FrancophonIA/ELRC3.0 huggingface dataset:
English: When spray devices are used it is advisable to consult the technical staff of the distributors before using this technique.
Danish: Ved anvendelse af sprayudstyr anbefales det at rådføre sig med leverandørens tekniske personale, før brug af denne teknik.
English: The protection against other circulating IB strains has not been investigated.
Danish: Beskyttelse mod andre cirkulerende IB-stammer er ikke blevet undersøgt.
English: 3) One drop containing one dose should be applied into one nostril or one eye.
Danish: 3) En dråbe indeholdende en dosis bør indgives i et næsebor eller et øje.
English: 4) Offer to birds immediately.
Danish: 4) Administreres straks til fuglene.
English: Wash and disinfect hands and equipment after vaccination to avoid the spread of the virus.
Danish: Vask og desinficer hænder og udstyr efter vaccination for at undgå spredning af virussen.
English: Precautionary measures should be taken to prevent spreading to wildlife.
Danish: Der bør tages forholdsregler for at undgå spredning til dyrelivet.
English: All chickens on the site should be vaccinated at the same time.
Danish: Alle kyllinger på stedet skal vaccineres på samme tidspunkt.
English: Do not use the product if the contents are brownish and stick to the container as this indicates that the integrity of the container has been breached.
Danish: Brug ikke produktet, hvis indholdet er brunligt og klæber til beholderen, da dette er tegn på, at beholderen har været brudt.
English: Duration of immunity: 8 weeks.
Danish: Immunitetens varighed: 8 uger.
English: Date of last renewal: 13/06/2019.
Danish: Dato for seneste fornyelse af markedsføringstilladelse: 13/06/2019.
English: The safety parameters of the mixed vaccines are not different from those described for the vaccines administered separately.
Danish: Sikkerhedsprofilen for de blandede vacciner er ikke forskellig fra den, der er beskrevet for vaccinerne, når de administreres enkeltvis.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu).
English: EID50/dose
Danish: EID50/dosis
English: 50% egg infective dose.
Danish: 1 50% æg-infektiøs dosis
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne (inklusive adjuvanter) som er anført i punkt 6.1 af SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer at MRL-værdier ikke er påkrævet eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: Live IBV, D388
Danish: Levende IBR, D388
English: Do not mix with any other veterinary medicinal product, except Nobilis IB Ma5 or Solvent Oculo/Nasal recommended for use with the veterinary medicinal product.
Danish: Må ikke blandes med andre lægemidler til dyr undtagen Nobilis IB Ma5 eller Solvent Oculo/Nasal, der anbefales til brug med dette veterinærlægemiddel.
English: The vaccine has been demonstrated to provide protection against QX-like variant.
Danish: Det er påvist, at vaccinen yder beskyttelse mod QX-lignende varianter.
English: Vaccinated chickens may excrete the vaccine strain up to 20 days following vaccination.
Danish: Vaccinerede kyllinger kan udskille vaccinestammen i op til 20 dage efter vaccination.
English: Spray or oculonasal administration.
Danish: Via spray eller okulonasal administration.
English: Store below 25 °C.
Danish: Opbevares under 25 °C.
English: 10 x 1,000 doses 10 x 2,500 doses 10 x 5,000 doses 10 x 10,000 doses
Danish: 10 x 1.000 doser 10 x 2.500 doser 10 x 5.000 doser 10 x 10.000 doser
English: 2) Add the contents of the correct number of cups while stirring.
Danish: 2) Tilsæt indholdet af det korrekte antal bægre under omrøring.
English: A mild transient respiratory reaction (including nasal exudates) may very rarely occur for at least 10 days after vaccination.
Danish: En mild forbigående respiratorisk reaktion (herunder nasale ekssudater) kan meget sjældent forekomme i mindst 10 dage efter vaccination.
English: Solvent:
Danish: Solvens:
English: EXP Once reconstituted use within 2 hours.
Danish: EXP Skal anvendes inden for 2 timer efter rekonstitution.
