FrancophonIA/ELRC3.0 huggingface dataset:
English: This means that Ivabradine Zentiva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Procoralan.
Danish: Det betyder, at Ivabradine Zentiva er identisk med et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union (EU), og som hedder Procoralan.
English: Treatment must be stopped if the heart rate decreases persistently below 50 beats per minute or if symptoms of bradycardia (slow heart rate) continue.
Danish: Behandlingen skal standses, hvis hjertefrekvensen vedholdende er lavere end 50 slag pr. minut, eller hvis den langsomme hjertefrekvens (bradykardi) fortsætter.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ivabradine Zentiva has been shown to have comparable quality and to be bioequivalent to Procoralan.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Ivabradine Zentiva er af sammenlignelig kvalitet og er bioækvivalent med Procoralan.
English: Ivabradine Zentiva is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (heart disease caused by blockage of the blood vessels that supply the heart muscle).
Danish: Ivabradine Zentiva er et hjertelægemiddel, der anvendes til at behandle symptomer på kronisk stabil angina pectoris (smerter i brystet, kæben og ryggen, som opstår ved fysisk anstrengelse) hos voksne med koronararteriesygdom (hjertesygdom, hvor de blodkar, der forsyner hjertemuskulaturen med blod, er blokerede).
English: Ivabradine Zentiva therefore reduces or prevents the symptoms of angina.
Danish: Ivabradine Zentiva nedsætter eller forhindrer derved symptomerne på angina pectoris.
English: What measures are being taken to ensure the safe and effective use of Ivabradine Zentiva?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ivabradine Zentiva?
English: By lowering the heart rate, Ivabradine Zentiva reduces the stress on the heart, thereby slowing the progression of heart failure and improving symptoms.
Danish: Ved at sænke hjertefrekvensen nedsætter Ivabradine Zentiva belastningen af hjertet og bremser dermed forløbet af hjertesvigt og giver bedring i symptomerne.
English: For more information about treatment with Ivabradine Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ivabradine Zentiva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Ivabradine Zentiva ivabradine
Danish: Ivabradine Zentiva ivabradin
English: Ivabradine Zentiva contains the active substance ivabradine.
Danish: Ivabradine Zentiva indeholder det aktive stof ivabradin.
English: It is used either in patients who cannot take beta-blockers (another type of medicine to treat angina) or in combination with a beta-blocker in patients whose disease is not controlled by a beta-blocker alone.
Danish: Det anvendes enten hos patienter, der ikke kan behandles med betablokkere (en anden type medicin mod angina pectoris), eller i kombination med en betablokker hos patienter, som ikke opnår kontrol med en betablokker alene.
English: Ivabradine Zentiva is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body) and a normal heart rhythm whose heart rate is at least 75 beats per minute.
Danish: Ivabradine Zentiva anvendes desuden hos patienter med kronisk hjertesvigt (dvs. hjertet kan ikke pumpe tilstrækkeligt med blod rundt i kroppen) og normal hjerterytme med en hjertefrekvens på mindst 75 slag pr. minut.
English: What are the benefits and risks of Ivabradine Zentiva?
Danish: Hvilke fordele og risici er der forbundet med Ivabradine Zentiva?
English: Other information about Ivabradine Zentiva
Danish: Andre oplysninger om Ivabradine Zentiva
English: It is not intended to provide practical advice on how to use Ivabradine Zentiva.
Danish: Det er ikke en praktisk vejledning i, hvordan Ivabradine Zentiva bør anvendes.
English: What is Ivabradine Zentiva and what is it used for?
Danish: Hvad er Ivabradine Zentiva, og hvad anvendes det til?
English: Because Ivabradine Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Ivabradine Zentiva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Because Ivabradine Zentiva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Procoralan.
Danish: Da Ivabradine Zentiva er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Procoralan.
English: For practical information about using Ivabradine Zentiva, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Ivabradine Zentiva, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The active substance in Ivabradine Zentiva, ivabradine, blocks the ‘If current' in the sinus node, the natural ‘pacemaker' that regulates the heart rate.
Danish: Det aktive stof i Ivabradine Zentiva, ivabradin, blokerer If-strømmen i sinusknuden, der er hjertets naturlige pacemaker, og som regulerer hjertefrekvensen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ivabradine Zentiva have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Ivabradine Zentiva.
English: Why is Ivabradine Zentiva approved?
Danish: Hvorfor blev Ivabradine Zentiva godkendt?
English: How is Ivabradine Zentiva used?
Danish: Hvordan anvendes Ivabradine Zentiva?
