natgillin/translations-raw huggingface dataset:
In cattle and pigs, subcutaneous, intramuscular and intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of cattle treated in clinical studies. 
Govedo in prašiči dobro prenašajo podkožno, intramuskularno in intravenozno injiciranje; pri manj kot 10 % goveda, zdravljenega v kliničnih študijah, je bila opažena samo blaga prehodna oteklina na mestu podkožnega injiciranja.
Milk can be taken five days after administration in cattle. 
Pri govedu se lahko mleko uporabi pet dni po prejemu zdravila.
The medicine should not be used in horses producing milk for human consumption. 
Zdravilo se ne sme uporabljati pri kobilah, ki dajejo mleko za prehrano ljudi.
Recocam contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs). 
Zdravilo Recocam vsebuje meloksikam, ki spada v skupino zdravil, imenovanih nesteroidna protivnetna zdravila (NSPVZ).
Recocam is a ‘generic' medicine which means that Recocam is similar to a ‘reference veterinary medicine' already authorised in the EU (Metacam). 
Zdravilo Recocam je generično zdravilo, kar pomeni, da je podobno referenčnemu veterinarskemu zdravilu, ki je že odobreno v EU (zdravilu Metacam).
It can be used with oral re-hydration therapy for diarrhoea in calves of over one week of age and in young, non-lactating cattle. 
Uporablja se lahko tudi s peroralno rehidracijo pri diareji pri teletih, starejših od enega tedna, ter pri mladem govedu izven obdobja laktacije.
Recocam is a medicine for cattle, pigs and horses that contains the active substance meloxicam. 
Recocam je zdravilo za govedo, prašiče in konje, ki vsebuje zdravilno učinkovino meloksikam.
What is the risk associated with Recocam? 
Kakšna tveganja so povezana z zdravilom Recocam?
It is used in pigs to reduce the symptoms of lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move) and for the treatment of certain diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome), together with appropriate antibiotic therapy. 
Pri prašičih se zdravilo Recocam uporablja za ublažitev simptomov šepavosti in vnetij pri neinfekcijskih boleznih gibal (boleznih, ki vplivajo na zmožnost gibanja) ter pri zdravljenju nekaterih bolezni po oprasitvi, kot so puerperalna septikemija in toksemija (sindrom mastitis-metritis-agalactia), skupaj z ustreznim antibiotičnim zdravljenjem.
Recocam is ‘bioequivalent' to the reference medicine which means that it is equivalent to Metacam in the way it is absorbed and used by the body. 
Zdravilo Recocam je biološko enakovredno referenčnemu zdravilu, kar pomeni, da je enakovredno zdravilu Metacam, in sicer glede na to, kako ga telo absorbira in uporablja.
It is also the time allowed after administration of the medicine before the milk can be used for human consumption. 
Nanaša se tudi na čas, ki mora preteči po uporabi zdravila, preden se lahko mleko uporabi za prehrano ljudi.
The Committee recommended that Recocam be given a marketing authorisation. 
Zato je priporočil, da se za zdravilo Recocam odobri dovoljenje za promet.
As the prostaglandins trigger inflammation, pain, exudation and fever, meloxicam reduces these clinical signs. 
Prostaglandini povzročajo vnetje, bolečino, izločanje tekočine in povišano telesno temperaturo, meloksikam pa zmanjšuje obseg teh kliničnih znakov.
It is given as a single injection of 0.4 mg per kg body weight into a muscle. 
Injicira se v enem 0,4-miligramskem odmerku na kilogram telesne mase v mišico.
Recocam is used in horses to relieve colic (abdominal pain) and for the alleviation of inflammation and relief of pain in musculo-skeletal disorders. 
Zdravilo Recocam se uporablja pri konjih za lajšanje kolike (trebušnih bolečin) ter ublažitev vnetja in lajšanje bolečin pri mišično-skeletnih obolenjih.
The CVMP considered that, in accordance with European Union requirements, Recoocam is bioequivalent to Metacam. 
CVMP je menil, da se je zdravilo Recocam v skladu z zahtevami Evropske unije izkazalo kot biološko enakovredno zdravilu Metacam.
Why has Recocam been approved? 
Zakaj je bilo zdravilo Recocam odobreno?
In cattle it is used together with appropriate antibiotics, to reduce clinical signs of acute respiratory infection (infection of the lungs and airways) and to treat acute mastitis (inflammation of the udder). 
