natgillin/translations-raw huggingface dataset:
In view of the risk of accidental self-injection and the known adverse class-effects of NSAIDs and other prostaglandin inhibitors on pregnancy and/or embryofoetal development, the veterinary medicinal product should not be administered by pregnant women or women attempting to conceive.
Zaradi tveganja nenamernega samo-injiciranja in znanih neželenih učinkov skupine NSAID in drugih prostaglandinskih inhibitorjev na nosečnost in/ali razvoj zarodka zdravila za uporabo v veterinarski medicini nosečnice ali ženske, ki poskušajo zanositi, ne smejo dajati.
This local reaction resolved within 8 hours following subcutaneous administration.
Ta lokalna reakcija mine v 8 urah po subkutanem dajanju.
Treatment of calves with Novem 20 minutes before dehorning reduces post-operative pain.
Zdravljenje telet z zdravilom Novem 20 minut pred odstranitvijo rogov zmanjša pooperativno bolečino.
Cattle (calves and young cattle) and pigs
Goveda (teleta in mlada goveda) in prašiči
For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.
Za pomožno zdravljenje pri zdravljenju puerperalne septikemije in toksemije (sindroma mastitisa, metritisa in agalaktije) ob ustreznem antibiotičnem zdravljenju.
Cattle: Can be used during pregnancy.
Goveda: Lahko se uporablja v obdobju brejosti.
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATCvet code: QM01AC06
Farmakoterapevtska skupina: protivnetna in protirevmatična zdravila, nesteroidna (oksikami) Oznaka ATCvet: QM01AC06.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri)
EXP {month/year} Once broached use within 28 days.
EXP {mesec/leto} Odprto zdravilo uporabite v 28 dneh.
Boehringer Ingelheim Vetmedica GmbH GERMANY
Boehringer Ingelheim Vetmedica GmbH NEMČIJA
Treatment of piglets with Novem before castration reduces post-operative pain.
Zdravljenje pujskov z zdravilom Novem pred kastracijo blaži postoperativno bolečino.
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Za pomožne snovi, navedene v poglavju 6.1 SPC, tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo (ES) št. 470/2009.
In very rare cases anaphylactoid reactions which may be serious (including fatal) may occur and should be treated symptomatically.
Zelo redko se lahko pojavijo anafilaktične reakcije, ki so lahko resne (vključno s smrtnimi) in jih je treba zdraviti simptomatsko.
IM injection.
injekcija.
For the treatment of diarrhoea in cattle, do not use in animals of less than 1 week of age.
Pri zdravljenju driske pri govedu ne uporabite pri živalih, mlajših od enega tedna.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI
Shelf-life of the veterinary medicinal product as packaged for sale (20 ml, 50 ml, 100 ml or 250 ml vials): 3 years
Rok uporabnosti zdravila v pakiranju za prodajo (viale po 20 ml, 50 ml, 100 ml ali 250 ml): 3 leta.
Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
Farmakoterapevtska skupina: Protivnetna in protirevmatična zdravila, nesteroidna (oksikami).
Take care of accurate dosing, use of appropriate dosing device and estimation of body weight.
Poskrbite za natančno odmerjanje, uporabo ustrezne priprave za odmerjanje in oceno telesne mase.
People with known hypersensitivity to non-steroidal antiinflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Osebe z znano preobčutljivostjo za nesteroidna protivnetna zdravila (NSAID) naj se izogibajo stiku z zdravilom.
EXP {month/year} Once broached, use by…
EXP {mesec/leto} Načeto zdravilo uporabite do…
Do not use after the expiry date stated on the carton and vial after EXP.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini in viali po EXP.
People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Osebe z znano preobčutljivostjo za nesteroidna protivnetna zdravila (Non-Steroidal Anti-Inflammatory Drugs, NSAID) naj se izogibajo stiku z zdravilom.
Cattle: SC injection.
Goveda: s.c. injekcija.