English: How has Ivabradine Zentiva been studied?
Danish: Hvordan blev Ivabradine Zentiva undersøgt?
English: How does Ivabradine Zentiva work?
Danish: Hvordan virker Ivabradine Zentiva?
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur (EMA) (http://www.ema.europa.eu/).
English: Do not use this veterinary medicinal product after the expiry date which is stated on the package after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på pakningen efter udløbsdato/EXP.
English: 10 DATE OF REVISION OF THE TEXT <{MM/YYYY}>
Danish: DATO FOR ÆNDRING AF TEKSTEN <{MM/ÅÅÅÅ}>
English: The veterinary medicinal product is intended for:
Danish: Dette veterinærlægemiddel er beregnet til:
English: If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Danish: Hvis Du bemærker alvorlige bivirkninger eller andre bivirkninger, som ikke er omtalt i denne indlægsseddel, bedes Du kontakte Din dyrlæge.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 1 ml contains:
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER 1 ml indeholder:
English: MANUFACTURER'S BATCH NUMBER Lot.
Danish: FREMSTILLERENS BATCHNUMMER Lot.
English: Address: Forellenweg 16 4941 SJ Raamsdonksveer The Netherlands
Danish: Adresse: Forellenweg 16 4941 SJ Raamsdonksveer Nederlandene
English: Marketing authorisation holder: Name:
Danish: Indehaver af markedsføringstilladelsen: Navn:
English: Box 374
Danish: P.O. Box 374
English: Sedadex contains dexmedetomidine as the active substance, which produces sedation and analgesia in dogs and cats.
Danish: Sedadex indeholder dexmedetomidin som det aktive stof, der frembringer sedation og analgesi hos hunde og katte.
English: It is recommended that animals are fasted for 12 hours prior to Sedadex administration.
Danish: Det anbefales, at dyret bliver fastet i 12 timer inden anvendelsen af Sedadex.
English: C/O Oriola Oy P.O.
Danish: C/O Oriola Oy P.O. Box 8
English: Manufacturer responsible for batch release: Name:
Danish: Fremstiller ansvarlig for batchfrigivelse: Navn:
English: WITHDRAWAL PERIOD Not applicable.
Danish: 10. TILBAGEHOLDELSESTID Ikke relevant
English: 1 ml con Dexmed (equivale
Danish: 1 ml ind Dexmed (svarend
English: MARKETING AUTHORISATION NUMBER(S) EU/2/16/198/002
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/16/198/002
English: TE
Danish: TI
English: PRODULAB PHARMA B.V. Forellenweg 16, Raamsdonksveer 4941SJ
Danish: Forellenweg 16, Raamsdonksveer 4941SJ
English: Dogs: IV Cats: IM
Danish: Hunde: I Katte: IM
English: MARKETING AUTHORISATION NUMBER(S) EU/2/16/198/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/16/198/001
English: Concomitant use of dexmedetomidine and butorphanol produces sedative and analgesic effects beginning no later than 15 minutes after administration.
Danish: Samtidig brug af dexmedetomidin og butorphanol medfører sedation og analgesi senest 15 minutter efter indgivelse.
English: The specific α2adrenoceptor antagonist, atipamezole, which is approved for use in animals, has been used in humans only experimentally to antagonize dexmedetomidine-induced effects.
Danish: Den specifikke α2-adrenoceptor-antagonist, atipamezol, som er godkendt til brug hos dyr, er kun blevet anvendt eksperimentelt hos mennesker til at ophæve virkningen af dexmedetomidin-inducerede virkninger.
English: Major biotransformations in the dog include hydroxylation, glucuronic acid conjugation and N-methylation in the liver.
Danish: Væsentlige biotransformationer hos hunde inkluderer hydroxylering, konjugering med glukoronsyre og N-methylering i leveren.
English: These may include profound sinus bradycardia, 1st and 2nd degree AV block, sinus arrest or pause, as well as atrial, supraventricular and ventricular premature complexes.
Danish: Dette kan inkludere kraftig sinus-bradycardia, første og anden grad AV-blok, sinusophør eller -pause samt atriale, supraventriculære og ventrikulære præmature komplekser.
English: LL IMMED
Danish: SE ANGIVE
English: HT, BY VOL
Danish: ÆGT, VOLU
English: 4.2 Indications for use, specifying the target species Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats.
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Til ikke invasive, svagt til moderat smertefulde procedurer og undersøgelser, der kræver fiksering, sedation og analgesi af hunde og katte.
