natgillin/translations-raw huggingface dataset:
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALCI BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA SPROŠČANJE SERIJE
Name and address of the manufacturers of the biological active substances Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp The Netherlands
Fort Dodge Animal Health Holland C. J. van Hautenplaan 36 1381 CP Wesp Nizozemska
Name and address of the manufacturer(s) responsible for batch release Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp The Netherlands
Fort Dodge Animal Health Holland C. J. van Hautenplaan 36 1381 CP Wesp Nizozemska
According to Article 71 of Directive 2001/ 82/ EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/ or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
V skladu z 71. členom Direktive 2001/ 82/ ES Evropskega parlamenta in Sveta, države članice prepovejo ali lahko prepovejo uvoz, prodajo, oskrbo in/ ali uporabo zdravila za uporabo v veterinarski medicini na celotnem svojem ozemlju ali delu ozemlja, če se ugotovi da:
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
b) bolezen, za katero se z zdravilom za uporabo v veterinarski medicini pridobi imunost, na območju skoraj ni.
STATEMENT OF THE MRLs
Dodatek II Uredbe Sveta (EGS) št.
Annex II of Council Regulation (EEC) No 2377/ 90 Pharmacologically active substance Aluminium hydroxide Disodiumhydrogenphosphate Mannitol Mineral oil Polysorbate 80 Sodiumhydrogenphosphate Thiomersal
Farmakološko aktivna snov
Animal Species All food-producing species
Živalska vrsta
LABELLING AND PACKAGE INSERT
Navedba ni potrebna.
10 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
OZNAČEVANJE
(Carton label 1 x 10 doses)
Kartonska nalepka 1 x 10 odmerkov
Suvaxyn Aujeszky 783 + O/ W, powder and solvent for emulsion for injection
Suvaxyn Aujeszky 783 + O/ W Prašek in topilo za pripravo emulzije za injiciranje Za prašiče
Live attenuated Aujeszky’ s Disease Virus, strain NIA3-783: ≥ 105.2 CCID50* per 2 ml dose of reconstituted emulsion. * CCID50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
105. 2. ≥CCID50 * v 2 ml odmerkih po pripravi emulzije * CCID50 = količina virusa, ki inficira 50% inokuliranih celičnih kultur
Aluminium hydroxide, Mineral oil (Marcol 52), Mannide mono oleate (Arlacel A), Polysorbate 80 (Tween 80), Thiomersal
Aluminijev hidroksid, mineralno olje (Marcol 52), manidijev monooleat (Arlacel A), polisorbat 80 (Tween 80), tiomersal
1 vial with powder for injection (10 doses) and 1 bottle of solvent for injection (20 ml)
1 prebodna viala s praškom (10 odmerkov) in 1 prebodna steklenička s topilom (20 ml).
Active and passive immunisation of pigs against Aujeszky’ s Disease.
Aktivna in pasivna imunizacija prašičev proti Aujeszkyjevi bolezni.
For intramuscular use of 1 dose (2 ml) per pig
1 odmerek (2 ml) na prašiča apliciramo intramuskularno.
EXP {month/ year} Shelf life after reconstitution:
EXP {mesec/ leto} Rok uporabe po rekonstituciji:
Use within one hour
1 ura
Store (and transport) at 2ºC - 8ºC (in a refrigerator).
Shranjujte (in prevažajte) pri temperaturi 2˚ C- 8˚ C (v hladilniku).
For animal treatment only Veterinary medicinal product subject to prescription.
Veterinarsko zdravilo se izda le na recept.
{number} for the powder:
Serija: {številka} za prašek:
{number} for the solvent:
Serija: {številka} za topilo:
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
14 PODATKI NA ZUNANJI OVOJNINI
(Carton label 1 x 50 doses)
Kartonska nalepka 1 x 50 odmerkov
Powder::
Prašek:
Live attenuated Aujeszky’ s Disease Virus, strain NIA3-783: ≥ 105.2 CCID50* per 2 ml dose of reconstituted emulsion. * CCID50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
105. 2. ≥CCID50 * v 2 ml odmerka po pripravi emulzije * CCID50 = količina virusa, ki inficira 50% inokuliranih celičnih kultur
Aluminium hydroxide, Mineral oil (Marcol 52), Mannide mono oleate (Arlacel A), Polysorbate 80 (Tween 80), Thiomersal
Aluminijev hidroksid, mineralno olje (Marcol 52), manidijev monooeleat (Arlacel A), polisorbat 80 (Tween 80), tiomersal
1 vial with powder for injection (50 doses) and 1 bottle of solvent for injection (100 ml)
1 prebodna viala s praškom (50 odmerkov) in 1 prebodna steklenička s topilom (100 ml)
Use within one hour
EXP {mesec/ leto} Rok uporabe po rekonstituciji: 1 ura
Store (and transport) at 2ºC - 8ºC (in a refrigerator).
