natgillin/translations-raw huggingface dataset:
Da en utilsigtet indtagelse af lægemidlet kan forårsage alvorlige reaktioner hos børn, leveres tabletterne i en flaske forsynet med børnesikker lukning.
Since accidental ingestion might cause serious reactions in children, the tablets are supplied in a bottle fitted with a child resistant closure.
Hvis en person ved en fejl indtager lægemidlet, skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
If a person accidentally takes the medicine, seek medical advice immediately and show the package leaflet or the label to a doctor.
Hvorfor blev Clomicalm godkendt?
Why has Clomicalm been approved?
Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Clomicalm er større end risiciene, når det anvendes i kombination med adfærdsændrende teknikker som en hjælp i behandlingen af hunde med separationsrelaterede lidelser, og anbefalede udstedelse af markedsføringstilladelse for Clomicalm.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Clomicalm exceed the risks when used in combination with behavioural modification techniques as an aid in the treatment of dogs with separation-related disorders, and recommended that Clomicalm be given a marketing authorisation.
Andre oplysninger om Clomicalm:
Other information about Clomicalm:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clomicalm til Novartis Tiergesundheit GmbH i Tyskland den 1. april 1998 og fornyede den i 2003 og 2008.
The European Commission granted a marketing authorisation valid throughout the European Union, for Clomicalm to Novartis Tiergesundheit GmbH, Germany on 1 April 1998, which was renewed in 2003 and 2008.
© EMEA 2008 Side 2/ 2
Page 2/ 2
5, 00 mg (svarende til 4, 5 mg clomipramin)
5 mg (equivalent to 4.5 mg Clomipramine)
Clomipramin hydrochlorid Clomipramin hydrochlorid
Clomipramine hydrochloride Clomipramine hydrochloride
20, 00 mg (svarende til 17, 9 mg clomipramin) 80, 00 mg (svarende til 71, 7 mg clomipramin)
20 mg (equivalent to 17.9 mg Clomipramine) 80 mg (equivalent to 71.7 mg Clomipramine)
4. 4 Særlige advarsler < for hver enkelt dyreart, som lægemidlet er beregnet til >
4.4 Special warnings
Effektiviteten og sikkerheden af Clomicalm er ikke undersøgt hos hunde med en legemsvægt under på mindre end 1, 25 kg eller under 6 måneders alder.
The efficacy and safety of Clomicalm has not been established in dogs weighing less than 1.25 kg or under six months of age.
Særlige forsigtighedsregler vedrørende brug til dyr Til hunde med nedsat hjertefunktion og epilepsi anbefales det at administrere Clomicalm med forsigtighed, og kun efter at have vurderet ratio af risk- benefit.
Special precautions for use in animals It is recommended that Clomicalm be administered to dogs with cardiovascular dysfunction or epilepsy with caution and only after an assessment of the benefit risk ratio.
2 Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Hvis børn ved et uheld indtager præparatet, skal dette betragtes med alvor.
2 Special precautions to be taken by the person administering the veterinary medicinal product to animals In children, accidental ingestion should be regarded as serious.
Sygdomme i lever og galdesystem har været rapporteret, specielt ved præ- eksisterende forhold og ved samtidig administration af lægemidler, der metaboliseres via leveren.
Hepato-biliary disease has been reported, especially with pre-existing conditions, and concurrent administrations of drugs metabolized via the hepatic system.
Clomicalm kan potensere effekten af det anti- arrytmiske middel quinidin, anticholinerge stoffer (f. eks. atropin), andre CNS- aktive stoffer (f. eks. barbiturater, benzodiazepiner, anæstetika, neuroleptika), sympatomimetika (f. eks. adrenalin) og coumarin derivater.
Clomicalm may potentiate the effects of the anti-arrhythmic drug quinidine, anticholinergic agents (e. g. atropine), other CNS active drugs (e. g. barbiturates, benzodiazepines, general anaesthetics, neuroleptics), sympathomimetics (e. g. adrenaline) and coumarin derivatives.
Det anbefales at undgå administration af Clomicalm i kombination med eller indenfor 2 uger efter ophør med behandling med monoamin- oxidasehæmmere.
The administration of Clomicalm is not recommended in combination with, or within 2 weeks of therapy with, monoamine oxidase inhibitors.
