FrancophonIA/ELRC3.0 huggingface dataset:
English: Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 103.1 TCID50* 105.1 TCID50 Suspension (inactivated):
Danish: Hundeparainfluenza type 2 virus, stamme CPiV-2 Bio 15 103,1 TCID50* 105,1 TCID50* Suspension (inaktiveret):
English: ** Antibody micro agglutination-lytic reaction.
Danish: ** Antistof mikroagglutinationsreaktion - lytisk reaktion (antibody micro agglutination-lytic reaction.
English: WITHDRAWAL PERIOD(S) Not applicable.
Danish: TILBAGEHOLDELSESTID(ER) Ikke relevant.
English: Komenského 212, 683 23 Ivanovice na Hané, CZECH REPUBLIC
Danish: 683 23 Ivanovice na Hané DEN TJEKKISKE REPUBLIK
English: Suspension (inactivated): L. interrogans serovar Icterohaemorrhagiae
Danish: Suspension (inaktiveret): L. interrogans serovar Icterohaemorrhagiae
English: Canine parainfluenza virus Type 2
Danish: Hundeparainfluenza virus type 2
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: Særlige forholdsregler, der skal træffes af personer, der administrerer lægemidlet til dyr: I tilfælde af selvinjektion skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: Shake well and administer immediately the entire content (1 ml) of the reconstituted product.
Danish: Indgiv straks al indholdet (1 ml) af det rekonstituerede produkt.
English: Two doses of Versican Plus Pi/L4R 3-4 weeks apart from 8-9 weeks of age.
Danish: To doser af Versican Plus Pi/L4R med 3 til 4 ugers mellemrum fra 8-9-ugers alderen.
English: At least three years following the primary vaccination course for rabies.
Danish: Mindst 3 år efter basisvaccination for rabies.
English: Duration of immunity for rabies was demonstrated after one vaccination at 12 weeks of age.
Danish: Varighed af immunitet for rabies blev påvist efter en vaccination ved 12-ugers alderen.
English: Suspension: pink colour with fine sediment.
Danish: Suspension: Lyserød væske med fint bundfald.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Anvendes subkutant.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Danish: Der foreligger ingen oplysninger om sikkerhed og virkning ved brug af vaccinen sammen med andre veterinærlægemidler til dyr.
English: However, in a minority of animals pain was observed at the injection site immediately after administration of a 10-fold overdose of the vaccine.
Danish: Der blev dog observeret smerte ved injektionsstedet hos et mindretal af dyrene efter indgift af en tidobbelt dosis af vaccinen.
English: Some animals may also not show titres > 0.5 IU/ml after the primary vaccination.
Danish: Nogle vaccinerede dyr viser ikke > 0,5 IE/ml antistoftiter efter basisvaccinationen.
English: Dose and route of administration:
Danish: Dosis og indgivelsesvej:
English: The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine parainfluenza virus, Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa, Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, and rabies virus.
Danish: Vaccinen er beregnet til aktiv immunisering af raske hvalpe og hunde mod sygdomme forårsaget af hundeparainfluenzavirus, Leptospira interrogans serogruppe Australis serovar Bratislava, Leptospira interrogans serogruppe Canicola servar Canicola, Leptospira kirschneri serogruppe Grippotyphosa serovar Grippotyphosa og Leptospira interrogans serogruppe Icterohaemorrhagiae serovar Icterohaemorrhagiae samt rabiesvirus.
English: Reconstituted vaccine: pink/red, or yellowish colour with slight opalescence.
Danish: Rekonstitueret vaccine: Lyserød/rød eller gullig brun, let opalisering.
English: Clinical signs of immune-mediated diseases, such as haemolytic anaemia, thrombocytopenia or polyarthritis have been reported in very rare cases.
Danish: I meget sjældne tilfælde er kliniske tegn på immunmedierede sygdomme, såsom hæmolytisk anæmi, trombocytopeni eller polyarthritis blevet rapporteret.
English: Therefore, the first dose may be given using Versican Plus Pi/L4.
Danish: Den første dosis kan derfor administreres med Versican Plus Pi/L4.
English: Therefore a single dose of compatible vaccine Versican Plus Pi/L4 can be used annually as required.
Danish: En enkelt dosis med forligelig Versican Plus Pi/L4-vaccine kan derfor anvendes årligt som påkrævet.
English: Lyophilisate: spongy matter of white colour.
Danish: Lyofilisat: Svampeagtig hvid substans.