English: PHARMACEUTICAL FORM Solution for injection Clear, colourless solution.
Danish: LÆGEMIDDELFORM Injektionsvæske, opløsning Klar, farveløs opløsning
English: EXP {m Once bro
Danish: EXP: {m Efter anb
English: THE WORDS "KEEP OUT OF THE SIGHT AND REACH OF CHILDREN" Keep out of the sight and reach of children.
Danish: TEKSTEN ”OPBEVARES UTILGÆNGELIGT FOR BØRN” Opbevares utilgængeligt for børn.
English: HE VETER injection ydrochloride
Danish: RLÆGEMI injektionsvæ drochlorid
English: Excipients: Methyl parahydroxybenzoate (E 218)
Danish: Hjælpestoffer: Methylparahydroxybenzoat (E 218)
English: Dogs: in Cats: int Read the
Danish: Hunde: I Katte: In Læs indl
English: Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 2 år Holdbarhed efter første åbning af den inderste emballage: 56 dage.
English: ICULARS T
Danish: EKSTEN ”T
English: TATEMEN ntains: detomidine hy ent to dexme
Danish: DLØBSDAT : {måned/år} brud anvende
English: ATCH NUM mber}
Danish: ATCHNUM mmer}
English: Colourless Type I glass vials of 10 ml closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box.
Danish: Farveløst 10 ml hætteglas (type I) med prop af brombutylgummi og aluminiumkapsel i papæske.
English: IVE AND O
Danish: ER OG AND
English: Water for injections
Danish: LÆ Injektion
English: Q 0.5 mg/m
Danish: M 0,5 mg/m
English: For higher weight ranges, use Sedadex 0.5 mg/ml and its dosing tables.
Danish: Til større katte anvendes Sedadex 0,5 mg/ml og dets doseringstabeller.
English: PH Solution
Danish: DELFORM løsning.
English: Q 0.1 mg/m
Danish: M 0,1 mg/m
English: e
Danish: VE
English: Advice to physicians: Sedadex is an α2-adrenoreceptor agonist, symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia.
Danish: Symptomerne efter absorption kan omfatte kliniske virkninger såsom dosisafhængig sedation, respiratorisk depression, bradykardi, hypotension, tør mund og hyperglykæmi.
English: Intramuscularly: up to 500 micrograms/square metre body surface area.
Danish: Den intramuskulære dosis er: op til 500 mikrogram pr. kvadratmeter legemsoverflade.
English: ACKAGE S
Danish: AKNINGSS OSER
English: E(S) OF ADM lar use use.
Danish: SESMÅDE ller intramus r anvendelse nden brug.
English: T OF ACTI
Danish: E AF AKTIV
English: The dose for cats is 40 micrograms dexmedetomidine hydrochloride/kg bw equal to a dose volume of 0.08 ml Sedadex/kg bw when used for non-invasive, mildly to moderately painful procedures requiring restraint, sedation and analgesia.
Danish: Dosis til katte er 40 mikrogram dexmedetomidinhydrochlorid pr. kg legemsvægt, svarende til en dosisvolumen på 0,08 ml Sedadex pr. kg legemsvægt ved anvendelse til ikke-invasive, let til moderat smertefulde procedurer, der kræver fiksering, bedøvelse og analgesi.
English: CKAGING U
Danish: ET SOM VÆ
English: OUTE(S) O M, IV M
Danish: NDGIVELS IM, IV M
English: The dose for cats is 40 micrograms dexmedetomidine hydrochloride/kg bw equal to a dose volume of 0.4 ml Sedadex/kg bw when used for non-invasive, mildly to moderately painful procedures requiring restraint, sedation and analgesia.
Danish: Doseringen til katte er 40 mikrogram dexmedetomidinhydrochlorid pr.kg legemsvægt, svarende til en dosisvolumen på 0,4 ml Sedadex pr. kg legemsvægt ved anvendelse til ikke-invasive, let til moderat smertefulde procedurer, der kræver fiksering, bedøvelse og analgesi.
English: Intravenously: up to 375 micrograms/square metre body surface area.
Danish: Den intravenøse dosis er: op til 375 mikrogram pr. kvadratmeter legemsoverflade.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Sedadex 0.5 mg/ml solution for injection for dogs and cats dexmedetomidine hydrochloride
Danish: VETERINÆRLÆGEMIDLETS NAVN Sedadex 0,5 mg/ml injektionsvæske, opløsning, til hunde og katte Dexmedetomidinhydrochlorid
English: N(S)
Danish: ESVEJ(E)
English: The dose volume of atipamezole at the concentration of 5 mg/ml equals the dose volume of Sedadex 0.5 mg/ml that was given to the dog, regardless of route of administration of Sedadex.