Plasmakoncentrationen af visse anti- epileptiske lægemidler, så som phenytoin og carbamazepin, kan stige ved samtidig administration af Clomicalm.
Plasma levels of certain anti- epileptic drugs, such as phenytoin and carbamazepine, may be increased by co-administration with Clomicalm.
Clomicalm gives oralt i en doser på 1- 2 mg/ kg to gange dagligt med en total daglig dosis på 2- 4 mg/ kg svarende til nedenstående tabel:
Clomicalm should be administered orally at a dose of 1-2 mg/ kg clomipramine twice daily to give a total daily dose of 2-4 mg/ kg according to the following table:
Dosis per indgift Kropsvægt 1. 25 - 2. 5 kg > 2. 5 - 5 kg > 5 - 10 kg > 10 - 20 kg > 20 - 40 kg > 40 - 80 kg
Dosage per administration Body weight 1.25 - 2.5 kg > 2.5 - 5 kg > 5 - 10 kg > 10 - 20 kg > 20 - 40 kg > 40 - 80 kg
Clomicalm 5 mg ½ tablet 1 tablet
Clomicalm 5 mg ½ tablet 1 tablet
Clomicalm 20 mg ½ tablet 1 tablet
Clomicalm 20 mg ½ tablet 1 tablet
Clomicalm 80 mg ½ tablet 1 tablet
Clomicalm 80 mg ½ tablet 1 tablet
Kliniske afprøvninger har vist at 2- 3 måneders behandling med Clomicalm i kombination med modificerende opdragelsesteknikker er tilstrækkeligt til at kontrollere symptomerne på separationsrelaterede problemer.
In clinical trials, a treatment time of 2-3 months with Clomicalm in combination with behavioural modification techniques was sufficient to control the symptoms of separation-related disorders.
3 4. 10 Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt
3 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
12 timer efter administration.
At overdose with 20 mg/ kg Clomicalm (5 times the maximum therapeutic dose), bradycardia and arrhythmias (atrioventricular node block and ventricular escape beats) were observed approximately 12 hours after dosing.
Overdosering med 40 mg/ kg (20 gange den anbefalede dosis) Clomicalm forårsagede krumrygget stilling, mindre rystelser, udspilet bug og nedsat aktivitet hos hunde.
Overdose with 40 mg/ kg (20 times the recommended dose) of Clomicalm produced hunched posture, tremors, flushed abdomen and decreased activity in dogs.
Højere doser (500 mg/ kg, d. v. s.
Higher doses (500 mg/ kg i. e.
Endnu højere doser (725 mg/ kg) forårsagede desuden kramper og død.
Still higher doses (725 mg/ kg) produced, in addition, convulsions and death.
ATCvet- kode:
Non-selective monoamine re-uptake inhibitors, ATCvet code:
Dets egenskaber svarer derfor både til en serotonin reuptake- hæmmer og et tricyklisk antidepressivum.
It therefore possesses the properties of a serotonin re-uptake inhibitor and a tricyclic antidepressant.
Både clomipramin og desmethylclomipramin bidrager til effekten af Clomicalm: clomipramin er en potent og selektiv 5- HT reuptake- hæmmer, medens desmethylclopramin er en potent og selektiv noradrenalin reuptake- hæmmer.
Both clomipramine and desmethylclomipramine contribute to the effects of Clomicalm: clomipramine is a potent and selective 5-HT reuptake inhibitor while desmethylclomipramine is a potent and selective noradrenaline reuptake inhibitor.
Den principielle virkning af Clomicalm er potensering af effekten af 5- HT og noradrenalin i hjernen ved hæmning af deres neurale reuptake.
The principle mechanism of action of clomipramine is potentiation of the effects of 5-HT and noradrenaline in the brain by inhibiting their neuronal reuptake.
Clomipramin absorberes godt (> 80%) fra mavetarmkanalen i hunde, når det administreres oralt, men den systemiske biotilgængelighed af clomipramin og desmethylclomipramin er 22- 26% på grund af omfattende first pass metabolisme i leveren.
Clomipramine is well absorbed (> 80%) from the gastrointestinal tract in dogs when administered orally but the systemic bioavailability for clomipramine and desmethylclomipramine is 22-26% due to extensive first pass metabolism by the liver.
