FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Pexion, imepitoin, is an anti-epileptic and anti-anxiety medicine.
Danish: Det aktive stof i Pexion, imepitoin, er et lægemiddel mod epilepsi og angst.
English: Even though the proportion of seizure-free dogs was lower with Pexion than with phenobarbital, some dogs were well-controlled with Pexion.
Danish: Selvom andelen af hunde uden anfald var lavere med Pexion end med phenobarbital, var nogle hunde velkontrollerede med Pexion.
English: To prevent accidental ingestion, the bottle cap should be replaced immediately after withdrawing the required number of tablets for one dose.
Danish: For at undgå utilsigtet indtagelse bør låget sættes tilbage på beholderen med det samme, når det ønskede antal tabletter svarende til én dosis er taget frem.
English: Ingestion of this medicine may cause dizziness, lethargy and nausea.
Danish: Indtagelse af dette lægemiddel kan medføre svimmelhed, apati og kvalme.
English: As side-effects were less frequent than with phenobarbital, Pexion is a suitable treatment option for some dogs, considering in particular its safety profile.
Danish: Da bivirkninger forekom mindre hyppigt med Pexion end med phenobarbital, er Pexion en velegnet behandlingsmulighed for nogle hunde, navnlig i betragtning af sikkerhedsprofilen.
English: These are pores which let calcium move into the nerve cells allowing electrical impulses to be transmitted between nerve cells.
Danish: Kalciumkanalerne er porer, der lukker kalcium ind i nervecellerne, så der kan sendes elektriske impulser rundt mellem nervecellerne.
English: For the full list of side effects and restrictions of Pexion, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Pexion fremgår af indlægssedlen.
English: For noise phobia, the most common side effects with Pexion (which may affect more than 1 in 10 dogs) are short-lived ataxia, increased appetite, and lethargy (lack of energy).
Danish: Ved støjfobi er de hyppigste bivirkninger ved Pexion (som kan forekomme hos mere end 1 ud af 10 hunde) kortvarig ataksi, øget appetit og letargi (manglende energi).
English: For epilepsy, the most common side effects with Pexion (which may affect more than 1 in 10 dogs) are ataxia (inability to coordinate muscle movements), vomiting, polyphagia (excessive eating), and somnolence (sleepiness).
Danish: Ved epilepsi er de hyppigste bivirkninger ved Pexion (som kan forekomme hos mere end 1 ud af 10 hunde) ataksi (manglende evne til at koordinere muskelbevægelser), opkastning, polyfagi (overspisning) og søvnighed.
English: If seizures are not adequately controlled after one week, the veterinary surgeon may increase the dose by 50 - 100% at a time, to a maximum of 30 mg per kg bodyweight twice a day.
Danish: Hvis krampeanfaldene ikke er tilstrækkeligt kontrolleret efter en uge, kan dyrlægen øge dosen med 50-100 % ad gangen op til maks.
English: Pexion-treated dogs also had reduced anxiety scores compared to the placebo group.
Danish: Pexion-behandlede hunde havde også lavere scores for angst end de placebo-behandlede hunde.
English: For epilepsy, treatment with Pexion should be started at a dose of 10 mg per kg bodyweight twice a day.
Danish: Ved epilepsi bør startdosen af Pexion være 10 mg pr. kg legemsvægt to gange dagligt.
English: Imepitoin partially activates the receptors for the neurotransmitter GABA, a substance that reduces electrical activity in the brain.
Danish: Imepitoin aktiverer delvist receptorerne for signalstoffet GABA, der nedsætter den elektriske aktivitet i hjernen.
English: By activating its receptors, imepitoin increases GABA's effects and helps to prevent seizures.
Danish: Når imepitoin aktiverer GABA's receptorer, øges effekten af GABA, hvorved krampeanfald forebygges.
English: In an EU field study looking at effects on noise phobia, the effectiveness of 3 days' treatment with Pexion, at a dose of 30 mg/kg bodyweight twice daily, was investigated during New Year's Eve fireworks in dogs diagnosed with noise phobia.
Danish: I et feltstudie i EU, der undersøgte virkningen på støjfobi, blev virkningen af 3 dages behandling med Pexion ved en dosis på 30 mg pr. kg legemsvægt to gange dagligt undersøgt i forbindelse fyrværkeri nytårsaften hos hunde, der var diagnosticeret med støjfobi.
English: How is Pexion used?
Danish: Hvordan anvendes Pexion?
English: What benefits of Pexion have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Pexion?
