natgillin/translations-raw huggingface dataset:
Take the syringe out of the tray
Vzemite brizgo iz embalaže
Discard if left out of the refrigerator for more than 7 days.
Če je bil izven hladilnika več kot 7 dni, ga zavrzite.
Nucala pre-filled syringe is for use under the skin only (subcutaneous).
Zdravilo Nucala napolnjena injekcijska brizga je namenjeno le za podkožno (subkutano) uporabo.
White plunge
Bel bat
Percent reduction Rate ratio (95% CI) p-value
Razmerje deležev (95 % IZ) Vrednost p
Nucala 100 mg solution for injection in pre-filled syringe mepolizumab
Nucala 100 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku mepolizumab
Store in the original container to protect from light.
Brizgo shranjujte v originalnem vsebniku za zagotovitev zaščite pred svetlobo.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - PRE-FILLED PEN
PODATKI NA ZUNANJI OVOJNINI ŠKATLA - NAPOLNJEN INJEKCIJSKI PERESNIK
Take the pen out of the tray
Vzemite peresnik iz embalaže
In children aged 6 to 11 years old with severe refractory eosinophilic asthma administered mepolizumab subcutaneously every 4 weeks for 52 weeks, blood eosinophils were reduced from a geometric mean count at baseline to week 52 of 306 (n=16) to 48 (n=15) following 40 mg (for a weight < 40kg) and 331 to
Pri otrocih, starih od 6 do 11 let, s težko trdovratno eozinofilno astmo, ki so prejemali mepolizumab subkutano na 4 tedne 52 tednov, se je število eozinofilcev v krvi z izhodiščne geometrične sredine do
Safely, throw the pen away if it has been kept out of the refrigerator for more than 7 days.
Če je bil napolnjen injekcijski peresnik shranjen izven hladilnika več kot 7 dni, ga varno zavrzite.
Needle cap (needle inside)
(igla znotraj)
Odds ratio (95% CI) p-value
Mediana razlika (95 % IZ) Vrednost p
Take out your pre-filled syringe
Vzemite napolnjeno injekcijsko brizgo ven
Reduction of exacerbation rate by baseline blood eosinophil count
Zmanjšanje deležev poslabšanj glede na izhodiščno število eozinofilcev
Store syringe in the original carton in order to protect from light.
Peresnik shranjujte v originalnem vsebniku za zagotovitev zaščite pred svetlobo.
Solution for injection in pre-filled pen.
Raztopina za injiciranje v napolnjenem injekcijskem peresniku
Each 1 ml pre-filled syringe contains 100 mg mepolizumab.
En 1 ml napolnjen injekcijski peresnik vsebuje 100 mg mepolizumaba.
Make sure you have within reach:
Preverite, ali imate pri roki:
Nucala pre-filled pen is for use under the skin only (subcutaneous).
Zdravilo Nucala napolnjen injekcijski peresnik je namenjen le za podkožno (subkutano) uporabo.
Each 1 mL pre-filled syringe contains 100 mg of mepolizumab.
En 1-ml napolnjene injekcijske brizge vsebuje 100 mg mepolizumaba.
Nucala 100 mg solution for injection in pre-filled pen
Zdravilo Nucala 100 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
Store in the original package in order to protect from light.
Shranjujte v originalnem vsebniku za zagotovitev zaščite pred svetlobo.
Hepatic impairment
Bolezni živčevja glavobol zelo pogosti
Yellow needle guard (needle inside)
Rumeni ščitnik igle
Know your pre-filled syringe
Seznanite se s svojo napolnjeno injekcijsko brizgo
{text}
{besedilo}
Timetable for the implementation of this position
Časovnica za uveljavitev tega stališča
<Summary of Product Characteristics>
<Povzetek glavnih značilnosti zdravila>
Adoption of CMDh position: {Month Year} CMDh meeting
Sprejetje stališča skupine CMDh: Zasedanje skupine CMDh {mesec leto}
<Amendments to be included in the relevant sections of the Product Information (new text underlined and in bold, deleted text strike through)>
<Spremembe, ki jih je treba vključiti v ustrezna poglavja informacij o zdravilu (novo besedilo je podčrtano in označeno krepko, izbrisano besedilo je prečrtano)>
Annex <III> <IV>
Priloga <III> <IV>
To the extent that additional medicinal products containing {active substance(s) as EURD list entry} are currently authorised in the EU or are subject to future authorisation procedures in the EU, the CMDh recommends that the concerned Member States and applicant/marketing authorisation holders take due consideration of this CMDh position.
