FrancophonIA/ELRC3.0 huggingface dataset:
English: In case of accidental exposure of protective clothing to the veterinary medicinal product, immediately remove any contaminated clothing.
Danish: Hvis beskyttelsestøjet udsættes for utilsigtet eksponering over for veterinærlægemidlet, fjernes det kontaminerede tøj straks.
English: To avoid anaesthetic overdose in dogs treated with the veterinary medicinal product, anaesthetic agents should be administered until the desired effect is produced.
Danish: For at undgå anæstetisk overdosis hos hunde, der behandles med veterinærlægemidlet, skal anæstetika indgives, indtil den ønskede virkning er fremkaldt.
English: Once applied to the skin, the veterinary medicinal product rapidly dries resulting in percutaneous absorption of fentanyl.
Danish: Når det er blevet påført huden, tørrer veterinærlægemidlet hurtigt, hvilket resulterer i perkutan absorption af fentanyl.
English: Before using the product it is recommended to consider the availability of an opiate antagonist, e.g. naloxone, in case reversal is required (see sections 4.6 and 4.10).
Danish: Før produktet anvendes, anbefales det at overveje tilgængeligheden af en opiatantagonist, f.eks. naloxon, i tilfælde af, at en ophævelse er påkrævet (se pkt.
English: PHARMACEUTICAL FORM Transdermal solution.
Danish: LÆGEMIDDELFORM Transdermal opløsning.
English: Fentanyl is highly lipid soluble and distributes rapidly into a variety of tissues readily crossing the blood-brain barrier in the dog.
Danish: Fentanyl er meget fedtopløseligt og fordeler sig hurtigt ind i en række væv og krydser ubesværet blod-hjerne-barrieren hos hunden.
English: Do not administer to skin that does not have an intact stratum corneum due to injury or disease.
Danish: Bør ikke anvendes på hud, hvis stratum corneum ikke er intakt grundet skade eller sygdom.
English: Administration of naloxone at 0.04 mg/kg may be used to reverse adverse reactions associated with topical fentanyl.
Danish: Indgivelse af naloxon ved 0,04 mg/kg kan anvendes til at ophæve bivirkninger, der er forbundet med topisk fentanyl.
English: To accurately withdraw the correct amount, align the top of the O-ring on the syringe plunger with the appropriate tick mark on the syringe barrel.
Danish: For nøjagtigt at tappe den korrekte mængde, justeres den øverste del af O-ringen på sprøjtestemplet med det behørige mærke på sprøjtecylinderen.
English: The maximum plasma fentanyl concentrations of 0.7 to 4.7 ng/ml are reached within 10 to 18 hours of dose administration.
Danish: De maksimale plasmafentanylkoncentrationer på 0,7 til 4,7 ng/ml nås inden for 10 til 18 timer efter dosisindgivelse.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE EMBALLAGER
English: In the event that any of the following observations are made following the application/overdose of the veterinary medicinal product, reversal should be initiated: severe sedation, unconsciousness, seizures, laboured or abdominal breathing or severe hypotension.
Danish: Hvis en eller flere af de følgende observationer finder sted efter applikationen/overdosis af veterinærlægemidlet, skal der indgives en modgift: svær sedation, bevidstløshed, kramper, besværet vejrtrækning eller vejrtrækning fra maven eller alvorlig hypotension.
English: The mean plasma fentanyl concentration from time 0 through 96 hours post-dose administration is approximately 1.32 ng/ml.
Danish: Middelplasmafentanylkoncentrationen fra tid 0 til og med 96 timer efter dosisindgivelse er ca. 1,32 ng/ml.
English: Facilities for the maintenance of a patent airway, intermittent positive pressure ventilation (IPPV) and oxygen supplementation should be available.
Danish: Der skal være faciliteter til rådighed til opretholdelse af åbne luftveje, volumenkontrolleret ventilation (IPPV) og iltsupplement.
English: Read the Summary of Product Characteristics before use.
Danish: Læs produktresuméet inden brug.
