natgillin/translations-raw huggingface dataset:
God veterinær praksis foreskriver, at antiemetika bør bruges sammen med andre veterinære og støttende forholdsregler, som kontrolleret fodring og væsketerapi rettet mod den specifikke årsag til opkastningerne.
2 Good veterinary practice indicates that antiemetics should be used in conjunction with other veterinary and supportive measures, such as dietary control and fluid replacement therapy while addressing the underlying causes of the vomiting.
Det veterinærmedicinske lægemiddels sikkerhed er ikke undersøgt hos hunde yngre end 16 uger og hos drægtige og diegivende tæver.
The safety of the veterinary medicinal product has not been established in dogs less than 16 weeks of age and in pregnant or lactating bitches.
Bruges kun efter risikovurdering af den ansvarlige dyrlæge.
Use only according to the benefit/risk assessment by the responsible veterinarian.
Cerenia bør bruges med forsigtighed til dyr, der lider af eller er prædisponerede for hjertelidelse, da maropitant har affinitet til Ca - og K - ion kanaler.
Cerenia should be used with caution in animals suffering from or with predisposition for cardiac diseases as maropitant has affinity to Ca- and K-ion channels.
Denne stigning sandsynligvis uden klinisk betydning.
Increases of approximately 10% in the QT interval of the ECG were observed in a study on healthy beagle dogs administered 8 mg/kg orally; however, such an increase is unlikely to be of clinical significance.
Efter administration af en dosis på 8 mg/ kg sås af og til tilfælde af opkastning inden rejsens begyndelse, som regel inden for to timer efter dosering.
Incidents of pre-travel vomiting, usually within two hours post-dosing were commonly reported after administration of the 8 mg/kg dose.
Må kun bruges efter risikovurdering af den ansvarlige dyrlæge, da der for ingen dyrearters vedkommende er foretaget konklusive reproduktionstoksikologiske undersøgelser.
Use only according to the benefit/risk assessment by the responsible veterinarian, because conclusive reproductive toxicity studies have not been conducted in any animal species.
Cerenia bør ikke bruges samtidigt med potente Ca- antagonister, da maropitant har affinitet til Ca- ion- kanalerne.
Cerenia should not be used concomitantly with Ca-channel antagonists as maropitant has affinity to Ca-channels.
3 4. 9 Dosering og indgivelsesvej
4.9 Amounts to be administered and administration route
Mod transportsyge anbefales at give et let måltid eller en godbid før dosering, Lang faste inden administrationen bør undgås.
For motion sickness a light meal or snack before dosing is recommended; prolonged fasting before administration should be avoided.
Cerenia- tabletter bør ikke gives ” indpakket ” i foder, da dette kan forsinke opløsningen af tabletten og dermed tablettens virkning.
However, Cerenia tablets should not be administered wrapped or encapsulated in food as this may delay dissolution of the tablet and consequently the onset of efficacy.
Til behandling og forebyggelse af opkastning (undtagen transportsyge)
3 For the Treatment and Prevention of Vomiting (except Motion Sickness)
Derfor kan tabletten gives aftenen før behandling med et middel, der kan fremkalde 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 dagligt 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 five days.
Behandling og forebyggelse af opkastning (undtagen transportsyge)
Treatment and prevention of vomiting (except motion sickness)
Hundens vægt
Dog body weight
Antal tabletter
of Tablets
(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 – 1 2.0 12.1 – 24.0 24.1 – 30.0 30.1 – 60.0
Til forebyggelse af opkastning forårsaget af transportsyge
For Prevention of Vomiting induced by Motion Sickness
For at forebygge opkastning forårsaget af transportsyge gives Cerenia- tabletter en gang dagligt med en dosis på 8 mg maropitant pr. kg. legemsvægt med det antal tabletter, som er angivet i nedenstående tabel.
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.