Če so dovoljenje za promet v EU pridobila tudi druga zdravila, ki vsebujejo {učinkovina(-e), kot je (so) zapisana(-e) na seznamu EURD}, ali če bodo taka zdravila v prihodnje predmet postopkov za pridobitev dovoljenja za promet v EU, skupina CMDh priporoča, da zadevne države članice in predlagatelji/imetniki dovoljenja za promet s temi zdravili ustrezno upoštevajo to stališče.
Transmission to National Competent Authorities of the translations of the annexes to the position: {DD/MM/YYYY}
Posredovanje prevodov prilog k stališču pristojnim nacionalnim organom: {DD/MM/LLLL}
On the basis of the scientific conclusions for {active substance(s) as EURD list entry} the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) containing {active substance(s) as EURD list entry} is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za {učinkovina(-e), kot je (so) zapisana(-e) na seznamu EURD} skupina CMDh meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) {učinkovina(-e), kot je (so) zapisana(-e) na seznamu EURD} nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
The CMDh reaches the position that the marketing authorisation(s) of products in the scope of this single PSUR assessment should be varied.
Skupina CMDh je sprejela stališče, da je potrebna sprememba dovoljenja (dovoljenj) za promet z zdravili, ki so zajeta v to enotno oceno PSUR.
Implementation of the position by the Member States (submission of the variation by the Marketing Authorisation Holder): {DD/MM/YYYY}
Uveljavitev stališča v državah članicah (predložitev spremembe s strani imetnika dovoljenja za promet z zdravilom): {DD/MM/LLLL}
<Annex III>
<Priloga III>
Taking into account the PRAC Assessment Report on the PSUR(s) for {active substance(s) as EURD list entry}, the scientific conclusions are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni redno posodobljenih poročil o varnosti zdravila (PSUR) za {učinkovina(-e), kot je (so) zapisana(-e) na seznamu EURD} so bili sprejeti naslednji znanstveni zaključki:
Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s)
Znanstveni zaključki in podlaga za spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom
Amendments to the product information of the nationally authorised medicinal product(s)
Spremembe informacij o zdravilu za zdravila, ki so pridobila dovoljenje(-a) za promet po nacionalnem postopku
<Conditions to the Marketing Authorisation(s)>
<Pogoji dovoljenja (dovoljenj) za promet z zdravilom>
<Package Leaflet>
<Navodilo za uporabo>
8000 units (40 mg)
8.000 enot (40 mg)
10000 units (50 mg) Powder and solvent for solution for injection
10.000 enot (50 mg) prašek in vehikel za raztopino za injiciranje
These effects were transitory and usually resolved without any treatment within 5 to 15 days, but could persist up to 49 days.
Učinki so bili prehodni in so izveneli brez zdravljenja znotraj 5 do 15 dni, vendar lahko trajajo tudi do 49 dni.
Meat and offal: 56 days.
Meso in organi: 56 dni
For the full list of excipients, see section 6.1
Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
Use only according to the benefit-risk assessment by the responsible veterinarian.
Uporabite le v skladu z oceno razmerja korist-tveganje odgovornega veterinarja.
However, a clear antipyretic effect has been demonstrated in the first 48 hours after administration.
Je pa bil ugotovljen očiten antipiretični učinek v prvih 48 urah po dajanju.
In the absence of safety data it is not recommended to use the product in calves less than 4 weeks old.