To obtain the best possible pain relieving effect post-surgery Novem should be administered 30 minutes before surgical intervention.
Najboljše možno lajšanje bolečine po operaciji boste dosegli, če boste zdravilo Novem uporabili 30 minut pred kirurškim posegom.
Single IM injection before surgery.
injekcija pred operacijo.
EXP {month/year} Shelf-life of broached vial: 28 days.
EXP {mesec/leto} Rok uporabnosti odprte viale: 28 dni.
Date of first authorisation: Date of last renewal:
Datum zadnjega podaljšanja dovoljenja za promet:
MANUFACTURER´S BATCH NUMBER
PROIZVAJALČEVA ŠTEVILKA SERIJE
A slight transient painless swelling at the injection site was observed in laboratory studies.
V laboratorijskih študijah so na mestu injiciranja opazili prehodno nebolečo oteklino.
Meloxicam is eliminated with a half-life of 26 hours after subcutaneous injection in young cattle.
Razpolovna doba izločanja meloksikama je po podkožni injekciji pri mladih govedih 26 ur.
Cattle: Single SC injection.
Goveda: Enkratna s.c. injekcija.
In case of overdose symptomatic treatment should be initiated.
Pri prevelikem odmerku uvedite simptomatsko zdravljenje.
Meloxicam in Novem 20 mg/ml solution for injection for cattle and pigs is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Meloksikam v zdravilu Novem 20 mg/ml, raztopina za injiciranje za goveda in prašiče, je dovoljena učinkovina, kot je navedena v tabeli 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št. 37/2010:
Meloxicam in Novem 5 mg/ml solution for injection for cattle and pigs is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Meloksikam v zdravilu Novem 5 mg/ml, raztopina za injiciranje za goveda in prašiče, je dovoljena učinkovina, kot je navedena v tabeli 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št. 37/2010:
Excipient: Ethanol
Pomožna snov: Etanol,
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
Prašiči: Za ublažitev ohromelosti in vnetja pri neinfekcijskih lokomotornih motnjah.
Each vial is closed with a rubber stopper and sealed with an aluminium cap.
Viale so zaprte z gumijastimi zamaški in aluminijastimi zaporkami.
Interaction with other medicinal products and other forms of interaction: Do not administer concurrently with glucocorticosteroids, other NSAIDs or with anticoagulant agents.
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij: Zdravila ne smemo dajati hkrati z glukokortikosteroidi, drugimi NSAID ali antikoagulanti.
Active substance: Meloxicam
Zdravilna učinkovina: Meloksikam
THE WORDS "KEEP OUT OF THE SIGHT AND REACH OF CHILDREN"
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM”
Pregnancy and lactation Can be used during pregnancy and lactation.
Brejost in laktacija Lahko se uporablja v obdobju brejosti in laktacije.
Manufacturer responsible for batch release: Labiana Life Sciences S.A.
Proizvajalec odgovoren za sproščanje serij: Labiana Life Sciences S.A.
Subcutaneous and intramuscular injection 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.
Podkožno in intramuskularno injiciranje živali dobro prenašajo; v kliničnih raziskavah so zasledili samo blago in prehodno oteklino na mestu podkožne injekcije in sicer pri manj kot 10 % goved.
Marketing authorisation holder: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Imetnik dovoljenja za promet z zdravilom: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein NEMČIJA
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/25 kg body weight).
Enkratna intramuskularna injekcija odmerka po 0,4 mg meloksikama na kilogram telesne mase (to je 2,0 ml/25 kg telesne mase).
EU/2/04/042/015-018
ŠTEVILKE DOVOLJENJ ZA PROMET EU/2/04/042/015-018
Vial, 50 ml
Viala, 50 ml
Vials, 20 ml and 50 ml
Viale, 20 ml in 50 ml
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.