English: Cups may contain 3 spheres to up to 400 spheres depending on the required dosages and production yields.
Danish: Et bæger kan indeholde fra 3 kugler op til 400 kugler afhængigt af den nødvendige dosis og produktudnyttelse.
English: Ensure that the nasal drop is inhaled before freeing the bird.
Danish: Kontroller, at den nasalt indgivne dråbe er inhaleret, før fuglen slippes fri.
English: This vaccine should only be used after it has been established that the QX-like IBV variant strain is epidemiologically relevant.
Danish: Denne vaccine bør kun anvendes, såfremt det er fastslået, at den QX-lignende IBV-stammevariant er epidemiologisk relevant.
English: 2) Shake the vaccine suspension.
Danish: 2) Ryst vaccinesuspensionen.
English: Shelf life after reconstitution according to directions: 2 hours.
Danish: Opbevaringstid efter rekonstituering ifølge anvisning: 2 timer.
English: All containers used for reconstitution should be clean and free from any traces of detergent or disinfectant.
Danish: Alle beholdere, der anvendes til rekonstituering, bør være rene og uden rester af rengøringsmiddel eller desinfektionsmiddel.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
Danish: Der foreligger ingen oplysninger om sikkerhed og virkning af vaccinen ved samtidig brug med andre lægemidler til dyr end det veterinærlægemiddel, der er nævnt ovenfor.
English: Pharmacotherapeutic group: Immunologicals for aves, domestic fowl, live viral vaccine.
Danish: Farmakoterapeutisk gruppe: Immunologica til hønsefugle, levende virale vacciner.
English: Onset of immunity: 3 weeks.
Danish: Immunitetens indtræden: 3 uger.
English: 1) The contents of a cup (1,000 doses only) can be added to Solvent Oculo/Nasal using the included adapter and administered after connecting the included dropper.
Danish: 1) Indholdet af et bæger (kun 1.000 doser) kan opblandes i ”Solvent Oculo/Nasal” ved hjælp af den medfølgende tragt og derefter administreres ved at påsætte den medfølgende dråbepipette.
English: The safety and efficacy of the veterinary medicinal product has not been established during lay.
Danish: Veterinærlægemidlets sikkerhed og effekt under æglægning er ikke fastlagt.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - 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 almindelige (mere end 1 ud af 10 behandlede dyr får bivirkninger) - almindelige (mere end 1, men færre end 10 dyr ud af 100 behandlede dyr) - ualmindelige (mere end 1, men færre end 10 dyr ud af 1.000 behandlede dyr) - sjældne (mere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - meget sjældne (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: Special precautions for use in animals: All chickens on the site should be vaccinated at the same time.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr Alle kyllinger på stedet skal vaccineres på samme tidspunkt.
English: Sodium hydroxide or hydrochloric acid (for pH adjustment) Water for injections
Danish: Natriumhydroxid eller saltsyre (til pH-justering) Vand til injektionsvæsker
English: 3) Mix thoroughly with a clean stirrer, ensuring that all vaccine is dissolved.
Danish: 3) Bland grundigt med en ren omrører, indtil vaccinen er helt opløst.
English: Oculonasal use.
Danish: Okulonasal anvendelse.
English: Solvent: Store below 25 °C.
Danish: Solvens: Opbevares under 25 °C.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Nobilis IB Ma5 for spray or oculonasal application.
Danish: Der foreligger oplysninger om sikkerhed og virkning, der viser, at vaccinen kan blandes og gives sammen med Nobilis IB Ma5 til administration via spray eller okulonasalt.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Danish: Ikke anvendte veterinærlægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: Read the product information of Nobilis IB Ma5 before use.
Danish: Læs produktinformationen for Nobilis IB Ma5 før brug.
English: Shelf life of the lyophilisate as packaged for sale: 24 months.
Danish: Opbevaringstid for lyofilisat i salgspakning: 24 måneder.