4 Forebyggelse af transportsyge
Prevention of motion sickness
Antal tabletter Hundens vægt (kg)
Number of Tablets
60 mg 1
mg 60 mg ½ 1 2 1
7, 6 – 10, 0 10, 1 – 15, 0 15, 1 – 20, 0 20, 1 – 30, 0 30, 1 – 40, 0 40, 1 – 60, 0
2
2
½ 1
½ 1 1½ 2 3
1½ 2 3
Da den farmakokinetiske variation er stor og maropitant akkumuleres i kroppen efter en daglig, gentagent dosis, kan lavere dosis end den anbefalede være tilstrækkelig hos nogle hunde, når dosis skal gentages.
4 As the pharmacokinetic variation is large and maropitant accumulates in the body after once daily repeated administration, lower doses than recommended might be sufficient in some individuals and when repeating the dose.
Cerenia tabletter givet daglig i 15 dage i doser op til 10 mg/ kg legemsvægt per dag tåltes godt.
Cerenia tablets were well tolerated when administered for 15 days at dosages up to 10 mg/kg bodyweight per day.
Ved doser højere end 20 mg/ kg er der set sporadiske 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 administered at doses in excess of 20 mg/kg.
Antiemetikum ATCvet- kode:
Antiemetics and Antinauseants, ATCvet code:
QA04AD90 Maropitant er en potent og selektiv neurokinin (NK- 1) receptor antagonist, som virker ved at hæmme bindingen af substans P, et neuropeptid af tachykinin gruppen, i centralnervesystemet.
Maropitant is a potent and selective neurokinin (NK-1) receptor antagonist, which acts by inhibiting the binding of substance P, a neuropeptide of the tachykinin family, in the CNS.
Maropitant er en neurokinin 1 (NK1) receptor- antagonist, som virker ved at hæmme bindingen af substans P, et neuropeptid af tachykinin gruppen.
Maropitant is a neurokinin 1 (NK1) receptor antagonist, which acts by inhibiting the binding of substance P, a neuropeptide of the tachykinin family.
En række forskellige in vitro tests har vist, at maropitant binder sig selektivt til NK1 receptoren med dosisafhængig funktionel
A variety of in vitro assays have demonstrated that maropitant binds selectively at the NK1 receptor with dose-dependent functional antagonism of substance P activity.
In vivo undersøgelser i hunde viste den antiemetiske effekt af maropitant mod centrale og perifere emetika inklusive apomorfin, cisplatin og syrupus ipecacuana.
In vivo studies in dogs demonstrated the anti-emetic efficacy of maropitant against central and peripheral emetics including apomorphine, cisplatin and syrup of ipecac.
Dette blev nået inden for 1, 9 timer efter dosering (Tmax).
The pharmacokinetic profile of maropitant when administered as a single oral dose of 2 mg/kg body weight to dogs was characterised by a maximum concentration (Cmax) in plasma of approximately 81 ng/ml; this was achieved within 1.9 hours post-dosing (Tmax).
Peak- koncentrationerne blev fulgt af et fald i systemisk eksponering med en omtrentlig eliminationshalveringstid (t ½,) på 4, 03 timer.
Peak concentrations were followed by a decline in systemic exposure with an apparent elimination half-life (t0.5) of 4.03 hours.
Ved en dosis på 8 mg/ kg, blev Cmax på 776 ng/ ml nået 1, 7 timer efter dosering.
At a dose of 8 mg/kg, Cmax of 776 ng/ml was reached at 1.7 hours post-dosing.
Eliminationshalveringstiden efter 8 mg/ kg var 5, 47 timer.
The elimination half- life at 8 mg/kg was 5.47 hours.
Den individuelle variation i kinetikken kan være stor, op til 70 CV% for AUC.
The inter-individual variation in kinetics may be large, up to 70 CV% for AUC.
I kliniske studier viste maropitant plasma niveauerne effekt fra 1 time efter administrationen.
During clinical studies maropitant plasma levels conferred efficacy from 1 hour after administration.