English: The veterinary medicinal product should be used with caution in conjunction with morphine or other opioid type analgesics as the effects have not been studied.
Danish: Veterinærlægemidlet skal anvendes med forsigtighed sammen med morfin eller andre opioider, da virkningerne ikke er blevet undersøgt.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Fentanyl 50 mg/ml
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Fentanyl 50 mg/ml
English: This product should only be administered by a veterinary surgeon.
Danish: Dette produkt bør kun indgives af en veterinær kirurg.
English: Do not blow out any residual volume in the syringe or applicator tip as this has been accounted for in the dosing table.
Danish: Der må ikke blæses restmængder ud i sprøjten eller applikatorspidsen, da der er taget højde for dette i doseringstabellen.
English: Fentanyl is extensively metabolised and excreted into the urine.
Danish: Fentanyl omsættes i vid udstrækning og udskilles i urinen.
English: Your veterinarian should use Recuvyra with caution in conjunction with other morphine or other opioid pain relievers, or α-adrenergic agonists because the possible side-effects have not been studied.
Danish: Din dyrlæge bør anvende Recuvyra med forsigtighed sammen med andre morfinholdige eller andre opioide smertestillende midler, eller α-adrenerge agonister, da de mulige bivirkninger ikke er blevet undersøgt.
English: Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Danish: Eventuelt ubrugt veterinærlægemiddel eller affaldsmateriale, der hidrører anvendelse af sådanne veterinærlægemidler skal bortskaffes i henhold til lokale krav.
English: Recuvyra is a strong and long-lasting painkiller, and should only be used for major surgery that requires opiate analgesia for a duration of at least 4 days.
Danish: Recuvyra er et stærkt og langtidsvirkende smertestillende middel, og bør kun anvendes til større operationer, der kræver opiatanalgesi af mindst 4 dages varighed.
English: Attach the applicator tip to the syringe by turning the applicator tip 1/3 turn clockwise 2.
Danish: Fastgør applikatorspidsen på sprøjten ved at dreje applikatorspidsen 1/3 omgang med uret 2.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Fentanyl 50 mg/ml
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Fentanyl 50 mg/ml
English: Recuvyra is a solution designed to be applied to the skin between the shoulder blades of your dog (see picture) only by a veterinarian using a specially designed single use applicator, which does not involve any needles.
Danish: Recuvyra er en opløsning, der er designet til kun af en dyrlæge at blive påført huden mellem hundens skulderblade (se billedet) vha. en særligt designet applikator til engangsbrug, som ikke involverer nogen nåle.
English: Do not use in dogs with cardiac failure, hypotension, hypovolaemia, respiratory depression, hypertension, a history of epilepsy, non age related corneal pathology or those who have or are suspected of having a paralytic ileus.
Danish: Bør ikke anvendes til hunde med hjertesvigt, hypotension, hypovolæmi, respiratorisk depression, hypertension, en anamnese med epilepsi, ikke-alderdomsrelateret corneapatologi eller dem, der har en paralytisk ileus eller hos hunde, hvor man har mistanke om en paralytisk ileus.
English: Recuvyra should only be used for major surgery that requires opiate analgesia for a duration of at least 4 days.
Danish: Recuvyra bør kun anvendes til større operationer, der kræver opiatanalgesi af mindst 4 dages varighed.
English: Type I amber glass vial containing 10 ml solution, closed with a grey butyl rubber stopper sealed with a two piece aluminium seal with a grey flip-off plastic disc.
Danish: Ravgult hætteglas, type I, med 10 ml opløsning, lukket med en grå butylgummiprop forseglet med en aluminiumsforsegling i to dele med en grå, aftagelig plastikskive.
English: At a high dose, fentanyl is known to cause a potentially fatal respiratory depression.
Danish: Ved en høj dosis vides fentanyl at forårsage en potentiel fatal respiratorisk depression.
English: • very rare (less than 1 animal in 10,000 animals, including isolated reports).
Danish: • Meget sjælden (mindre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter)
English: The product should only be applied by a veterinarian.