English: 1) Reconstitute the lyophilisate using water of good quality (e.g. free from chlorine and/or disinfectants).
Danish: 1) Rekonstitueres ved hjælp af vand af god kvalitet (fx uden tilsætning af chlor og/eller desinfektionsmidler).
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJE
English: Shelf life of the solvent as packaged for sale: 4 years.
Danish: Opbevaringstid for solvens i salgspakning: 4 år.
English: Sealed aluminium laminate cup with a polypropylene (cup) and polypropylene/polyethylene (lid) contact layer containing 1,000; 2,500; 5,000 or 10,000 doses.
Danish: Forseglet aluminiumlamineret bæger med et kontaktlag af polypropylen (bæger) og polypropylen/polyethylen (låg) indeholdende 1.000, 2.500, 5.000 eller 10.000 doser.
English: STORAGE CONDITIONS
Danish: OPBEVARINGSBETINGELSER
English: Store in a refrigerator (2 C - 8 C).
Danish: Opbevares i køleskab (2°C - 8°C).
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Withdrawal period: zero days.
Danish: Tilbageholdelsestid: 0 dage
English: Chickens should be vaccinated against other prevalent IBV serotypes (e.g. Massachusetts) according to the local IB vaccination programme.
Danish: Kyllinger bør vaccineres mod andre udbredte IBV-serotyper (fx Massachusetts) i henhold til lokale IBvaccinationsprogrammer.
English: During this time, the contact of immunosuppressed and unvaccinated chickens with vaccinated chickens should be avoided.
Danish: I denne periode bør kyllinger, som har nedsat immunforsvar, eller som ikke er vaccinerede, undgå kontakt med vaccinerede kyllinger.
English: Solvent (Solvent Oculo/Nasal):
Danish: Solvens (Solvent Oculo/Nasal):
English: For the mixed products the onset of immunity is 3 weeks and the duration of immunity is 8 weeks for the claimed protection against Massachusetts and QX-like strains of IBV.
Danish: For blandede produkter indtræder immunitet efter 3 uger, og hvad angår den angivne beskyttelse mod Massachusetts og QX-lignende IBV-stammer, er varigheden af immunitet 8 uger.
English: Coarse spray:
Danish: Grov spray:
English: Nobilis IB Primo QX is intended to protect chickens against clinical signs of disease caused by IBV variant strain D388 only and should not be used as a replacement for other IBV vaccines.
Danish: Nobilis IB QX Primo har til formål at beskytte kyllinger mod kliniske tegn på sygdom forårsaget af IBV-stammevariant D388, og bør ikke anvendes som erstatning for andre IBV-vacciner.
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: Very mild inflammatory changes have occasionally been found in the kidneys of specific pathogen free (SPF) chickens after administration of a 10-fold overdose.
Danish: Der er i enkelte tilfælde konstateret meget milde inflammatoriske forandringer i nyrerne hos specifik patogen frie (SPF) kyllinger efter administration af en overdosis på 10gange dosis.
English: The vaccine virus is capable of spreading to in contact birds for a minimum of 20 days after vaccination and appropriate care should be taken to separate vaccinated from non-vaccinated chickens.
Danish: Vaccinevirussen kan spredes til andre fugle, med hvilke der er direkte kontakt, i mindst 20 dage efter vaccinationen, og der bør træffes passende foranstaltninger for at holde vaccinerede kyllinger adskilt fra ikke-vaccinerede kyllinger.
English: Read the package leaflet of Nobilis IB Ma5 before use.
Danish: Læs indlægssedlen for Nobilis IB Ma5 før brug.
English: Solvent Oculo/Nasal for chickens
Danish: Solvent Oculo/Nasal til kyllinger
English: Lyophilisate: Store in a refrigerator (2 C - 8 C).
Danish: Lyofilisat: Opbevares i køleskab (2°C - 8°C).
English: Chickens
Danish: Kyllinger
English: The premises must be cleaned and disinfected after each production round.
Danish: Lokalerne skal rengøres og desinficeres efter vaccination.