Maksimalt plasmaniveau af clomipramin og desmethylclomipramin opnås hurtigt (1½- 2½ time).
1.5-2.5 hours).
De maksimale plasmakoncentrationer (Cmax) efter oral administration af enkelte doser af 2 mg/ kg clomipraminhydrochlorid var 240 nmol/ l for clomipramin og 48 nmol/ l for desmethylclomipramin.
240 nmol/ l for clomipramine and 48 nmol/ l for desmethylclomipramine.
Gentagen administration af Clomicalm forårsager moderate stigninger i plasmakoncentrationer, akkumuleringsratio efter oral administration to gange daglig var 1. 2 for clomipramin og 1. 6 for desmethylclomipramin, steady state blev nået indenfor 3 dage.
Repeated administration of Clomicalm causes moderate increases in plasma concentrations, accumulation ratios after oral administration twice daily were 1.2 for clomipramine and 1.6 for desmethylclomipramine, with steady state being reached within 3 days.
3: 1.
At steady state, the ratio of plasma clomipramine to desmethylclomipramine concentrations is approximately 3:1.
Clomipramin bindes i udstrakt grad til plasmaproteiner (> 97%) hos hunde.
Clomipramine is extensively bound to plasma proteins (> 97%) in dogs.
Biotransformationen af clomipramin
In dogs, the volume of distribution (VDss) is 3.8 l/ kg.
demethylering til desmethylclomipramin.
The major route of biotransformation of clomipramine is demethylation to desmethylclomipramine.
Eliminations- t½ efter intravenøs administration af clomipraminhydroklorid hos hund var 6. 4 timer for clomipramin og 3. 6 timer for desmethylclomipramin.
The elimination t1/ 2 after intravenous administration of clomipramine hydrochloride in dogs was 6.4 hours for clomipramine and 3.6 hours for desmethylclomipramine.
Den primære udskillelsesvej hos hunde er via galden (> 80%), resten udskilles gennem nyrerne.
The principle route of excretion in dogs is via the bile (> 80%) with the remainder via the urine.
4 6. 1 Fortegnelse over hjælpestoffer
6.1 List of excipients
Lactosemonohydrat Mikrokrystallinsk cellulose Kunstig kødsmag Crospovidon Povidon Kolloid vandfri silica Magnesiumstearat
Lactose monohydrate Microcristalline cellulose Artificial meat flavour Crospovidone Povidone Colloidal anhydrous silica Magnesium stearate
Novartis Tiergesundheit GmbH Zielstattstrasse 40 D- 81379 München Tyskland
Novartis Tiergesundheit GmbH Zielstattstrasse 40 D-81379 Munich Germany
DATO FOR ÆNDRING AF TEKSTEN
5 10 DATE OF REVISION OF THE TEXT
Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur (EMEA) http: // www. emea. europa. eu.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN, BEGRÆNSNINGER FOR UDLEVERING OG BRUG
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Usine de Huningue 26, rue de la Chapelle F- 68332 Huningue Cedex Frankrig
Usine de Huningue 26, rue de la Chapelle F-68332 Huningue Cedex France
BEGRÆNSNINGER FOR UDLEVERING OG BRUG
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Clomicalm 5 mg tabletter til hunde
Clomicalm 5 mg tablets for dogs
5 mg (svarende til 4, 5 mg clomipramin)
5 mg (equivalent to 4.5 mg Clomipramine)
INDIKATION( ER)
INDICATION
Clomicalm indgives to gange dagligt i en doser af 1 - 2 mg/ kg med en total dagsdosis på 2 - 4 mg/ kg i henhold til følgende tabel:
Clomicalm is administered twice daily at a dose of 1-2 mg/ kg clomipramine to give a total daily dose of 2 - 4 mg/ kg according to the following table:
Kropsvægt 1, 25 - 2, 5 kg > 2, 5 - 5 kg
1.25-2.5 kg > 2.5-5 kg
Clomicalm 5 mg ½ tablet 1 tablet
½ tablet 1 tablet
SÆRLIG( E) ADVARSEL/ ADVARSLER, OM NØDVENDIGT
SPECIAL WARNINGS, IF NECESSARY
EXP (måned/ år)
EXP {month/ year}
Lot {nummer} OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
Lot {number}
12 1.