Danish: Dette produkt bør kun indgives af en dyrlæge.
English: 10 DATE OF REVISION OF THE TEXT {MM/YYYY}
Danish: 10 DATO FOR ÆNDRING AF TEKSTEN
English: Following application to the skin, fentanyl is rapidly absorbed into the skin.
Danish: Efter applikation til huden absorberes fentanyl hurtigt i huden.
English: For the control of post-operative pain associated with major orthopaedic and soft tissue surgery in dogs.
Danish: Til kontrol af postoperative smerter forbundet med større, ortopædiske og bløddelsoperationer af hunde.
English: Once seated, do not remove the adaptor.
Danish: Når den sidder på plads, fjernes den ikke.
English: 5.2 Pharmacokinetic particulars
Danish: 5.2 Farmkokinetiske oplysninger
English: B-1000 Brussels Tel.: +32 2 548 8484 Belgium
Danish: B-1000 Brussels Tel.: +32 2 548 8484
English: Store the Summary of Product Characteristics together with the vial, and read before use
Danish: Opbevar produktresuméet sammen med hætteglasset og læs før anvendelse
English: • very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
Danish: • Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling)
English: INDICATION(S) Recuvyra controls pain in dogs that have undergone major orthopaedic or soft tissue surgery.
Danish: Recuvyra kontrollerer smerter hos hunde, der har været udsat for en større ortopædisk eller bløddelsoperation.
English: In case of accidental eye contact with the veterinary medicinal product, rinse with abundant quantities of water and seek medical advice immediately.
Danish: Hvis øjnene ved et uheld kommer i kontakt med veterinærlægemidlet, skylles med rigelige mængder vand, og der søges straks lægehjælp.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Danish: TEKSTEN “TIL DYR” Kun til dyr.
English: de la Industria, 30 E-28108 Alcobendas (Madrid) Tel.: +34 91 663 5000
Danish: E-28108 Alcobendas (Madrid) Tel.: +34 91 663 5000 Spain
English: 6.5 Nature and composition of immediate packaging Vial:
Danish: 6.5 Den indre emballages art og indhold
English: The unbroached vial does not require any special storage conditions.
Danish: Dette veterinærlægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: SPECIAL WARNING(S), IF NECESSARY Accidental administration is dangerous - see Summary of Product Characteristics before use
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER, OM NØDVENDIGT Utilsigtet injektion er farlig - læs produktresuméet inden brug.
English: Centre the adaptor directly over the top of the vial.
Danish: Midterstil adapteren direkte over hætteglasset.
English: A single topical application provides pain relief for at least 4 days.
Danish: En enkelt topisk applikation giver smertelindring i mindst 4 dage.
English: Invert vial and pull back on the syringe plunger until the appropriate volume is withdrawn.
Danish: Vend hætteglasset om og træk sprøjtestemplet tilbage, indtil den passende mængde er tappet.
English: SPECIAL STORAGE CONDITIONS Store the broached vial with the adaptor in an upright position.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevar det påbegyndte hætteglas med adapteren i en opretstående stilling.
English: Dogs that are moderately sedated and not drinking water and eating voluntarily should be evaluated for dehydration and administered supplemental fluid and nutrition support as necessary.
Danish: Hunde, der er moderat sederede og ikke drikker vand eller spiser frivilligt, bør evalueres for dehydrering og indgives supplerende væske og ernæringsmæssig støtte efter behov.
English: Also, the veterinary medicinal product might cause skin irritation.
Danish: Veterinærlægemidlet kan også forårsage hudirritation.
English: When the vial is broached for the first time, the date on which any product remaining in the vial should be discarded should be written in the space provided on the label, using the in-use shelf-life.
Danish: Når hætteglasset åbnes for første gang, skal der i feltet på mærkaten oplyses om bortskaffelsesdatoen for ubrugt produkt i hætteglasset i henhold til holdbarheden for produkt efter anbrud.
English: Store vial upright with the adaptor attached.
Danish: Opbevar hætteglasset opretstående med adapteren tilsluttet.