Beregninger af den orale biotilgængelighed af maropitant var 23, 7% efter 2 mg/ kg og 37, 0% efter 8 mg/ kg.
5 Estimates for the oral bioavailability of maropitant were 23.7% at 2 mg/kg and 37.0% at 8 mg/kg.
Steady- state fordelingsvolumen (Vss) bestemt efter intravenøs administration af 1- 2 mg/ kg lå fra omkring 4, 4 til 7, 0 l/ kg.
The volume of distribution at steady-state (Vss) determined after intravenous administration at 1 - 2 mg/kg ranged from approximately 4.4 to 7.0 l/kg.
Maropitant viser non- lineær farmakokinetik (AUC forøges mere end proportionalt med stigende dosis) efter oral indgift i intervallet 1 – 16 mg/ kg.
Maropitant displays non-linear pharmacokinetics (AUC increases more than proportionally with increasing dose) when administered orally within the 1 - 16 mg/kg dose range.
Efter gentagen daglig oral administration i fem på hinanden følgende dage af 2 mg/ kg var akkumulationen 151%.
Following repeated oral administration for five consecutive days at a daily dose of 2 mg/kg, accumulation was 151%.
Efter oral administration gentaget i to på hinanden følgende dage med en daglig dosis på 8 mg/ kg var akkumulationen 218%.
Following repeated oral administration for two consecutive days at a daily dose of 8 mg/kg, accumulation was 218%.
Renal clearance er en ubetydelig eliminationsvej med mindre end 1% genfundet i urinen enten som maropitant eller dens største metabolit efter en oral dosis på 8 mg/ kg.
Renal clearance is a minor route of elimination, with less than 1% of an 8 mg/kg oral dose appearing in the urine as either maropitant or its major metabolite.
Plasma proteinbindingen af maropitant er hos hunde højere end 99%.
Plasma protein binding of maropitant in dogs is more than 99%.
Croskarmellose natrium Laktose monohydrat Magnesiumstearat Mikrokrystallinsk cellulose
Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Sunset Yellow (E110) as a colourant
Sunset Yellow (E110) som farve.
6.2 Incompatibilities
6 6. 3 Opbevaringstid
6. 3 Shelf life
Opbevaringstid for veterinærlægemidlet i salgspakning:
Shelf life of the product as packaged for sale:
3 år Opbevaringstid efter halvering af tabletter:
3 years Shelf life of half tablets:
2 dage.
2 days.
Papæske indeholdende en aluminium- aluminium blister pakning med fire tabletter i hver pakke.
Cardboard box containing one aluminium-aluminium blister pack, each containing four tablets per pack.
Pfizer Limited Ramsgate Road Sandwich Kent CT 13 9NJ England
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
EU/ 2/ 06/ 062/ 001 (16 mg tabletter) EU/ 2/ 06/ 062/ 002 (24 mg tabletter) EU/ 2/ 06/ 062/ 003 (60 mg tabletter) EU/ 2/ 06/ 062/ 004 (160 mg tabletter)
EU/2/06/062/001 (16 mg tablets) EU/2/06/062/002 (24 mg tablets) EU/2/06/062/003 (60 mg tablets) EU/2/06/062/004 (160 mg tablets)
Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur (EMEA) http: // www. emea. europa. eu /
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
7 INJEKTIONSVÆSKE, OPLØSNING
7 SOLUTION FOR INJECTION
Cerenia 10 mg pr. ml, injektionsvæske, opløsning.
Cerenia 10 mg/ml solution for injection for dogs.
Injektionsvæsken indeholder 10 mg maropitant pr. ml som maropitant citrat monohydrat.
The solution for injection contains 10 mg maropitant per ml as maropitant citrate monohydrate.
Injektionsopløsningen indeholder 3, 3 mg/ ml metakresol (som konserveringsmiddel).
The solution for injection contains 3.3 mg/ml metacresol (as preservative).
En klar, farveløs til svagt gul opløsning.
Solution for injection A clear, colourless to light yellow solution.
