natgillin/translations-raw huggingface dataset:
På forsiden er hver halvdel mærket med bogstaverne ” MPT ” og tal, der angiver mængden af maropitant.
On the obverse side, each half is marked with the letters “MPT” and figures denoting the quantity of maropitant.
Til forebyggelse af opkastning, inklusive opkastning forårsaget af kemoterapi.
For the prevention of vomiting including that induced by chemotherapy.
Til behandling af opkastning i forbindelse med behandling med Cerenia injektionsvæske, opløsning og i kombination med anden støttebehandling.
For the treatment of vomiting, in conjunction with Cerenia solution for injection and in combination with other supportive measures.
Til indgift gennem munden.
For oral use
Til behandling og forebyggelse af opkastning (anden årsag end køre - og søsyge)
For Treatment and Prevention of Vomiting (except Motion Sickness)
For at behandle eller forebygge opkastning, som ikke skyldes køre - eller søsyge, gives Cerenia tabletter en gang daglig med en dosis på 2 mg pr. kg. legemsvægt med det antal tabletter, som er angivet i nedenstående tabel.
To treat and/or prevent vomiting except motion sickness, Cerenia tablets should be administered once daily, at a dose of 2 mg maropitant per kg bodyweight, using the number of tablets given in the table below.
24 timer, og derfor kan tabletterne gives aftenen før administrationen af et stof, der kan forårsage opkastning (f. eks. kemoterapi).
The duration of the effect is approximately 24 hours and, therefore, tablets can be given the night before administration of an agent that may cause emesis (e.g. chemotherapy).
Cerenia kan bruges til at behandle opkastning enten som tabletter eller som injektion en gang daglig i op til 5 dage.
Cerenia can be used to treat vomiting either as tablets or as solution for injection once daily for up to five days.
Behandling og forebyggelse af opkastning (anden årsag end køre - og søsyge)
Treatment and prevention of vomiting (except motion sickness)
(kg) 3, 0 – 4, 0 * 4, 1 – 8, 0 8, 1 – 12, 0 12, 1 – 24, 0 24, 1 – 30, 0 30, 1 – 60, 0
(kg) 3.0 – 4.0 * 4.1 – 8.0 8.1 – 12.0 12.1 – 24.0 24.1 – 30.0 30.1 – 60.0
60
60 mg
For at forebygge opkastning forårsaget af køre - og søsyge gives Cerenia tabletter en gang daglig med en dosis på 8 mg maropitant pr. kg. legemsvægt med det antal tabletter, som er angivet i nedenstående tabel.
For Prevention of Vomiting induced by Motion Sickness To prevent vomiting induced by motion sickness, Cerenia tablets should be administered once daily, at a dose of 8 mg maropitant per kg bodyweight, using the numbers of tablets given in the table below.
Tabletterne bør gives mindst én time før rejsens påbegyndelse.
34 Tablets should be administered at least one hour before starting the journey.
Dosering med Cerenia på en fuldstændig tom mave kan forårsage opkastning hos din hund.
Prevention of motion sickness only
At give din hund et let måltid eller en godbid før dosering hjælper til at undgå denne virkning.
Dog
Forebyggelse af køre - og søsyge
body weight (kg)
7, 6 – 10, 0 10, 1 – 15, 0 15, 1 – 20, 0
7.6 – 10.0 10.1 – 15.0 15.1 – 20.0 20.1 – 30.0 30.1 – 40.0 40.1 – 60.0
20, 1 – 30, 0 30, 1 – 40, 0 40, 1 – 60, 0
2
1½ 2 3
½ 1 1½ 2 3
• Fold eller skær først langs den stiplede linie mellem hver tablet angivet ved saksesymbolet • Find afrivningsslippen eller skær som vist ved pilesymbolet • Mens der holdes fast på den ene side ved snittet, trækkes den anden side mod midten af blisterpakningen til tabletten kan ses. • Fjern tabletten fra pakningen og giv tabletten som anvist.
To remove a tablet from the blister the following sequence should be carried out; • Firstly, fold or cut along the perforation between each tablet as shown by the scissor symbol . • Find the pull-back notch (or cut) as shown by the arrow symbol. • Holding one side of the cut firmly, pull the other side towards the centre of the blister until the tablet is visible • Remove table from blister and administer as instructed.
Man bør ikke forsøge at trykke tabletten gennem bagsiden af blister pakningen, da dette både vil beskadige tabletten og blisterpakningen.
No attempt should be made to remove the tablet by pushing it through the blister backing as this will damage both the tablet and blister.
Mod transportsyge anbefales at give et let måltid eller en godbid før dosering.
