natgillin/translations-raw huggingface dataset:
Dette afslørede begrænsede læsioner som misfarvning og granulom i størstedelen af dyrene, ligesom nekrose eller fibrose (i ca. halvdelen af dyrene).
In clinical studies, the post-mortem examination of the injection sites performed at most 50 days after the vaccination revealed limited lesions such as a discoloration and a granuloma in the majority of animals, as well as necrosis or fibrosis in approximately half of the animals.
Inden for 2 dage efter injektion kan der ses en gennemsnitlig stigning i legemstemperatur på op til 1, 4 o C.
Within the 2 days following the injection, an average increase in rectal temperature of up to 1.4°C can occur.
Stigning i legemstemperatur på mere end 2, 5 oC, der varer under 24 timer, ses sjældent.
Rarely, an increase in rectal temperature of higher than 2.5°C, lasting less than 24 hours, may occur.
Dette normaliseres spontant.
In rare cases, slight apathy or reduction in appetite may be observed, which should resolve spontaneously.
I sådanne tilfælde bør en korrekt symptomatisk behandling iværksættes.
In such cases, an appropriate symptomatic treatment should be provided.
Anvendelse under laktation – ikke relevant.
Use during lactation – not applicable.
Der foreligger ingen oplysninger om sikkerhed og virkning ved brug af vaccinen sammen med andre.
No information is available on the safety and efficacy from the concurrent use of this vaccine with any other.
Det frarådes derfor at anvende andre vacciner inden for 14 dage inden eller efter vaccinationen med dette lægemiddel.
It is therefore recommended that no other vaccines should be administered concurrently within 14 days before or after vaccination with the product.
Ved anvendelse af vaccinen skal hætteglasset med antigen suspension rystes omhyggeligt, hvorefter indholdet injiceres over i hætteglasset med emulsion.
3 To use the vaccine, shake vigorously the vial of antigen suspension and inject its content into the vial of emulsion containing adjuvant.
3 Administrer 1 dosis på 2 ml ved dyb intramuskulær injektion i henhold til følgende vaccinationsprogram:
Administer one 2 ml dose by deep intramuscular injection in accordance with the following vaccination scheme:
Basisvaccination: • Polte og gylte:
Basic vaccination: • Gilts:
En injektion, der efterfølges af en anden injektion 3- 4 uger senere, mindst 2 uger før løbning.
One injection, followed 3 to 4 weeks later by a second injection, at least 2 weeks before mating.
En tredje injektion skal gives mindst 2 uger før faring. • Søer:
One further injection must be given, at least 2 weeks before farrowing. • Sows:
2 injektioner med 3- 4 ugers mellemrum, mindst 2 uger før faring.
One injection, followed 3 to 4 weeks later by a second injection, at least 2 weeks before farrowing.
Revaccination: • 1 injektion i hver drægtighed, mindst 2- 4 uger før faring.
Revaccination: • One injection at each gestation, at least 2 to 4 weeks before farrowing.
4. 6 nævnte blev iagttaget efter administration af en dobbelt dosis af vaccinen.
No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double dose of vaccine.
ATCvet- kode:
Swine inactivated viral vaccine ATC vet code:
Den opløste vaccine indeholder et inaktiveret, porcint circovirus type 2 (PCV2) i olieadjuvans (o/ v).
The reconstituted vaccine contains an inactivated porcine circovirus type 2 (PCV2) in an oily adjuvant (o/ w).
Tynd paraffinolie (emulsion) Thiomersal (suspension og emulsion) Sorbitanoleat (emulsion) Polysorbat 80 (emulsion) Polysorbat 85 (emulsion) Natriumklorid / kaliumdihydrogenfosfat / dinatriumfosfatdihydrat (suspension og emulsion) Vand til injektion
Light paraffin oil (Emulsion) Thiomersal (Suspension and Emulsion) Sorbitan oleate (Emulsion) Polysorbate 80 (Emulsion) Polysorbate 85 (Emulsion) Sodium chloride/ potassium dihydrogen phosphate/ disodium phosphate dihydrate (Suspension and Emulsion) Water for injections
Må ikke blandes med andre vacciner eller immunologiske lægemidler.
Do not mix with any other medicinal product.