English: Dogs that are moderately sedated, and are not drinking water and eating voluntarily at an appropriate level for the condition that required surgery, should be evaluated for dehydration and administered supplemental fluid and nutrition support as necessary.
Danish: Hunde, der er moderat sederede og ikke drikker vand eller spiser frivilligt på et passende niveau for tilstanden, der forårsagede operation, bør evalueres for dehydrering og indgives supplerende væske og ernæringsmæssig støtte efter behov.
English: Do not re-use syringes or applicator tips.
Danish: Sprøjter og applikatorspidser må ikke genbruges.
English: Turn the vial into the upright position, grasp the adaptor, turn the syringe ¼ turn anti-clockwise and remove the syringe.
Danish: Vend hætteglasset til opretstående stilling, grib fat i adapteren, drej sprøjten 1/4 omgang mod uret og fjern sprøjten.
English: • Is lactating, pregnant or a dog used for breeding.
Danish: • Diegivende er drægtig eller et avlsdyr.
English: In case of accidental ingestion of the veterinary medicinal product, seek medical advice immediately.
Danish: Ved utilsigtet indtagelse af veterinærlægemidlet, søges der straks lægehjælp.
English: Do not re-use syringes.
Danish: Sprøjterne må ikke genanvendes.
English: (hrs)
Danish: (timer)
English: Do not use near a naked flame.
Danish: Må ikke anvendes i nærheden af åben ild.
English: Eli Lilly Romania SRL
Danish: Eli Lilly Romania SRL Str. Menuetului nr. 12
English: Should subsequent surgery be intended in a dog previously treated with Recuvyra, a minimum of a 7 day dosing interval must be observed before administering another dose.
Danish: Hvis efterfølgende operation skal foretages på en hund, der tidligere er blevet behandlet med Recuvyra, skal et interval på mindst 7 dage overholdes, før der indgives en ny dosis.
English: Product Application
Danish: Produktapplikation
English: To withdraw the solution from the vial, press the provided syringe tip into the centre of the adaptor and gently turn the syringe approximately ¼ turn clockwise until fully seated.
Danish: Tap opløsning fra hætteglasset ved at trykke den vedlagte sprøjtespids ind i midten af adapteren og drej forsigtigt sprøjten ca. ¼ omgang med uret, indtil den sidder forsvarligt på plads.
English: Dogs weighing 20 kg or more will be kept at the veterinary clinic for at least 48 hours after treatment with Recuvyra.
Danish: Hunde, der vejer 20 kg eller mere, vil blive på dyrlægeklinikken i mindst 48 timer efter behandling med Recuvyra.
English: • Decreased stool production and some temporary weight loss.
Danish: • Nedsat afføring og forbigående vægttab
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Recuvyra 50 mg/ml transdermal solution for dogs.
Danish: VETERINÆRLÆGEMIDLETS NAVN Recuvyra 50 mg/ml transdermal opløsning til hunde.
English: Do not use the veterinary medicinal product in lactating or pregnant bitches or breeding animals (see section 4.7).
Danish: Veterinærlægemidlet må ikke anvendes til lakterende eller drægtige tæver eller avlsdyr (se pkt.
English: Should subsequent surgery be intended in a dog previously treated with the veterinary medicinal product, a minimum of a 7 day dosing interval must be observed before administering another dose.
Danish: Hvis efterfølgende operation skal foretages på en hund, der tidligere er blevet behandlet med veterinærlægemidlet, skal et interval på mindst 7 dage overholdes, før der indgives en ny dosis.
English: If your dog weighs more than 20 kg, then it will remain in hospital for at least 48 hours following application of Recuvyra.
Danish: Hvis din hund vejer mere end 20 kg vil den blive på hospitalet i mindst 48 timer efter anvendelse af Recuvyra.
English: Two to four hours before your dog has surgery, the recommended dose (2.6 mg fentanyl/kg bodyweight) of Recuvyra solution is applied directly on the skin between the dog's shoulder blades.