English: In a second US field study looking at effects on epilepsy and involving 151 dogs, Pexion treatment for 12 weeks at a fixed dose of 30 mg/kg bodyweight twice daily resulted in 21% of dogs (21 out of 99) being free of generalised seizures compared to 8% of dogs (4 out of 52) given a dummy treatment.
Danish: I et andet feltstudie fra USA, der omfattede 151 hunde, resulterede Pexion-behandling i 12 uger med en fast dosis på 30 mg pr. kg legemsvægt to gange dagligt i, at 21 % af hundene (21 ud af 99) blev fri for generaliserede krampeanfald, sammenholdt med 8 % af de hunde (4 ud af 52), der fik placebo (ikkeaktivt stof).
English: How does Pexion work?
Danish: Hvordan virker Pexion?
English: For noise phobia, treatment with Pexion is given at a dose of 30 mg per kg bodyweight twice a day, starting 2 days before an expected noise event and continuing through it.
Danish: Ved støjfobi gives en dosis på 30 mg pr. kg legemsvægt to gange dagligt, og behandlingen påbegyndes 2 dage før en forventet støjhændelse og fortsætter, indtil støjhændelsen er afsluttet.
English: Therefore, Pexion should not be used as a primary treatment for dogs with cluster seizures (group of seizures occurring close together) and status epilepticus (continual seizures).
Danish: Derfor bør Pexion ikke anvendes som førstevalg hos hunde med klyngeanfald og status epilepticus.
English: In an EU field study looking at effects on epilepsy, Pexion at a dose of 10 to 30 mg/kg bodyweight twice daily reduced the average number of generalised seizures from 2.3 to 1.1 per month after 20 weeks of treatment.
Danish: I et feltstudie i EU af virkningen på epilepsi blev det gennemsnitlige antal generaliserede krampeanfald reduceret fra 2,3 til 1,1 om måneden efter 20 ugers behandling med Pexion ved en dosis på 10-30 mg pr. kg legemsvægt to gange dagligt.
English: The effectiveness of Pexion to treat dogs with status epilepticus and cluster seizures has not been studied.
Danish: Virkningen af Pexion til behandling af hunde, der lider af såkaldt status epilepticus (vedvarende anfald) og klyngeanfald (række af anfald tæt på hinanden), er ikke undersøgt.
English: An inspection of the site will therefore be needed before the medicine can be approved.
Danish: Der behøves derfor en inspektion af fremstillingsstedet, før lægemidlet kan godkendes.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 January 2017
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The other concern was the lack of a certificate of Good Manufacturing Practice (GMP) for the medicine's manufacturing site.
Danish: Den anden betænkelighed bestod i, at der ikke foreligger et certifikat for god fremstillingspraksis (GMP) på fremstillingsstedet for lægemidlet.
English: granulocyte-colony-stimulating factor (G-CSF).
Danish: granulocyt-koloni-stimulerende faktor (C-CSF).
English: Because filgrastim is pegylated, its removal from the body is slowed down, allowing the medicine to be given less often.
Danish: Fordi filgrastim er pegyleret, udskilles det langsommere fra kroppen, så lægemidlet ikke behøver gives så ofte.
English: Filgrastim is very similar to a human protein called
Danish: Filgrastim svarer i høj grad til et menneskeligt protein, der hedder
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it would not be able to provide the additional data required by the CHMP within the timeframe allowed for the procedure.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at det ikke ville være muligt at fremskaffe de supplerende data, der krævedes af CHMP, inden for den tidsramme, som er fastsat til proceduren.
English: On 18 January 2017, Sandoz GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zioxtenzo, intended for treating neutropenia in patients taking cancer treatments.
Danish: Den 18. januar 2017 meddelte Sandoz GmbH officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Zioxtenzo til behandling af neutropeni hos patienter, som får kræftmedicin.
English: It encourages the bone marrow to produce more neutrophils and improves the patient's ability to fight off infections.
Danish: Det stimulerer knoglemarven til at danne flere neutrofiler og forbedrer dermed patientens evne til at bekæmpe infektioner.
English: The reference medicine for Zioxtenzo is Neulasta.
Danish: Referencelægemidlet for Zioxtenzo er Neulasta.
English: Neutropenia is a side effect of certain cytotoxic (cell-killing) cancer treatments and can lead to development of serious infections.
Danish: Neutropeni er en bivirkning ved visse celledræbende (cytotoksiske) kræftmidler og kan føre til alvorlige infektioner.
English: For more information on biosimilar medicines, see the question-and-answer document here.
Danish: Der kan indhentes yderligere oplysninger om biosimilære lægemidler i dokumentet med spørgsmål og svar her.