Podkožno in intramuskularno dajanje živali dobro prenašajo; v kliničnih raziskavah so zasledili samo blago in prehodno oteklino na mestu podkožne injekcije, in sicer pri manj kot 10 % goved.
The active substance in Novem is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Zdravilna učinkovina v zdravilu Novem je dovoljena učinkovina, kot je navedena v tabeli 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št. 37/2010:
Special precautions to be taken by the person administering the veterinary medicinal product to animals: Accidental self-injection may give rise to pain.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Nenamerno samoinjiciranje lahko povzroči bolečino.
meat and offal: 15 days
meso in organi: 15 dni
Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves and pigs.
Deluje tudi antiendotoksično, saj so dokazali, da zavira nastajanje tromboksana B2, izzvano z vnosom endotoksina E. Coli pri teletih in prašičih.
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 g/ml.
Withdrawal periods: Cattle:
Karenca: Goveda:
Interaction with other medicinal products and other forms of interaction Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Zdravila ne smete dajati hkrati z glukokortikosteroidi, drugimi nesteroidnimi protivnetnimi zdravili ali antikoagulansi.
Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young cattle and lactating cows, respectively.
Razpolovna doba izločanja meloksikama je po subkutani injekciji pri mladem govedu in kravah v obdobju laktacije 26 ur in 17,5 ure.
Carton for 20 ml, 50 ml, 100 ml and 250 ml
Škatla za 20 ml, 50 ml, 100 ml in 250 ml
Following single intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.1 to 1.5 µg/ml was reached within 1 hour in pigs.
Po enkratnih intramuskularnih odmerkih meloksikama po 0,4 mg/kg je znašala Cmax pri prašičih po 1 uri 1,1 do 1,5 g/ml.
Overdose (symptoms, emergency procedures, antidotes): In case of overdose, symptomatic treatment should be initiated.
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi): Pri prevelikem odmerjanju uvedemo simptomatsko zdravljenje.
Active substance: Meloxicam 5 mg
Zdravilna učinkovina: Meloksikam 5 mg
Active substance: Meloxicam 20 mg
Zdravilna učinkovina: Meloksikam 20 mg
Special precautions to be taken by the person administering the veterinary medicinal product to animals Accidental self-injection may give rise to pain.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Nenamerno samo-injiciranje lahko povzroči bolečino.
Cardboard box with 1 or 12 colourless glass injection vial(s) of 20 ml, 50 ml or 100 ml, closed with a rubber stopper and sealed with an aluminium cap.
Kartonska škatla z 1 ali 12 brezbarvnimi steklenimi injekcijskimi vialami po 20 ml, 50 ml ali 100 ml, zaprtimi z gumijastim zamaškom in aluminijasto zaporko.
Cattle: SC Pigs:
Goveda: s.c.
Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves and lactating cows.
Deluje tudi antiendotoksično, saj so dokazali, da zavira nastajanje tromboksana B2, izzvano z vnosom endotoksina E. coli pri teletih in kravah v obdobju laktacije.
Name and address of the manufacturers responsible for batch release Labiana Life Sciences S.A.
Ime in naslov izdelovalcev zdravila, odgovornih za sprostitev serije Labiana Life Sciences S.A.
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmaxvalues of 2.1 µg/ml and 2.7 µg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
Po enkratnem podkožnem odmerku meloksikama po 0,5 mg/kg je znašala Cmax pri mladih govedih in kravah v obdobju laktacije 2,1 g/ml in 2,7 g/ml po 7,7 ure in 4 urah.
Meat and offal: 15 days; milk: 5 days.
Meso in organi: 15 dni; mleko: 5 dni.
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Zdravila ne smete dajati hkrati z glukokortikosteroidi, drugimi nesteroidnimi protivnetnimi zdravili ali antikoagulansi.
Special precautions to be taken by the person administering the veterinary medicinal product Accidental self-injection may give rise to pain.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki daje zdravilo Nenamerno samo-injiciranje lahko povzroči bolečino.
