FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety of the vaccine was studied in two main laboratory safety studies carried out in sheep and two studies carried out in pregnant ewes.
Danish: Vaccinens sikkerhed blev undersøgt i to hovedsikkerhedsundersøgelser i laboratorium hos får og to undersøgelser hos drægtige får.
English: In 2012 the CVMP considered that the submitted data were adequate for the authorisation of Zulvac 1 Ovis to convert to normal.
Danish: I 2012 konkluderede CVMP, at de forelagte oplysninger var tilstrækkelige for at kunne omdanne godkendelsen af Zulvac 1 Ovis til en normal godkendelse.
English: The vaccine is safe for sheep from one and a half months of age onwards and in pregnant ewes.
Danish: Vaccinen er sikker for får, fra de er halvanden måned gamle, og hos drægtige får.
English: Inactivated vaccine against Bluetongue disease virus, serotype 1
Danish: Inaktiveret vaccine mod bluetongue-virus, serotype 1
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Zulvac 1 Ovis exceed the risks in the prevention of viraemia caused by Bluetongue Virus, serotype 1 in sheep from one and a half months of age.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Zulvac 1 Ovis opvejer risiciene ved forebyggelse af viræmi forårsaget af bluetongue-virus, serotype 1, hos får i alderen halvanden måned og derover.
English: The effectiveness of the vaccine was studied in three main laboratory studies in lambs from 1 months of age.
Danish: Vaccinens virkning blev undersøgt i tre hovedundersøgelser i laboratorium hos lam i alderen én måned og derover.
English: The animals were challenged with bluetongue virus serotype 1, after receiving Zulvac 1 Bovis vaccine containing different amounts of virus.
Danish: Dyrene blev udsat for bluetongue-virus, serotype 1, efter at have fået Zulvac 1 Ovisvaccine med forskellige mængder virus.
English: The vaccine is used to prevent viraemia (the presence of the viruses in the blood) in sheep from one and a half months of age.
Danish: Vaccinen anvendes til at forebygge viræmi (tilstedeværelse af virus i blodet) hos får i alderen halvanden måned og derover.
English: Zulvac 1 Bovis contains bluetongue virus of one serotype (serotype 1).
Danish: Zulvac 1 Ovis indeholder bluetongue-virus af én serotype (serotype 1).
English: Zulvac 1 Ovis is used in sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Danish: Zulvac 1 Ovis anvendes til får som beskyttelse mod sygdommen bluetongue, en infektion forårsaget af bluetongue-virus, der overføres gennem mitter.
English: Zulvac 1 Ovis contains bluetongue viruses that have been inactivated so that they cannot cause the disease.
Danish: Zulvac 1 Ovis indeholder bluetongue-vira, som er blevet inaktiveret, så de ikke kan fremkalde sygdommen.
English: Zulvac 1 Ovis is a vaccine.
Danish: Zulvac 1 Ovis er en vaccine.
English: Other information about Zulvac 1 Ovis:
Danish: Andre oplysninger om Zulvac 1 Ovis:
English: This means that it was not possible to obtain complete information about Zulvac 1 Ovis at the time of the initial authorisation.
Danish: Det betyder, at det på tidspunktet for den oprindelige godkendelse ikke var muligt at indhente fyldestgørende oplysninger om Zulvac 1 Ovis.
English: Zulvac 1 Ovis is a vaccine that is available as a suspension for injection.
Danish: Zulvac 1 Ovis er en vaccine, der fås som en suspension til injektion.
English: What is the risk associated with Zulvac 1 Ovis?
Danish: Hvilken risiko er der forbundet med Zulvac 1 Ovis?
English: Why has Zulvac 1 Ovis been approved?
Danish: Hvorfor blev Zulvac 1 Ovis godkendt?
English: What is Zulvac 1 Ovis?
Danish: Hvad er Zulvac 1 Ovis?
English: How has Zulvac 1 Ovis been studied?
Danish: Hvordan blev Zulvac 1 Ovis undersøgt?
English: What is ZULVAC 1 Ovis used for?
Danish: Hvad anvendes Zulvac 1 Ovis til?
English: How does Zulvac 1 Ovis work?
Danish: Hvordan virker Zulvac 1 Ovis?
English: What benefit has Zulvac 1 Ovis shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Zulvac 1 Ovis?
English: The incidence is about 59 %.
Danish: Hyppigheden er ca. 5-9 %.
English: In rare cases development of alopecia has also been observed.
Danish: I sjældne tilfælde er der endvidere set udvikling af alopeci.
English: Incurin is intended for once daily oral administration.