For motion sickness a light meal or snack before dosing is recommended, prolonged fasting before administration should be avoided.
Lang faste inden administrationen bør undgås Cerenia tabletter bør ikke gives ” indpakket ” i foder, da dette kan forsinke opløsningen af tabletten og dermed tidspunktet for tablettens virkning.
Cerenia tablets should not be administered wrapped or encapsulated in food as this may delay dissolution of the tablet and consequently the onset of the effect.
35 10.
35 11.
TILBAGEHOLDELSESTID
SPECIAL STORAGE CONDITIONS
Halve tabletter bør højst opbevares i 2 dage efter de er trykket ud af blisterpakken.
Half tablets should be stored for a maximum of two days after removal from the blister.
Må ikke anvendes efter den udløbsdato, som er angivet på blisterpakken efter EXP.
Do not use after the expiry date, which is mentioned on the blister after EXP.
Sikkerheden af det veterinærmedicinske lægemiddel er ikke undersøgt i hunde yngre end 16 uger og hos drægtige og diegivende tæver..
The safety of Cerenia has not been established in dogs less than 16 weeks of age and in pregnant or lactating bitches.
Den ansvarlige dyrlæge bør foretage en risikovurdering før brug af Cerenia til hunde under 16 uger eller til drægtige og diegivende tæver.
The responsible veterinarian should make a benefit-risk assessment before using Cerenia in dogs under 16 weeks of age or in pregnant or lactating bitches.
Efter overdosering højere end 20 mg/ kg er set spredte kliniske symptomer som opkastning efter første indgift, forøget spytsekretion og vandig afføring.
Clinical signs including vomiting on first administration, excess salivation and watery faeces have been observed when the product has been overdosed in excess of 20 mg/kg.
I tilfælde af selvindgivelse ved hændeligt uheld skal der straks søges læge, og indlægssedlen eller etiketten bør vises til lægen.
In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician..
38 INDLÆGSSEDDEL
38 PACKAGE LEAFLET FOR:
Cerenia 10 mg/ ml injektionsvæske, opløsning.
Cerenia 10 mg/ml solution for injection for dogs
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT
Indehaver af markedsføringstilladelsen Pfizer Limited Ramsgate Road Sandwich Kent CT 13 9NJ England
Marketing Authorisation Holder Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UK
Pfizer PGM 37530 Poce sur Cisse Frankrig
Manufacturing Authorisation Holder Responsible For Batch Release Pfizer PGM 37530 Pocé sur Cisse France
Cerenia 10 mg/ ml injektionsvæske, opløsning.
Cerenia 10 mg/ml solution for injection for Dogs Maropitant
Den indeholder også metakresol som konserveringsmiddel.
The solution for injection contains 10 mg maropitant per ml as maropitant citrate monohydrate as a clear, colourless to light yellow solution It also contains metacresol (as preservative).
Til forebyggelse af opkastning med undtagelse af opkastning i forbindelse med transportsyge.
For the prevention of vomiting except that induced by motion sickness.
Til behandling af opkastning i kombination med anden veterinær - og støttende terapi
For the treatment of vomiting, in combination with other veterinary and supportive measures.
Til subkutan injektion.
For subcutaneous use
Cerenia injektionsvæske, opløsning skal injiceres subkutant, en gang daglig med en dosis på 1 mg pr. kg legemsvægt (1 ml pr. 10 kg legemsvægt).
Cerenia solution for injection should be injected subcutaneously, once daily, at a dose of 1 mg/kg bodyweight (1 ml/10 kg bodyweight).
Cerenia kan bruges til at behandle eller forebygge opkastning enten som tabletter eller som injektion en gang daglig i op til 5 dage.
Cerenia can be used to treat or prevent vomiting either as tablets or as solution for injection once daily for up to 5 days.
Varigheden af effekten er omkring 24 timer og derfor kan behandlingen gives aftenen før behandlingen med et brækningsfremkaldende middel, f. eks. kemoterapi.
The effect duration is approximately 24 h and therefore treatment can be given the night before administration of an agent that may cause emesis e.g. chemotherapy.
Efter åbning bør indholdet af hætteglasset bruges inden for højst 28 dage.
Once opened, the vial should be used within 28 days.
Må ikke anvendes efter den udløbsdato, som er angivet på etiketten på hætteglasset efter EXP.
Do not use after the expiry date, which is mentioned on the label of the vial after EXP.
Sikkerheden af det veterinærmedicinske lægemiddel er ikke undersøgt i hunde yngre end 16 uger og hos drægtige og diegivende tæver.