CARDBOX
20 mg (svarende til 17, 9 mg clomipramin)
20 mg (equivalent to 17.9 mg Clomipramine)
Clomicalm indgives to gange dagligt i en doser af 1 - 2 mg/ kg med en total dagsdosis på 2- 4 mg/ kg i henhold til følgende tabel:
Clomicalm is administered twice daily at a dose of 1-2 mg/ kg clomipramine to give a total daily dose of 2 - 4 mg/ kg according to the following table:
Kropsvægt > 5 - 10 kg > 10 - 20 kg
Clomicalm 20 mg
Clomicalm 20 mg ½ tablet 1 tablet
½ tablet 1 tablet
13 Ikke relevant
WITHDRAWAL PERIOD
14 1.
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
80 mg (svarende til 71, 7 mg clomipramin)
80 mg (equivalent to 71.7 mg Clomipramine)
Clomicalm indgives to gange dagligt i en doser af 1 - 2 mg/ kg med en total dagsdosis på 2- 4 mg/ kg i henhold til følgende tabel:
Clomicalm is administered twice daily at a dose of 1-2 mg/ kg clomipramine to give a total daily dose of 2-4 mg/ kg according to the following table:
Kropsvægt > 20 - 40 kg > 40 - 80 kg
Body weight
Clomicalm 80 mg ½ tablet 1 tablet
Clomicalm 80 mg
Læs indlægssedlen inden brug.
> 20-40 kg > 40-80 kg
TILBAGEHOLDELSESTID
½ 5 tablet 1 tablet
15 Ikke relevant
WITHDRAWAL PERIOD
16 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
16 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Clomicalm 5 mg tabletter til hunde
5 mg tablets for dogs
Clomipramin hydrochlorid
Clomipramine hydrochloride 5 mg (equivalent to 4.5 mg Clomipramine)
1- 2 mg Clomipramin hydrochlorid / kg kropsvægt to gange dagligt.
1-2 mg clomipramine/ kg bw twice daily.
Opbevares utilgængeligt for børn, Utilsigtet indtagelse kan være farlig
Accidental ingestion should be regarded as serious.
18 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
18 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Clomicalm 20 mg tabletter til hunde
Clomicalm 20 mg tablets for dogs Clomipramine hydrochloride
20 mg (svarende til 17, 9 mg clomipramin)
Clomipramine hydrochloride 20 mg (equivalent to 17.9 mg Clomipramine)
Utilsigtet indtagelse kan være farlig
Keep out of the reach and sight of children. Accidental ingestion should be regarded as serious.
Lot {Nummer}
Lot {number}
20 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
20 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Clomicalm 80 mg tabletter til hunde
80 mg tablets for dogs
80 mg (svarende til 71, 7 mg clomipramin)
Clomipramine hydrochloride 80 mg (equivalent to 71.7 mg Clomipramine)
1 - 2 mg Clomipramin hydrochlorid / kg kropsvægt to gange dagligt.
1-2 mg clomipramine/ kg bw twice daily.
23 INDLÆGSSEDDEL FOR:
23 PACKAGE LEAFLET FOR:
20 mg (svarende til 17, 9 mg clomipramin) 80 mg (svarende 71, 7 mg clomipramin)
20 mg (equivalent to 17.9 mg Clomipramine) 80 mg equivalent to 71.7 mg Clomipramine)
DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ( E)
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Kropsvægt 1. 25 - 2. 5 kg > 2. 5 - 5 kg > 5 - 10 kg > 10 - 20 kg > 20 - 40 kg > 40 - 80 kg
Body weight 1.25 - 2.5 kg > 2.5 - 5 kg > 5 - 10 kg > 10 - 20 kg > 20 - 40 kg > 40 - 80 kg
Clomicalm 5 mg ½ tablet 1 tablet
Clomicalm 5 mg ½ tablet 1 tablet --- --- --- ---
Clomicalm 20 mg ½ tablet 1 tablet
Clomicalm 20 mg --- --- ½ tablet 1 tablet --- ---
Clomicalm 80 mg ½ tablet 1 tablet
Clomicalm 80 mg --- --- --- --- ½ tablet 1 tablet
25 12.
25 12.
12. 1 Særlige forsigtighedsregler vedrørende brugen.