Shranjujte (in prevažajte) pri temperaturi 2 ˚C- 8 ˚C (v hladilniku).
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
17 PODATKI NA ZUNANJI OVOJNINI
(Carton label 1 x 100 doses)
Kartonska nalepka 1 x 100 odmerkov
Suvaxyn Aujeszky 783 + O/ W, powder and solvent for emulsion for injection.
Za prašiče
Live attenuated Aujeszky’ s Disease Virus, strain NIA3-783: ≥ 105.2 CCID50* per 2 ml dose of reconstituted emulsion. * CCID50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
105. 2. ≥CCID50 * v 2 ml odmerka po pripravi emulzije * CCID50 = količina virusa, ki inficira 50% inokuliranih celičnih kultur Topilo:
1 vial with powder for injection (100 doses) and 1 bottle of solvent for injection (200 ml)
1 prebodna viala s praškom (100 odmerkov) in 1 prebodna steklenička s topilom (200 ml)
Accidental injection is dangerous - see package insert before use for further information and additional warnings.
Nenamerno injiciranje je nevarno- pred uporabo preberite priložena navodila.
(Carton label 10 x 10 doses)
Kartonska nalepka 10 x 10 odmerkov
10 vials with powder for injection (each containing 10 doses) and 10 bottles of solvent for injection (each containing 20 ml)
10 prebodnih vial s praškom (v vsaki je 10 odmerkov) in 10 prebodnih stekleničk s topilom (vsaka vsebuje 20 ml)
(Carton label 10 x 50 doses)
Kartonska nalepka 10 x 50 odmerkov
10 vials with powder for injection (each containing 50 doses) and 10 bottles of solvent for injection (each containing 100 ml)
10 prebodnih vial s praškom (v vsaki je 50 odmerkov) in 10 prebodnih stekleničk s topilom (vsaka vsebuje 100 ml)
(Carton label 10 x 100 doses)
Kartonska nalepka 10 x 100 odmerkov
10 vials with powder for injection (each containing 10 doses) and 10 bottles of solvent for injection (each containing 200 ml)
10 prebodnih vial s praškom (v vsaki je 100 odmerkov) in 10 prebodnih stekleničk s topilom (vsaka vsebuje 200 ml)
For intramuscular use of 1 dose (2 ml) per pig
1 odmerka (2 ml) na prašiča apliciramo intramuskularno.
THE WORDS “ FOR ANIMAL TREATMENT ONLY”
BESEDILO „ SAMO ZA ŽIVALI “ IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
THE WORDS “ KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
BESEDILO „ ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM “
28 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
29 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
(10 doses)
(10 odmerkov)
Vials for the powder:
Viala za prašek
Suvaxyn Aujeszky 783 + O/ W, powder for injection.
Za prašiče.
Live attenuated Aujeszky’ s Disease Virus
Živ, atenuiran virus Aujeszkyjeve bolezni
For intramuscular use
Za intramuskularno dajanje.
THE WORDS “ FOR ANIMAL TREATMENT ONLY”
BESEDILO „ SAMO ZA ŽIVALI “
Bottles for the solvent:
Steklenička s topilom
Suvaxyn Aujeszky 783 + O/ W, solvent for injection.
Za prašiče.
QUANTITY
KOLIČINA ZDRAVILNE( IH) UČINKOVIN( E)
EXP {month/ year} Use within one hour after reconstitution
Po rekonstituciji je uporabno 1 uro.
Accidental injection is dangerous – see package insert before use
Nenamerno injiciranje je nevarno- pred uporabo preberite priložena navodila.