• Til forebyggelse af opkastning med undtagelse af opkastning i forbindelse med transportsyge. • Til behandling af opkastning i kombination med anden støtteterapi.
For the treatment of vomiting, in combination with other supportive measures.
Brug af Cerenia- injektionsvæske, opløsning mod opkastning forårsaget af køresyge anbefales ikke.
The use of Cerenia solution for injection against vomiting due to motion sickness is not recommended.
8 4. 5 Særlige forsigtighedsregler vedrørende brugen
8 4.5 Special precautions for use
Cerenia bør bruges med forsigtighed til dyr, der lider af, eller er prædisponerede for hjertelidelser, da maropitant har affinitet til Ca - og K- ion- kanalerne.
Cerenia should be used with caution in animals suffering from or with predisposition for cardiac diseases as maropitant has affinity to Ca- and K-ion channels.
Denne stigning er sandsynligvis uden klinisk betydning.
Increases of approximately 10% in the QT interval of the ECG were observed in a study on healthy beagle dogs administered 8 mg/kg orally; however, such an increase is unlikely to be of clinical significance.
I tilfælde af at stoffet ved et uheld kommer i øjet, skyl øjet med masser af vand og søg læge.
In the case of accidental eye exposure, flush the eyes with plenty of water and seek medical attention
Smerte på injektionsstedet kan forekomme.
Pain at injection site may occur.
Må kun bruges efter risikovurdering af den ansvarlige dyrlæge, da der for ingen dyrearters vedkommende er gennemført konklusive reproduktionstoksikologiske undersøgelser.
Use only according to the benefit/risk assessment by the responsible veterinarian, because conclusive reproductive toxicity studies have not been conducted in any animal species.
Cerenia bør ikke bruges samtidigt med potente Ca- antagonister, da maropitant har affinitet til Ca - kanalerne.
Cerenia should not be used concomitantly with Ca-channel antagonists as maropitant has affinity to Ca-channels.
Cerenia er i udstrakt grad plasmaproteinbundet og kan konkurrere med andre stærkt bundne stoffer.
Maropitant is highly bound to plasma proteins and may compete with other highly bound medicines.
Cerenia injektionsvæske, opløsning skal injiceres subkutant, en gang dagligt med en dosis på 1 mg/ kg legemsvægt (1 ml/ 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 fem dage.
Cerenia can be used to treat or prevent vomiting either as tablets or as solution for injection once daily for up to five days
Varigheden af effekten er omkring 24 timer og derfor kan behandlingen gives aftenen før behandling med et middel, der kan give opkastning, 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.
9 4. 10 Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt Der blev ikke observeret nogen toksisk effekt i forsøg, hvor hunde fik daglige injektioner med Cerenia injektionsvæske, opløsning op til 5 mg/ kg (5 gange dosis) i 15 på hinanden følgende dage (3 gange den anbefalede doseringsvarighed).
Cerenia solution for injection was well tolerated in dogs injected daily with up to 5 mg/kg (5 times the use dose) for 15 consecutive days (3-times the recommended duration of administration).
Antiemetikum, ATCvet- kode:
Antiemetic, ATCvet code:
Maropitant er en potent og selektiv neurokinin (NK- 1) receptor- antagonist, som virker ved at hæmme bindingen af substans P, et neuropeptid af tachykinin gruppen, i centralnervesystemet.
Maropitant is a potent and selective neurokinin (NK-1) receptor antagonist, which acts by inhibiting the binding of substance P, a neuropeptide of the tachykinin family, in the CNS.
En række forskellige in vitro tests har vist, at maropitant binder sig selektivt til NK1- receptoren med dosisafhængig funktionel antagonisme af aktiviteten af substans P.
A variety of in vitro assays have demonstrated that maropitant binds selectively at the NK1 receptor with dose-dependent functional antagonism of substance P activity.