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 µg/ml were reached after 7.7 hours in young cattle.
Po enkratnem podkožnem odmerku meloksikama po 0,5 mg/kg je znašala Cmax pri mladih govedih 2,1 g/ml po 7,7 ure.
Poloxamer 188 Sodium chloride Glycine
6.1 Seznam pomožnih snovi etanol poloksamer 188 natrijev klorid glicin natrijev hidroksid glikofurol meglumin voda za injekcije
Do not administer concurrently with glucocorticosteroids, other NSAIDs or with anticoagulant agents.
Zdravila ne smemo dajati hkrati z glukokortikosteroidi, drugimi NSAID ali antikoagulanti.
Novem 5 mg/ml solution for injection for cattle and pigs
Novem 5 mg/ml, raztopina za injiciranje za goveda in prašiče
Carton for 20 ml, 50 ml and 100 ml
Škatla za 20 ml, 50 ml in 100 ml
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years Shelf-life after first opening the immediate packaging: 28 days
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki po EXP. Rok uporabnosti po prvem odpiranju vsebnika: 28 dni.
Novem 40 mg/ml solution for injection for cattle
Novem 40 mg/ml, raztopina za injiciranje za govedo
Overdose (symptoms, emergency procedures, antidotes) In case of overdose, symptomatic treatment should be initiated.
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) Pri prevelikem odmerku uvedite simptomatsko zdravljenje.
Novem 20 mg/ml solution for injection for cattle and pigs
Novem 20 mg/ml, raztopina za injiciranje za goveda in prašiče
QUANITITY OF THE ACTIVE SUBSTANCE(S)
Farmakološko aktivna snov(i)
Disodium edetate Sodium hydroxide Hydrochloric acid Meglumine Water for injection
6.1 Seznam pomožnih snovi etanol poloksamer 188 makrogol 300 glicin dinatrijev edetat natrijev hidroksid klorovodikova kislina meglumin voda za injekcije
PACKAGE LEAFLET: Novem 40 mg/ml solution for injection for cattle
NAVODILO ZA UPORABO Novem 40 mg/ml, raztopina za injiciranje za govedo
PACKAGE SIZE(S)
KOLIČINA UČINKOVIN(E)
Expiry date
EXP {mesec/leto}
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate.
Prašiči: Enkratna intramuskularna injekcija odmerka po 0,4 mg meloksikama na kilogram telesne mase (to je 2,0 ml/100 kg telesne mase), po potrebi v kombinaciji z antibiotičnim zdravljenjem.
Novem 5 mg/ml solution for injection for cattle and pigs Meloxicam
Novem 5 mg/ml, raztopina za injiciranje za goveda in prašiče Meloksikam
Ethanol
Rp-Vet
Once broached, use by….
Načeto zdravilo uporabite do…
PACKAGE LEAFLET: Novem 20 mg/ml solution for injection for cattle and pigs
NAVODILO ZA UPORABO Novem 20 mg/ml, raztopina za injiciranje za goveda in prašiče
PACKAGE LEAFLET: Novem 5 mg/ml solution for injection for cattle and pigs
NAVODILO ZA UPORABO Novem 5 mg/ml, raztopina za injiciranje za goveda in prašiče
Novem 40 mg/ml solution for injection for cattle meloxicam
Novem 40 mg/ml, raztopina za injiciranje za govedo meloksikam
Novem 20 mg/ml solution for injection for cattle and pigs Meloxicam
Novem 20 mg/ml, raztopina za injiciranje za goveda in prašiče Meloksikam
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJE B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE
Name and address of the manufacturer responsible for batch realease Labiana Life Sciences S.A.
Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije Labiana Life Sciences S.A.
Single subcutaneous injection at a dose of 0.5 mg meloxicam/kg body weight (i.e. 1.25 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Enkratna subkutana injekcija v odmerku 0,5 mg meloksikama/kilogram telesne teže (to je 1,25 ml/100 kg telesne teže), po potrebi v kombinaciji z antibiotičnim zdravljenjem ali s peroralno rehidracijsko terapijo.
