FrancophonIA/ELRC3.0 huggingface dataset:
English: ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: BILAG II A. FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG C. ANGIVELSE AF MRL-VÆRDIER D. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: Each dose of 2 ml of vaccine contains:
Danish: Hver dosis på 2 ml vaccine indeholder:
English: It can be used during lactation in cattle.
Danish: Kan anvendes under laktation hos kvæg.
English: Per dose of 2 ml:
Danish: Pr. dosis på 2 ml:
English: There is evidence of BTV-1 seroneutralising antibodies indicative of protection for up to 21 months after primary vaccination.
Danish: Der er tegn på BTV-1-sero-neutraliserende antistoffer, der tyder på beskyttelse i op til 21 måneder efter basisvaccination.
English: Pharmacotherapeutic group: Immunologicals for Bovidae, inactivated viral vaccines for cattle.
Danish: Farmakoterapeutisk gruppe: Immunologiske midler til kvæg, inaktiverede virale vacciner til kvæg.
English: The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of bluetongue.
Danish: Anvendelse af dette veterinære lægemiddel er kun tilladt under de særlige omstændigheder, der er fastsat af EU-lovgivning vedr.
English: In this category of animals the vaccine should be used only according to the benefit-risk assessment by the responsible veterinarian and/or national competent authorities on the current vaccination policies against bluetongue virus (BTV).
Danish: Anvend derfor kun vaccinen til denne kategori af dyr i henhold til en benefit/risk-vurdering foretaget af den ansvarlige dyrlæge og/eller de nationale myndigheder, der er ansvarlige for den foreliggende vaccinationspolitik for bluetongue virus (BTV).
English: Subcutaneous use (sheep) or intramuscular use (cattle).
Danish: Subkutan anvendelse (får) eller intramuskulær anvendelse (kvæg).
English: The target species will also be shown on the label.
Danish: Dyrearter, som lægemidlet er beregnet til, angives også på etiketten.
English: 20 ml (10 doses)
Danish: 20 ml (10 doser)
English: High density polyethylene (HDPE) bottles of 20, 100 or 240 ml with chlorobutyl elastomer stopper and aluminium seal.
Danish: Høj densitet polyethylen (HDPE) hætteglas 20, 100 eller 240 ml med chlorobutyl elastomer prop og aluminiumshætte.
English: 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: After administration with a double dose (4 ml), reactions in sheep are similar to those seen after administration of a single dose, but injection site reactions may persist for a longer time (general swelling at the injection site persisting for not more than 9 days or subcutaneous granuloma possibly persisting for more than 63 days).
Danish: Efter en dobbelt dosis (4 ml), reaktioner hos får ligner dem, der ses efter administration af en enkelt dosis, men lokale reaktioner på administrationsstedet kan vare i længere tid (generel hævelse omkring injektionsstedet kan vare højst 9 dage eller subkutan granulom som kan vare i mere end 63 dage).
English: Pregnancy: Can be used during pregnancy in sheep and cattle.
Danish: Drægtighed: Kan anvendes under drægtighed hos får og kvæg.
English: Sheep and cattle
Danish: Får og kvæg
English: **Relative potency by a mice potency test compared to a reference vaccine efficacious in sheep.
Danish: **Relativ styrke bestemt ved en styrketest i mus, som blev sammenlignet med en referencevaccine, der er effektiv hos får.
English: A transient increase in rectal temperature, not exceeding 2 °C, may occur in 10% of the animals during the 24 hours following administration of a two-fold overdose.
Danish: Der kan forekomme en forbigående stigning i rektaltemperaturen, der ikke overstiger 2° C, hos 10 % af dyrene i løbet af 24 timer efter administration af en 2 fold overdosis.
English: *Relative potency by a mice potency test compared to a reference vaccine efficacious in sheep and cattle.
Danish: *Relativ styrke bestemt ved en styrketest i mus, som blev sammenlignet med en referencevaccine, der er effektiv hos får og kvæg.
English: A transient increase in rectal temperature, not exceeding 1.6 °C, may very commonly occur during the 48 hours following vaccination.
Danish: En forbigående stigning i rektaltemperaturen på højst 1,6°C kan meget almindeligt forekomme i løbet af de første 48 timer efter vaccination.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten efter EXP. Opbevaringstid efter første åbning af beholderen: anvendes straks.
English: Method of administration (sheep and cattle)
Danish: Indgivelsesmåde (får og kvæg):
English: Local reactions of up to 5 cm diameter were very commonly observed and reactions > 5 cm diameter were commonly observed after repeated administration of a single dose in field safety studies.