In vivo undersøgelser forsøg med hunde viste den maropitant antiemetiske effekt mod centrale og perifere emetika inklusive apomorfin, cisplatin og syrupus ipecacuana.
In vivo studies in dogs demonstrated the anti-emetic efficacy of maropitant against central and peripheral emetics including apomorphine, cisplatin and syrup of ipecac.
Symptomer på kvalme som kraftig savlen og sløvhed kan fortsætte efter behandling.
Signs of nausea including excessive salivation and lethargy might remain after treatment.
Dette blev nået inden for 0, 75 timer efter dosering (Tmax).
The pharmacokinetic profile of maropitant when administered as a single subcutaneous dose of 1 mg/kg body weight to dogs was characterised by a maximum concentration (Cmax) in plasma of approximately 92 ng/ml; this was achieved within 0.75 hours post-dosing (Tmax).
Peak- koncentrationerne blev fulgt af et fald i systemisk eksponering med en omtrentlig eliminationshalveringstid (t ½,) på 8, 84 timer.
Peak concentrations were followed by a decline in systemic exposure with an apparent elimination half-life (t1/2) of 8.84 hours.
I kliniske forsøg havde Maropitant plasmaniveauer effekt en time efter administration.
During clinical studies maropitant plasma levels conferred efficacy from 1 hour after administration.
Den subkutane biotilgængelighed af maropitant til hunde var 90, 7%.
The bioavailability of maropitant after subcutaneous administration in dogs was 90.7%.
Steady- state fordelingsvolumen (Vss) bestemt efter intravenøs administration på 1- 2 mg/ kg lå fra omkring 4, 4 til 7, 0 l/ kg.
The volume of distribution at steady-state (Vss) determined after intravenous administration at 1 - 2 mg/kg ranged from approximately 4.4 to 7.0 L/kg.
Maropitant viser lineær farmakokinetik efter subkutan indgivelse af 0, 5 – 2 mg/ kg.
Maropitant displays linear kinetics when administered subcutaneously within the 0.5 – 2 mg/kg dose range.
Efter gentagen subkutan administration i daglige doser på 1 mg/ kg legemsvægt i fem på hinanden følgende dage var akkumulationen 146%.
Following repeated subcutaneous administration of once-daily doses of 1 mg / kg bodyweight for five consecutive days, accumulation was 146%.
10 Renal clearance er en ubetydelig eliminationsvej med mindre end 1% af en subkutan dosis på 1 mg/ kg genfundet i urinen enten som maropitant eller dens største metabolit.
10 Renal clearance is a minor route of elimination, with less than 1% of a 1 mg/kg subcutaneous dose appearing in the urine as either maropitant or its major metabolite.
Plasma proteinbindingen af maropitant hos hunde er højere end 99%.
Plasma protein binding of maropitant in dogs is more than 99%.
6. 1 Fortegnelse over hjælpestoffer Sulfobutylether β- cyklodekstrin (SBECD) Vand til injektionsvæske Metakresol (som konserveringsmiddel).
Sulphobutyl ether β-cyclodextrin (SBECD) Water for injections Metacresol (as preservative)
2 år Opbevaringstid efter åbning:
2 years.
28 dage.
Once broached, use within 28 days.
20 ml, ravfarvet glashætteglas type 1, chlorobutyl gummiprop og aluminiumhætte med afrivningsflap.
20 ml, amber molded glass type 1 vial, chlorobutyl rubber stopper and aluminium overseal with flip- off button.
Hver æske indeholder 1 hætteglas.
Each cardboard outer contains 1 vial.
11 10.
11 10.
FORBUD MOD SALG, UDLEVERING OG/ ELLER BRUG Ikke relevant.
PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
Pfizer Global Manufacturing (PGM) Z. I. de Pocé F- 37530 Pocé sur Cisse Frankrig
I. de Pocé 29 route des Industries F-37530 Pocé sur Cisse France
Indehaveren af denne markedsføringstilladelse må informere Europa Kommissionen om markedsføringsplanerne for lægemidlet autoriseret ved denne beslutning.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
16 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Æske af karton. / Tabletter
CARDBOARD CARTON / Tablets
Cerenia 16 mg tabletter
Cerenia 16 mg tablets for dogs
Maropitant
Maropitant
Tabletterne indeholder Sunset Yellow (E110) som farvestof.
