/008 Sustiva 600 mg Filmovertrukken tablet Oral anvendelse flaske (HDPE)
English: Adopted at the 11-14 June 2018 PRAC
Danish: Vedtaget på PRAC's møde den 11.-14. juni 2018
English: Stop using <medicine> if you develop these symptoms and contact your doctor or seek medical attention immediately.
Danish: Stop med at bruge <lægemiddel>, hvis du udvikler disse symptomer, og kontakt straks din læge eller søg lægehjælp.
English: Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first two months of treatment.
Danish: Patienterne har formentlig højere risiko for at få disse reaktioner tidligt i behandlingsforløbet, idet reaktionen i de fleste tilfælde opstår inden for de første to måneder af behandlingen.
English: Varenicline - Loss of consciousness (EPITT no 19146)
Danish: Vareniclin - Bevidsthedstab (EPITT nr. 19146)
English: If signs and symptoms suggestive of these reactions appear, nabumetone should be withdrawn immediately and an alternative treatment considered (as appropriate).
Danish: Hvis der opstår tegn og symptomer på sådanne reaktioner, bør nabumeton straks seponeres, og en alternativ behandling bør overvejes (hvis relevant).
English: Effects on ability to drive and use machines
Danish: Virkning på evnen til at føre motorkøretøj og betjene maskiner
English: If the patient has developed a serious reaction such as SJS, TEN or DRESS with the use of nabumetone, treatment with nabumetone must not be restarted in this patient at any time.
Danish: Hvis patienten udvikler et alvorligt udslæt som f.eks. SJS, TEN eller DRESS under behandlingen med nabumeton, må behandling med nabumeton ikke genstartes på noget tidspunkt hos denne patient.
English: At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Danish: Ved ordinering bør patienterne gøres opmærksomme på tegn og symptomer på og de monitoreres nøje for hudreaktioner.
English: Not known Transient loss of consciousness
Danish: Ikke kendt Forbigående bevidsthedstab
English: What you need to know before you take CHAMPIX
Danish: Det skal De vide, før De begynder at tage CHAMPIX Trafik- og arbejdssikkerhed
English: Summary of product characteristics 4.7.
Danish: Produktresumé 4.7.
English: CHAMPIX may have minor or moderate influence on the ability to drive and use machines.
Danish: CHAMPIX kan have mindre eller moderat indflydelse på evnen til at føre motorkøretøj og betjene maskiner.
English: Patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether this medicinal product affects their ability to perform these activities.
Danish: Patienter opfordres til at undgå at føre motorkøretøj, betjene komplekse maskiner eller deltage i andre potentielt farlige aktiviteter, før det er afklaret, om dette lægemiddel påvirker deres evne til at udføre disse aktiviteter.
English: You should not drive, operate complex machinery or engage in any other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.
Danish: De bør derfor ikke føre motorkøretøj, betjene komplekse maskiner eller deltage i andre potentielt farlige aktiviteter, før det er afklaret, om denne medicin påvirker Deres evne til at udføre disse aktiviteter.
English: Nabumetone should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.
Danish: Nabumeton bør seponeres ved første tegn på hududslæt, læsioner i slimhinderne eller andre tegn på overfølsomhed.
English: CHAMPIX may cause dizziness, somnolence and transient loss of consciousness, and therefore may influence the ability to drive and use machines.
Danish: CHAMPIX kan forårsage svimmelhed, søvnighed og forbigående bevidsthedstab og kan derfor have indflydelse på evnen til at føre motorkøretøj og betjene maskiner.
English: Nabumetone - Drug reaction with eosinophilia and systemic symptoms (DRESS)(EPITT no 19241)
Danish: Nabumeton - Medikamentelt udslæt med eosinofili og systemiske symptomer (DRESS)(EPITT nr. 19241)
English: CHAMPIX may be linked with produce dizziness, sleepiness and transient loss of consciousness.
Danish: CHAMPIX kan givevære forbundet med svimmelhed, og søvnighed og forbigående bevidsthedstab.
English: Very rare: Bullous reactions including toxic epidermal necrolysis, Stevens Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, erythema multiforme, angioedema, pseudoporphyria, alopecia
Danish: Meget sjælden: Bulløse reaktioner, herunder toksisk epidermal nekrolyse, Stevens-Johnsons syndrom, medikamentelt udslæt med eosinofili og systemiske symptomer, erythema multiforme, angioødem, pseudoporfyri, alopeci
English: Undesirable effects
Danish: Bivirkninger
English: Undesirable effects Nervous system disorders
Danish: Nervesystemet
English: Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (drug reaction with eosinophilia and systemic symptoms which is also known as DRESS or drug hypersensitivity syndrome).
Danish: Udbredt udslæt, forhøjet kropstemperatur, forhøjede leverenzymer, unormale blodværdier (eosinofili), forstørrede lymfekirtler og påvirkning af andre organer (medikamentelt udslæt med eosinofili og systemiske symptomer ((DRESS) eller lægemiddelinduceret overfølsomhedssyndrom)).