Zaradi pomanjkanja podatkov o varnosti ni priporočljivo uporabiti zdravila pri teletih mlajših od 4 tednov.
Otherwise, the use of a multiple-dose syringe is recommended.
Drugače se priporoča uporaba večodmerne brizge.
Surveillance data of the susceptibility of target field isolates from cattle, collected between 2004 and 2012 across Europe, show consistent efficacy of florfenicol with no finding of resistant isolates.
Nadzorni podatki o občutljivosti ciljnih terenskih izolatov goveda, zbranih med 2004 in 2012 v Evropi, kažejo dosledno učinkovitost florfenikola brez najdbe odpornih izolatov.
The in vitro Minimum Inhibitory Concentration (MIC) distribution values for these field isolates are presented in the table below.
Vrednosti distribucije in vitro minimalne inhibitorne koncentracije (MIC) za te terenske izolate so predstavljene v spodnji tabeli.
The impact of this difference on anti-inflammatory effects has not been investigated in field trials.
Vpliv te razlike na protivnetni učinek ni bil raziskan v terenskih študijah.
The genes corresponding to these mechanisms are coded on mobile genetic elements such as plasmids, transposon or genes cassettes.
Geni, ki ustrezajo tem mehanizmom so kodirani na mobilnih genetskih elementih kot so plazmidi, transpozoni ali genske kasete.
The single dose volume should not exceed 15 ml per injection site.
Volumen enega odmerka ne sme presegati 15 ml na mestu injiciranja.
The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Pomožne snovi, navedene v poglavju 6.1 SPC so dovoljenje snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben.
Date of first authorisation: 15/05/2017.
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 15/05/2017
Whenever possible, the veterinary medicinal product should only be used based on susceptibility testing.
Kadar je mogoče, naj se zdravilo za uporabo v veterinarski medicini uporablja le na podlagi testiranja občutljivosti.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton after "EXP".
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli po ''EXP''.
Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.
Pri uporabi zdravila za uporabo v veterinarski medicini je potrebno upoštevati uradno, nacionalno in regionalno antimikrobno politiko.
During injection of this product animals may exhibit signs of moderate pain, manifested as movement of the head or neck.
Med injiciranjem zdravila lahko živali kažejo znake zmerne bolečine, ki se kažejo kot gibanje glave ali vratu.
It reduces leukocyte infiltration into the inflamed tissue.
Zmanjšuje infiltracijo leukocitov v vnetnem tkivu.
Avoid use in severely dehydrated, hypovolaemic or hypotensive animals, as there may be a potential risk of renal toxicity.
Izogibajte se uporabi pri zelo dehidriranih, hipovolemičnih ali hipotenzivnih živalih, ker je možna nevarnost ledvične toksičnosti.
Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne FRANCE
Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne Francija
The bioavailability of meloxicam in this combination product is lower compared to the use of meloxicam when administered on its own.
Biorazpoložljivost meloksikama v tej kombinaciji je nižja v primerjavi z uporabo meloksikama, ki ga dajemo samostojno.
The injection should only be given in the neck area.
Injicirajte le na področju vratu.
People with known hypersensitivity to florfenicol, meloxicam or to any of the excipients should avoid contact with the veterinary medicinal product.
Osebe z znano preobčutljivostjo na florfenikol, meloksikam ali katerokoli pomožno snov, naj se izogibajo stiku z zdravilom.
Do not use in adult bulls intended for breeding.
Ne uporabite pri odraslih bikih namenjenih za vzrejo.
To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.
Da bi zagotovili pravilno odmerjanje, je potrebno kar se da natančno določiti telesno težo živali, da se izognemo premajhnemu odmerku.
Marketing authorisation holder and manufacturer responsible for batch release: Ceva Santé Animale
Imetnik dovoljenja za promet z zdravilom in proizvajalec odgovoren za sproščanje serij: Ceva Santé Animale
Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or when there is evidence of ulcerogenic gastrointestinal lesions.
Ne uporabite pri živalih z oslabljeno jetrno, srčno ali ledvično funkcijo in hemoragičnimi motnjami ali v primeru dokazanih ulcerogenih gastrointestinalnih poškodb.