English: Low density polyethylene (LDPE) vial of 35 ml with a halogenobutyl rubber stopper and aluminium cap.
Danish: Hætteglas fremstillet af polyethylen med lav densitet (LDPE) a 35 ml lukket med gummiprop af halogenobutyl og aluminiumsforsegling.
English: Solvent (Solvent Oculo/Nasal): blue-coloured solution.
Danish: Solvens (Solvent Oculo/Nasal): blåfarvet opløsning.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Danish: 6.6 Eventuelle særlige forholdsregler ved bortskaffelse af ubrugte veterinærlægemidler eller affaldsmaterialer fra brugen af sådanne
English: For active immunisation of chickens in order to reduce respiratory signs of avian infectious bronchitis caused by QX-like variants of infectious bronchitis virus (IBV).
Danish: Til aktiv immunisering af kyllinger for at reducere respiratoriske symptomer på aviær infektiøs bronkitis forårsaget af QX-lignende varianter af infektiøs bronchitis virus (IBV).
English: Special precautions for use in animals
Danish: Særlige forholdsregler vedrørende brug til dyr:
English: Administer 1 dose of reconstituted vaccine by coarse spray or by oculonasal route to chickens from 1 day of age or older.
Danish: En dosis rekonstitueret vaccine administreres via spray med grov forstøvning eller okulonasalt til kyllinger, som er 1 dag gamle eller ældre.
English: LABEL - Lyophilisate CUPS
Danish: LABEL - Lyofilisat BÆGRE
English: Apply coarse spray ≥250 microns.
Danish: Anvend spray med grov forstøvning ≥ 250 µm.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Danish: ANGIVELSE AF DET AKTIVE STOF OG ANDRE INDHOLDSSTOFFER
English: 1,000 doses (3-100 spheres) 2,500 doses (3-100 spheres) 5,000 doses (3-100 spheres) 10,000 doses (3-400 spheres)
Danish: 1.000 doser (3-100 kugler) 2.500 doser (3-100 kugler) 5.000 doser (3-100 kugler) 10.000 doser (3-400 kugler)
English: It is important to avoid introduction of the IB D388 vaccine virus into premises in which the wild type strain is not present.
Danish: Det er vigtigt at undgå introduktion af IB D388-vaccinevirus i lokaler, hvor den vilde stammetype ikke er til stede.
English: EU/2/14/174/002 (10 x 1,000 doses + 10 x 35 ml solvent) EU/2/14/174/003 (10 x 5,000 doses)
Danish: EU/2/14/174/002 (10 x 1.000 doser + 10 x 35 ml solvens) EU/2/14/174/003 (10 x 5.000 doser)
English: Lyophilisate: Off white, predominantly sphere shaped.
Danish: Lyofilisat: Råhvide, overvejende kugleformede.
English: It is important to avoid introduction of the IB D388/QX vaccine virus into premises in which the wild type strain is not present.
Danish: Det er vigtigt at undgå introduktion af IB D388/QX vaccinevirus i lokaler, hvor den vilde stammetype ikke er til stede.
English: In case of coarse spray, personal protective equipment consisting of masks with eye protection should be worn when handling the veterinary medicinal product.
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Ved administration af dette veterinærlægemiddel via grov spray bør der anvendes personligt beskyttelsesudstyr i form af maske med øjenbeskyttelse.
English: The IB D388 vaccine should only be applied in hatcheries to chickens from 1 day of age or older if adequate controls are in place to avoid the spread of the vaccine virus to birds that will be transported to non-IB QX exposed flocks.
Danish: IB D388-vaccine bør kun administreres i rugerier til kyllinger, som er 1 dag gamle eller ældre, hvis der er truffet tilstrækkelige kontrolforanstaltninger for at undgå spredning af vaccinevirus til fugle, som skal transporteres til flokke, der ikke har været eksponeret for IB QX.
