natgillin/translations-raw huggingface dataset:
(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 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Nobivac Piro been studied?
(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 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo Nobivac Piro raziskano?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobivac Piro exceed the risks for active immunisation of dogs of six months or older against B. canis to reduce the severity of clinical signs associated with acute babesiosis (B. canis) and anaemia as measured by packed cell volume, and recommended that Nobivac Piro be given a marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Nobivac Piro odobri dovoljenje za promet.
The European Commission granted a marketing authorisation valid throughout the European Union for Nobivac Piro to Intervet International B. V. on 2 September 2004.
Evropska Komisija je dovoljenje za promet z zdravilom Nobivac Piro, veljavno po vsej Evropski uniji, odobrila družbi Intervet International B. V. dne 2. septembra 2004.
Trade name Strength
Farmacevtska oblika
Route of administratio n
Način uporabe zdravila
606 (301- 911) total antigenic mass units
911) skupne
Lyophilisate + solvent for suspension for injection
prašek + vehikel
Dogs
enote
Subcutaneous Cardboard box use
za suspenzijo za
1 vial of freeze- dried antigen and 1 vial of aqueous adjuvant
antigena in 1 viala
3 ml vials of glass Type I (Ph. Eur.) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap
vodni osnovi
606 (301- 911) total antigenic mass units
606 (301 - 911) skupne enote antigene mase
Lyophilisate + solvent for suspension for injection
Liofilizirani prašek + vehikel za suspenzijo za injiciranje
Subcutaneous Cardboard box use
Kartonasta škatla
5 vials of freeze- dried antigen and 5 vials of aqueous adjuvant
5 vial liofiliziranega antigena in 5 vial adjuvansa na vodni osnovi
3 ml vials of glass Type I (Ph. Eur.) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap
3 ml steklene viale tipa I (Ph. Eur.) nepredušno zaprto z gumijastim zamaškom in aluminijsko zaporko
10 vials of freeze- dried antigen and 10 vials of aqueous adjuvant
10 vial liofiliziranega antigena in 10 vial adjuvansa na vodni osnovi
606 (301-911) total antigenic mass units of soluble parasite antigen (SPA) from Babesia canis and Babesia rossi cultures
606 (301– 911) masnih enot topnega parazitskega antigena (TPA) iz kultur Babesie canis in Babesie rossi
Adjuvant (in the solvent) 250 (225-275) µg saponin
250 (225– 275) µg saponina
Three weeks after the basic vaccination course.
Razvoj imunosti: tri tedne po osnovnem cepljenju.
6 months after the last (re-)vaccination.
Trajanje imunosti: šest mesecev po zadnji revakcinaciji.
See section 4.7.
Glejte poglavje 4. 7.
2/ 17 Currently there is only evidence of the efficacy of the vaccine against challenge with B. canis.
2/ 17 Dokazana je samo učinkovitost cepiva proti B. canis.
As a consequence a milder form of disease caused by B. canis can occur.
Cepljenje z Nobivacom Piro okužbe ne prepreči, zato se lahko pojavi blažja oblika bolezni, ki jo povzroča B. canis.
Commonly reported post-vaccination reactions are a diffuse swelling and/ or hardened nodule, accompanied by pain, at the site of vaccination.
Pogosta reakcija na cepljenje je difuzna boleča oteklina in/ ali zatrdlina na mestu vboda.
4.7 Use during pregnancy and lactation
4. 7 Uporaba v obdobju brejosti in laktacije
No information is available on the safety and efficacy of the concurrent use of this vaccine with any other.
O varnosti in učinkovitosti sočasne uporabe cepiva z drugimi cepivi ni podatkov.
It is therefore recommended that no other vaccines should be administered concurrently or simultaneously.
Zato sočasno ne priporočamo uporabe drugih cepiv.
Basic vaccination course:
Osnovno cepljenje:
First injection from 6 months of age, second injection 3 to 6 weeks later.
Prvi odmerek pri psih starejših od 6 mesecev, drugi pa 3 do 6 tednov po prvem.