Resistance to florfenicol is mainly mediated by an efflux system due to a specific (Flo-R) or multidrug transporter (AcrAB-TolC).
Odpornost na florfenikol je vglavnem mediirana z iztočnim sistemom zaradi specifičnega (Flo-R) ali večprepustnega transporterja (AcrAB-TolC).
Repeated weekly administration of overdoses (3x and 5x the recommended dose) in calves was associated with decreased milk consumption, decreased weight gain, loose faeces or diarrhoea.
Ponavljajoče se tedensko dajanje prevelikega odmerka (3x in 5x priporočenega odmerka) teletom je bilo povezano z zmanjšanim zauživanjem mleka, zmanjšanjem pridobivanja telesne teže, mehkim blatom ali drisko.
Meloxicam is extensively bound to plasma proteins (97%) and is distributed in all well-perfused organs.
Meloksikam se v veliki meri veže na plazemske beljakovine (97%) in se porazdeli v dobro prekrvavljene organe.
The extent of these adverse effects was dose-dependent.
Obseg neželenih učinkov je bil odvisen od odmerka.
Do not use in pregnant cows, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Ne uporabite pri brejih živalih, katerih mleko je namenjeno prehrani ljudi, v obdobju 2 mesecev pred pričakovanim porodom.
Not for animals from which milk is produced for human consumption
Ni za živali katerih mleko se uporablja v prehrani ljudi
Range (µg/ml) MIC50 (µg/ml) MIC90 (µg/ml)
Vrednost (µg/ml) MIC50 (µg/ml) MIC90 (µg/ml)
Florfenicol is a synthetic broad-spectrum antibiotic effective against most Gram-positive and Gramnegative bacteria isolated from domestic animals.
Florfenikol je sintetični široko spektralni antibiotik učinkovit proti večini gram-pozitivnih in gramnegativnih bakterij izoliranih pri domačih živalih.
Milk: Not authorised for use in lactating animals producing milk for human consumption.
Mleko: ni dovoljena uporaba pri živalih, katerih mleko je namenjeno prehrani ljudi.
To a minor extent it also inhibits collagen-induced thrombocyte aggregation.
V manjšem obsegu zavira tudi kolagensko inducirano zlepljanje trombocitov.
For the 250 ml vials, the rubber stopper may safely be punctured up to 20 times.
Pri 250 ml viali lahko gumijast zamašek varno prebodete do 20 krat.
Fertility Do not use in adult bulls intended for breeding (see section 4.3).
Plodnost Ne uporabite pri odraslih bikih namenjenih za vzrejo (glej poglavje 4.3).
Sum of florfenicol and its metabolites measured as florfenicolamine
Seštevek florfenikola in metabolitov izmerjenih kot florfenikolamin
The active substances in Zeleris are allowed substances as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovine v zdravilu Zeleris so dovoljene učinkovine, kot so navedene v tabeli 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št. 37/2010:
Pack size: 1 vial per cardboard box
1 viala v kartonski škatli.
Shelf life after first opening the immediate packaging: 28 days.
Rok uporabnosti po prvem odpiranju vsebnika: 28 dni.
Therefore, the veterinary medicinal product should not be administered by pregnant women.
Zato naj tega zdravila ne dajejo nosečnice.
Do not use in case of hypersensitivity to the active substances or to any of the excipients.
Ne uporabite v primerih preobčutljivosti na učinkovine ali na katero koli pomožno snov.
The safety of the veterinary medicinal product has not been established in breeding, pregnant and lactating animals.
Varnost zdravila v obdobju vzrejanja, brejosti in laktacije ni bila ugotovljena.
Muscle Liver Kidney Milk
Mišice Jetra Ledvice Mleko
Florfenicol is largely distributed in the whole body and has a low plasma protein binding (approximately 20%).
Florfenikol se v veliki meri porazdeli po celem telesu in ima nizko vezavo na plazemske beljakovine (približno 20%).