The safety of Cerenia has not been established in dogs less than 16 weeks of age and in pregnant or lactating bitches.
Den ansvarlige dyrlæge bør foretage en risikovurdering før brug af Cerenia til hunde under 16 uger eller til drægtige eller diegivende tæver.
The responsible veterinarian should make a benefit-risk assessment before using Cerenia in dogs under 16 weeks of age or in pregnant or lactating bitches.
Cerenia bør bruges med forsigtighed til dyr, der lider af eller er prædisponerede for hjertelidelser.
Cerenia should be used with caution in animals suffering from or with predisposition for heart diseases.
I tilfælde af selvindgivelse ved hændeligt uheld skal der straks søges læge, og indlægssedlen eller etiketten bør vises til lægen.
In case of accidental self injection seek medical advice immediately and show the package leaflet or the label to the physician.
I laboratorieundersøgelser har maropitant
In the case of accidental eye exposure, flush the eyes with plenty of water and seek medical attention.
Cerenia bør ikke bruges samtidig med Ca - kanal antagonister, da maropitant har affinitet til Ca - kanaler.
40 Cerenia should not be used concomitantly with Ca-channel antagonists as maropitant has affinity to Ca-channels.
Cerenia 10 mg/ ml injektionsvæske, opløsning til hunde findes i 20 ml ravfarvet hætteglas.
Cerenia 10 mg per ml solution for injection for dogs is available in 20 ml amber glass vials.
Det leveres i to hætteglas, hvoraf det ene indeholder en suspension, og det andet indeholder en emulsion.
It comes in two vials, one containing a suspension and the other containing an emulsion, and these need to be mixed before injection.
At viruset er "inaktiveret", betyder, at det er blevet dræbt, så det ikke er sygdomsfremkaldende.
Circovac contains an inactivated porcine circovirus type 2 (PCV2) virus strain. ‘ Inactivated’ means that the virus has been killed so that it can no longer cause disease.
Circovac anvendes til at reducere forandringer og beskadigelse af lymfoidt væv, der er knyttet til PCV2- infektion hos smågrise, og til at reducere den samlede dødelighed hos smågrise af denne infektion.
Circovac is used to reduce the changes in and damage to lymphoid tissues associated with PCV2 infection in piglets and to help reduce the overall deaths in piglets connected with this infection.
Vaccinen gives til hundyrene før og/ eller under drægtighedsperioden.
The vaccine is given to female pigs before and/ or during pregnancy.
Smågrisene bliver derefter immuniseret, når de drikker råmælken fra det immuniserede moderdyr.
Their piglets then become immunised when they drink the colostrum (first milk) from their vaccinated mothers.
Circovac gives ved dyb intramuskulær injektion (indsprøjtning i en muskel).
Circovac is given by deep intramuscular (into a muscle) injection.
Gylter (hundyr, der endnu ikke har faret) skal have tre injektioner, mens søer (dyr, der tidligere har faret) skal have to injektioner, og tidligere vaccinerede søer behøver kun én injektion.
The number of injections needed varies according to the type of female pig being treated: gilts (female pigs that have not yet had piglets) need to receive three injections; sows (female pigs that have had piglets before) need to receive two injections; and sows that have been vaccinated before need only one injection.
Tidspunktet for injektionen afpasses efter datoerne for bedækning og faring.
The timing of the injection is adjusted according to the dates of mating and farrowing (giving birth).
I alle tilfælde gives den sidste dosis (som ved revaccination er den eneste dosis) mindst to uger før den forventede faring.
In all cases the last dose (and only dose, in case of re-vaccination) is given at least two weeks before the expected date of farrowing.
Svine- circovirus type 2 (PCV2) vides at være årsag til infektioner hos grise med en lang række kliniske tegn og sygdomskomplekser, hvoraf nogle muligvis skyldes PCV2 i kombination med andre sygdomsfremkaldende årsager.
Porcine circovirus type 2 (PCV2), is known to infect, and cause a wide variety of clinical signs and syndromes in pigs, some of which may be caused by PCV2 in combination with other agents.
Hos smågrise kan infektioner knyttet til PCV2 medføre symptomer som vægttab (eller manglende vækst), forstørrede lymfeknuder, åndenød, og, mere sjældent, diarré, bleg hud og gulsot.
In piglets, PCV2 associated infections may include symptoms such as weight loss (or failure to grow), enlarged lymph nodes, difficulties in breathing, and, less commonly, diarrhoea, pale skin and jaundice (yellowing of the skin).
Circovac indeholder inaktiveret PCV2.
Circovac contains inactivated PCV2.