Danish: I sikkerhedsfeltstudier blev der observeret lokale reaktioner på op til 5 cm i diameter med hyppigheden ”meget almindelig” og reaktioner på > 5 cm i diameter med hyppigheden ”almindelig” efter gentagen administration af en enkelt dosis.
English: These reactions take the form in most cases of a diffuse swelling of the injection site (persisting for not more than 7 days) or of palpable nodules up to a size of 60 cm2 (subcutaneous granuloma, decreasing in size over time but possibly persisting for more than 50 days).
Danish: Reaktionen er som oftest generel hævelse omkring injektionsstedet (varer højst 7 dage) eller mærkbare knuder op til en størrelse på 60 cm2 (subkutan granulom aftagende i størrelse over tid, men som kan vare i mere end 50 dage).
English: 20 ml (10 doses) 100 ml (50 doses) 240 ml (120 doses)
Danish: 20 ml (10 doser) 100 ml (50 doser) 240 ml (120 doser)
English: 100 ml (50 doses) 240 ml (120 doses)
Danish: 100 ml (50 doser) 240 ml (120 doser)
English: Inactivated bluetongue virus, serotype 4, strain SPA-1/2004
Danish: Inaktiveret bluetonguevirus, serotype 4, stamme SPA-1/2004
English: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02
Danish: Inaktiveret bluetonguevirus, serotype 8, stamme BTV-8/BEL2006/02
English: One of the following inactivated bluetongue virus strains: Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1
Danish: En af følgende inaktiverede bluetounge-virusstammer: Inaktiveret bluetonguevirus, serotype 1, stamme BTV-1/ALG2006/01 E1
English: Per dose of 2 ml: Inactivated BTV, serotype 4
Danish: Pr. dosis på 2 ml: Inaktiveret BTV, serotype 4
English: Al3+ (as hydroxide)
Danish: Aluminiumhydroxid (Al3+)
English: Quil-A (Quillaja saponaria saponin extract)
Danish: Saponin Quil-A (Quillaja saponaria ekstrakt)
English: To stimulate active immunity of sheep and cattle against bluetongue virus serotype(s) related to those contained in the vaccine.
Danish: Til stimulation af aktiv immunitet mod bluetonguevirus, serotyper forbundet med dem indeholdt i vaccinen hos får og kvæg.
English: Administer one dose of 2 ml according to the following vaccination scheme: 1st injection: from 12 weeks of age.
Danish: Indgiv en dosis på 2 ml i henhold til følgende vaccinationsprogram: Første injektion: fra 12 ugers-alderen.
English: Administer one dose of 2 ml according to the following vaccination scheme: 1st injection: from 6 weeks of age.
Danish: Indgiv en dosis på 2 ml i henhold til følgende vaccinationsprogram: Første injektion: fra 6 ugers-alderen.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: Ikke relevant.
English: SC (sheep) / IM (cattle)
Danish: s.c. (får), i.m.
English: **Below the level of detection of < 3.4 log10 genome copies/ml by a validated RT-qPCR method, indicating no presence of viral genome.
Danish: ** Under detektionsgrænsen på <3,4 log10 genom kopier/ml bestemt ved en valideret RT-qPCRmetode, hvilket indikerer at der ikke er tilstedeværelse af viralt genom.
English: *Below the level of detection of < 3.9 log10 genome copies/ml by the validated RT-qPCR method, indicating no presence of viral genome.
Danish: * Under detektionsgrænsen på <3,9 log10 genom kopier/ml bestemt med en valideret RT-qPCRmetode, hvilket indikerer at der ikke er tilstedeværelse af viralt genom.
English: Potassium dihydrogen phosphate Disodium phosphate dihydrate Sodium chloride
Danish: Kaliumdihydrogenphosphat Dinatriumhydrogenphosphatdodecahydrat Natriumchlorid
English: Local reactions of < 2 cm diameter were very commonly observed while reactions of up to 5 cm diameter were commonly observed after administration of a single dose in field safety studies.
Danish: Efter administration af en enkelt dosis i sikkerhedsfeltstudier blev der observeret lokale reaktioner på < 2 cm i diameter med hyppigheden ”meget almindelig”, mens reaktioner på op til 5 cm i diameter blev observeret med hyppigheden ”almindelig”.
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: - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr).
English: Cardboard box with 1 bottle of 10 doses (20 ml).
Danish: Pakke med 1 flaske med 10 doser (20 ml).
English: Cardboard box with 1 bottle of 120 doses (240 ml).