Danish: Incurin er beregnet til én daglig oral administration.
English: Ensure the dose used to achieve the therapeutic effect is as low as possible.
Danish: Man bør sikre sig, at den dosis, der gives for at opnå den terapeutiske effekt, er så lav som mulig.
English: BATCH NUMBER Batch number.
Danish: BATCH NR. Batchnummer:
English: The minimum dose given should not be less than 0.5 mg per dog per day.
Danish: Minimumsdosis bør ikke være under 0,5 mg pr. hund pr. dag.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Danish: 4.10 Overdosering (symptomer, nødhjælpsprocedurer, modgift)
English: Dog.
Danish: Hund.
English: Animals should be re-examined every 6 months during treatment.
Danish: Dyrene bør undersøges hver 6. måned, så længe de er i behandling.
English: Nearly the whole Estriol is bound to Albumin in Plasma.
Danish: Næsten alt estriol er bundet til albumin i plasma.
English: Pharmacotherapeutic group: estrogens, ATCvet code: QG03CA04.
Danish: Farmakoterapeutisk gruppe: østrogener, ATCvet-kode: QG03CA04.
English: The use of Incurin is contraindicated during pregnancy, lactation and in animals younger than 1 year.
Danish: Anvendelse af Incurin er kontraindikeret under drægtighed, laktation og i dyr, der er yngre end 1 år.
English: Do not use more than 2 tablets per dog per day.
Danish: Giv ikke mere end 2 tabletter pr. hund pr. dag.
English: Do not use after the expiry date which is stated on the label after Exp.
Danish: Må ikke anvendes efter den udløbsdato, som er angivet på etiketten.
English: 9 DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: March 2000
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første tilladelse: Marts 2000
English: B.V. Kloosterstraat 6 5349 AB Oss The Netherlands
Danish: Kloosterstraat 6 5349 AB Oss Holland
English: If no response to treatment is obtained the diagnosis should be reconsidered in order to investigate other causes for the incontinence such as neurological disorders, bladder neoplasia, etc.
Danish: Hvis der ikke opnås respons på behandlingen, bør man revurdere diagnosen og overveje andre årsager til inkontinensen som f.eks. neurologiske lidelser, blæretumorer etc.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Intervet International B.V.
English: Each strip is packed in a carton box.
Danish: Hvert blisterkort er pakket i en kartonæske.
English: In the target animal safety study and the clinical trials, including long-term treatment, no signs of bone marrow suppression were observed.
Danish: I sikkerhedsstudierne og i de kliniske undersøgelser, inklusive langtidsbehandling, blev der ikke observeret tegn på knoglemarvsdepression.
English: Date of last renewal: March 2010
Danish: Dato for den sidste fornyelse af tilladelsen: Marts 2010.
English: 11 PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
Danish: FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG Ikke relevant.
English: Animals showing a polyuria-polydipsia should not be treated with Incurin.
Danish: Dyr med symptomerne polyuri og polydipsi bør ikke behandles med Incurin.
English: Upon oral administration a steady state is reached after the second treatment day and no accumulation occurs after multiple dosing.
Danish: Ved oral administration opnås steady state efter den 2. behandlingsdag, og der sker ingen akkumulation ved gentagen dosering.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/00/018/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/00/018/001
English: The dose has to be fixed for each dog on an individual basis.
Danish: Dosis skal fastlægges individuelt for den enkelte hund.
English: In rare cases vaginal bleeding occurred.
Danish: I sjældne tilfælde kan blødning fra vagina ses.
English: Further, in some dogs, symptoms of nausea were observed.
Danish: Endvidere så man symptomer på kvalme hos nogle hunde.
English: Estriol is excreted in conjugated from via the urine.
Danish: Estriol udskilles i konjugeret form via urinen.
English: STATEMENT OF THE MRLs Not applicable.
Danish: D. ANGIVELSE AF MRL-VÆRDIER Ikke relevant.
English: High doses of oestrogen may have a tumour-promoting effect in target organs with oestrogen receptors (mammary glands).
Danish: Høje østrogendoser kan have en tumorfremmende virkning på organer med østrogenreceptorer (mælkekirtler).
English: Some dogs do not need daily treatment; treatment every other day may be tried, once the effective daily dose has been established.
Danish: Nogle hunde har ikke behov for daglig behandling; behandling hver 2. dag kan forsøges, når den effektive daglige dosis er blevet fastlagt.
English: These effects are reversible after lowering the dose.
Danish: Disse effekter er reversible efter reduktion af dosis.
English: Aspen Oss.