Macroscopic intestinal lesions were observed post-mortem (presence of fibrin, abomasal ulcers, haemorrhagic dots and thickening of the abomasal wall).
Post-mortem so bile opažene makroskopske intestinalne poškodbe (prisotnost fibrina, ulkus siriščnika, pikčaste krvavitve in zadebelitev stene siriščnika).
Pharmacotherapeutic group: Antibacterials for systemic use, amphenicols, combinations.
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje sistemskih infekcij, amfenikoli, kombinacije.
Florfenicol acts by inhibiting protein synthesis at the ribosomal level and its action is bacteriostatic and time-dependent.
Florfenikol zavira sintezo beljakovin na ravni ribosoma in deluje bakteriostatično ter odvisno od časa.
Fertility Do not use in adult bulls intended for breeding (see section “Contraindications”).
Plodnost Ne uporabite pri odraslih bikih namenjenih za vzrejo (glej poglavje ''Kontraindikacije'').
Resistance to florfenicol in the target pathogens has only been reported on rare occasions, and was associated with efflux pump and the presence of the floR gene.
Odpornost na florfenikol v ciljnih patogenih je bila opažena le v redkih primerih in je bila povezana z iztočno črpalko in prisotnostjo floR gena.
Meloxicam also has anti-endotoxic properties, because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin after administration in calves, lactating cows and pigs.
Meloksikam ima tudi antiendotoksične lastnosti, saj so dokazali, da zavira nastajanje tromboksana B2, izzvano z vnosom endotoksina E. coli po uporabi pri teletih, kravah v laktaciji in prašičih.
Use during pregnancy, lactation or lay
Uporaba v obdobju brejosti, laktacije ali nesnosti
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 nesteroidno protivnetno zdravilo (NSAID) iz skupine oksikamov, ki deluje z zaviranjem tvorbe prostaglandinov in tako deluje protivnetno, antieksudativno, analgetično in antipiretično.
Translucent multi-layered plastic vials (polypropylene/ethylene vinyl alcohol/polypropylene) with chlorobutyl rubber stoppers and aluminium and plastic flip capsules, containing 50 ml, 100 ml or 250 ml.
Prosojne večplastne plastične viale (polipropilen/etilen vinil alkohol/polipropilen) s klorbutilnim gumijastim zamaškom in aluminijasto ter plastično flip kapsulo, ki vsebujejo 50 ml, 100 ml ali 250 ml. Velikost pakiranja:
Repeated weekly administration of a 5x dose was fatal in 7 out of 8 calves after the third administration.
Ponavljajoče se tedensko dajanje 5x odmerka je bilo smrtno za 7 od 8 telet po tretjem dajanju.
Overdose (symptoms, emergency procedures, antidotes), if necessary In pre-ruminant calves, repeated administration of the recommended dose once per week for three weeks was well tolerated as well as a single administration of 3 times (3x) the recommended dose.
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) Pri teletih, ki še ne prežvekujejo, je bilo ponavljajoče se dajanje priporočenega odmerka enkrat na teden v obdobju treh tednov dobro sprejeto, kot tudi enkratni odmerek trikratnega (3x) priporočenega odmerka.
Florfenicol is considered to be a bacteriostatic agent, but in vitro studies demonstrate its bactericidal activity against Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Florfenikol se smatra kot bakteriostatik, vendar in vitro študije kažejo njegove baktericidne lastnosti proti Mannheimia haemolytica, Pasteurella multocida in Histophilus somni.
For Mannheimia haemolytica, Pasteurella multocida and Histophilus somni the following breakpoints have been determined by CLSI (Clinical and Laboratory Standards institute) for bovine respiratory pathogens: susceptible ≤ 2 µg/ml, intermediate: 4 µg/ml, resistant: ≥ 8 µg/ml.
Za bakterije Mannheimia haemolytica, Pasteurella multocida in Histophilus somni so bile določene naslednje mejne vrednosti po CLSI (Clinical and Laboratory Standards institute) za florfenikol za goveje respiratorne patogene: dovzetni ≤ 2 µg/ml, vmesni: 4 µg/ml, odporni: ≥ 8 µg/ml.