6. 3 Opbevaringstid
4 6.3 Shelf life
18 måneder.
18 months as packaged for sale.
4 Opbevares i den originale pakning for at beskytte mod lys.
Store in the original package in order to protect from light.
Type I glasflasker med en butyl/ nitryl elastomer- prop, forseglet med en aluminiumshætte. • 5 doser:
Type I glass vials with a butyl/ nitryl elastomer closures and sealed with an aluminium cap
1 hætteglas suspension (indeholdende 5 doser) + 1 hætteglas emulsion (indeholdende 5 doser) • 10 x 5 doser:
10 vials of suspension (5 dose size) + 10 vials of emulsion (5 dose size).
10 hætteglas suspension (indeholdende 5 doser) + 10 hætteglas emulsion (indeholdende 5 doser) • 25 doser:
- 25 doses:
1 hætteglas suspension (indeholdende 25 doser) + 1 hætteglas emulsion (indeholdende 25 doser) • 10 x 25 doser:
1 vial of suspension (25 dose size) + 1 vial of emulsion (25 dose size).
10 hætteglas suspension (indeholdende 25 doser) + 10 hætteglas emulsion (indeholdende 25 doser)
10 vials of suspension (25 dose size) + 10 vials of emulsion (25 dose size).
Merial 29 avenue Tony Garnier 69007 Lyon Frankrig
MERIAL 29 avenue Tony Garnier 69007 LYON FRANCE
Dette med henvisning til nationale dyresundhedsprogrammer.
The import, sale, supply and/ or use of Circovac is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Enhver person, som har til hensigt at indføre, sælge, levere og/ eller anvende Circovac, skal rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik forinden indførsel, salg, levering og/ eller anvendelse finder sted.
Any person intending to import, sell, supply and/ or use Circovac must consult the relevant Member State’ s competent authority on the current vaccination policies prior to the import, sale, supply and/ or use
Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur (EMEA) http: // www. emea. europa. eu.
5 Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
5 BILAG II
6 ANNEX II
Merial, Laboratoire Lyon Gerland 254, Avenue Marcel Mérieux 69007 Lyon Frankrig
Mérial, Laboratoire Lyon Gerland 254, Avenue Marcel Mérieux 69007 Lyon France
Merial, Laboratoire Porte des Alpes Rue de l' Aviation 69800 Saint Priest Frankrig
Mérial, Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest France
Må kun udleveres efter veterinærrecept.
Veterinary medicinal product subject to medical prescription.
Markedsføringsindehaver skal meddele Den Europæiske Kommission planer for markedsføring af det lægemiddel, der er godkendt i henhold til 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.
2377/ 90 i overensstemmelse med nedenstående tabel:
The following substances contained in the final product are included in Annex II of Council Regulation (EEC) No 2377/ 90:
7 De farmakologisk aktive stoffer
8 Substance Light liquid paraffin
Indeholdt i Annex II for alle fødevareproducerende dyrearter
MRL status Included in Annex II for all food producing species
CR- nr.
Comments Mineral hydrocarbons, low to high viscosity including microcrystalline waxes, approximately C10-C60; aliphatic, branched aliphatic and alicyclic compounds.
Indeholdt i Annex II for alle fødevareproducerende dyrearter
Included in Annex II for all food producing species
Anvendes udelukkende som et konserveringsmiddel i flerdosis - vacciner i en koncentration, der ikke overstiger 0. 02%.
For use only as preservatives in multidose vaccines at a concentration not exceeding 0.02%.
Polysorbat 85 (Polyoxyethylen sorbitan - trioleat)
Sorbitan oleate (sorbitan monoleate) Polysorbate 85 (Polyoxyethylene sorbitan trioleate)
Indeholdt i Annex II for alle fødevareproducerende dyrearter
Included in Annex II for all food producing species Included in Annex II for all food producing species