Danish: Dosisvolumen af atipamezol ved en koncentration på 5 mg/ml svarer til den dosisvolumen af Sedadex 0,5 mg/ml, som blev givet til hunden, uanset administrationsvej.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Sedadex 0.1 mg/ml solution for injection for dogs and cats dexmedetomidine hydrochloride
Danish: VETERINÆRLÆGEMIDLETS NAVN Sedadex 0,1 mg/ml injektionsvæske, opløsning, til hunde og katte dexmedetomidinhydrochlorid
English: BY NUMBE
Danish: STØRRELS
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one fifth (1/5) of the dose volume of Sedadex 0.1 mg/ml that was given to the dog, regardless of route of administration of Sedadex.
Danish: Dosisvolumen af atipamezol ved en koncentration på 5 mg/ml er en femtedel (1/5) af den dosisvolumen Sedadex 0,1 mg/ml, som blev givet til hunden, uanset administrationsvej.
English: ONTENTS
Danish: OLDELSES
English: N
Danish: AN
English: TA Dogs an
Danish: DY Hund og
English: TARGET SPECIES Dogs and cats
Danish: DYREARTER Hund og kat.
English: OUTE(S) O V , IM M
Danish: NDGIVELS IV, IM M
English: TH For anim
Danish: Efter anb
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one-half the volume of Sedadex 0.5 mg/ml that was given to the cat.
Danish: Dosisvolumen af atipamezol i en koncentration af 5 mg/ml er halvdelen af det volumen Sedadex, 0,5 mg/ml, som er givet til katten.
English: EDICINAL
Danish: AKNINGSS
English: SP Read the
Danish: SÆ Læs indl
English: Sodium chloride
Danish: drochlorid detomidin
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Sedadex 0.5 mg/ml solution for injection for dogs and cats
Danish: VETERINÆRLÆGEMIDLETS NAVN Sedadex 0,5 mg/ml injektionsvæske, opløsning, til hunde og katte
English: MBER
Danish: IGT
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Sedadex 0.1 mg/ml solution for injection for dogs and cats
Danish: VETERINÆRLÆGEMIDLETS NAVN Sedadex 0,1 mg/ml injektionsvæske, opløsning, til hunde og katte
English: BSTANCES
Danish: NDIKATION
English: NA
Danish: TO
English: Pharmacotherapeutic group: Psycholeptics, hypnotics and sedatives.
Danish: FARMAKOLOGISKE EGENSKABER Farmakoterapeutisk gruppe: psykoleptika, hypnotika og sedativa ATCvet-kode: QN05CM18.
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one-tenth (1/10) the volume of Sedadex 0.1 mg/ml that was given to the cat.
Danish: Dosisvolumen af atipamezol i en koncentration af 5 mg/ml er en tiendedel (1/10) af det volumen Sedadex, 0,1 mg/ml, som er givet til katten.
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one-half (1/2) the volume of Sedadex 0.5 mg/ml that was given to the cat.
Danish: Dosisvolumen af atipamezol i en koncentration af 5 mg/ml er halvdelen (1/2) af det volumen Sedadex, 0,5 mg/ml, som er givet til katten.
English: AME OF TH x 0.5 mg/ml s etomidine hy
Danish: NINGER, D ke ETERINÆR x 0,5 mg/ml i etomidinhyd
English: AME OF TH x 0.1 mg/ml s etomidine hy
Danish: NINGER, D ke ETERINÆR x 0,1 mg/ml i etomidinhyd
English: S)
Danish: EJ(E)
English: ONLY”
Danish: TIL DYR”
English: P.O.
Danish: UDL.D.
English: UANTITY ml
Danish: MÆNGDEN ml
English: EUTICAL F n
Danish: SLER, OM N
English: PACKAGE LEAFLET FOR Sedadex 0.1 mg/ml solution for injection for dogs and cats
Danish: INDLÆGSSEDDEL TIL: Sedadex 0,1 mg/ml injektionsvæske, opløsning, til hunde og katte
English: PACKAGE LEAFLET FOR Sedadex 0.5 mg/ml solution for injection for dogs and cats
Danish: INDLÆGSSEDDEL TIL: Sedadex 0,5 mg/ml injektionsvæske, opløsning, til hunde og katte
English: STRATION
Danish: ALLAGE
English: SARY
Danish: ANFØRES
English: METHOD AN ntravenous or tramuscular u e package lea
Danish: NVENDEL intravenøs el ntramuskulær lægssedlen in
English: ARGET SP d cats
Danish: AVN ng, til hunde
English: CKAGE
Danish: MMER
English: SES
Danish: SE
English: ARNINGS, aflet before u
Danish: IDLETS NA ske, opløsnin
English: EX
Danish: UD
English: MUM PARTI ial of 10 ml AME OF TH x 0.1 mg/ml i etomidine hy
Danish: TEKRAV T ætteglas ETERINÆR x 0,1 mg/ml i etomidinhyd
English: • At the request of the EMEA
Danish: • på anmodning fra EMEA.