Each ml contains:
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsak ml vsebuje:
Interactions with other medicinal products and other forms of interaction Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ne uporabite istočasno z glukokortikoidi, drugimi nesteroidnimi protivnetnimi zdravili ali antikoagulanti.
In pre-ruminant calves, repeated administration of the recommended dose once per week for three weeks was well tolerated, as well as a single administration of 3 times (3x) the recommended dose.
Pri teletih, ki še ne prežvekujejo, je bilo ponavljajoče se dajanje priporočenega odmerka enkrat na teden v obdobju treh tednov dobro sprejeto, kot tudi enkratni odmerek trikratnega (3x) priporočenega odmerka.
Dimethyl sulfoxide Glycerol formal, stabilised
Glicerolformal, stabiliziran
Repeated weekly administration of a 3x dose was fatal in 1 out of 8 calves after the third administration.
Ponavljajoče se tedensko dajanje 3x odmerka je bilo smrtno za 1 od 8 telet po tretjem dajanju.
EXP Once broached, use within 28 days.
EXP Načeto zdravilo uporabite v 28 dneh.
ATCvet code: QJ01BA99.
Oznaka ATC vet: QJ01BQ99
Laboratory tests have shown that florfenicol is active against the most commonly isolated bacterial pathogens involved in bovine respiratory disease which include Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Laboratorijski testi kažejo, da florfenikol deluje proti večini pogosto izoliranih bakterijskih patogenov, ki sodelujejo pri respiratorni bolezni goveda, kar vključuje tudi bakterije Mannheimia haemolytica, Pasteurella multocida in Histophilus somni.
SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
MANUFACTURER'S BATCH NUMBER
PROIZVAJALČEVA ŠTEVILKA SERIJE Lot
The product is slightly irritant to the eye. Rinse any splashes from eyes immediately with plenty of water.
Takoj sperite morebitne vbrizge v oko z veliko količino vode.
Animal species
Živalsk a vrsta
Efficacious plasma levels of florfenicol are maintained above the MIC90 of 1 µg/ml, 0.5µg/mL and 0.2 µg/ml for 72 h, 120 h and 160 h, respectively.
Učinkovit plazemski nivo florfenikola vzdrži nad MIC90 1 µg/ml, 0,5µg/ml in 0,2 µg/ml 72 ur, 120 ur in 160 ur.
Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Ne uporabite istočasno z glukokortikoidi, drugimi nesteroidnimi protivnetnimi zdravili ali antikoagulanti.
Solution for injection.
FARMACEVTSKA OBLIKA Raztopina za injiciranje.
No entry Antiinflammatory agents/Nonsteroidal antiinflammatory agents
Brez vnosa proti vnetna/ nesteroidna protivnetna zdravila
METHOD AND ROUTE(S) OF ADMINISTRATION
NAČIN IN POT(I) UPORABE Subkutana uporaba.
After subcutaneous administration of the product at recommended dose of 1 ml/10 kg bodyweight maximum mean plasma concentration (Cmax) of 4.6 mg/l and 2.0 mg/l occurred 10 hours (h) and 7 h after dosing for florfenicol and meloxicam respectively.
Po subkutanem dajanju zdravila v priporočenem odmerku 1 ml/10 kg telesne teže je bila povprečna maksimalna plazemska koncentracija (Cmax) 4,6 mg/l in 2,0 mg/l dosežena v 10 urah in 7 ur po dajanju za florfenikol in meloksikam.
A single subcutaneous injection at a dosage of 40 mg florfenicol/kg bodyweight and 0.5 mg meloxicam/ kg bodyweight (i.e. 1 ml/10 kg bodyweight).
Ena subkutana injekcija odmerka 40 mg florfenikola/kg telesne teže in 0,5 mg meloksikama/kg telesne teže (to je 1 ml/10 kg telesne teže).