Når gylten eller soen bliver vaccineret, opfatter dens immunsystem det inaktiverede virus som "fremmed" og reagerer ved at producere antistoffer for at ødelægge det.
When the gilt or sow is injected, the pig’ s immune system recognises the inactivated virus as ‘ foreign’ and reacts to this by producing antibodies to destroy it.
Antistofferne overføres fra soen til smågrisene gennem råmælken og hjælper smågrisene til at bekæmpe PCV2- viruset, hvis de udsættes for det efter fødslen.
These antibodies are transferred from the mother to the piglets through the colostrum, and they help the piglets to fight the PCV2 virus if they become exposed to it after they are born.
Både søer og gylter (og deres smågrise) indgik i undersøgelserne, hvoraf nogle fandt sted i laboratorieomgivelser og nogle 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged på landbrug.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Circovac been studied?
Produktets virkning blev påvist ved at måle mængden af antistoffer mod PCV2 i blod fra de vaccinerede søer (eller gylter) og desuden i blodet hos deres smågrise (efter at disse havde fået råmælk).
Both sows and gilts (and their piglets) were investigated in these studies, some of which were carried out under laboratory conditions and some on farms.
Produktets virkning blev videre undersøgt i smågrise, der direkte blev udsat fra viruset og derefter observeret for symptomer på circovirus- betingede symptomer.
The effectiveness of the product was demonstrated by measuring the amount of antibodies to PCV2 in the blood of the vaccinated sows (or gilts) and also in the blood of their piglets (after they have had the colostrum).
Der blev bl. a. registreret kropsvægt og mængderne af PCV2 i bestemte lymfeknuder og i blod og fæces.
The effectiveness of the product was further investigated in piglets which were directly exposed to the virus, by observing them for the development of circovirus-related symptoms.
Desuden registreredes det samlede antal dødsfald, der forekom under feltbetingelser blandt smågrise, født af vaccinerede søer og gylter.
Parameters such as body weight, and the amounts of PCV2 found in some specific lymph nodes and in their blood and faeces, were taken into account.
Dette blev sammenlignet med tilsvarende tal for grise, født af uvaccinerede moderdyr.
Additionally, the overall number of deaths occurring in field conditions amongst piglets born to vaccinated sows and gilts was investigated and compared to those born to unvaccinated mothers.
Undersøgelserne viste, at vaccination af moderdyrene med Circovac kan mindske forekomsten af de forandringer, der er forbundet med circovirus- infektion i det lymfoide væv hos smågrisene.
The trials showed that vaccination of the mothers with Circovac can reduce the incidence of lesions associated with circovirus infection in the lymphoid tissues of their piglets.
Hos et stort antal grise i undersøgelserne (fra 63 landbrug) var der alligevel en reduktion på mellem 3, 6% og 10% i den samlede circovirus- betingede dødelighed hos smågrise trods de forskelligartede eksperimentelle og kliniske betingelser
Although the outcome of some of the trials was partially compromised by the complex nature of PCV2 infections, the large number of pigs involved (from 63 farms) and the variety of experimental and clinical conditions did show a reduction in the overall death rates of piglets related to circovirus infections of between 3.6% and 10%.
Det blev påvist, at hos smågrise, født af vaccinerede gylter eller søer, holdt immuniteten sig indtil fem uger efter, at smågrisene havde drukket råmælken.
Immunity in piglets born from vaccinated gilts or sows was shown to last for up to five weeks after they drank the colostrum.
Circovac kan omkring indstiksstedet give anledning til en uskadelig rødme eller hævelse, som kan vare i indtil fire dage efter injektionen.
Circovac can cause a harmless temporary redness or swelling at or around the injection site, which can last for up to four days after the injection.
Efter injektionen kan svinene have en temperaturforhøjelse på 1, 4 °C i indtil to dage, i nogle svin op til 2, 5 °C, der dog ikke skulle vare ud over 24 timer efter injektionen.
Following injection, pigs may have an increased body temperature of 1.4°C for up to two days, and in some pigs of up to 2.5°C, but this should not last more than 24 hours after the injection.
Den fuldstændige liste over de indberettede bivirkninger ved Circovac fremgår af indlægssedlen.
For a full list of all side effects reported with Circovac, see the Package Leaflet.
I sjældne tilfælde kan dette medføre tab af fingeren.
Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger, which can in rare cases lead to the loss of the finger.
Indlægssedlen skal vises til lægen.
If someone is accidentally injected with even a very small amount of this product, they must seek medical advice immediately and the Package Leaflet should be shown to the doctor.
Hvor lang tid skal der gå, før dyret kan slagtes, og kødet kan anvendes til menneskeligt forbrug (tilbageholdelsestid)?