Danish: Aspen Oss B.V.
English: Since there exists no relation between the final effective dose and the body weight, a fixed dose per kg body weight is not feasible.
Danish: Da der ikke findes nogen relation mellem den endelige effektive dosis og legemsvægten, er anvendelse af en fast dosis pr. kg. legemsvægt ikke egnet.
English: In case of overdose typical oestrogen effects may occur.
Danish: Ved overdosering kan typiske østrogeneffekter forekomme.
English: After oral administration Estriol is nearly completely absorbed from gastrointestinal tract.
Danish: Efter oral administration er estriol næsten fuldstændigt absorberet fra mave-tarm-kanalen.
English: Amylopectin Potato starch Magnesium stearate Lactose
Danish: Amylopectin Kartoffelstivelse Magnesiumstearat Lactose
English: Do not use in intact bitches, as the efficacy has only been established in ovariohysterectomised bitches.
Danish: Må ikke anvendes til intakte tæver, da virkningen kun er dokumenteret på ovariehysterectomerede tæver.
English: SPECIAL WARNINGS, IF NECESSARY Not applicable.
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER, OM NØDVENDIGT Ikke relevant.
English: Do not use this product during pregnancy or lactation.
Danish: Brug ikke dette veterinærlægemiddel under drægtighed og laktation.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Danish: Navn og adresse på fremstilleren (fremstillerne) af de(t) biologisk aktive stof(fer)
English: ADVICE ON CORRECT ADMINISTRATION Not applicable.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Ikke relevant.
English: See also 4.3 Contraindications.
Danish: Se også pkt 4.3: Kontraindikationer
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: Eventuelle ubrugte lægemidler eller affald fra sådanne skal destrueres i overensstemmelse med de lokale krav.
English: Estriol is a short-acting natural oestrogen.
Danish: Estriol er et kortvarigt virkende naturligt østrogen.
English: The following dosing schedule is advised: start treatment with 1 tablet (1 mg estriol) every day.
Danish: Følgende doseringsskema anbefales: Begynd behandlingen med 1 tablet (1 mg estriol) om dagen.
English: 6.5 Nature and composition of immediate packaging Blister package of clear PVC film backed by aluminium foil provided with heat seal coating (vinyl copolymer) on the side in contact with the tablets.
Danish: Blisterpakning af klar PVC-film med bagside af aluminiumfolie, forsynet med varmeforseglet belægning (vinyl copolymer) på den side, som er i kontakt med tabletterne.
English: METHOD AND ROUTE OF ADMINISTRATION For oral administration.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Til oral administration.
English: EXPIRY DATE (Month / year)
Danish: UDLØBSDATO Udløb: (Måned / år)
English: 4.7 Use during pregnancy, lactation or lay
Danish: 4.7 Anvendelse under drægtighed og laktation
English: 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Fortegnelse over hjælpestoffer
English: This is probably due to the short-acting oestrogenic character of estriol.
Danish: Dette skyldes formodentligt estriols kortvarigt virkende østrogeneffekt.
English: The following dosing schedule is advised: start treatment with 1 tablet every day.
Danish: Følgende doseringsskema anbefales: Begynd behandlingen med 1 tablet om dagen.
English: PACKAGE SIZE Carton box with 1 blister.
Danish: PAKNINGSSTØRRELSE Kartonæske med 1 blisterkort.
English: A relationship between final effective dose and body weight has not been established and therefore the dose has to be determined for each dog on an individual basis.
Danish: Da relationen mellem den endelige effektive dosis og legemsvægten ikke er fastlagt, må dosis fastsættes individuelt for den enkelte hund.
English: One blister contains 30 tablets.
Danish: En blister indeholder 30 tabletter.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON BOX
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Kartonæske
English: MANUFACTURER'S BATCH NUMBER Batch number.
Danish: FREMSTILLERENS BATCHNUMMER
English: To be supplied only on veterinary prescription
Danish: Veterinærlægemidlet må kun udleveres efter recept.
English: In the incontinent female dog it has a beneficial effect on the urinary incontinence.
Danish: Hos den inkontinente tæve har det en positiv effekt på urininkontinens.
English: Oestrogenic effects such as swollen vulva, swollen mammary glands and/or attractiveness to males and vomiting have been observed at the highest recommended dose of 2 mg per dog.
Danish: 4.6 Bivirkninger (hyppighed og alvorlighed) Østrogeneffekter såsom opsvulmet vulva, hævede mammae og/eller tiltrækkende virkning på hanhunde samt opkastning er set ved den højeste anbefalede dosis på 2 mg pr. hund.