Single dose, every 6 months after the last (re-)vaccination.
Enkratni odmerek vsakih 6 mesecev po zadnji (re -) vakcinaciji.
Allow the solvent to reach room temperature (15 - 25°C).
Vehikel se mora ogreti na sobno temperaturo (15 do 25 ºC).
Not different from one dose.
Enako kot pri enkratnem odmerku.
Vaccine: culture medium Solvent: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, water for injection.
Cepivo: gojišče kulture Vehikel: natrijev dihidrogenfosfat dihidrat, dinatrijev fosfat dihidrat, voda za injekcije
Do not mix with any other vaccine or immunological product.
Ne mešajte z drugim cepivom ali imunološkim zdravilom.
57 months (4 years and 9 months) Solvent:
57 mesecev (4 leta in 9 mesecev) Vehikel:
2 years Reconstituted product should be used immediately.
2 leti Po rekonstituciji je treba zdravilo takoj uporabiti.
Store and transport refrigerated (2°C - 8°C).
Shranjujte in prevažajte v hladilniku (2 °C do 8 °C).
3-ml vials of glass Type I closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Liofilizat in vehikel: viale po 3 ml iz stekla tipa I, zaprte z zamaški iz halogenobutilne gume in zatesnjene z aluminijastimi zaporkami s šifro.
Cardboard box containing 10 vials of lyophilisate and 10 vials of solvent.
Zloženka z 1 vialo liofilizata in 1 vialo vehikla Zloženka s 5 vialami liofilizata in 5 vialami vehikla Zloženka z 10 vialami liofilizata in 10 vialami vehikla
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, ki nastanejo iz teh zdravil
Wim de Körverstraat 35 NL - 5831 AN Boxmeer
Intervet International BV Wim de Körverstraat 35 NL – 5831 AN Boxmeer
First authorisation:
Datum odobritve:
2 September 2004
September 2004
Veterinary medicinal product subject to medical prescription.
Izdaja zdravila za uporabo v veterinarski medicini je le na recept.
9/ 17 PARTICULARS TO APPEAR ON THE OUTER PACKAGE OR, WHERE THERE IS NO OUTER PACKAGE, ON THE IMMEDIATE PACKAGE
PRIMARNI OVOJNINI
STATEMENT OF ACTIVE AND OTHER SUBSTANCE(S)
NAVEDBA ZDRAVILNE( IH) UČINKOVIN( E) IN DRUGHIH SESTAVIN
1 x 1 dose 5 x 1 dose 10 x 1 dose
1 x 1 odmerek 5 x 1 odmerek 10 x 1 odmerek
S. C. injection
s. c. injekcija
{date}
{datum}
Store and transport at 2 - 8°C.
Shranjujte in prevažajte pri temperaturi 2– 8 °C.
THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
BESEDILO ''SAMO ZA ŽIVALI'' IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
THE WORDS "KEEP OUT OF REACH AND SIGHT OF CHILDREN"
BESEDILO ''ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM «
11/ 17 PARTICULARS TO APPEAR ON SMALL SINGLE DOSE CONTAINERS OTHER THAN AMPOULES
11/ 17 PODATKI, KI MORAJO BITI NAVEDENI NA MANJŠIH ENOODMERNIH VSEBNIKIH, RAZEN NA AMPULAH
1 dose:
1 odmerek:
606 (301-911)units Babesia antigens
606 (301– 911) enot antigenov Babesie
12/ 17 PARTICULARS TO APPEAR ON SMALL SINGLE DOSE CONTAINERS OTHER THAN AMPOULES
12/ 17 PODATKI, KI MORAJO BITI NAVEDENI NA MANJŠIH ENOODMERNIH VSEBNIKIH, RAZEN NA AMPULAH
Label of the adjuvant
Nalepka na adjuvansu
Adjuvated solvent for Nobivac Piro.