Danish: Pakke med 1 flaske med 120 doser (240 ml).
English: Shelf life of the veterinary medicinal product as packaged for sale: 1 year.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 1 år Opbevaringstid efter første åbning af den indre emballage: anvendes umiddelbart.
English: A transient increase in rectal temperature, not exceeding 2.7 °C, was commonly observed during the 48 hours following vaccination in field safety studies.
Danish: I sikkerhedsfeltstudier blev der observeret en forbigående stigning i rektaltemperaturen, der ikke oversteg 2,7 °C i løbet af 48 timer efter vaccinationen, med hyppigheden ”almindelig”.
English: Al3+ (as hydroxide), Quil-A (Quillaja saponaria saponin extract), thiomersal.
Danish: Aluminiumhydroxid Al3+ Saponin Quil-A (Quillaja saponaria ekstrakt) Thiomersal
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box 1 x 20 ml, 1 x 100 ml and 1 x 240 ml (BTV-4 for sheep)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Kartonæske med 1 x 20 ml, 1 x 100 ml og 1 x 240 ml (BTV-4 til får)
English: Cardboard box with 1 bottle of 50 doses (100 ml).
Danish: Pakke med 1 flaske med 50 doser (100 ml).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 100 ml and 240 ml (BTV-4 for sheep)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Flaske med 100 ml og 240 ml (BTV-4 til får)
English: Zulvac BTV suspension for injection for sheep and cattle
Danish: Zulvac BTV injektionsvæske, suspension, til får og kvæg
English: Zulvac BTV suspension for injection for sheep
Danish: Zulvac BTV injektionsvæske, suspension, til får
English: PACKAGE LEAFLET: Zulvac BTV suspension for injection for sheep and cattle
Danish: INDLÆGSSEDDEL Zulvac BTV injektionsvæske, suspension, til får og kvæg
English: Inactivated BTV, serotype 1 Inactivated BTV, serotype 8
Danish: Inaktiveret BTV, serotype 1 Inaktiveret BTV, serotype 8
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle of 20 ml (BTV-4 for sheep)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Flaske 20 ml (BTV-4 til får)
English: Detailed information on this veterinary medicinal product is available on the website of the European
Danish: Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box 1 x 20 ml, 1 x 100 ml and 1 x 240 ml (BTV-1 for sheep and cattle; BTV-8 for sheep and cattle)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Kartonæske med 1 x 20 ml, 1 x 100 ml og 1 x 240 ml (BTV-1 til får og kvæg, BTV-8 til får og kvæg)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle of 20 ml (BTV-1 for sheep and cattle; BTV-8 for sheep and cattle)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Flaske 20 ml (BTV-1 til får og kvæg, BTV-8 til får og kvæg)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 100 ml and 240 ml (BTV-1 for sheep and cattle; BTV-8 for sheep and cattle)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Flaske med 100 ml og 240 ml (BTV-1 til får og kvæg, BTV-8 til får og kvæg)
English: The safety of the vaccine has not been established during lactation in sheep.
Danish: Der foreligger ingen oplysninger om sikkerheden hos diegivende får.
English: Bluetongue virus, serotype 8: 25 days after completion of the primary vaccination scheme.
Danish: Bluetonguevirus, serotype 8: 25 dage efter afslutning af basisvaccinationsprogrammet.
English: Active immunisation of sheep from 6 weeks of age for the reduction* of viraemia caused by bluetongue virus, serotype 4.
Danish: Aktiv immunisering af får fra 6 ugers-alderen til reduktion* af viræmi, som er forårsaget af bluetonguevirus, serotype 4.
English: Inactivated BTV, serotype 1
Danish: Inaktiveret BTV, serotype 1
English: Inactivated BTV, serotype 8
Danish: Inaktiveret BTV, serotype 8
English: Inactivated BTV, serotype 4
Danish: Inaktiveret BTV, serotype 4
English: Bluetongue virus, serotype 8: 12 months after completion of the primary vaccination scheme.
Danish: Bluetonguevirus, serotype 8: 12 måneder efter afslutning af basisvaccinationsprogrammet.
English: For protection against serotype 1, administer one dose of 2 ml, every 12 months.
Danish: Til beskyttelse mod serotype 1, indgiv en dosis på 2 ml, hver 12. måned.
English: EU/2/17/207/001 (20 ml) BTV 1 EU/2/17/207/002 (100 ml) BTV 1 EU/2/17/207/003 (240 ml) BTV 1 EU/2/17/207/007 (20 ml) BTV 8 EU/2/17/207/008 (100 ml) BTV 8
Danish: EU/2/17/207/002 (100 ml) BTV 1 EU/2/17/207/003 (240 ml) BTV 1 EU/2/17/207/008 (100 ml) BTV 8 EU/2/17/207/009 (240 ml) BTV 8
English: For animal treatment only.