12.1 Special precautions for use:
Effektiviteten og sikkerheden af Clomicalm er ikke undersøgt hos hunde med en legemsvægt under 1, 25 kg eller under 6 måneders alder.
The efficacy and safety of Clomicalm has not been established in dogs weighing less than 1.25 kg or under six months of age.
12. 2 Anvendelse under drægtighed og diegivning:
12.2 Use during pregnancy and lactation:
Interaktioner med interaktioner:
12.3 Interaction with other medicaments:
Clomicalm kan forøge effekten af det anti- arrytmiske middel quinidin, anticholinerge stoffer (f. eks. atropin), andre CNS- aktive stoffer (f. eks. barbiturater, benzodiazepiner, anæstetika, neuroleptika), sympatomimetika (f. eks. adrenalin) og coumarin derivater.
Clomicalm may increase the effects of the anti-arrhythmic drug quinidine, anticholinergic agents (e. g. atropine), other CNS active drugs (e. g. barbiturates, benzodiazepines, general anaesthetics, neuroleptics), sympathomimetics (e. g. adrenaline) and coumarine derivatives.
Plasmakoncentrationen af visse anti- epileptiske lægemidler, så som phenytoin og carbamazepin, kan stige ved samtidig administration af Clomicalm.
Plasma levels of certain anti- epileptic drugs, such as phenytoin and carbamazepine, may be increased by coadministration with Clomicalm.
12. 4 Overdosering:
12.4 Overdose:
12 timer efter administrationen.
At overdose with 20 mg/ kg Clomicalm (5 times the maximum therapeutic dose), bradycardia and arrhythmias (atrioventricular node block and ventricular escape beats) were observed approximately 12 hours after dosing.
Overdosering med 40 mg/ kg (20 gange den anbefalede dosis) Clomicalm forårsagede krumrygget stilling, mindre rysteler, udspilet bug og nedsat aktivitet hos hunde.
Overdose with 40 mg/ kg (20 times the recommended dose) of Clomicalm produced hunched posture, tremors, flushed abdomen and decreased activity in dogs.
26 14.
14.
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
For yderligere oplysninger om præparatet bedes henvendelse rettet til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Alle disse cefalosporin- antibiotika, herunder cefovecin, dræber bakterierne ved at forstyrre opbygningen af bakteriernes cellevægge, således at bakterierne dør, og infektionen kureres.
All these cephalosporin antibiotics, including cefovecin, kill bacteria by disrupting the building of the bacterial cell walls, so the bacteria die and the infection is cured.
Én injektion varer i op til 14 dage.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Convenia been studied?
Convenia er blevet undersøgt hos hunde med infektioner i hud og blødt væv, (hvor det blev sammenlignet med et andet antibiotikum, der indeholdt amoxicillin og clavulansyre), og hos hunde med urinvejsinfektioner, (hvor det blev sammenlignet med et andet cefalosporin - antibiotikum, cefalexin).
Convenia has been studied in dogs with skin and soft tissue infections (where it was compared to another antibiotic containing amoxicillin and clavulanic acid) and in dogs with urinary tract infections (where it was compared to another cephalosporin antibiotic, cefalexin).
Convenia bør dog ikke anvendes hos hunde eller katte, der har vist sig at være allergiske over for cefalosporin - antibiotika eller antibiotika af penicillintypen.
However, it should not be used in dogs or cats which have shown an allergy to any cephalosporin or penicillin-type antibiotics.
Cefalosporin- antibiotika og antibiotika af penicillintypen kan forårsage allergier hos mennesker, og sommetider kan disse allergier være meget alvorlige.
Cephalosporin and penicillin antibiotics can cause allergies in humans, and sometimes these allergies can be very serious.
Alle personer, der er allergiske over for penicilliner eller cefalosporiner, bør ligeledes undgå kontakt med strøelse/ kattegrus der er anvendt af hunde eller katte, der er behandlet med Convenia.
Anyone allergic to penicillins or cephalosporins should also avoid contact with litter used by dogs or cats treated with Convenia.
Side 2/ 3 ©EMEA 2006 Hvorfor er Convenia blevet godkendt?
Page 2/ 3 ©EMEA 2006 Why has Convenia been approved?