English: What was Zioxtenzo expected to be used for?
Danish: Hvad forventedes Zioxtenzo anvendt til?
English: Zioxtenzo was developed as a ‘biosimilar' medicine.
Danish: Zioxtenzo blev udviklet som et "biosimilært" lægemiddel.
English: What is Zioxtenzo?
Danish: Hvad er Zioxtenzo?
English: This means that it was intended to be highly similar to a biological medicine (the ‘reference medicine') already authorised in the European Union.
Danish: Det betyder, at det var hensigten, at Zioxtenzo skulle svare meget nøje til et biologisk lægemiddel, som allerede er godkendt i Den Europæiske Union ("referencelægemidlet").
English: Zioxtenzo is a medicine that contains the active substance pegfilgrastim.
Danish: Zioxtenzo er et lægemiddel, der indeholder det aktive stof pegfilgrastim.
English: Zioxtenzo was to be used in cancer patients to treat neutropenia (low levels of neutrophils, a type of white blood cell that helps fight infection).
Danish: Zioxtenzo forventedes anvendt hos kræftpatienter til behandling af neutropeni (lavt antal hvide blodlegemer af typen neutrofiler, der medvirker til at bekæmpe infektioner).
English: It was to be available as a solution for injection under the skin.
Danish: Det var hensigten, at det skulle kunne fås som injektionsvæske, opløsning, til indsprøjtning under huden.
English: The company presented results of studies designed to show that Zioxtenzo is highly similar to its reference medicine Neulasta in terms of chemical structure, purity, the way it works and how the body handles the medicine.
Danish: Virksomheden fremlagde resultaterne af undersøgelser, der var udformet til at vise, at Zioxtenzo svarer nøje til referencelægemidlet Neulasta i sin kemiske opbygning, renhed, virkemåde og kroppens håndtering af lægemidlet.
English: At the time of the withdrawal, the company had not demonstrated that Zioxtenzo is highly similar to Neulasta and an inspection to confirm that it was being manufactured according to GMP standards had not yet taken place.
Danish: På tidspunktet for tilbagetrækningen havde virksomheden ikke påvist, at Zioxtenzo meget nøje svarer til Neulasta, og der var endnu ikke foretaget en inspektion til bekræftelse af, at det blev fremstillet i henhold til GMP-standard.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had two main concerns and was of the provisional opinion that Zioxtenzo could not have been approved as a biosimilar of Neulasta.
Danish: På baggrund af dataene på tidspunktet for tilbagetrækningen havde CHMP to hovedbetænkeligheder og var af den foreløbige opfattelse, at Zioxtenzo ikke kunne være blevet godkendt som et lægemiddel, der var biosimilært til Neulasta.
English: The active substance in Zioxtenzo, pegfilgrastim, consists of filgrastim that has been 'pegylated' (attached to a chemical called polyethylene glycol).
Danish: Det aktive stof i Zioxtenzo, pegfilgrastim, er filgrastim, som er blevet bundet til det kemiske stof polyethylenglycol ("pegyleret").
English: Zioxtenzo was to be used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).
Danish: Det var hensigten, at Zioxtenzo skulle anvendes til at nedsætte varigheden af neutropeni og forekomsten af neutropeni med feber.
English: The company informed the CHMP that there is no impact of the withdrawal of Zioxtenzo on ongoing clinical trials and there are no compassionate use programmes for Zioxtenzo.
Danish: Virksomheden har til CHMP oplyst, at tilbagetrækningen af Zioxtenzo ikke har nogen konsekvenser for igangværende kliniske undersøgelser, og at der ikke er programmer for anvendelse af Zioxtenzo med særlig udleveringstilladelse.
English: What consequences does this withdrawal have for patients in clinical trials?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Zioxtenzo?
English: One concern was that study results were not able to show that the concentrations of pegfilgrastim in blood were the same after taking Zioxtenzo and Neulasta.
Danish: Den ene betænkelighed bestod i, at undersøgelsens resultater ikke viste, at indtagelse af Zioxtenzo og Neulasta medførte samme koncentration af pegfilgrastim i blodet.
English: In addition, two studies in patients receiving cancer medicines compared the safety and effectiveness of Zioxtenzo and Neulasta.
Danish: Der var desuden udført to undersøgelser til sammenligning af sikkerheden og virkningen af Zioxtenzo og Neulasta hos patienter i behandling med kræftmidler.
English: How does Zioxtenzo work?
Danish: Hvordan virker Zioxtenzo?