Danish: Må kun anvendes til raske dyr.
English: Cattle: Active immunisation of cattle from 12 weeks of age for the prevention** of viraemia caused by bluetongue virus, serotype 1 or serotype 8.
Danish: Aktiv immunisering af kvæg fra 12 ugers-alderen til forebyggelse** af viræmi, som er forårsaget af bluetonguevirus, serotype 1 eller serotype 8.
English: For protection against serotype 4, administer two doses of 2 ml three weeks apart, every 12 months.
Danish: Til beskyttelse mod serotype 4, indgiv to doser på 2 ml tre ugers mellemrum, hver 12 måned.
English: For protection against serotype 1 or serotype 8, administer one dose of 2 ml, every 12 months.
Danish: Til beskyttelse mod serotype 1 og 8, indgiv en dosis på 2 ml, hver 12. måned.
English: For protection against serotype 8, administer two doses of 2 ml three weeks apart, every 12 months.
Danish: Til beskyttelse mod serotype 8, indgiv to doser på 2 ml tre ugers mellemrum, hver 12 måned.
English: Bluetongue virus, serotype 1: 12 months after completion of the primary vaccination scheme.
Danish: Varighed af immunitet: Bluetonguevirus, serotype 1: 12 måneder efter afslutning af basisvaccinationsprogrammet.
English: Active immunisation of sheep from 6 weeks of age for the prevention* of viraemia caused by bluetongue virus, serotype 1 or serotype 8.
Danish: Aktiv immunisering af får fra 6 ugers-alderen til forebyggelse* af viræmi, som er forårsaget af bluetonguevirus, serotype 1 og 8.
English: Bluetongue virus, serotype 1: 15 days after completion of the primary vaccination scheme.
Danish: Indtræden af immunitet: Bluetonguevirus, serotype 1: 15 dage efter afslutning af basisvaccinationsprogrammet.
English: Lot
Danish: Girona
English: EU/2/17/207/002 (100 ml) BTV 1 EU/2/17/207/003 (240 ml) BTV 1 EU/2/17/207/008 (100 ml) BTV 8
Danish: EU/2/17/207/002 (100 ml) BTV 1 EU/2/17/207/003 (240 ml) BTV 1 EU/2/17/207/007 (20 ml)
English: ROUTE(S) OF ADMINISTRATION
Danish: INDGIVELSESVEJ( E)
English: Once broached, use immediately.
Danish: EXP {måned/år} Anvendes straks efter anbrud.
English: EU/2/17/207/009 (240 ml) BTV 8
Danish: EU/2/17/207/004 (20 ml)
English: Aluminium hydroxide
Danish: Aluminiumhydroxid, saponin, thiomersal
English: Revaccination: For protection against serotype 1 or serotype 8, administer one dose of 2 ml, every 12 months.
Danish: Til beskyttelse mod serotype 1 og 8: indgiv en dosis på 2 ml, hver 12. måned.
English: The tablets are given once a day.
Danish: Tabletterne gives en gang dagligt.
English: Symptoms are expected to improve within 1 to 2 weeks.
Danish: Symptomerne forventes at aftage i løbet af 1-2 uger.
English: The European Commission granted a marketing authorisation valid throughout the EU for Reconcile on 8 July 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Reconcile den 8. juli 2008.
English: In case there is no improvement within 4 weeks, the veterinarian should re-evaluate treatment.
Danish: Ses der ingen forbedring inden for 4 uger, bør dyrlægen revurdere behandlingen.
English: Reconcile fluoxetine
Danish: Reconcile fluoxetin
English: This is a summary of the European public assessment report (EPAR) for Reconcile.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Reconcile.
English: The study showed that Reconcile was as effective as clomipramine.
Danish: Undersøgelsen viste, at Reconcile var lige så effektivt som clomipramin.
English: Reconcile should only be given in combination with behavioural therapy.
Danish: Reconcile bør kun gives i kombination med adfærdsbehandling.
English: The tablet strength should be chosen according to the dog's weight.
Danish: Tabletstyrken bør svare til hundens vægt.
English: The full EPAR for Reconcile can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Reconcile findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Fluoxetine works by increasing the levels of the neurotransmitter serotonin in the central nervous system.
Danish: Fluoxetin virker ved at forøge niveauet af neurotransmitteren serotonin i centralnervesystemet.