30 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
31 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
(50 doses)
(50 odmerkov)
Suvaxyn Aujeszky 783 + O/ W, powder for injection
Za prašiče.
Suvaxyn Aujeszky 783 + O/ W, solvent for injection
Za prašiče.
32 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
33 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
(100 doses)
(100 odmerkov)
200 ml (100 doses)
200 ml (100 odmerkov)
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
NAVEDBA ZDRAVILNE( IH) UČINKOVIN( E) IN DRUGIH SESTAVIN
Live attenuated Aujeszky’ s Disease Virus, strain NIA3-783: ≥ 105.2 CCID50* per 2 ml dose of reconstituted emulsion. * CCID50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
Živ, atenuiran virus Aujeszkyjeve bolezni, sev NIA3- 783: ≥105. 2. ≥CCID50 * v 2 ml odmerka po pripravi emulzije * CCID50 = količina virusa, ki inficira 50% inokuliranih celičnih kultur
Passive immunisation of piglets from vaccinated gilts and sows to reduce mortality and clinical signs of Aujeszky’ s Disease and to reduce the excretion of Aujeszky’ s Disease field virus.
Pasivna imunizacija pujskov, katerih matere so bile cepljene, z namenom zmanjšanja pogina in manifestacije kliničnih znakov zaradi Aujeszkyjeve bolezni in za zmanjšanje prisotnosti virusa v okolju.
- Active immunity:
- Akitvna imunost:
for 3 months after basic vaccination.
Imunost traja 3 mesece po osnovnem cepljenju.
A transient increase in body temperature, up to about 40,5oC and lasting for up to 2 days, may occur in a small number of pigs after vaccination.
Tako stanje lahko traja do 2 dni.
• Inject one dose per fattening pig from the age of 10 weeks.
• Z enim odmerkom cepiva cepimo prašiče pitance pri starosti 10 tednov.
The presence of maternal antibodies against Aujeszky’ s Disease Virus may have a negative influence on the result of vaccination. • Inject one dose per breeding pig (gilts, sows and boars) from the age of 10 weeks followed by a second injection 3 – 4 weeks after the first injection.
Cepljenje ponovimo čez 3- 4 tedne.
Re-vaccination of breeding pigs (gilts, sows and boars):
Re- vakcinacija plemenskih prašičev (mladic, svinj in merjascev):
• Inject one dose per gilt before the first mating, or • Inject one dose per gilt or sow during each gestation at 3 - 6 weeks before the expected date of farrowing. • Inject one dose per boar at least every 6 months.
• Injiciraj en odmerek na mladico pred prvim parjenjem, ali • Injiciraj en odmerek na mladico ali svinjo v obdobju 3- 6 tednov pred pričakovano gonitvijo • Injiciraj en odmerek na merjasca najmanj vsakih 6 mesecev.
For whole herd vaccination, an injection of one dose may be administered per gilt, sow and boar every 4 months.
Za cepljenje cele črede se priporoča injicirati po enim odmerkom na mladico, svinjo in merjasca vsake 4 mesece.
To reconstitute the vaccine, inject 3 ml of solvent into the small vial with the powder.
Za rekonstitucijo cepiva injiciraj 3 ml topila v vialo s praškastim delom.
Administer by intramuscular injection of 1 dose (2 ml) per pig in the neck in the area behind the ear.
Eno odmerek (2 ml) na prašiča apliciraj intramuskularno v vratni predel za ušesom.
Keep out of the reach and sight of children.
Hranite zunaj dosega otrok.
Store and transport refrigerated (2°C – 8°C).
Shranjujte (in prevažajte) pri temperaturi 2 ˚C- 8 ˚C (v hladilniku).
Shelf-life after reconstitution according to directions:
Zdravila ne smete uporabljati po datumu izteka uporabnosti.
1 hour.
Rok uporabnosti po rekonstituciji je 1 ura.
Any person intending to import, sell, supply and/ or use Suvaxyn Aujeszky 783 + OW has to consult the relevant Member States competent Authorities on the current vaccination policies prior to the import, sale, supply and/ or use.
Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ ali uporabljati Suvaxyn Aujeszky 783+OW, se mora posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja, še pred uvozom prodajo, oskrbo in/ ali uporabo.