English: Aluminium hydroxide
Danish: Aluminiumhydroxid
English: Adjuvant: Aluminium hydroxide
Danish: Adjuvans: Aluminiumhydroxid
English: Anorexia and decreased activity are rarely observed.
Danish: I sjældne tilfælde kan der forekomme anoreksi eller nedsat aktivitet.
English: A single dose of Versican Plus Pi/L4R should be given every 3 years.
Danish: En enkeltdosis af Versican Plus Pi/L4R bør indgives hvert 3. år.
English: Minimum Maximum Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 10
Danish: Hundeparainfluenza type 2 virus, stamme CPiV-2 Bio 15
English: Hypersensitivity reactions (e.g. gastrointestinal signs such as diarrhoea and vomiting, anaphylaxis, angioedema, dyspnoea, circulatory shock, collapse) may occur rarely.
Danish: Overfølsomhedsreaktioner kan der i sjældne tilfælde forekomme (gastrointestinale symptomer som diarré og opkastning, anafylaksi, angioødem, dyspnø, kredsløbsshock, kollaps).
English: Plastic box containing 25 vials (1 dose) of lyophilisate and 25 vials (1 ml) of suspension.
Danish: Plastikæske indeholdende 25 hætteglas (1 dosis) lyofilisat og 25 hætteglas (1 ml) suspension.
English: Lyophilisate: Trometamol Edetic Acid Sucrose Dextran 70
Danish: Trometamol Edetinsyre Saccharose Dextran 70
English: Plastic box containing 50 vials (1 dose) of lyophilisate and 50 vials (1 ml) of suspension.
Danish: Plastikæske indeholdende 50 hætteglas (1 dosis) lyofilisat og 50 hætteglas (1 ml) suspension.
English: − to prevent clinical signs, infection and urinary excretion caused by L. interrogans serogroup Australis serovar Bratislava,
Danish: − for at forebygge kliniske symptomer, infektion og udskillelse i urinen forårsaget af L. interrogans serogruppe Australis serovar Bratislava
English: ADVICE ON CORRECT ADMINISTRATION Aseptically reconstitute the lyophilisate with the suspension.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Rekonstituer lyofilisat med suspension aseptisk.
English: At least one year following the primary vaccination course for canine parainfluenza virus and Leptospira components.
Danish: Mindst et år efter basisvaccination for hundeparainfluenzavirus og Leptospira komponenter.
English: In this case the second vaccination with Versican Plus Pi/L4R should not be given before 12 weeks.
Danish: I så tilfælde bør den anden dosis med Versican Plus Pi/L4R ikke administreres tidligere end 12 ugers alderen.
English: − to prevent clinical signs and reduce infection and urinary excretion caused by L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa and
Danish: − for at forebygge kliniske symptomer og reducere infektion og udskillelse i urinen forårsaget af L. kirschneri serogruppe Grippotyphosa serovar Grippotyphosa og
English: Annual re-vaccination is required for canine parainfluenza and Leptospira components.
Danish: Årlige revaccinationer er påkrævet for hundeparainfluenza og Leptospira komponenter.
English: CLINICAL PARTICULARS 4.1 Target species Dogs
Danish: 4.1 Dyrearter, som lægemidlet er beregnet til Hund
English: PHARMACEUTICAL FORM Lyophilisate and suspension for suspension for injection.
Danish: LÆGEMIDDELFORM Lyofilisat og suspension til injektionsvæske, suspension.
English: − to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus,
Danish: − for at forebygge kliniske symptomer (næse- og øjenudflåd) og begrænse virusudskillelse forårsaget af hundeparainfluenzavirus (CPiV)
English: Annual re-vaccination is required for canine parainfluenza virus and Leptospira components.
Danish: Årlige revaccinationer er påkrævet for hundeparainfluenzavirus og Leptospira komponenter.
English: − to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae,
Danish: − for at forebygge kliniske symptomer og udskillelse i urinen og reducere infektion forårsaget af L. interrogans serogruppe Canicola og L. interrogans serogruppe Icterohaemorrhagiae serovar Icterohaemorrhagiae
English: Aseptically reconstitute the lyophilisate with the suspension.
Danish: Rekonstituer lyofilisat med suspension aseptisk.
English: Type 1 glass vial containing 1 ml of suspension closed with a chlorobutyl rubber stopper and aluminium cap.
Danish: Vaccinen leveres i hætteglas Type I. Hætteglassene med suspension er lukket med en prop af chlorbutylgummi og et aluminiumlåg.