Vehikel z adjuvansom za Nobivac Piro
ROUTE(S) OF ADMINISTRATION
POT( I) UPORABE
14/ 17 PACKAGE LEAFLET
14/ 17 NAVODILO ZA UPORABO
606 (301-911) total antigenic mass units of soluble parasite antigen (SPA) from Babesia canis and Babesia rossi cultures Adjuvant:
606 (301– 911) masnih enot topnega parazitskega antigena (TPA) iz kultur Babesie canis in Babesie rossi Adjuvans:
250 (225-275) µg saponin (from the solvent)
250 (225- 275) µg saponina (v topilu)
Onset of immunity:
Razvoj imunosti: tri tedne po osnovnem cepljenju.
Three weeks after the basic vaccination course.
Trajanje imunosti: šest mesecev po zadnji (re -) vakcinaciji.
Duration of immunity:
KONTRAINDIKACIJE
First injection from 6 months of age, second injection 3-6 weeks later.
Prvi odmerek pri psih, starejših od 6 mesecev, drugi pa 3 do 6 tednov po prvem.
Single dose, every six months after the last (re-) vaccination.
Enkratni odmerek vsakih šest mesecev po zadnji (re -) vakcinaciji.
Make sure that the lyophilisate is completely dissolved before use Withdraw the entire contents of the reconstituted vaccine into a sterile syringe and administer the whole contents subcutaneously.
S sterilno brizgo odvzemite vso količino rekonstituiranega cepiva in vse cepivo vbrizgajte subkutano.
Store and transport refrigerated (2°C - 8°C).
Shranjujte in prevažajte v hladilniku (2 °C do 8 ºC).
In the absence of compatibility studies, do not mix with any other product except the solvent supplied for use with the vaccine.
Cepiva ne smemo mešati z drugimi zdravili, razen s priloženim vehiklom, ker ni na voljo ustreznih študij kompatibilnosti.
What is Novem?
Kaj je zdravilo Novem?
Novem is a solution for injection, which comes in two strengths:
Novem je raztopina za injiciranje, ki je na voljo v dveh jakostih:
5 mg/ ml and 20 mg/ ml.
5 mg/ ml in 20 mg/ ml
What is Novem used for?
Za kaj se zdravilo Novem uporablja?
Novem is used to relieve inflammation and pain in both acute and chronic musculo-skeletal disorders.
Zdravilo Novem se uporablja za lajšanje vnetij in bolečin pri akutnih in kroničnih obolenjih mišičja in okostja.
Novem is used in cattle for acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs.
Zdravilo Novem se uporablja za umirjanje kliničnih znakov pri govedu z akutnimi okužbami dihal ob ustreznem antibiotičnem zdravljenju.
It is also used for diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle; and also as supportive therapy in the treatment of acute mastitis, in combination with antibiotics.
Uporablja se tudi kot podporna terapija pri zdravljenju akutnega mastitisa v kombinaciji z antibiotiki.
In pigs it is used for non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation, and also for supportive therapy in the treatment of septicaemia and toxaemia around farrowing (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.
Pri prašičih so uporablja pri neinfekcijskih lokomotoričnih motnjah za zmanjšanje simptomov šepavosti in vnetja ter za podporno zdravljenje pri zdravljenju septikemije in toksemije ob oprasitvi (sindrom mastitis- metritis- agalakcija) skupaj z ustreznim antibiotičnim zdravljenjem.
Novem contains meloxicam, which belongs to a class of medicines called non-steroidal anti- inflammatory drugs (NSAIDs).
Zdravilo Novem vsebuje meloksikam, ki spada v skupino zdravil, imenovanih nesteroidna protivnetna zdravila (NSPVZ).
As the prostaglandins are substances that trigger inflammation, pain, exudation and fever, meloxicam reduces those responses.
Prostaglandini so snovi, ki sprožajo vnetje, bolečino, izločanje tekočine in zvišano telesno temperaturo, meloksikam pa zmanjšuje obseg teh odzivov.
How has Novem been studied?
Kako je bilo zdravilo Novem raziskano?
Appropriate studies have been made to show the safety and effectiveness in the target animals.
Varnost in učinkovitost zdravila pri ciljnih živalih so dokazali z ustreznih študijami.
What benefit has Novem showed during the studies?