CR- nr. 1231/ 06
Approved food additive (E 494) CR No 2034 CR No 1231/ 06
9 A.
9 ANNEX III
10 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
11 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
5 doser:
5 doses:
1 hætteglas suspension (indeholdende 5 doser) + 1 hætteglas emulsion (indeholdende 5 doser) 10 x 5 doser:
1 vial of suspension (5 dose size) + 1 vial of emulsion (5 dose size) 10 x 5 doses:
10 hætteglas suspension (indeholdende 5 doser) + 10 hætteglas emulsion (indeholdende 5 doser) 25 doser:
10 vials of suspension (5 dose size) + 10 vials of emulsion (5 dose size) 25 doses:
1 hætteglas suspension (indeholdende 25 doser) + 1 hætteglas emulsion (indeholdende 25 doser) 10 x 25 doser:
1 vial of suspension (25 dose size) + 1 vial of emulsion (25 dose size) 10 x 25 doses:
10 hætteglas suspension (indeholdende 25 doser) + 10 hætteglas emulsion (indeholdende 25 doser)
10 vials of suspension (25 dose size) + 10 vials of emulsion (25 dose size)
Circovac Emulsion og suspension til emulsion til injektionsvæske til svin.
Circovac Emulsion and suspension for emulsion for injection for pigs
ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER
Active substance:
Inaktiveret porcint circovirus type2 (PCV2) ……………………………… ≥ 2. 1 log10 ELISA- enheder Hjælpestof:
Thiomersal................................................................................................................................. ..0.20 mg Adjuvant:
Emulsion og suspension til emulsion, injektionsvæske.
Emulsion and suspension for emulsion for injection.
11 Passiv immunisering af pattegrisene for at reducere læsioner i det lymfoide væv og som en hjælp til at nedsætte PCV2- relateret dødelighed.
Passive immunisation of piglets to reduce lesions in lymphoid tissues and as an aid to reduce PCV2- linked mortality.
0 dage.
Withdrawal period: zero days.
(måned/ år) Skal anvendes inden for 3 timer efter blanding.
EXP {month/ year} Use within 3 hours after mixing.
Opbevares og transporteres nedkølet (2 oC – 8 oC).
Store and transport refrigerated (2 °C – 8 °C).
Merial 29 avenue Tony Garnier F- 69007 Lyon Frankrig
MERIAL 29 Avenue Tony Garnier F-69007 Lyon France
EU/ 2/ 07/ 075/ 001 5 doser:
EU/ 2/ 07/ 075/ 001 5 doses:
1 hætteglas suspension (indeholdende 5 doser) + 1 hætteglas emulsion (indeholdende 5 doser) EU/ 2/ 07/ 075/ 00210 x 5 doser:
1 vial of suspension (5 dose size) + 1 vial of emulsion (5 dose size) EU/ 2/ 07/ 075/ 002 10 x 5 doses:
10 hætteglas suspension (indeholdende 5 doser) + 10 hætteglas emulsion (indeholdende 5 doser) EU/ 2/ 07/ 075/ 003 25 doser:
10 vials of suspension (5 dose size) + 10 vials of emulsion (5 dose size) EU/ 2/ 07/ 075/ 003 25 doses:
1 hætteglas suspension (indeholdende 25 doser) + 1 hætteglas emulsion (indeholdende 25 doser) EU/ 2/ 07/ 075/ 004 10 x 25 doser:
1 vial of suspension (25 dose size) + 1 vial of emulsion (25 dose size)
13 MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER
14 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Hætteglas med 5 doser suspension Hætteglas med 25 doser suspension
Vial of 5 doses of suspension Vial of 25 doses of suspension
Circovac Suspension
Circovac Suspension
(måned/ år)
EXP {month/ year}
14 MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Hætteglas med 5 doser emulsion Hætteglas med 25 doser emulsion
Vial of 5 doses of emulsion Vial of 25 doses of emulsion
Circovac Emulsion
Circovac Emulsion
Indeholder PCV2 efter opløsning.
Light paraffin oil and Thiomersal After reconstitution contains PCV2.
Tilbageholdelsestid: nul dage.
Zero days.