English: In ovarioectomised female dogs it has a beneficial effect on urinary incontinence.
Danish: I ovarieectomerede tæver har det en gavnlig effekt på urininkontinens.
English: 4.2 Indications for use, specifying the target species The treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in ovariohysterectomised bitches.
Danish: 4.2 Terapeutiske indikationer, med angivelse af de dyrearter, som lægemidlet er beregnet til Behandling af urininkontinens som følge af hormonafhængig sphincter-mekanisme inkompetence hos ovariehysterectomerede tæver.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
Danish: C. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN, HERUNDER BEGRÆNSNINGER FOR SIKKERHED OG EFFEKTIV ANVENDELSE
English: Mild, oestrogenic effects such as swollen vulva, swollen teats and/or attractiveness for males have been observed at the high dose of 2 mg.
Danish: Milde østrogen effekter såsom opsvulmede ydre kønsorganer, hævede mælkekirtler og/eller tiltrækkende virkning på hanhunde er set ved den høje dosis på 2 mg.
English: Each blister contains 30 tablets.
Danish: Hvert blisterkort indeholder 30 tabletter.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Danish: ORDENE ”TIL DYR” Til dyr.
English: MINIMUM PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE BLISTER
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Blisterkort
English: Round single-scored tablets.
Danish: Runde tabletter med delekærv.
English: Pack size: carton box with 1 blister
Danish: Pakningsstørrelse: kartonæske med 1 blisterpakning.
English: Dogs (bitches).
Danish: DYREARTER Hunde.
English: STATEMENT OF ACTIVE AND OTHER SUBTANCES Active substance: estriol 1 mg/tablet
Danish: ANGIVELSE AF AKTIV(E) STOF(FER) Aktivt stof: estriol 1 mg/tablet
English: PHARMACEUTICAL FORM Tablet.
Danish: LÆGEMIDDELFORM Runde tabletter med delekærv.
English: Treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in female dogs.
Danish: Behandling af hormonafhængig urininkontinens som følge af inkompetence i lukkemusklen hos steriliserede tæver
English: If treatment is not successful, increase the dose to 2 tablets a day to be given in one dose.
Danish: Hvis resultatet af behandlingen ikke er tilfredsstillende, øges dosis til 2 tabletter om dagen, der gives som én dosis.
English: If treatment is successful, lower the dose to half a tablet a day.
Danish: Hvis resultatet af behandlingen er tilfredsstillende, sænkes dosis til en halv tablet om dagen.
English: If treatment is not successful increase the dose to 2 tablets a day.
Danish: Hvis resultatet af behandlingen ikke er tilfredsstillende, øges dosis til 2 tabletter om dagen.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: estriol
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Aktivt stof: estriol 1 mg/tablet
English: 1 mg/tablet For a full list of excipients, see section 6.1
Danish: Se afsnit 6.1 for en fuldstændig fortegnelse over hjælpestoffer.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT INCURIN 1 mg tablet
Danish: VETERINÆRLÆGEMIDLETS NAVN INCURIN 1 mg tabletter
English: SPECIAL STORAGE CONDITIONS Keep out of the reach and sight of children.
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VEDRØRENDE OPBEVARING Opbevares utilgængeligt for børn.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Active substance: estriol
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Aktivt stof: estriol 1 mg /tablet
English: After oral administration of multiple doses no accumulation occurs.
Danish: Der sker ingen akkumulation ved gentagen oral dosering.
English: PHARMACOLOGICAL PROPERTIES
Danish: FARMAKOLOGISKE EGENSKABER OG FARMAKOKINETISKE OPLYSNINGER
English: ANNEX II A. <MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND> MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: BILAG II A. FREMSTILLER AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG INDEHAVER(E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN, HERUNDER BEGRÆNSNINGER FOR UDLEVERING OG BRUG C. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN, HERUNDER BEGRÆNSNINGER FOR SIKKERHED OG EFFEKTIV ANVENDELSE D. ANGIVELSE AF MRL-VÆRDIER
English: 4.9 Amount(s) to be administered and administration route
Danish: 4.9 Dosering og indgivelsesmåde
English: PACKAGE LEAFLET INCURIN 1 mg tablet
Danish: INDLÆGSSEDDEL Incurin 1 mg, tabletter
English: Special precautions for use in animals
Danish: 4.5 Særlige forsigtighedsregler vedrørende brugen Særlige forsigtighedsregler vedrørende brug til dyr I tilfælde af østrogeneffekt skal dosis sænkes
English: In case of oestrogenic effects, the dose should be lowered.