English: Hydrolysed gelatine Pancreatic digest of casein Disodium phosphate dihydrate
Danish: Hydrolyseret gelatine Kasein, enzymfordøjet Dinatriumphosphatdihydrat
English: CARDBOARD BOX with 10 cups of lyophilisate
Danish: PAPÆSKE med 10 bægre lyofilisat
English: The IB D388/QX vaccine should only be applied in hatcheries if adequate controls are in place to avoid the spread of the vaccine virus to birds that will be transported to non-IB QX exposed flocks.
Danish: IB D388/QX-vaccine bør kun administreres i rugerier, hvis der er truffet tilstrækkelige kontrolforanstaltninger for at undgå spredning af vaccinevirus til fugle, som skal transporteres til flokke, der ikke har været eksponeret for IB QX.
English: Lyophilisate for oculonasal suspension
Danish: Lyofilisat til okulonasal suspension
English: Reconstitute the lyophilisate immediately and entirely after opening of the cup.
Danish: Når bægeret er åbnet, rekonstitueres lyofilisatet straks og fuldstændigt.
English: CARDBOARD BOX with 10 vials of solvent
Danish: Papæske med 10 hætteglas med solvens
English: After reconstitution, administer 1 dose of vaccine by coarse spray or by the oculonasal route of administration to chickens from 1 day of age or older.
Danish: Efter rekonstitution administreres 1 dosis vaccine via grov spray eller ved anvendelse i øjet og/eller næsen hos kyllinger, som er 1 dag gamle eller ældre.
English: Nobilis IB Primo QX lyophilisate and solvent for oculonasal suspension for chickens Nobilis IB Primo QX lyophilisate for oculonasal suspension for chickens
Danish: Nobilis IB Primo QX, lyofilisat og solvens til okulonasal suspension, til kyllinger Nobilis IB Primo QX, lyofilisat til okulonasal suspension, til kyllinger
English: Nobilis IB Primo QX lyophilisate for oculonasal suspension for chickens
Danish: Nobilis IB Primo QX, lyofilisat til okulonasal suspension, til kyllinger
English: Solvent Oculo/Nasal should be used for oculonasal application.
Danish: Solvensen ”Solvent Oculo/Nasal” bør anvendes til okulonasal administration.
English: Do not use in birds in lay and within 4 weeks before the start of the laying period.
Danish: Må ikke anvendes til æglæggende fugle og inden for 4 uger forud for æglægningsperiodens begyndelse.
English: Do not use in laying birds or within 4 weeks before the onset of the laying period.
Danish: Må ikke anvendes til æglæggende fugle eller inden for 4 uger forud for æglægningsperiodens begyndelse.
English: Solvent for oculonasal suspension.
Danish: Solvens til okulonasal suspension.
English: Lyophilisate:
Danish: Indgivelsesveje:
English: Read the vaccine package before use.
Danish: Læs indlægssedlen inden brug.
English: 50% egg infective dose For the full list of excipients, see section 6.1.
Danish: 1 50% æg-infektiøs dosis Alle hjælpestoffer er anført under pkt.
English: Cardboard box with 10 cups of lyophilisate (1,000 doses per 42 mm diameter cup (3-100 spheres)) + cardboard box with 10 x 35 ml vial of solvent supplemented with dropper and adapter.
Danish: Papæske med 10 bægre lyofilisat (1.000 doser pr. bæger 42 mm/diameter (3-100 kugler)) + papæske med 10 x 35 ml hætteglas med solvens samt dråbepipette og tragt.
English: Active substance: Live attenuated avian infectious bronchitis virus, strain D388: 10
Danish: Aktivt stof: Levende svækket aviær infektiøs bronchitis virus, stamme D388: 10
English: Lyophilisate and solvent for oculonasal suspension Lyophilisate for oculonasal suspension.
Danish: Lyofilisat og solvens til okulonasal suspension.
English: To stimulate active immunity against the D388/QX type of avian infectious bronchitis virus.
Danish: Til stimulering af aktiv immunitet mod infektiøs bronchitis virus, stamme D388/QX.