English: Package leaflet
Danish: Produktresumé
English: Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with nabumetone treatment (see section 4.4).
Danish: Alvorlige hudreaktioner, herunder exfoliativ dermatitis, Stevens-Johnsons syndrom (SJS), toksisk epidermal nekrolyse (TEN) og medikamentelt udslæt med eosinofili og systemiske symptomer (DRESS), er rapporteret i forbindelse med behandling med nabumeton (se pkt.
English: Possible side effects - Not known o Transient loss of consciousness
Danish: - Ikke kendt o Forbigående bevidsthedstab
English: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported very rarely in association with the use of NSAIDs, including nabumetone (see section 4.8).
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen Alvorlige hudreaktioner, som kan være fatale, er rapporteret meget sjældent i forbindelse med brugen af NSAID-præparater, herunder exfoliativ dermatitis, Stevens-Johnson syndrom (SJS), og toksisk epidermal nekrolyse (TEN) og medikamentelt udslæt med eosinofili og systemiske symptomer (DRESS), der kan være livstruende eller letalt, er rapporteret sjældent i forbindelse med behandling med NSAID´er, herunder nabumeton (se pkt.
English: The Member States who raised concerns regarding the potential risk to animal health were Belgium, Denmark, France, Germany, Ireland, Italy, Portugal and Spain.
Danish: Nederlandene, Østrig, Belgien, Danmark, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Luxembourg, Norge, Polen, Portugal og Spanien
English: The residue data provided was inadequate and the withdrawal period is therefore inadequately supported.
Danish: De indleverede oplysninger om restmængder var utilstrækkelige, og seponeringsperioden understøttes derfor ikke nok.
English: The CVMP recommended the refusal of the granting of the Marketing Authorisation and the suspension of the Marketing Authorisation for Equimectin where appropriate.
Danish: CVMP anbefalede afslag på markedsføringstilladelse og suspension af markedsføringstilladelsen til Equimectin, hvor dette er relevant.
English: Therefore, the relevance of the bibliographical data regarding Eqvalan to the test product cannot be confirmed.
Danish: Relevansen af de bibliografiske data vedrørende Eqvalan for testproduktet kan derfor ikke bekræftes.
English: The efficacy of the product for the treatment of endo- and ectoparasitic infections has not been demonstrated.
Danish: Produktets virkning til behandling af endo- og ektoparasitiske infektioner er ikke blevet påvist.
English: The amended indication for the treatment of gastrointestinal endoparasitic infections in horses had not been demonstrated by the data provided.
Danish: Selv den ændrede indikation for behandlingen af gastrointestinale endoparasitiske infektioner hos heste er ikke blevet påvist med de indleverede data.
English: The Committee, having considered the matter, concluded that on the basis of the available data for Equimectin, bioequivalence with the reference product had not been shown.
Danish: Efter overvejelse af sagen konkluderede komitéen, at på baggrund af de tilgængelige data for Equimectins er bioækvivalens med referenceproduktet ikke påvist.
English: BACKGROUND INFORMATION
Danish: VIDENSKABELIGE KONKLUSIONER
English: The documentation submitted with this application consisted of literature referring to the use of the originator product Eqvalan, a comparative pharmacokinetic study using Equimectin and Eqvalan, and a supplementary clinical field study.
Danish: Dokumentationen, der er indsendt sammen med denne ansøgning, består af litteratur, som refererer til anvendelsen af det oprindelige produkt, Eqvalan, en komparativ farmakokinetisk undersøgelse med anvendelse af Equimectin og Eqvalan samt en supplerende klinisk feltundersøgelse.
English: During the referral procedure, it was established that the submitted bioequivalence study was inadequate to demonstrate bioequivalence (as defined in current guidance EMEA/CVMP/016/00-corr- FINAL); however, from the comparative pharmacokinetic data it is possible that the test product is systemically less bioavailable than the reference product.
Danish: Under henvisningsproceduren blev det fastlagt, at den indsendte bioækvivalensundersøgelse ikke var tilstrækkelig til at påvise bioækvivalens (endelig definition i den gældende vejledning EMEA/CVMP/016/00-corr-FINAL).
English: OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR EQUIMECTIN 12MG/G ORAL GEL FOR HORSES
Danish: 12 mg/g Heste
English: Equimectin 12mg/g oral gel for horses contains ivermectin.
Danish: En enkelt indgift af 0,2 mg ivermectin pr. kg legemsvægt.
English: European Medicines Agency Veterinary Medicines and Inspections
Danish: BILAG I LÆGEMIDLETS NAVN, LÆGEMIDDELFORM, STYRKE, DYREARTER, INDGIVELSESVEJE OG INDEHAVER AF MARKEDSFØRINGSTILLADELSEN
English: The Marketing Authorisation Holder was requested to substantiate the bioavailability/bioequivalence of the product, justifying the efficacy of the product.
Danish: En enkelt feltundersøgelse blev indsendt til understøttelse af produktets effekt.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)
Danish: Særnavn Lægemiddelform Styrke DyrearterIndgivelsesvej og -hyppighed