Therefore the safety and efficacy of this product when used with any other (either used on the same day or at different times) has not been demonstrated.
Zato varnosti in učinkovitosti tega zdravila ob uporabi z drugimi zdravili (bodisi na isti ali drugi dan) niso ugotavljali
Wash and disinfect hands and equipment after use.
Po dajanju si operi in razkuži roke in opremo.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED
DATUM ZADNJE REVIZIJE NAVODIL ZA UPORABO
By reconstitution of the immunogen in the oil emulsion the stimulation of immunity after injection is prolonged.
Po predhodni rekonstituciji zdravilne učinkovine v oljno emulzijo, se po injiciranju prolongira stimulacija imunosti.
Eesti UAB Magnum Veterinarija Smelynes str.
40 Eesti Österreich UAB Magnum Veterinarija Smelynes str.
Latvija UAB Magnum Veterinarija Smelynes str.
41 Latvija UAB Magnum Veterinarija Smelynes str.
Trocoxil contains the active substance mavacoxib, which belongs to a class of medicines with anti-inflammatory action.
Zdravilo Trocoxil vsebuje zdravilno učinkovino mavakoksib, ki spada v skupino zdravil s protivnetnim delovanjem.
It is used when continuous treatment for more than one month is needed.
Uporablja se, kadar je potrebno neprekinjeno zdravljenje, daljše od enega meseca.
Trocoxil is given at a dose of 2 mg per kilogram body weight, immediately before or with the dog’ s main meal.
Zdravilo Trocoxil se daje v odmerku 2 mg na kilogram telesne mase, neposredno pred ali skupaj z glavnim obrokom psa.
The dose and duration of treatment (maximum 6.5 months) will depend on the weight and type of animal and condition to be treated.
Odmerjanje in trajanje zdravljenja (največ 6, 5 meseca) je odvisno od telesne mase in vrste živali ter bolezenskega stanja, ki zahteva zdravljenje.
The active substance in Trocoxil, mavacoxib, belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Zdravilna učinkovina v zdravilu Trocoxil, mavakoksib, spada v skupino zdravil, imenovanih nesteroidna protivnetna zdravila (NSAID).
It works by blocking an enzyme called cyclo-oxygenase-2 (COX-2).
Deluje tako, da zavira encim, imenovan ciklo - oksigenaza- 2 (COX- 2).
Trocoxil has been studied in laboratory animals, as well as in dogs that were treated in various veterinary practices and clinics across Europe (“ clinical studies”).
Zdravilo Trocoxil je bilo raziskano na laboratorijskih živalih in psih, ki so bili zdravljeni v različnih veterinarskih ambulantah in klinikah po Evropi („ klinične študije “).
Dogs of both sexes and various breeds were included in the study.
Zdravilo so 6, 5 meseca primerjali s karprofenom (drugim nesteroidnim protivnetnim zdravilom), preučevali pa so se tudi dolgoročni učinki zdravljenja.
The results showed an improvement in lameness score in dogs with 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
V študijo so 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged established osteoarthritis.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged bili vključeni psi obeh spolov in različnih pasem.
Administration of the product in accordance with the recommended monthly dosing schedule for a period of up to 6.5 months resulted in an improvement in lameness and quality of life in dogs with established osteoarthritis, as assessed by the dogs’ owners.
Uporaba zdravila v skladu s priporočenim načrtom mesečnega odmerjanja za obdobje do 6, 5 meseca je po ocenah lastnikov psov pokazala izboljšanje hromosti in kakovosti življenja pri psih, obolelih z osteoartritisom.
What are the side-effects associated with Trocoxil?
Kakšni so neželeni učinki zdravila Trocoxil?
The side effects of Trocoxil are similar to those seen with other medicines in this product class (NSAIDs) and include loss of appetite, soft faeces/ diarrhoea, vomiting, apathy (lack of interest in surroundings) and signs of kidney problems.
Neželeni učinki zdravila Trocoxil so podobni neželenim učinkom, opaženim pri zdravljenju z drugimi zdravili iz te skupine zdravil (nesteroidnih protivnetnih zdravil), in vključujejo izgubo teka, mehko blato/ drisko, bruhanje, apatijo (pomanjkanje zanimanja za okolico) in znake težav z ledvicami.