English: LABEL - Solvent VIALS
Danish: LABEL - HÆTTEGLAS til solvens
English: EU/2/14/174/005 (10 x 2,500 doses)
Danish: EU/2/14/174/005 (10 x 2.500 doser)
English: Live attenuated avian infectious bronchitis virus, strain D388: 10
Danish: Levende svækket aviær infektiøs bronchitis virus, stamme D388: 10
English: Special warnings for each target species: Vaccinate healthy animals only.
Danish: Særlige advarsler for hver dyreart:
English: EU/2/14/174/001 (10 x 1,000 doses)
Danish: EU/2/14/174/001 (10 x 1.000 doser)
English: Packaging:
Danish: Æglægning:
English: ROUTE OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ
English: EU/2/14/174/004 (10 x 10,000 doses)
Danish: EU/2/14/174/004 (10 x 10.000 doser)
English: Potassium dihydrogen phosphate Disodium phosphate dihydrate Disodium edetate dihydrate
Danish: Kaliumdihydrogenphosphat Dinatriumphosphatdihydrat Dinatriumedetatdihydrat Natriumchlorid
English: Cardboard box with 10 cups of lyophilisate (10,000 doses per 61 mm diameter cup (3-400 spheres)).
Danish: Papæske med 10 bægre lyofilisat (10.000 doser pr. bæger 61 mm/diameter (3-400 kugler)).
English: Each dose of reconstituted vaccine contains: Live attenuated avian infectious bronchitis virus, strain D388: 104.0 - 105.5 EID50
Danish: En dosis rekonstitueret vaccine indeholder: Levende svækket aviær infektiøs bronchitis virus, stamme D388: 10
English: Oculonasal use:
Danish: Lyofilisat:
English: Cardboard box with 10 cups of lyophilisate (2,500 doses per 42 mm diameter cup (3-100 spheres)).
Danish: Papæske med 10 bægre lyofilisat (2.500 doser pr. bæger 42 mm/diameter (3-100 kugler)).
English: Cardboard box with 10 cups of lyophilisate (5,000 doses per 42 mm diameter cup (3-100 spheres)).
Danish: Papæske med 10 bægre lyofilisat (5.000 doser pr. bæger 42 mm/diameter (3-100 kugler)).
English: Cardboard box with 10 cups of lyophilisate (1,000 doses per 42 mm diameter cup (3-100 spheres)).
Danish: Papæske med 10 bægre lyofilisat (1.000 doser pr. bæger 42 mm/diameter (3-100 kugler)).
English: Lay:
Danish: Batch:
English: SUMMARY OF PRODUCT CHARACTERISTICS
Danish: BILAG I PRODUKTRESUME
English: 4.4 Special warnings for each target species
Danish: 4.4 Særlige advarsler
English: --1 ≥ 3.2 x 10
Danish: --1 ≥ 3,2 x 106 ELISA-enheder
English: Packaging Content Package size
Danish: Indhold Pakningsstørrelse
English: Strength Pharmaceutical form
Danish: Særnavn Styrke Lægemiddel¬ form
English: Route of administration
Danish: Indgivelsesvej Emballage
English: It can be found here (in English only).
Danish: Den kan ses her (kun på engelsk).
English: Uncommon Rare Not known
Danish: Sjælden Ikke kendt
English: Current text to be deleted is struck through.
Danish: Nuværende tekst, der skal slettes, er gennemstreget.
English: New text to be added to the product information is underlined.
Danish: Ny tekst, der skal tilføjes i produktinformationen, er understreget.
English: When used concomitantly, a dose reduction of propofol may be considered.
Danish: Ved samtidig brug kan det overvejes at nedsætte dosis af propofol.
English: Adopted at the 9-12 January 2017 PRAC
Danish: Vedtaget på PRAC's møde 9.-12. januar 2017
English: Summary of product characteristics 4.8.
Danish: Produktresumé 4.8.
English: Pericardial effusion
Danish: Perikardial effusion