Danish: Bivirkningerne er reversible efter reduktion af dosis.
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Danish: {Navn og adresse} <{tlf.}> <{fax}> <{email}>
English: A single high dose is better tolerated than the same dose administered several times a day.
Danish: En enkelt høj dosis tolereres bedre end den samme dosis flere gange om dagen.
English: Haematological monitoring is thus necessary.
Danish: Hæmatologisk monitorering er derfor nødvendigt.
English: • Of these 76% were treated for breast cancer and 24% for a variety of advanced cancers.
Danish: • Af disse blev 76% behandlet for brystcancer og 24% for en lang række avancerede cancerformer.
English: If any of the above apply, you must not be given this medicine.
Danish: Hvis noget af det ovenstående gælder for dig, må du ikke få denne medicin.
English: This substance belongs to a group of medicines which protect the heart (cardioprotective medicines).
Danish: Dette stof tilhører en gruppe af lægemidler, som virker beskyttende på hjertet (kardioprotektive lægemidler).
English: Your blood counts may however return to normal after each treatment cycle)
Danish: Dine blodværdier kan dog blive normale efter hver behandlingscyklus).
English: Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: very common ( 1/10); common ( 1/100 to  1/10); uncommon ( 1/1,000 to  1/100); not known (cannot be estimated from the available data).
Danish: Bivirkningerne er listet under overskrifter om hyppighed, den hyppigste først, ved hjælp af følgende konvention: Meget almindelig (1/10), almindelig (1/100 til 1/10); ikke almindelig (1/1.000 til 1/100), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: You may experience some of the side effects listed in section 4, “Possible side effects”.
Danish: Du kan opleve nogle af de bivirkninger, der er opført i afsnit 4, “Bivirkninger”.
English: The plasma concentrations declined thereafter with an average half-life value of 2.2 ± 1.2 hours.
Danish: Plasmakoncentrationerne faldt derefter med en gennemsnitlig halveringstid på 2,2 ± 1,2 timer.
English: This will start approximately 30 minutes before your cancer treatment (doxorubicin and/or epirubicin).
Danish: Dette vil starte ca. 30 minutter før din kræftbehandling (doxorubicin og/eller epirubicin).
English: The majority of controlled clinical studies were performed in patients with advanced breast cancer.
Danish: De fleste af de kontrollerede kliniske studier blev udført hos patienter med fremskreden brystcancer.
English: The difference was not statistically significant and no consistent cause was apparent, however a contribution of dexrazoxane to the difference cannot be ruled out.
Danish: Forskellen var ikke statistisk signifikant, og der var ingen tydelig, konsistent årsag, dog kan det ikke udelukkes, at dexrazoxan bidrager til forskellen.
English: An increased risk of the development of second primary malignancies, particularly AML, has been reported.
Danish: En øget risiko for anden primær malignitet, især AML, er rapporteret.
English: {(Invented) Name} should not be used during pregnancy unless clearly necessary.
Danish: {Lægemidlets (sær)navn} bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: There are no animal studies on the transfer of the active substance and/or its metabolites into milk.
Danish: Der er ingen dyreforsøg om udskillelse af det aktive stof og/eller dets metabolitter i mælk.
English: There are no adequate data from the use of dexrazoxane in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af dexrazoxan til gravide kvinder.
English: You will not be given {(Invented) Name} if you are pregnant or had planned to become pregnant, unless your doctor decides it is necessary.
Danish: Du vil ikke blive behandlet med {Lægemidlets (sær)navn}, hvis du er gravid eller planlægger at blive gravid, medmindre din læge beslutter, at det er nødvendigt.
English: {(Invented) Name} should not be mixed with any other medicinal products during infusion.
Danish: {Lægemidlets (sær)navn} må ikke blandes med andre lægemidler under infusionen.
English: Like all medicines, {(Invented) Name} can have side effects, although not everybody gets them.
Danish: {Lægemidlets (sær)navn} kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Some side effects can be serious and need immediate medical attention: Very common (affecting more than 1 in 10 patients):
Danish: Nogle bivirkninger kan være alvorlige og kræver øjeblikkelig lægehjælp: Meget almindelig (forekommer hos flere end 1 ud af 10 patienter):
English: Due to the spontaneous nature of post-marketing reporting, such events are listed with frequency “not known” if they were not already identified as reactions from clinical trials.
Danish: På grund af den spontane natur af postmarketing-rapportering er disse bivirkninger listet med frekvensen ”ukendt”, hvis de ikke allerede var identificerede som bivirkninger fra kliniske forsøg.