Meloxicam 20 mg Ethanol
Meloksikam 20 mg
Cattle: meat and offal: 15 days; milk: 5 days Pigs:
Goveda: meso in organi: 15 dni; mleko: 5 dni Prašiči: meso in organi: 5 dni
Cardboard box with 1 or 12 colourless glass injection vial(s) of 20 ml, 50 ml or 100 ml.
Kartonska škatla z 1 ali 12 brezbarvnimi steklenimi injekcijskimi vialami po 20 ml, 50 ml ali 100 ml. Kartonska škatla z 1 ali 6 brezbarvnimi steklenimi injekcijskimi vialami po 250 ml.
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.
Meloksikam je nesteroidna protivnetna učinkovina (NSAID) iz skupine oksikamov.
Pack sizes of 1 or 12 colourless glass injection vial(s) each containing 50 ml or 100 ml.
Pakiranja z 1 ali 12 brezbarvnimi steklenimi injekcijskimi vialami po 50 ml ali 100 ml. Ni nujno, da so v prometu vsa navedena pakiranja.
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 properties.
Meloksikam je nesteroidno protivnetno zdravilo (NSAID) iz skupine oksikamov.
Withdrawal periods: Cattle: meat and offal: 15 days; milk: 5 days
Goveda:n Meso in organi: 15 dni; mleko: 5 dni.
Single subcutaneous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 10.0 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Goveda: 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.
Single subcutaneous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Goveda: 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.
Route of Administration
Pot uporabe zdravila
Date of last renewal: 30/08/2012
Datum zadnjega podaljšanja : 30/08/2012
Other animals, such as rabbits and small rodents, have not been tested.
Drugih živali, na primer kuncev in malih glodavcev, niso testirali.
21960 Intervet Lane, Delaware 19966, Millsboro U.S.A.
21960 Intervet Lane, Delaware 19966, Millsboro ZDA
Intermittent spreading is possible as well.
Možno je tudi širjenje s prekinitvami.
ATC vet code: QI06AE02
Oznaka ATCvet: QI06AE02
375 South Lake Street, Minnesota 56187, Worthington U.S.A.
375 South Lake Street, Minnesota 56187, Worthington ZDA
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of their territory if it is established that:
Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta, država članica lahko v skladu s svojo državno zakonodajo prepove zdelovanje, uvoz, posest, prodajo, oskrbo in/ali uporabo imunološkega zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če se ugotovi, da:
Such individuals should also be aware that cats can shed the organism for up to 1 year after vaccination.
Te osebe morajo vedeti, da lahko mačke izločajo mikroorganizem do 1 leto po cepljenju.
Duration of immunity: The duration of immunity is up to 1 year.
Trajanje imunosti: Imunost traja do 1 leta.
a) the administration of the product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
bi uporaba zdravila ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
Excipients: For a full list of excipients, see section 6.1.
Pomožne snovi Za popoln seznam pomožnih snovi glejte poglavje 6.1.
The duration of immunity is up to 1 year.
Imunost traja do 1 leta.
Only healthy cats should be vaccinated.
Cepiti smemo samo zdrave mačke.
After overdose, identical signs appear particularly in very young susceptible kittens.
Po vnosu prevelikega odmerka se pojavijo enaki znaki, zlasti pri zelo mladih občutljivih mladičih.
Any person intending to import, sell, supply and/or use Nobivac Bb for cats must consult the relevant Member State's competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ali uporabljati Nobivac Bb za mačke, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred uvozom, prodajo, oskrbo in/ali uporabo.
Shelf-life after reconstitution according to directions: 4 hours
Rok uporabnosti po rekonstituciji v skladu z navodili: 4 ure
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10/09/2002
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve : 10-09-2002