English: Potassium dihydrogen phosphate
Danish: Kaliumdihydrogenphosphat Dinatriumphosphatdodecahydrat Vand til injektionsvæsker
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Danish: 6.6 Eventuelle særlige forholdsregler ved bortskaffelse af ubrugte veterinærlægemidler eller affaldsmaterialer fra brugen af sådanne
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only
Danish: TEKSTEN ”TIL DYR”
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4R lyophilisate for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Versican Plus Pi/L4R lyofilisat til hund
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4R suspension for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Versican Plus Pi/L4R suspension til hund
English: No other adverse effects other than those mentioned under section 6 (Adverse reactions) have been observed after administration of a 10-fold overdose of the vaccine.
Danish: 6 (Bivirkning), efter indgift af en overdosis af vaccinen.
English: PACKAGE LEAFLET: Versican Plus Pi/L4R lyophilisate and suspension for suspension for injection for dogs
Danish: INDLÆGSSEDDEL Versican Plus Pi/L4R lyofilisat og suspension til injektionsvæske, suspension til hund
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4R lyophilisate and suspension for suspension for injection for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Versican Plus Pi/L4R lyofilisat og suspensionsuspension til injektionsvæske, suspension til hund
English: 6.5 Nature and composition of immediate packaging Type I glass vial containing 1 dose of lyophilisate closed with a bromobutyl rubber stopper and aluminium cap.
Danish: Vaccinen leveres i hætteglas Type I. Hætteglassene med lyofilisat er lukket med en prop af brombutylgummi og et aluminiumlåg.
English: Primary vaccination scheme:
Danish: Basisvaccination:
English: VIAL (1 ML SUSPENSION)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER HÆTTEGLAS (SUSPENSION, 1 ML)
English: No other adverse reactions other than those mentioned in section 4.6 were observed after administration of a 10-fold overdose of the vaccine.
Danish: Efter indgift af en tidobbelt overdosis af vaccinen er der ikke set andre bivirkninger end dem, der er anført i pkt.
English: The procedure started in November 2010.
Danish: Proceduren blev indledt i november 2010.
English: Suppositories containing terpenic derivatives have been authorised through national procedures in Europe since the 1950s and are currently authorised and marketed in seven EU member states.
Danish: Suppositorier indeholdende terpenderivater er blevet godkendt via nationale procedurer i Europa siden 1950'erne og er for øjeblikket godkendt og markedsføres i syv EU-medlemsstater.
English: The overall therapeutic benefit was considered to be limited;
Danish: Den overordnede terapeutiske fordel blev anset for at være begrænset.
English: In particular, the minimum age recommendations varied from the neonatal period for some products, to 1 or even 6 months of age for others.
Danish: Især den anbefalede minimumsalder varierede fra den neonatale periode for nogle lægemidler til en 1 eller sågar 6 måneder for andre.
English: In children less than 30 months, no data on efficacy is available.
Danish: For børn under 30 måneder foreligger der ingen data om virkning..
English: In most cases, medication errors involved the use of a child formulation instead of the infant formulation.
Danish: I de fleste tilfælde skyldtes medicineringsfejlene anvendelsen af en børneformulering i stedet for en spædbarnsformulering.
English: Rectal lesions, including rectal burning, are of particular concern because of their severity and because they represent a limiting factor for treatment duration.
Danish: Rektale læsioner, herunder rektal brænden, giver særlig anledning til bekymring på grund af deres sværhed, og fordi de udgør en begrænsende faktor i forbindelse med behandlingsvarigheden.
English: Changes to the product information (PI)
Danish: Ændringer i produktinformationen
English: In order to address these divergences and taking into account the risk of medication error related to age, the CHMP decided to harmonise certain sections of the product information texts.
Danish: For at afhjælpe disse forskelle og tage højde for risikoen for medicineringsfejl relateret til alder, besluttede CHMP at harmonisere visse afsnit af produktinformationsteksterne.
English: In addition, the suppositories can also be associated with the risk of rectal burning.
Danish: Suppositorier kan ligeledes være forbundet med en risiko for rektal brænden.
English: Overall summary of the scientific evaluation of suppositories containing terpenic derivatives (see Annex I).
Danish: Samlet resumé af den videnskabelige vurdering af suppositorier indeholdende terpenderivater (se bilag I)
English: The CHMP also noted that the limited available data made it impossible to establish whether a direct relationship exists between the administered dose and the ADRs observed.