Kakšne koristi je zdravilo Novem izkazalo med študijami?
Studies in cattle showed that the addition of Novem to antibiotics therapy significantly improved clinical parameters and reduced fever compared to antibiotics alone.
Študije pri govedu so pokazale, da je v primerjavi z antibiotiki samimi dodajanje zdravila Novem antibiotičnemu zdravljenju bistveno izboljšalo klinične parametre in znižalo povišano telesno temperaturo.
Studies in pigs showed that Novem reduces the symptoms of lameness and inflammation in non- infectious locomotor disorders.
Študije pri prašičih so pokazale, da zdravilo Novem zmanjša simptome šepavosti in vnetij pri neinfekcijskih lokomotoričnih motnjah.
Similarly, treatment of mastitis-metritis-agalactia syndrome with adjunctive treatment of Novem and an appropriate antibiotic was shown to be superior to an antibiotic therapy alone.
Podobno se je izkazalo, da je zdravljenje sindroma mastitis - metritis- agalakcija z zdravilom Novem in ustreznim antibiotikom učinkovitejše kot antibiotik sam.
What is the risk associated with Novem?
Kakšna tveganja so povezana z zdravilom Novem?
In cattle and pigs both subcutaneous and intramuscular administration are well tolerated; only a slight temporary swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
Pri manj kot 10% goveda, zdravljenega v kličnih študijah, je bila opažena samo blaga in prehodna oteklina na mestu podkožne injekcije.
After the last administration of Novem cattle should not be slaughtered for 15 days, and pigs should not be slaughtered for 5 days.
Govedo, ki je prejelo zdravilo Novem, se lahko zakolje po 15 dneh, prašiči pa po petih dneh.
After the last administration of Novem to cattle, the milk should not be used for 5 days.
Po zadnjem dajanju zdravila Novem govedu, se mleko ne sme uporabljati še pet dni.
Why has Novem been approved?
Zakaj je bilo zdravilo Novem odobreno?
The Committee for Medicinal Products for Veterinary Use (CVMP) decided that the benefits of Novem are greater than any risks of treatment and they recommended that Novem should be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je sklenil, da so koristi zdravila Novem večje od vseh tveganj zdravljenja, in je priporočil odobritev dovoljenja za promet z zdravilom Novem.
The European Commission granted a marketing authorisation valid throughout the European Union, for Novem to Boehringer Ingelheim Vetmedica, Germany on 2 March 2004.
Evropska komisija je dovoljenje za promet z zdravilom Novem, veljavno po vsej Evropski uniji, odobrila družbi Boehringer Ingelheim Vetmedica, Nemčija, dne 2. marca 2004.
©EMEA 2008
Povzetek je bil nazadnje posodobljen 08- 2008.
Page 2/ 2
Stran 2/ 2 ©EMEA 2008
Pharmaceutical Form
Farmacevtsk Ciljna a oblika živalska vrsta
Solution for injection
raztopina Goveda za injiciranje in prašiči
Cattle: subcutaneous injection Pigs: intramuscular injection
Goveda: podkožno Prašiči: intramuskularno
15 days (cattle), 5 days (pigs) Milk:
15 dni (goveda), 5 dni (prašiči) mleko:
Novem 5 mg/ ml solution for injection for cattle and pigs
Novem 5 mg/ ml, raztopina za injiciranje za goveda in prašiče
Each ml of Novem 5 mg/ ml solution for injection contains:
Vsak ml raztopine za injiciranje Novem 5 mg/ ml vsebuje:
150 mg
Etanol, brezvodni 150 mg
Subcutaneous and intramuscular administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
Prenašanje podkožnega in intramuskularnega dajanja je dobro; v kliničnih raziskavah so zasledili samo blago in prehodno oteklino na mestu podkožne injekcije, in sicer pri manj kot 10% goved.
10.0 ml/ 100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Enkratna podkožna injekcija odmerka po 0, 5 mg meloksikama na kilogram telesne mase (to je 10, 0 ml/ 100 kg telesne mase), po potrebi v kombinaciji z antibiotičnim zdravljenjem ali s peroralno rehidracijsko terapijo.