Other information about Trocoxil:
Druge informacije o zdravilu Trocoxil:
The European Commission granted a marketing authorisation valid throughout the European Union, for Trocoxil to Pfizer Ltd on 09/ 09/ 2008.
Evropska Komisija je dovoljenje za promet z zdravilom Trocoxil, veljavno po vsej Evropski uniji, odobrila družbi Pfizer Ltd. dne 9. september 2008.
1 blister of 2 tablets
1 pretisni omot s 2 tableti po 2 tabletama
Trocoxil 6 mg chewable tablets for dogs Trocoxil 20 mg chewable tablets for dogs Trocoxil 30 mg chewable tablets for dogs Trocoxil 75 mg chewable tablets for dogs Trocoxil 95 mg chewable tablets for dogs
Trocoxil 6mg žvečljive tablete za pse Trocoxil 20mg žvečljive tablete za pse Trocoxil 30mg žvečljive tablete za pse Trocoxil 75mg žvečljive tablete za pse Trocoxil 95mg žvečljive tablete za pse
Mavacoxib Mavacoxib Mavacoxib Mavacoxib Mavacoxib
Mavakoksib Mavakoksib Mavakoksib Mavakoksib Mavakoksib
Triangular tablet with mottled brown appearance embossed with the tablet strength on one side and the word “ Pfizer ” on the other.
Trikotna tableta lisasto rjavega videza izbočeno označena z jakostjo tablete na eni strani ter z besedo “ Pfizer ” na drugi.
Dogs aged 12 months or more.
Psi stari 12 mesecev ali več.
For the treatment of pain and inflammation associated with degenerative joint disease in dogs in cases where continuous treatment exceeding one month is indicated.
Zdravljenje bolečine in vnetja povezanega z degenerativnim obolenjem sklepov pri psih v primerih, kjer je indicirano zdravljenje daljše od enega meseca.
Do not use in dogs less than 12 months of age and/ or less than 5 kg body weight Do not use in dogs suffering from gastro-intestinal disorders including ulceration and bleeding.
Ne uporabite pri psih z motnjami v delovanju gastro intestinalnega sistema vključno z ulkusi in krvavitvami.
Do not use where there is evidence of a haemorrhagic disorder.
Ne uporabite v primeru motenega delovanje ledvic ali jeter.
Do not use in cases of impaired renal or hepatic function Do not use in cases of cardiac insufficiency Do not use in pregnant, breeding or lactating animals.
Ne uporabite pri brejih, vzrejnih živalih ali živalih v laktaciji.
Do not use in case of hypersensitivity to the active substance or to any of the excipients Do not use in case of known hypersensitivity to sulphonamides.
Ne uporabite v primeru znane preobčutljivosti na sulfonamide.
Do not use concomitantly with glucocorticoids or other NSAIDs (see section 4.8).
Ne uporabite istočasno z glukokortikoidi ali drugimi nesteroidnimi proti vnetnimi zdravili (NSAID) (glej poglavje 4. 8).
4.4 Special warnings
2/ 33 4. 4 Posebna opozorila
Do not administer other NSAIDs within 1 month of the last administration of Trocoxil.
Ne aplicirajte drugih nesteroidnih protivnetnih zdravil istočasno ali 1 mesec od zadnjega dajanja Trocoxila.
2/ 32 4.5 Special precautions for use
4. 5 Posebni previdnostni ukrepi
This corresponds to a duration of effect of 1-2 months after administration of the second dose (and following doses).
Mavakoksib ima v plazmi podaljšan razpolovni čas (do > 80 dni, glej poglavje 5. 2) zaradi njegove nizke stopnje eliminacije, kar sovpada s trajanjem učinkovanja 1 - 2 meseca po dajanju drugega odmerka (in sledečih odmerkov).
Care should be taken to avoid treatment of animals that might not tolerate prolonged NSAID exposure.
Potrebna je previdnost pri zdravljenju živali, ki ne tolerirajo dolgotrajnega izpostavljanja nesteroidnim proti vnetnim zdravilom.