What is the time allowed before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Udvalget for Veterinærlægemidler (CVMP) fandt, at fordelene ved Circovac opvejer risiciene til reduktion af lymfevævsforandringer ved infektion med PCV2 hos smågrise og til reduktion af dødeligheden
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Circovac outweigh its risks for the reduction of the lesions in lymphoid tissues which are associated with circovirus infection in piglets and also to help reduce deaths connected with this disease in piglets.
markedsføringstilladelse for Circovac.
They recommended that Circovac should be given a marketing authorisation.
Dette sammendrag blev sidst ajourført i 06- 2007.
©EMEA 2007
EMEA Nummer
EMEA Number
Handels - Styrke navn
Invented Strength Name
Dyreart
Target Species
Administrations - Pakning vej
Route of Administration
Salgs - pakninger
Package Size
Tilbagehold - elsestid
Withdrawal Period
EU/ 2/ 07/ 075/ 001 Circovac
EU/ 2/ 07/ 075/ 001 Circovac
2 ml dosis
Inactivated porcine circovirus type 2: at least 2.1 log 10 ELISA U per 2 ml dose
Svin (polte, gylte og søer)
Pigs (gilts and sows)
Suspension: hætteglas (glas) Emulsion: hætteglas (glas)
Suspension: vial (glass) Emulsion: vial (glass)
5 doser Emulsion:
5 doses Emulsion:
1 hætteglas 0 dage + 1 hætteglas
1 vial + 1 vial
EU/ 2/ 07/ 075/ 002 Circovac
EU/ 2/ 07/ 075/ 002 Circovac
2. 1 log 10
Inactivated porcine circovirus type 2: at least 2.1 log 10 ELISA U per 2 ml dose
Emulsion og suspension til emulsion til
Emulsion and suspension for emulsion for injection
Svin (polte, gylte og
Pigs (gilts and sows)
Suspension: hætteglas (glas) Emulsion: hætteglas
Suspension: vial (glass) Emulsion: vial (glass)
10 hætteglas +
10 vials + 10 vials
2 ml dosis
Zero days
25 doser
25 doses Emulsion:
2 ml dosis
Inactivated porcine circovirus type 2:
Emulsion og suspension til emulsion til injektionsvæske
Emulsion and suspension for
Suspension: hætteglas (glas) Emulsion: hætteglas (glas)
Suspension: vial (glass)
25 10 doser hætteglas + Emulsion:
Emulsion:
25 doser 10 hætteglas
25 doses 10 vials
Circovac Emulsion og suspension til emulsion til injektionsvæske til svin
Circovac Emulsion and suspension for emulsion for injection for pigs
2.
One reconstituted 2 ml dose contains:
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Active substance:
Aktivt stof:
Inactivated porcine circovirus type 2 (PCV2)................................................ ≥ 2.1 log10 ELISA. Units Excipient:
Inaktiveret porcint circovirus type 2 (PCV2) ……………………………… ≥ 2. 1 log10 ELISA- enheder Hjælpestof:
Thiomersal................................................................................................................................. ..0.20 mg Adjuvant:
Thiomersal …………………………………………………………………………………….. 0, 20 mg Adjuvans:
Light paraffin oil..............................................................................................................
Let paraffinolie …………………………………………………………………………… 494 – 501 mg
494 to 501 mg
Emulsion og suspension til emulsion injektionsvæske.
Emulsion and suspension for emulsion for injection.
Svin (polte, gylte og søer).
Pigs (gilts and sows).
Herved reduceres læsioner i det lymfoide væv som følge af PCV2- infektion, og PCV2- relateret dødelighed nedsættes.
Passive immunisation of piglets via the colostrum, after active immunisation of sows and gilts, to reduce lesions in lymphoid tissues associated with PCV2 infection and as an aid to reduce PCV2- linked mortality.
2 Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr
2 Special precautions to be taken by the person administering the veterinary medicinal product to animals
Uforsætlig injektion/ selvinjektion kan medføre alvorlige smerter og hævelser, navnlig ved injektion i led eller fingre, og kan i sjældne tilfælde medføre tab af den pågældende finger, hvis den ikke behandles omgående.
Accidental injection/ self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
Der kræves ØJEBLIKKELIG kirurgisk behandling, og der kan opstå behov for tidlig incision og irrigation af det injicerede område, navnlig når det drejer sig om fingerbløddele eller - sener.
Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
4 dage i gennemsnit uden nogen følger for sundheden og zooteknisk adfærd.
These reactions resolve spontaneously in maximum 4 days in average without any consequence on the health and the zootechnical performances.