3 4.11 Withdrawal periods
4. 11 Karenca( e)
Pigs:
3 Prašiči:
6.2 Incompatibilities
4 6. 2 Inkompatibilnosti
02.03.2004 Date of last renewal:
02. 03. 2004 Datum podaljšanja dovoljenja za promet:
Novem 20 mg/ ml solution for injection for cattle and pigs
Novem 20 mg/ ml, raztopina za injiciranje za goveda in prašiče
Each ml of Novem 20 mg/ ml solution for injection contains:
Vsak ml raztopine za injiciranje Novem 20 mg/ ml vsebuje:
7 4.4 Special warnings
6 4. 4 Posebna opozorila
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
4. 5 Posebni previdnostni ukrepi
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity.
Posebni previdnostni ukrepi za uporabo pri živalih Če se pojavijo neželeni učinki, je treba zdravljenje ukiniti in se posvetovati z veterinarjem.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Zaradi možne nevarnosti toksičnih učinkov na ledvice se dajanju zdravila izogibamo pri zelo dehidriranih, hipovolemičnih ali hipotenzivnih živalih, ki potrebujejo parenteralno rehidracijo.
2.5 ml/ 100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Enkratna podkožna injekcija odmerka po 0, 5 mg meloksikama na kilogram telesne mase (to je 2, 5 ml/ 100 kg telesne mase), po potrebi v kombinaciji z antibiotičnim zdravljenjem ali s peroralno rehidracijsko terapijo.
8 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno)
4.11 Withdrawal periods
7 4. 11 Karenca( e)
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic effects.
Njegovo delovanje temelji na zaviranju tvorbe prostaglandinov.
It reduces leukocyte infiltration into the inflamed tissue.
Deluje protivnetno, antieksudativno, analgetično in antipiretično.
After two intramuscular doses of 0.4 mg meloxicam/ kg, a Cmax value of 1.9 µg/ ml was reached after 1 hour in pigs.
Po dveh intramuskularnih odmerkih meloksikama po 0, 4 mg/ kg je znašala Cmax pri prašičih po 1 uri 1, 9 µg/ ml.
9 In pigs, after intramuscular administration the mean plasma elimination half-life is approximately 2.5 hours.
Pri prašičih je srednja razpolovna doba izločanja po intramuskularnem dajanju približno 2, 5 ure.
Shelf-life of the veterinary medicinal product as packaged for sale (20, 50 or 100 ml vials):
Rok uporabnosti zdravila v pakiranju za prodajo (viale po 20, 50 ali 100 ml):
2 years Shelf-life after first opening the immediate packaging:
2 leti Rok uporabnosti po prvem odpiranju neposredne ovojnine:
Colourless glass injection vial of 20, 50, 100 or 250 ml, closed with a rubber stopper and sealed with an aluminium cap.
Brezbarvne steklene injekcijske viale po 20, 50, 100 ali 250 ml, zaprte z gumijastim zamaškom in aluminijasto zaporko.
11 ANNEX II
10 DODATEK II
12 Novem 5 mg/ ml solution for injection for cattle and pigs
11 Novem 5 mg/ ml, raztopina za injiciranje za goveda in prašiče
13 Annex II of Council Regulation (EEC) No 2377/ 90
2377/ 90:
The Committee considered that at the concentration of the dose in the product to be administered to the target species, the excipient glycofurol was not pharmacologically active.
natrijev hidroksid 5
It therefore concluded, in accordance with its recent position paper on pharmacologically active excipients, that an MRL was not required to be established for this substance.
Po mnenju Odbora pomožna snov glikofurol ni farmakološko aktivna v koncentraciji, v kateri jo vsebuje odmerek izdelka, namenjen za uporabo pri ciljni živalski vrsti.
14 Novem 20 mg/ ml solution for injection for cattle and pigs
13 Novem 20 mg/ ml, raztopina za injiciranje za goveda in prašiče
Pharmacologically
Živalska vrsta
Animal
Druge določbe
Novem 5 mg/ ml solution for injection for cattle and pigs Meloxicam
Novem 5 mg/ ml, raztopina za injiciranje za goveda in prašiče Meloksikam
Single subcutaneous injection.