Danish: Recuvyra er en opløsning, der er beregnet til forsigtigt at blive påført din hunds hud af en dyrlæge To til fire timer før din hund skal opereres påføres den anbefalede dosis (2,6 mg fentanyl/kg kropsvægt) Recuvyra-opløsning direkte på huden mellem hundens skulderblade.
English: Withdrawing the solution from the vial (see Figure 2):
Danish: Sådan tappes opløsning fra hætteglasset (se Figur 2):
English: Do not use the veterinary medicinal product in lactating or pregnant bitches or breeding animals.
Danish: Veterinærlægemidlet må ikke anvendes til lakterende eller drægtige tæver eller avlsdyr.
English: Cladirea D, et 2, 013713, sector 1, Bucuresti, Tel:
Danish: Cladirea D, et 2, 013713, sector 1, Bucuresti, Tel: +40-21-4023000, fax: +40-21-4023001
English: EXPIRY DATE EXP:MM/YYYY Once broached, use by….
Danish: UDLØBSDATO UDL.D {måneder/år} Efter anbrud anvendes inden…
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Recuvyra 50 mg/ml transdermal solution for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Recuvyra 50 mg/ml transdermal opløsning til hunde
English: Do not give a second dose of the veterinary medicinal product.
Danish: Der må ikke gives mere end én dosis af veterinærlægemidlet.
English: • common (more than 1 but less than 10 animals in 100 animals)
Danish: • Almindelig (mere end 1, men mindre end 10 dyr ud af 100 dyr)
English: PACKAGE LEAFLET Recuvyra 50 mg/ml transdermal solution for dogs
Danish: INDLÆGSSEDDEL TIL: Recuvyra 50 mg/ml transdermal opløsning til hunde
English: 02-092 Warszawa Tel.: +48 22 440 33 00 Austria
Danish: Żwirki i Wigury 18a 02-092 Warszawa Tel.: +48 22 440 33 00 Poland
English: A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: Withdrawing the solution from the vial Attaching the applicator tip (see Figure 3):
Danish: Tilslutning af applikatorspidsen (se Figur 3):
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children.
Danish: TEKSTEN ”OPBEVARES UTILGÆNGELIGT FOR BØRN” Opbevares utilgængeligt for børn.
English: • rare (more than 1 but less than 10 animals in 10,000 animals)
Danish: • Sjælden (mere end 1, men mindre end 10 dyr ud af 10.000 dyr)
English: Elanco Santé Animale 24 Boulevard Vital Bouhot 92200 Neuilly sur Seine Paris Tel. : +33/(0)1 55 49 35 29 France
Danish: Elanco Santé Animale 24 Boulevard Vital Bouhot 92200 Neuilly sur Seine Paris
English: Do not allow other animals contact with the application site for at least 72 hours after application.
Danish: Lad ikke andre dyr komme i kontakt med applikationsstedet i mindst 72 timer efter applikation.Veterinærlægemidlet bør ikke komme i direkte kontakt med hundens mundhule eller slimhinder.
English: Therefore, treated dogs of more than 20 kg body weight have to be kept at the hospital for 48 hours post-application.
Danish: Derfor skal hunde, der vejer mere end 20 kg, blive på hospitalet i 48 timer efter applikationen.
English: Applying gentle, even pressure, press the adaptor onto the vial until it is seated.
Danish: Adapteren trykkes forsigtigt og jævnt ned på hætteglasset, indtil den sidder på plads.
English: Slovenija (Slovenia)
Danish: Slovenská republika (Slovac republic)
English: Store the broached vial with the adaptor in an upright position.
Danish: Opbevar det påbegyndte hætteglas med adapteren i en opretstående stilling.
English: See section 4.10.
Danish: 4.6 og 4.10).
English: • uncommon (more than 1 but less than 10 animals in 1,000 animals)
Danish: • Ikke almindelig (mere end 1, men mindre end 10 dyr ud af 1.000 dyr)
English: Attaching the Applicator Tip
Danish: Tilslutning af applikatorspidsen
English: Polska (Poland)
Danish: España (Spain)
English: Dosing device:
Danish: Doseringsenhed:
English: In case of accidental spillage onto skin, immediately flush the area with water, then wash the area with copious amounts of soap and water and seek prompt medical advice, showing the physician this warning, the package leaflet or the label.