English: Fluoxetine is an antidepressant.
Danish: Fluoxetin er et antidepressivt lægemiddel.
English: Such problems may include destruction of property, excessive barking or howling and inappropriate defecation and urination in the home.
Danish: Sådanne problemer kan omfatte ødelæggelse af ejendom, overdreven gøen eller hylen og upassende defækation og urinering i hjemmet.
English: After 8 weeks of treatment, two separation anxiety behaviours were significantly improved in the Reconcile group (inappropriate defecation and destructive behaviour).
Danish: Efter otte ugers behandling var to typer adfærd forbundet med separationsangst signifikant forbedret i Reconcilegruppen (upassende defækation og destruktiv adfærd).
English: It contains the active substance fluoxetine.
Danish: Det indeholder det aktive stof fluoxetin.
English: Reconcile is available as tablets (8, 16, 32 and 64 mg) and can only be obtained with a prescription.
Danish: Reconcile fås som tabletter (8 mg, 16 mg, 32 mg og 64 mg) og udleveres kun efter recept.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Reconcile's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Reconcile opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What is Reconcile and what is it used for?
Danish: Hvad er Reconcile, og hvad anvendes det til?
English: It is not intended to provide practical advice on how to use Reconcile.
Danish: Det er ikke en praktisk vejledning i, hvordan Reconcile bør anvendes.
English: If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately.
Danish: Hvis en person utilsigtet indtager lægemidlet, bør der straks søges lægehjælp.
English: Since low levels of serotonin can be linked to depression and anxiety, increasing them can help dogs feel calmer so improving the behaviour in dogs with separation-related problems.
Danish: Da et lavt niveau af serotonin kan forbindes med depression og angst, kan en forøgelse af serotoninniveauet hjælpe hunden til at føle sig roligere og dermed forbedre adfærden hos hunde med adskillelsesproblemer.
English: A field study was conducted in a large number of dogs that were treated for separation anxiety in two European countries.
Danish: Der blev foretaget en feltundersøgelse hos et stort antal hunde, som blev behandlet for separationsangst, i to europæiske lande.
English: The main measure of effectiveness was the change in each of the nine different behaviours recognised as characteristic indicators of separation anxiety in dogs.
Danish: Virkningen blev hovedsagelig målt på ændringen i hver af de ni forskellige typer adfærd, der er anerkendt som karakteristiske indikatorer på separationsangst hos hunde.
English: The most common side effects with Reconcile (which may affect more than 1 in 10 dogs) are loss of appetite and lethargy (lack of energy).
Danish: De hyppigste bivirkninger ved Reconcile (som kan optræde hos mere end 1 ud af 10 hunde) er appetitløshed og letargi (manglende energi).
English: It must also not be used in dogs which are hypersensitive (allergic) to the active substance, any other ingredients or medicines in the same class as fluoxetine (serotonin-reuptake inhibitors).
Danish: Det må heller ikke anvendes til hunde, som er overfølsomme (allergiske) over for det aktive stof, andre af indholdsstofferne eller lægemidler i samme klasse som fluoxetin (serotoningenoptagelseshæmmere).
English: Why is Reconcile approved?
Danish: Hvorfor er Reconcile blevet godkendt?
English: What are the risks associated with Reconcile?
Danish: Hvilke risici er der forbundet med Reconcile?
English: All dogs received behavioural therapy and were treated either with Reconcile or with clomipramine (another medicine used to treat dogs with separation-related disorders).
Danish: Alle hundene modtog adfærdsbehandling og blev behandlet med enten Reconcile eller clomipramin (et andet lægemiddel, som anvendes til behandling af hunde med forstyrrelser i forbindelse med adskillelse).
English: Reconcile must not be given to dogs weighing less than 4 kg or to dogs with epilepsy or a history of fits.
Danish: Reconcile må ikke gives til hunde, der vejer under 4 kg, eller hunde med epilepsi, eller som tidligere har lidt af krampeanfald.
English: Other common side effects with Reconcile (which may affect up to 1 in 10 dogs) are urinary problems (inflammation of the bladder, lack of control in passing urine, inability to completely empty the bladder, and pain and difficulty in passing urine), and lack of coordination and disorientation.
Danish: Andre almindelige bivirkninger ved Reconcile (som kan optræde hos op til 1 ud af 10 hunde) er urinvejslidelser (blærebetændelse, manglende kontrol i forbindelse med vandladning, manglende evne til at tømme blæren helt og smerte og besvær ved vandladning) og manglende koordination og desorientering.