English: See sections 4.4, 4.8 and 6.1.
Danish: 4.4, 4.8 og 6.1
English: Using other medicines or vaccines
Danish: Brug af anden medicin eller vacciner
English: • Active substance:
Danish: • Aktivt stof:
English: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Danish: 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)
English: Read all of this leaflet carefully before you start receiving this vaccine.
Danish: Læs denne indlægsseddel grundigt inden du begynder at tage denne vaccine.
English: Immunisation should be postponed.
Danish: Vaccinationen bør udsættes.
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Danish: • når der modtages ny information, der kan have indflydelse på den nuværende sikkerhedsspecifikation, lægemiddelovervågningsplan eller på risikominimeringsaktiviteter
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26/09/2008
Danish: Dato for første markedsføringstilladelse: 26/09/2008
English: The symptoms of pandemic flu are similar to those of ordinary flu but are usually more severe.
Danish: Symptomerne på en pandemisk influenza er de samme som ved en "ordinær" influenza, men er normalt mere alvorlige.
English: Prompt analysis of cumulative safety information, in light of extent of exposure, will be crucial for regulatory decisions and protection of the population to be vaccinated.
Danish: Hurtig analyse af de kumulative sikkerhedsoplysninger er i lyset af omfanget af eksponering afgørende for myndighedernes beslutning og beskyttelse af den population, der skal vaccineres.
English: There is no experience in children.
Danish: Der er ingen erfaring med vaccination af børn.
English: 1 dose = 0.5 ml
Danish: 1 dosis = 0,5 ml
English: Pandemic flu is a type of influenza that occurs at intervals that vary from less than 10 years to many decades.
Danish: Pandemisk influenza er en type influenza, som forekommer med mellemrum, der kan strække sig fra 10 år og til mange årtier.
English: Excipients: It contains 5 micrograms thiomersal
Danish: Hjælpestoffer: indeholder 5 mikrogram thiomersal
English: The vaccine should not usually be given at the same time as other vaccines.
Danish: Vaccinen må ikke gives samtidig med andre vacciner.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Danish: Som ved alle andre injicerbare vacciner, bør passende medicinsk behandling og overvågning altid være til stede i tilfælde af, at en sjælden, anafylaktisk reaktion opstår efter administration af vaccinen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/478/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/478/001
English: After the addition of the emulsion to the suspension, the mixture should be well shaken.
Danish: Efter tilsætning af emulsionen til suspensionen, bør blandingen omrystes godt.
English: Dispose of in accordance with local regulations.
Danish: Destrueres i henhold til lokale retningslinjer.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Danish: Som angivet i CHMP's retningslinjer for risikohånteringssystemer til humane lægemidler, skal den opdaterede RMP indsendes samtidig med den næste periodiske sikkerhedsopdatering (Periodic Safety Update Report, PSUR)
English: Outside of the pandemic period, the normal PSUR periodicity and format will be maintained.
Danish: Uden for den pandemiske periode opretholdes normale intervaller for indsendelse af PSUR samt format.
English: From Post-marketing surveillance with interpandemic trivalent vaccines, the following adverse reactions have been reported:
Danish: I forbindelse med overvågning efter markedsføring af interpandemiske, trivalente vacciner er der indberettet følgende bivirkninger:
English: The first two injections should be given at the elected date and the two other injections should preferably be given 3 weeks after.
Danish: De to første indsprøjtninger gives på en given dato og de næste to indsprøjtninger bør gives tre uger efter.
English: The vial should be shaken prior to each administration.
Danish: Hætteglasset bør omrystes før hver administration.
English: The side effects listed below have occurred in the days or weeks after vaccination with vaccines given routinely every year to prevent flu.
Danish: Nedennævnte bivirkninger er set i dagene og ugerne efter vaccination med almindelig årlig influenzavaccine, som gives en gang om året til forebyggelse af influenza.