Danish: CHMP bemærkede endvidere, at de begrænsede tilgængelige data gør det umuligt at fastslå, om der er et direkte forhold mellem den administrerede dosis og de observerede bivirkninger.
English: Medication errors included 5 neurological ADRs.
Danish: Medicineringsfejlene omfattede fem neurologiske bivirkninger.
English: A total of 92 cases of ADRs were identified in the national pharmacovigilance database and the periodic safety update reports, with about 82% (76/92) of these cases occurring in children less than 30 months.
Danish: Der blev identificeret i alt 92 tilfælde af bivirkninger i den nationale lægemiddelovervågningsdatabase og de periodiske sikkerhedsopdateringer, hvoraf ca. 82 % (76/92) af disse tilfælde forekom hos børn under 30 måneder.
English: Finally, dispensing or administration errors were also identified with cases where the administered/prescribed suppository was not suitable for the age or weight of the child.
Danish: Endelig blev der identificeret doserings- eller administrationsfejl med tilfælde, hvor det administrerede/ordinerede suppositorium ikke var egnet til barnets alder eller vægt.
English: The main data was obtained from spontaneous reports, the literature and pre-clinical data.
Danish: De vigtigste data blev opnået via spontane indberetninger, litteraturen og prækliniske data.
English: Camphor, menthol and eucalyptol are the most studied substances from a preclinical and clinical point of view.
Danish: Kamfer, mentol og eucalyptol er de mest undersøgte stoffer set ud fra et præklinisk eller klinisk synspunkt.
English: Benefit-risk balance
Danish: Benefit/risk-forholdet
English: Thirty cases related to neurological disorders, and twenty-one serious cases with plausible relationship were reported.
Danish: Der blev indberettet 30 tilfælde med relation til neurologiske sygdomme og 21 alvorlige tilfælde med plausibel forbindelse.
English: Other disorders including skin disorders and respiratory disorders were also identified.
Danish: Der blev også identificeret andre sygdomme, herunder hudsygdomme og åndedrætslidelser.
English: These concerns are strengthened by the fact that no direct relationships could be established between the quantity of terpenic derivatives administered and the occurrence or severity of the adverse events.
Danish: Disse bekymringer bestyrkes af, at der ikke kunne påvises en direkte forbindelse mellem mængden af terpenderivater, der administreres, og forekomsten eller sværhedsgraden af de utilsigtede hændelser.
English: • The CHMP considered the totality of the available data, including the 2010 French safety review;
Danish: • CHMP vurderede alle de tilgængelige data, herunder den franske sikkerhedsvurdering fra 2010
English: France subsequently submitted a notification on 27th October 2010, initiating a referral procedure under Article 31(2) of Directive 2001/83/EC, to assess the potential neurological risk and its impact on the benefit-risk of suppositories containing terpenic derivatives in children less than 30 months.
Danish: Frankrig indsendte efterfølgende en anmeldelse den 27. oktober 2010, der iværksatte en indbringelsesprocedure i henhold til artikel 31, stk. 2, i direktiv 2001/83/EF, med henblik på at vurdere den potentielle neurologiske risiko og dens indvirkning på risk/benefit-forholdet for suppositorier indeholdende terpenderivater til børn under 30 måneder.
English: From a mechanistic point of view, based on the pharmacological properties of terpenic derivatives, these substances are non-polar (or lipophilic) compounds which show an affinity for non-polar human body structures.
Danish: Fra et mekanistisk synspunkt med udgangspunkt i terpenderivaters farmakologiske egenskaber er disse stoffer nonpolære (eller lipofile) forbindelser, som udviser en affinitet til nonpolære strukturer i den menneskelige krop.
English: This is of particular concern in children and infants, who have little fatty mass, as these substances instead cross into the central nervous system (CNS), practically the only apolar structure at that age.
Danish: Dette giver især anledning til bekymring ved børn og spædbørn, som har meget lidt fedtmasse, eftersom disse stoffer passerer ind i det centrale nervesystem, der i den alder praktisk talt er den eneste apolære struktur.
English: Most clinical data are derived from open studies as well as data from clinical practice or expert opinions.
Danish: Størstedelen af de kliniske data er opnået ved hjælp af åbne undersøgelser samt data fra klinisk praksis eller ekspertudtalelser.
English: The CHMP also took into account the 2010 safety review conducted by the French National Agency.