EXP: måned/ år
EXP {month/ year}
16 INDLÆGSSEDDEL Circovac Emulsion og suspension til emulsion til injektionsvæske til svin
PACKAGE LEAFLET
Merial, 29 avenue Tony Garnier, F- 69007 Lyon, Frankrig
MERIAL, 29 Avenue Tony Garnier, F-69007 Lyon, France
Merial, Laboratoire Porte des Alpes, Rue de l’ Aviation, F- 69800 Saint Priest, Frankrig
MERIAL, Laboratoire Porte des Alpes, Rue de l'Aviation, F-69800 Saint Priest, France
1 opløst dosis på 2 ml indeholder:
One reconstituted 2 ml dose contains:
Inaktiveret porcint circovirus type2 (PCV2) ……………………………… ≥ 2. 1 log10 ELISA- enheder Hjælpestof:
Inactivated porcine circovirus type 2 (PCV2)................................................ ≥ 2.1 log10 ELISA. Units Excipient:
Thiomersal …………………………………………………………………………………….. 0, 20 mg Adjuvans:
Thiomersal................................................................................................................................. ..0.20 mg Adjuvant:
Tynd paraffinolie ………………………………………………………………………… 494 – 501 mg
494 to 501 mg
Disse reaktioner heler spontant inden for højst 4 dage i gennemsnit uden nogen følger for sundheden og zooteknisk adfærd hos søer, polte og gylte.
These reactions resolve spontaneously, in a maximum of 4 days on average, without any consequence on the health and the zootechnical performance of the sow or gilt.
Dette afslørede begrænsede læsioner som misfarvning og granulom hos størstedelen af dyrene, ligesom nekrose eller fibrose (i ca. halvdelen af dyrene).
18 In clinical studies, post-mortem examination of the injection sites performed at most 50 days after the vaccination revealed limited lesions such as a discoloration and a granuloma in the majority of animals as well as necrosis or fibrosis (in approximately half of the animals).
Inden for 2 dage efter injektion kan der ses en gennemsnitlig stigning i legemstemperatur på op til 1, 4 o C.
Within the 2 days following the injection, an average increase in rectal temperature up to 1.4°C can occur.
I sjældne tilfælde kan der iagttages let nedstemthed eller nedsat ædelyst, der normaliseres spontant.
In rare cases, slight apathy or reduction in appetite may be observed, which should resolve spontaneously.
Ved anvendelse af vaccinen skal hætteglasset med suspension rystes omhyggeligt, hvorefter indholdet injiceres over i hætteglasset med emulsion.
To use the vaccine, shake vigorously the vial of suspension and inject its content into the vial of emulsion.
18 Opbevares utilgængeligt for børn.
SPECIAL STORAGE PRECAUTIONS 19 Keep out of the reach and sight of children.
Opbevares og transporteres nedkølet (2 °C – 8 °C).
Store and transport refrigerated (2 C – 8 C).
Kan anvendes til drægtige dyr.
Can be used during pregnancy.
Det frarådes derfor at anvende andre vacciner inden for 14 dage inden eller efter vaccination med dette lægemiddel.
It is therefore recommended that no other vaccines should be administered concurrently within 14 days before or after vaccination with the product.
Ingen bivirkninger undtagen de i afsnittet ” Bivirkninger ” nævnte blev iagttaget efter administration af en dobbelt dosis af vaccinen.
No adverse reactions, except those mentioned in the section “ Adverse Reactions” were observed after the administration of a double dose of vaccine.
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
Den opløste vaccine indeholder et dræbt, porcint circovirus type 2 (PCV2) i olieadjuvans (o/ v).
The reconstituted vaccine contains an inactivated porcine circovirus type 2 (PCV2) in an oily adjuvant (o/ w).
19 • 5 doser:
1 vial of suspension (5 dose size) + 1 vial of emulsion (5 dose size).
1 hætteglas suspension (indeholdende 5 doser) + 1 hætteglas emulsion (indeholdende 5 doser). • 10 x 5 doser:
10 vials of suspension (5 dose size) + 10 vials of emulsion (5 dose size).
10 hætteglas suspension (indeholdende 5 doser) + 10 hætteglas emulsion (indeholdende 5 doser). • 25 doser:
- 25 doses:
1 hætteglas suspension (indeholdende 25 doser) + 1 hætteglas emulsion (indeholdende 25 doser). • 10 x 25 doser:
1 vial of suspension (25 dose size) + 1 vial of emulsion (25 dose size).
10 hætteglas suspension (indeholdende 25 doser) + 10 hætteglas emulsion (indeholdende 25 doser).
10 vials of suspension (25 dose size) + 10 vials of emulsion (25 dose size).