Danish: Området vaskes dernæst med rigelige mængder sæbe og vand, og der søges straks lægehjælp.
English: Dogs of more than 20 kg bodyweight should remain in the hospital for a minimum of 48 hours following application.
Danish: Hunde, der vejer mere end 20 kg, skal forblive på dyrehospitalet i mindst 48 timer efter applikation.
English: EXP: MM/YYYY Once broached, use within 30 days.
Danish: Efter anbrud anvendes inden 30 dage.
English: Store the vial together with the Summary of Product Characteristics (SPC).
Danish: Opbevar hætteglasset sammen med produktresuméet.
English: Dogs.
Danish: DYREARTER Hunde.
English: Österreich (Ostrich) Eli Lilly Regional Operations GmbH Elanco Animal Health Kölblgasse 8-10
Danish: Österreich (Austria) Eli Lilly Regional Operations GmbH Elanco Animal Health Kölblgasse 8-10
English: Slovenská republika (Slovac Republic) Eli Lilly Regional Operations GmbH Elanco Animal Health Kölblgasse 8-10
Danish: Slovenija (Slovenia) Eli Lilly Regional Operations GmbH Elanco Animal Health Kölblgasse 8-10
English: A positive opinion was adopted 26 January 2006.
Danish: En positiv udtalelse blev vedtaget den 26. januar 2006.
English: The differences in section 4.3 and 4.6 were considered to be of serious public health concern.
Danish: Forskellene i afsnit 4.3 og 4.6 blev anset for at give anledning til alvorlig betænkelighed vedrørende folkesundheden.
English: The Reference Member State was Netherlands and the Concerned Member States were Belgium and the United Kingdom.
Danish: Referencemedlemsstaten var Nederlandene, og de berørte medlemsstater var Belgien og Det Forenede Kongerige.
English: London, 03 April 2006 EMEA/CHMP/106563/2006
Danish: London, den 3. april 2006 EMEA/CHMP/106563/2006
English: 1 Article 29(2) of Directive 2001/83/EC, as amended.
Danish: 1 Artikel 29, stk.2 i direktiv 2001/83/EF, som ændret.
English: The Rapporteur and Co-Rapporteur appointed were Tomas Salmonson and Eric Abadie, respectively.
Danish: Som rapportør og medrapportør udpegedes henholdsvis Tomas Salmonson og Eric Abadie.
English: These Member States were not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Danish: Disse medlemsstater har ikke kunnet nå til enighed om gensidig anerkendelse af den af referencemedlemsstaten udstedte markedsføringstilladelse.
English: The United Kingdom referred the reasons for disagreement to the EMEA on 23 August 2005.
Danish: Det Forenede Kongerige indbragte grundene til uenigheden for EMEA den 23. august 2005.
English: The final opinion was converted into a Decision by the European Commission on 03 April 2006.
Danish: Den endelige udtalelse blev omarbejdet til en beslutning af Europa-Kommissionen den 3. april 2006.
English: The Marketing Authorisation Holder provided written explanations on 13 October 2005.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 13. oktober 2005.
English: The Mutual Recognition Procedure started on 25 May 2005.
Danish: Den gensidige anerkendelsesprocedure blev indledt den 25. maj 2005.
English: The arbitration procedure started on 15 September 2005.
Danish: Voldgiftsproceduren blev indledt den 15. september 2005.
English: Section 4.3 and 4.6 of the SPC of the reference product in the UK contains the information that the product is contraindicated in pregnancy, for women capable of childbearing or for nursing mothers.
Danish: I afsnit 4.3 og 4.6 i produktresuméet for referenceproduktet i Det Forenede Kongerige angives, at produktet er kontraindiceret ved graviditet, for fødedygtige kvinder og for kvinder, der ammer.