English: Withdrawal of the marketing authorisation application for Zioxtenzo (pegfilgrastim) EMA/47326/2017
Danish: Den 27. januar 2017 EMA/47326/2017
English: Avoid contact with the product.
Danish: Undgå kontakt med produktet.
English: 24 months.
Danish: 24 måneder.
English: After oral administration in dogs few systemic effects were observed.
Danish: Efter oral administration i hunde blev få systemiske effekter observeret.
English: The Ministerie van Landbouw, Natuurbeheer en Visserij confirmed that the manufacturing site was authorised under number 324-BVEAK for pharmaceutical products.
Danish: Landbrugsministeriet, Natuurbeheer en Visserij bekræfter at fremstillingsstedet er autoriseret under nr. 324-BVEAK for farmaceutiske produkter.
English: Lesions should be monitored closely for signs of infection.
Danish: Læsioner skal nøje overvåges for tegn på infektioner.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/00/024/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/00/024/001
English: The treatment period should not exceed 14 days.
Danish: Behandlingsperioden bør ikke overstige 14 dage.
English: 4.10 Overdose
Danish: 4.10 Overdosering
English: Its mineralocorticoid and progestational activity is very low.
Danish: Dets mineralokortikoide og progestagene aktivitet er meget lav.
English: The expression of these effects depends on the mode of application and the dosage applied.
Danish: Hvordan disse effekter kommer til udtryk afhænger af indgivelsesmåde og den anvendte dosering.
English: Treat for 7 to 14 days.
Danish: Behandlingen bør vare i 7-14 dage.
English: D. STATEMENT OF THE MRLs Not applicable.
Danish: D. ANGIVELSE AF MRL-VÆRDIER Ikke relevant.
English: For example, the total surface area treated of a dog weighing 5 kg should not exceed 50 cm2).
Danish: For eksempel, det totale behandlede område på en hund, der vejer 5 kg, bør ikke overstige 50 cm2.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Pruban 0.1 % cream for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Pruban 0,1 % creme til hunde
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
Danish: NUMMER (NUMRE) I EU-REGISTRET FOR LÆGEMIDLER
English: PACKAGE SIZE Tube containing 15 g of cream
Danish: PAKNINGSSTØRRELSE Tube indeholdende 15 g creme
English: This product belongs to the class of dermocorticoids.
Danish: Dette produkt tilhører klassen af dermokortikoider.
English: For topical administration to the skin.
Danish: Til lokal administration på huden.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance(s)
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Aktiv(e) stof(fer)
English: The maximum total surface of lesions (treated in cm2) should not exceed 10 times the body weight (in kg).
Danish: Den maksimale totale læsionsoverflade (behandlet i cm2) bør ikke overstige 10 gange legemsvægten (i kg).
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Danish: Wim de Körverstraat 35 5831 AN Boxmeer Holland
English: Apply a 1 cm strip (0.2 g) of cream per 10 cm2 of lesion.
Danish: Påfør en 1 cm stribe (0,2 g) creme pr. 10 cm2 læsion.
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares over 25 °C
English: Overdosing, i.e. application rate of more than twice a day, or extension of the duration of treatment, increases the risk of glucocorticoid systemic effects particularly when administered on extensive lesions.
Danish: Overdosering, f.eks. en hyppigere behandling end to gange om dagen, eller forlængelse af behandlingsperioden, forøger risikoen for systemiske glukokortikoide effekter, især når det gælder udbredte læsioner.
English: Do not use in puppies under 6 months of age.
Danish: Må ikke anvendes til hvalpe, der er under 6 måneder.
English: Clean the affected areas and clip the hair covering the lesions before application.
Danish: Rens det behandlingskrævende område og klip hårene, som dækker læsionen før applikation.
English: 4.7 Use during pregnancy and lactation
Danish: 4.7 Anvendelse under drægtighed eller laktation
English: Do not store above 25 °C.
Danish: Må ikke opbevares over 25 °C
English: After topical application on the skin, a local anti-inflammatory effect is seen, which is accompanied by a moderate and reversible adrenal suppression at higher doses.
Danish: Efter topikal brug på huden ses en lokal anti-inflammatorisk effekt, som ledsages af en moderat og reversibel nedsat binyrefunktion ved højere doser.
English: Pharmacotherapeutic group: Glucocorticosteroid, ATCvet code: QD07AC90.
Danish: Farmakoterapeutisk gruppe: Glukokortikosteroid, ATCvet-kode: QD07AC90
English: SPECIAL WARNING(S), IF NECESSARY
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER OM NØDVENDIGT
English: It is recommended that the animal be distracted for several minutes following treatment to prevent licking (oral absorption of the cream is not harmful to the dog, but removal of the cream by licking directly after treatment might decrease efficacy).