Kun efter dyrlægerecept.
To be supplied only on veterinary prescription.
SærnavnStyrke
Invented name
Lægemiddel - form
Pharmaceutical Target Species form
Dyrearter, som Indgivelsesvej lægemidlet er beregnet til:
Route of administration
EU/ 2/ 98/ 007/ 001 Clomicalm 5 mg Tabletter
EU/ 2/ 98/ 007/ 001 Clomicalm
HDPE flaske med børnesikret låg
HDPE bottle with child resistant closure
30 tabletter og silicagel tørremiddel
30 tablets and a 1 bottle in a desiccant sachet cardboard box
1 flaske, pakket i Ikke relevant æske
N/ A
EU/ 2/ 98/ 007/ 002 Clomicalm 20 mg Tabletter
EU/ 2/ 98/ 007/ 002 Clomicalm
EU/ 2/ 98/ 007/ 003 Clomicalm 80 mg Tabletter
EU/ 2/ 98/ 007/ 003 Clomicalm
Hvad er Clomicalm?
What is Clomicalm?
Clomicalm er et veterinærlægemiddel, som indeholder det aktive stof clomipramin.
Clomicalm is a veterinary medicine containing the active substance clomipramine.
Det fås som tabletter, der indeholder 5 mg, 20 mg eller 80 mg clomipramin.
It is available as tablets containing 5 mg, 20 mg or 80 mg clomipramine.
Hvad anvendes Clomicalm til?
What is Clomicalm used for?
Clomicalm anvendes som en hjælp i behandlingen af hunde, som har adfærdsproblemer, når de adskilles fra deres ejere, deres sædvanlige hjem eller andre hunde.
Clomicalm is used as an aid in the treatment of dogs that have behavioural problems when separated from their owners, their normal home, or other dogs.
Disse adfærdsproblemer kan f. eks. komme til udtryk gennem destruktiv adfærd eller uønsket defækation eller urinering indendørs.
These behavioural problems might be expressed for example by destructive behaviour or inappropriate defecation or urination in the house.
Clomicalm bør ikke anvendes som eneste behandling, men kun til hunde, der også får adfærdsbehandling.
Clomicalm should not be used on its own but only in dogs that are also undergoing behavioural therapy.
Clomicalm tabletter gives to gange dagligt.
Clomicalm tablets are given twice a day.
Tabletternes styrke og antal bestemmes ud fra hundens vægt, således at hunden får mellem 2 og 4 mg clomipramin pr. kg af dyrets kropsvægt pr. dag.
The strength and number of tablet(s) to use is adjusted according to the dog’ s weight, so that the dog is given between 2 mg and 4 mg clomipramine per kg of the dog’ s bodyweight per day.
Det aktive stof i Clomicalm, clomipramin, tilhører gruppen af tricykliske antidepressive midler.
The active substance in Clomicalm, clomipramine, belongs to the group of the tricyclic antidepressants.
Clomipramin og dets vigtigste metabolit, desmethylclomipramin, forhindrer en række neurotransmittere i at blive genoptaget i nerveceller i hjernen og rygmarven.
In the body, clomipramine and its major metabolite, desmethylclomipramine prevent some neurotransmitters from being taken back up into nerve cells in the brain and spinal cord.
Neurotransmittere er stoffer, der overfører kemiske signaler fra en nervecelle til en anden.
Neurotransmitters are substances that transfer chemical signals from one nerve cell to another one.
Clomipramin forhindrer genoptagelsen af serotonin (5- hydroxytryptamin), og desmethylclomipramin forhindrer genoptagelsen af noradrenalin.
Clomipramine prevents the re-uptake of serotonin (5-hydroxytryptamine) and desmethylclomipramine prevents the re-uptake of noradrenalin.
Lave niveauer af neurotransmittere i det centrale nervesystem kan være forbundet med depression, angst eller aggression.
Low levels of neurotransmitters in the central nervous system may be associated with depression, anxiety or aggression.
Ved at blokere genoptagelsen af serotonin og noradrenalin i nervecellerne medvirker clomipramin og dets metabolit til at bibeholde højere serotonin - og noradrenalinniveauer.
By blocking the re-uptake of serotonin and noradrenalin into nerve cells, clomipramine and its metabolite allow the levels to remain higher.