A maximum treatment administration of 6.5 months continuous therapy is recommended so as to manage plasma levels of mavacoxib in animals which exhibit reduced elimination
Priporočena je maksimalna neprekinjena terapija 6. 5 mesecev za obvladovanje koncentracije mavakoksiba v plazmi pri živalih, ki kažejo znake zmanjšane eliminacije.
Animals should undergo a thorough clinical examination before commencing treatment with Trocoxil.
Pred zdravljenjem s Trocoxilom je potrebno pri živalih opraviti temeljit klinični pregled.
Animals with evidence of impaired renal or hepatic function, or with evidence of a protein or blood losing enteropathy are not suitable for treatment with Trocoxil.
Živali z znaki oslabelega delovanja funkcij ledvic ali jeter ali z znaki izgubljanja proteinov ali enteropatično izgubo krvi, niso primerne za zdravljenje s Trocoxilom.
It is recommended to repeat the clinical examination one month after commencing treatment with Trocoxil and prior to administration of the third dose.
Klinični pregled je priporočeno ponoviti en mesec po začetku zdravljenja s Trocoxilom in pred dajanjem tretjega odmerka.
Mavacoxib is excreted via bile and in dogs with hepatic disorders reduced elimination and thus excessive accumulation could occur.
Pri psih z motnjami v delovanju jeter se lahko pojavi zmanjšana eliminacija in posledično akumulacija.
Ensure appropriate hydration and haemodynamic status when animals receiving Trocoxil undergo anaesthesia and/ or surgical procedures or develop conditions which may result in dehydration or compromised haemodynamic status.
Zagotovite primerno hidracijo in hemodinamični status živalim, ki prejemajo mavakoksib in so v anesteziji in/ ali kirurškem posegu ali v primeru razvoja pogojev, ki lahko imajo za posledico dehidracijo ali prizadet hemodinamični status.
The key aim of intervention is to maintain renal perfusion.
Ključni cilj posredovanja je ohranitev funkcije ledvic.
(See also section 4.6)
(glejte tudi poglavje 4. 6)
Ingestion of Trocoxil may be harmful for children, and prolonged pharmacological effects leading to e. g. gastrointestinal disorders may be observed.
Opaziti je lahko podaljšano farmakološko delovanje, ki lahko vodi do, npr. - prebavnih motenj.
Adverse reactions of NSAIDs such as loss of appetite, diarrhoea, vomiting, apathy and degradation of renal biochemistry parameters and impaired renal function have occasionally been reported.
Občasno se poroča o neželenih učinkih nesteroidnih proti vnetnih zdravil kot so izguba apetita, driska, bruhanje, apatija, spremembe biokemičnih ledvičnih parametrov in poslabšano delovanje ledvic.
In rare cases these may be fatal.
V redkih primerih so lahko smrtni.
If an adverse reaction to the administration of Trocoxil occurs, no further tablets should be administered and general supportive therapy, as applied to clinical overdosage with NSAIDs, should be applied.
Če se pojavijo neželeni učinki po dajanju Trocoxila, se prekine nadaljnje dajanje tablet in se začne s splošno podporno terapijo, ki je primerna za klinično preveliko odmerjanje nesteroidnih protivnetnih zdravil.
4.7 Use during pregnancy, lactation or lay
3/ 33 4. 7 Uporaba v obdobju brejosti, laktacije ali nesnosti
However, studies in laboratory animals administered other NSAIDs have shown increased pre- and post-implantation loss, embryo-foetal lethality, and malformations.
Študije na laboratorijskih živali, ki so prejele druga nesteroidna protivnetna zdravila, so pokazale povečane izgube pred in po ugnezdenju zarodka, povečano embrionalno- fetalno smrtnost in malformacije.
3/ 32 4.8 Interaction with other medicinal products and other forms of interaction
4. 8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
In common with other NSAIDs, Trocoxil should not be administered simultaneously with other NSAIDs or glucocorticosteroids.
Kot pri drugih nesteroidnih proti vnetnih zdravilih, naj se Trocoxil ne uporablja istočasno z drugimi nesteroidnim proti vnetnimi zdravili ali glukokortikosteroidi.
1-2 months after administration of Trocoxil.
Tveganje za medsebojno delovanje zdravil je potrebno upoštevati skozi celotno obdobje delovanja, kar je1- 2 meseca po dajanju Trocoxila.