Danish: Det anbefales at distrahere hunden i nogle minutter efter behandling for at undgå, at den slikker sig (oral absorption af cremen er ikke skadelig for hunden, men hvis cremen slikkes af lige efter applikation, kan effekten nedsættes).
English: 11 PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
Danish: FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG Ikke relevant
English: 6.4 Nature and composition of immediate packaging Collapsible aluminium tube containing 15 g cream, sealed with aluminium and closed with a polyethylene screw cap, packed in cardboard boxes, one tube per box.
Danish: Sammentrykkelig aluminiumtube indeholdende 15 g creme, forseglet med aluminium og lukket med en polyethylen skruehætte, pakket i kartonæsker, en tube pr. æske.
English: In case of diabetes mellitus, the potential systemic effects of the product may influence glycaemia.
Danish: I tilfælde af diabetes mellitus kan produktets potentielle systemiske effekt påvirke blodsukkerniveauet.
English: PHARMACEUTICAL FORM Cream
Danish: LÆGEMIDDELFORM Creme
English: Since glucocorticosteroids can slow growth, use in young, growing animals should be well controlled and large lesions should not be treated.
Danish: Da glukokortikoider kan forårsage forringet vækst, bør anvendelse til unge dyr i vækst overvåges nøje, og store læsioner bør ikke behandles.
English: CONTRA-INDICATIONS
Danish: KONTRAINDIKATIONER
English: On rare occasions hyperaemia of the treated area has been observed.
Danish: I sjældne tilfælde ses hyperæmi i det behandlede område.
English: ANNEX III LABELLING AND PACKAGE INSERT
Danish: BILAG III ETIKETTERING OG INDLÆGSSEDDEL
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Danish: TEKSTEN “TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
English: Resocortol butyrate has local and systemic glucocorticoid effects.
Danish: Resocortol butyrat har lokal og systemisk glukokortikoid effekt.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THEMANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA
English: Do not use in animals suffering from Cushing's syndrome.
Danish: Må ikke anvendes til hunde, der lider af Cushing syndrom.
English: 4.11 Withdrawal periods
Danish: 4.11 Tilbageholdelsestid
English: Resocortol butyrate
Danish: Resocortol butyrat
English: Do not use in dogs with infected lesions of bacterial, viral, fungal or parasitic origin or with ulcerated lesions.
Danish: Må ikke anvendes til hunde med inficerede læsioner af bakteriel-, viral-, svampe- eller parasitær oprindelse eller med ulcererede læsioner.
English: The therapeutic use of these substances in humans has been recognised to induce local side effects such as skin thinning, skin weakness, delayed healing process and secondary infections.
Danish: Det er konstateret, at den terapeutiske anvendelse af disse substanser til mennesker kan give lokale bivirkninger som hudatrofi, forlænget helingstid og sekundære infektioner.
English: Pruban contains the active principle resocortol butyrate.
Danish: Pruban indeholder det aktive stof resocortol butyrat.
English: To be supplied only on veterinary prescription.
Danish: Til dyr- må kun udleveres efter veterinærrecept.
English: DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
Danish: BETINGELSER ELLER BEGRÆNSNINGER FOR MARKEDSFØRINGSTILLADELSEN HVAD ANGÅR SIKKER OG VIRKNINGSFULD ANVENDELSE
English: Do not use in dogs with extensive lesions.
Danish: Må ikke anvendes til hunde med udbredte læsioner.
English: Resocortol butyrate is a corticosteroid which has a high intrinsic glucocorticoid activity.
Danish: Resocortol butyrat er et kortikosteroid med høj intrinsisk glukokortikoid aktivitet.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 15 g
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: EXPIRY DATE Month/Year
Danish: UDLØBSDATO Måned/år
English: During initial treatment apply the cream twice daily.
Danish: Begynd behandlingen med administration to gange dagligt.
English: Special precautions for use in animals
Danish: Særlige forsigtighedsregler ved brug til dyr
English: Wear disposable gloves when applying the product.
Danish: Man bør anvende handsker, når cremen påføres.
English: WITHDRAWAL PERIOD Not applicable
Danish: TILBAGEHOLDELSESTID Ikke relevant
English: 6.3 Special precautions for storage
Danish: 6.3 Særlige opbevaringsforhold
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: Ubrugte veterinær lægemidler eller affald fra sådanne skal destrueres i overensstemmelse med de lokale krav.