Udvalget anbefalede, at der gives markedsføringstilladelse for Convenia.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Convenia exceed the risks for the treatment of dogs and cats with certain specified skin, soft tissue and urinary tract infections and recommended that Convenia should be given a marketing authorisation.
Europa- Kommissionen udstedte en markedsføringstilladelse for Convenia med gyldighed i hele Den Europæiske Union til Pfizer Ltd den 19. juni 2006.
The European Commission granted a marketing authorisation valid throughout the European Union, for Convenia to Pfizer Ltd on 19 June 2006.
Oplysninger om udleveringsbestemmelser for produktet findes på etiketten/ den ydre emballage.
Information on the prescription status of this product may be found on the label/ outer package.
Dette sammendrag blev sidst ajourført i juni 2006.
This summary was last updated in June 2006.
Side 3/ 3 ©EMEA 2006
Page 3/ 3 ©EMEA 2006
Handelsnavn Styrke
Pharmaceutical Form
Lægemiddelform
Target species
Dyrearter som Indgivelses lægemidlet er vej beregnet til
Route of administration
Pakningsstør relse
Package size
Pulver og opløsningsmiddel til
Powder and solvent for solution for
20 ml glas hætteglas
20 ml vial (glass)
852 mg
852 mg
injektionsvæske, opløsning
injection
Opløsningsmidd 15 ml glas hætteglas el:
15 ml vial (glass)
Convenia 80 mg/ ml pulver og solvens til injektionsvæske, opløsning til hunde og katte.
Convenia 80 mg/ ml powder and solvent for solution for injection for dogs and cats
Hvert hætteglas med frysetørret pulver indeholder:
Active substance:
Aktivt stof 852 mg cefovecin (som natriumsalt)
852 mg cefovecin (as sodium salt)
19, 17 mg methylparahydroxybenzoat (E218) 2, 13 mg propylparahydroxybenzoat (E216)
19.17 mg methyl parahydroxybenzoate (E218) 2.13 mg propyl parahydroxybenzoate (E216)
Hvert hætteglas med solvens indeholder:
Each vial of diluent contains:
13 mg/ ml benzylalkohol 10, 8ml vand til injektionsvæske
13 mg/ ml benzyl alcohol 10.8 ml water for injections
Efter opløsning ifølge anvisning på etiketten indeholder injektionsvæsken:
When reconstituted according to label instructions, the solution for injection contains:
80. 0 mg/ ml cefovecin (som natriumsalt) 1, 8 mg/ ml methyl parahydroxybenzoate (E218) 0, 2 mg/ ml propylparahydroxybenzoate (E216) 12, 3 mg/ ml benzylalkohol
80.0 mg/ ml cefovecin (as sodium salt) 1.8 mg/ ml methyl parahydroxybenzoate (E218) 0.2 mg/ ml propyl parahydroxybenzoate (E216) 12.3 mg/ ml benzyl alcohol
Pulveret er off- white til gulligt og opløsningsmidlet (solvensen) er en klar farveløs væske.
The powder is off-white to yellow and the diluent (solvent) is a clear, colourless liquid.
Til behandling af hud og bindevævsinfektioner inklusive pyodermi, sår og abscesser forårsaget af Staphylococcus intermedius, beta- haemolytiske Streptococci, Escherichia coli og/ eller Pasteurella multocida.
For the treatment of skin and soft tissue infections including pyoderma, wounds and abscesses associated with Staphylococcus intermedius, β -haemolytic Streptococci, Escherichia coli and/ or Pasteurella multocida.
Til behandling af urinvejsinfektioner forårsaget af Escherichia coli og Proteus spp.
For the treatment of urinary tract infections associated with Escherichia coli and/ or Proteus spp.
2 Katte:
Cats:
Til behandling af abscesser og sår i hud og bindevæv forårsaget af Pasteurella multocida, Fusobacterium spp., Bacteroides spp., Prevotella oralis, beta- haemolytiske Streptococci og/ eller Staphylococcus intermedius.
For the treatment of skin and soft tissue abscesses and wounds associated with Pasteurella multocida, Fusobacterium spp., Bacteroides spp., Prevotella oralis, β haemolytic Streptococci and/ or Staphylococcus intermedius.
Til behandling af urinvejsinfektioner forårsaget af Escherichia coli.
2 For the treatment of urinary tract infections associated with Escherichia coli.