Enkratna podkožna injekcija
20 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
19 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Cattle: subcutaneous injection.
Goveda: podkožna injekcija.
22 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
21 PODATKI NA ZUNANJI OVOJNINI
Novem 20 mg/ ml solution for injection for cattle and pigs Meloxicam
Novem 20 mg/ ml, raztopina za injiciranje za goveda in prašiče Meloksikam
23 Pigs:
Prašiči:
25 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
PRIMARNI OVOJNINI
SC injection.
Goveda: s. c. injekcija
27 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
25 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
SC
Goveda: s. c.
29 PACKAGE LEAFLET FOR:
27 NAVODILO ZA UPORABO
30 In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
Zelo redko se lahko pojavijo anafilaktoidne reakcije, ki jih je treba zdraviti simptomatsko.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
28 Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
31 Precautions to be taken by the person administering the product Accidental self-injection may give rise to pain.
29 Previdnostni ukrepi, ki jih mora izvajati oseba, ki daje zdravilo Nenamerno samoinjiciranje lahko povzroči bolečino.
32 PACKAGE LEAFLET FOR:
30 NAVODILO ZA UPORABO
33 Do not use in case of hypersensitivity to the active substance or to any of the excipients.
31 Ne uporabite v primeru preobčutljivosti na zdravilno učinkovino ali katero koli pomožno snov.
34 Do not use after the expiry date (EXP) stated on the carton and vial.
32 Zdravila ne smete uporabljati po datumu izteka roka uporabnosti (EXP), navedenega na zunanji ovojnini in viali.
Precautions for use in animals If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Previdnostni ukrepi za uporabo pri živalih Če se pojavijo neželene učinki, je treba zdravljenje prekiniti in se posvetovati z veterinarjem.
Use during pregnancy and lactation Can be used during pregnancy and lactation.
Uporaba v obdobju brejosti in laktacije Lahko se uporablja v obdobju brejosti in laktacije.
20, 50, 100 or 250 ml injection vials.
Injekcijske viale po 20, 50, 100 ali 250 ml.
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
Njegov namen je pojasniti, kako je Odbor za zdravila za uporabo v veterinarski medicini (CVMP) ocenil predloženo dokumentacijo, na podlagi česar je oblikoval poročila glede uporabe zdravila.
Onsior contains robenacoxib which belongs to a class of medicines that reduce fever, pain and inflammation.
Zdravilo Onsior vsebuje robenakoksib, ki spada v skupino zdravil, ki znižujejo povišano telesno temperaturo, bolečino in vnetje.
It is available as tablets in five different strengths (6 mg for cats, and 5 mg, 10 mg, 20 mg and 40 mg for dogs) and as a solution for injection (20 mg/ ml for dogs and cats).
Na voljo je v obliki tablet petih različnih jakosti (6 mg za mačke ter 5 mg, 10 mg, 20 mg in 40 mg za pse) in kot raztopina za injiciranje (20 mg/ ml za pse in mačke).
In cats, Onsior tablets are used for the treatment of acute pain and inflammation associated with musculoskeletal disorders (problems with the muscles and bones).
Pri mačkah se tablete Onsior uporabljajo za zdravljenje akutne bolečine in vnetja pri mišičnoskeletnih obolenjih (težave z mišicami in kostmi).
The solution for injection is used for the treatment of pain and inflammation associated with surgery of the soft tissues, such as neutering.
Raztopina za injiciranje se uporablja za zdravljenje bolečine in vnetja v povezavi z operativnimi posegi na mehkih tkivih, kot je sterilizacija.
In dogs, Onsior tablets are used for the treatment of pain and inflammation associated with chronic osteoarthritis (a long-term disease causing pain in the joints).
Pri psih se tablete Onsior uporabljajo za zdravljenje bolečine in vnetij pri kroničnem osteoartritisu (dolgotrajna bolezen, ki povzroča bolečino v sklepih).