Dette kan forbedre de kliniske tegn (adfærdsproblemer) på separationsrelaterede lidelser hos hunde.
This can improve the clinical signs (behavioural problems) in dogs with separation-related disorders.
For at kunne behandle en hund, der lider af angst, kan den ikke nøjes med at få medicin, men skal også gennemgå adfærdsbehandling.
In order to treat a dog with anxiety, the animal should not only receive medicines but also behavioural therapy.
Adfærdsændrende behandling er den vigtigste del af behandlingen, men brugen af medicin kan dog medvirke til en hurtigere helbredelse af dyret.
Behavioural modification therapy is the most important part of therapy; however, the use of the medicine allows for a more speedy recovery of the animal patient.
Hvordan blev Clomicalm undersøgt?
How has Clomicalm been studied?
Den effektive dosis af Clomicalm er blevet fastsat i kliniske undersøgelser af hunde.
The effective dose of Clomicalm has been established in clinical studies in dogs.
Lægemidlets virkning og tolerance blev fastslået hos syge dyr i kliniske undersøgelser i forskellige dyrlægepraksisser eller – klinikker i USA og i en række europæiske lande (“ feltundersøgelser ”).
The efficacy and tolerance of the medicine in animal patients was confirmed in clinical studies in various veterinary practices or clinics in the USA, and in a number of countries in Europe (“ field studies”).
I hver undersøgelse blev behandlingen med clomipramin kombineret med adfærdsændrende teknikker.
In each study, treatment with clomipramine was combined with behaviour modification techniques.
Behandlingsresultaterne hos disse hunde blev sammenlignet med behandlingsresultaterne hos hunde, der kun fik adfærdsbehandling (uden medicin).
The treatment results in these dogs were compared to treatment results in dogs receiving behavioural therapy alone (no medication).
Hvilken fordel viser undersøgelserne, at der er ved Clomicalm?
What benefit has Clomicalm shown during the studies?
Resultaterne af feltundersøgelserne viste, at behandling med clomipramin kombineret med adfærdsændrende teknikker var effektiv til at reducere de kliniske tegn på separationsangst.
Results of the field studies indicated that the administration of clomipramine in combination with behaviour modification techniques was effective in the relief of clinical signs of separation anxiety.
Behandling med clomipramin i doser på 1- 2 mg/ kg kropsvægt to gange dagligt var effektiv sammenlignet med lavere doser eller behandling med adfærdsbehandling alene (placebo).
Treatment with clomipramine at twice daily doses of 1 - 2 mg/ kg bodyweight was effective, when compared to lower doses or to treatment with behavioural therapy alone (placebo).
Hvilken risiko er der forbundet med Clomicalm?
What is the risk associated with Clomicalm?
Clomicalm kan i meget sjældne tilfælde forårsage opkastning, appetitforandringer, apati (søvnlignende sløvhedstilstand) eller en stigning i leverenzymer, som går over, når behandlingen med lægemidlet ophører.
Clomicalm may very rarely cause vomiting, changes in appetite, lethargy (sleepiness) or an elevation in liver enzymes, which are reversible when the product is discontinued.
Der er rapporteret om virkninger på leveren, navnlig hos hunde, der allerede har leverproblemer.
Effects on the liver have been reported, especially in dogs with existing liver problems.
Opkastninger kan reduceres ved at give tabletterne sammen med lidt mad.
Vomiting may be reduced by giving the tablets with a small quantity of food.
12 timer efter dosering.
At overdose with 20 mg/ kg Clomicalm (5 times the maximum therapeutic dose), a reduction in heart rate were observed approximately 12 hours after dosing.
Da Clomicalm ikke er undersøgt hos drægtige eller diegivende tæver, anbefales det ikke at anvende lægemidlet under drægtighed eller diegivning.
Since Clomicalm has not been tested in pregnant or lactating bitches, its use is not recommended during pregnancy and lactation.
På grund af mulige interaktioner anbefales det ikke at anvende Clomicalm i kombination med en række andre lægemidler, som fremgår af indlægssedlen.
Due to potential interactions, the administration of Clomicalm is not recommended in combination with a number of other medicines listed in the package leaflet.