Danish: CHMP tog endvidere højde for sikkerhedsvurderingen fra 2010 foretaget af det franske nationale organ.
English: The CHMP considered this to be of concern, especially when considering cases where children were exposed to an inadequate dosage or suppository formulation, for example due to parents using suppositories dispensed for older children in other younger children or infants in the family.
Danish: CHMP anså dette for at være bekymrende, især når man overvejer de tilfælde, hvor børn blev eksponeret for en utilstrækkelig dosis eller forkert formulering, f.eks. fordi forældre anvender suppositorier, der egentlig er udleveret til ældre børn, til yngre børn eller spædbørn i familien.
English: The CHMP also reviewed the French safety assessment of the use of suppositories containing terpenic derivatives in children, completed in May 2010.
Danish: CHMP gennemgik også den franske sikkerhedsvurdering af anvendelsen af suppositorier indeholdende terpenderivater til børn, der blev afsluttet i maj 2010.
English: In addition, the duration of use was limited to 3 days, due to risks related to terpenic derivatives storage in tissues and brain and the risk of rectal burning.
Danish: Derudover blev anvendelsens varighed begrænset til 3 dage på grund af risici i relation til terpenderivaters lagring i væv og hjerne og risikoen for rektal brænden.
English: Efficacy is based mainly on traditional use of these products and supported by data regarding pharmacodynamic properties and by their effects as cough suppressants and anti-inflammatory drug in pre-clinical models.
Danish: Virkningen er primært baseret på den traditionelle anvendelse af disse lægemidler og understøttes af data vedrørende farmakodynamiske egenskaber og af deres virkning som hostestillende og antiinflammatoriske lægemidler i prækliniske modeller.
English: For the cases where time to onset was reported, the neurological ADRs occurred on the day of treatment initiation.
Danish: For de tilfælde, hvor symptomdebuten blev indberettet, forekom de neurologiske bivirkninger på den dag, hvor behandlingen blev påbegyndt.
English: The CHMP reviewed a number of publications confirming that terpenic derivatives can induce convulsions in humans.
Danish: CHMP gennemgik en række publikationer, hvori det blev bekræftet, at terpenderivater kan fremkalde kramper hos mennesker.
English: • No dose-ADR relationship could be established and the observed risk of neurological adverse events could not be adequately addressed by measures other than contraindications in this population;
Danish: • Der kunne ikke påvises en forbindelse mellem dosis og bivirkninger, og den observerede risiko for neurologiske utilsigtede hændelser kunne ikke imødegås på anden måde end gennem kontraindikationer for denne population
English: The MAHs and the CHMP also agreed on the wording of a ‘Direct healthcare professional' communication, to inform prescribers on the above agreed contraindications to be sent to relevant health care professionals, including pharmacists.
Danish: Indehaverne af markedsføringstilladelserne og CHMP blev endvidere enige om ordlyden af en direkte meddelelse til fagfolk i sundhedssektoren, der skal informere behandlere om de ovenfor aftalte kontraindikationer og sendes til relevante fagfolk i sundhedssektoren, herunder apoteker.
English: The products are typically indicated for supportive treatment for benign (mild) acute bronchial disorders, particularly productive and non productive cough.
Danish: Lægemidlerne er typisk indiceret til understøttende behandling af godartede (milde) akutte sygdomme i bronkierne, navnlig produktiv og nonproduktiv hoste.
English: • The overall efficacy data is scarce in the paediatric population and absent in children less than 30 months.
Danish: • Alt i alt er data vedrørende virkning hos den pædiatriske population sparsomme og mangler helt hos børn under 30 måneder.
English: However, there is no clinical data derived from comparative studies (randomized, double-blind and controlled studies), pooled analyses or meta-analyses comparing efficacy of terpenic derivatives used by rectal route and no studies focused on infants and children are available.
Danish: Der er dog ikke opnået kliniske data fra sammenlignende undersøgelser (randomiserede, dobbeltblindede og kontrollerede undersøgelser), poolede analyser eller metaanalyser, der sammenligner virkningen af terpenderivater indgivet rektalt, og der findes ingen tilgængelige undersøgelser med fokus på spædbørn og børn.
English: Moreover, suppositories are known to distribute systemically, due to product absorption through the rectal mucous membrane which is particularly vascularised.
Danish: Suppositorier er desuden kendt for at fordele sig systemisk på grund af lægemidlets absorption via den rektale slimhinde, som er særligt vaskulariseret.