The tablets also contain Sunset yellow (E110) as a colourant.
4 tabletter.
4 tablets
Gives i munden.
Oral use.
8 mg/ kg legemsvægt mod transportsyge.
2 mg/kg bodyweight for prevention and treatment of vomiting 8 mg/kg bodyweight for motion sickness.
Det anbefales at starte behandling af opkastning med Cerenia injektionsvæske, opløsning.
It is recommended to initiate treatment of emesis with Cerenia Solution for Injection.
UDL. D.
EXP {month/year}
{måneder/ år}
Not applicable.
SÆRLIGE OPBEVARINGSBETINGELSER
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
TEKSTEN “ KUN TIL DYR ” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Pfizer Limited Ramsgate Road Sandwich Kent CT 13 9NJ England
Marketing Authorisation Holder Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UK
Lot nummer
Lot
18 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
18 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blister / tabletter
BLISTER / Tablets
(Måned/ år)
EXP {month/year}
TEKSTEN ” TIL DYR ”
THE WORDS “FOR ANIMAL TREATMENT ONLY”
19 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
19 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Cerenia 24 mg
Cerenia 24 mg tablets for dogs Maropitant
22 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
22 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Cerenia 60 mg
Cerenia 60 mg tablets for dogs
24 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
24 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
25 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
25 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Cerenia 160 mg
Cerenia 160 mg tablets for dogs Maropitant
8 mg/ kg legemsvægt mod transportsyge.
8 mg/kg bodyweight for motion sickness.
{måneder/ år}
EXP {month/year}
SÆRLIGE OPBEVARINGSBETINGELSER 26 Ingen
26 10.
28 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
28 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Æske af karton / Injektionsvæske. opløsning
CARDBOARD CARTON / Solution for injection
Cerenia 10 mg pr. ml injektionsvæske, opløsning.
Cerenia 10 mg/ml solution for injection for dogs
10 mg maropitant pr. ml som maropitant citrat monohydrat.
10 mg maropitant per ml as maropitant citrate monohydrate.
Metakresol som konserveringsmiddel.
Metacresol as preservative.
Injiceres subkutant.
Subcutaneous use.
1 mg/ kg legemsvægt.
1 mg/kg bodyweight
28 dage.
EXP {month/year} Once broached, use by:…………..
Pfizer Limited Ramsgate Road Sandwich Kent CT 13 9NJ England
Marketing Authorisation Holder Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
30 MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER
30 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Hætteglas / Injektionsvæske, opløsning
GLASS VIAL / Solution For Injection
Cerenia 10 mg pr. ml injektionsvæske, opløsning. Til hunde
Cerenia 10 mg / ml solution for injection for dogs
{måneder/ år} / EXP Efter anbrud/ åbning anvendes inden 28 dage
EXP {month/year} Once broached, use within 28 days.
32 INDLÆGSSEDDEL Cerenia tabletter til hunde
32 PACKAGE LEAFLET FOR:
Pfizer PGM 37530 Poce sur Cisse Frankrig
Manufacturing Authorisation Holder Responsible for Batch Release Pfizer PGM 37530 Pocé sur Cisse France
ANGIVELSE AF DET AKTIVE STOF( FER) OG ANDRE INDHOLDSSTOFFER
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Tabletterne er svagt orange og har delekærv på begge sider som gør, at tabletten kan deles i to stykker.
The tablets also contain Sunset Yellow (E110) as a colourant The tablets are pale orange and have a score line on both sides allowing the tablet to be halved.
Hver tablet er mærket med Pfizer logo på bagsiden.
Each tablet is marked with the Pfizer logo on the reverse side.