Zdravilo Recocam se pri govedu uporablja skupaj z ustreznim antibiotičnim zdravljenjem za zmanjšanje kliničnih znakov pri akutni okužbi dihal (okužbi pljuč in dihalnih poti) in za zdravljenje akutnega mastitisa (vnetja vimena).
Consequently, Recocam's benefit is taken as being the same as that of the reference medicine. 
Zaradi tega velja, da so koristi zdravila Recocam enake kot pri referenčnem zdravilu.
Recocam was considered to be bioequivalent with the reference medicine. 
Zdravilo Recocam se šteje kot biološko enakovredno referenčnemu zdravilu.
What is Recocam used for? 
Za kaj se zdravilo Recocam uporablja?
How has Recocam been studied? 
Kako je bilo zdravilo Recocam raziskano?
Recocam is given as a single injection of 0.6 mg per kg body weight into the horse's vein. 
Zdravilo Recocam se injicira v enem 0,6-miligramskem odmerku na kilogram telesne mase v konjevo veno.
Recocam is given in cattle as a single injection of 0.5 mg per kg body weight under the skin or into a vein. 
Zdravilo Recocam se injicira v enem 0,5-miligramskem odmerku na kilogram telesne mase v podkožje ali veno.
Therefore the CVMP's view was that, as for Metacam, Recocam's benefits are greater than its risks when used for the approved indications. 
Metacam, večje od z njim povezanih tveganj, kadar se uporablja za odobrene indikacije.
What is Recocam? 
Kaj je zdravilo Recocam?
How does Recocam work? 
Kako zdravilo Recocam deluje?
No information is available. 
Informacije niso na razpolago.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsak ml vsebuje:
Allergic reactions to these substances may occasionally be serious. 
Alergijske reakcije na te snovi so občasno lahko hude.
Reports of further cases, which were not available to JECFA, had also been reported in the published literature. 
Poročila o dodatnih primerih, ki odboru JECFA niso bili na voljo, so bila prav tako navedena v objavljeni literaturi.
1 Marketing Authorisation not granted Reference Member State for the Mutual recognition Procedure 
1 Brez dovoljenja za promet Referenčna država članica za postopek medsebojnega priznavanja
Use in such cases only according to the benefit/risk assessment by the responsible veterinarian. 
V takih primerih uporabite le v skladu z oceno koristi/tveganja odgovornega veterinarja.
Strict aseptic precautions should be observed. 
Potrebni so strogi aseptični previdnostni ukrepi.
Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention. 
Otekanje obraza, ustnic ali oči ali težave pri dihanju so resnejši simptomi in zahtevajo nujno zdravniško pomoč.
- Milk: 
- Mleko:
Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations. 
S tem zdravilom ne ravnajte, če veste, da ste občutljivi, ali če so vam svetovali, da ne delate s takšnimi preparati.
88 days 
88 dni
Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies. 
Uporaba zdravila mora temeljiti na testiranju dovzetnosti ter upoštevati uradne in lokalne antimikrobne politike.
By their nature such chromosomal mutations tend to be relatively slow in developing and occur primarily by vertical transmission. 
Po svoji naravi so takšne kromosomske mutacije razmeroma počasne pri razvoju in primarno nastanejo z vertikalnim prenosom.
In case of the occurrence of allergic reaction, the treatment should be immediately withdrawn. 
Če se pojavi alergična reakcija, je treba zdravljenje takoj prekiniti.
They exert a bactericidal action on growing cells only. 
Izvajajo baktericidne dejavnosti samo na rastoče celice.
Intramuscular injection (cattle, pigs). 
Intramuskularno injiciranje (govedo, prašiči).
The mean half-life of elimination is 7 hours. 
Srednja razpolovna doba eliminacije znaša 7 ur.
The mean half-life of elimination is 12 hours. 
Srednja razpolovna doba eliminacije znaša 12 ur.
- Pigs: 
- Prašiči:
The main elimination route of amoxicillin is via urine. 
Glavna pot eliminacije amoksicilina je prek urina.
10 DATE OF REVISION OF THE TEXT {MM/YYYY} or <month YYYY> PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable. 
10 DATUM REVIZIJE BESEDILA {MM/LLLL} ali <mesec LLLL> PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Navedba ni smiselna.
4.6 Adverse reactions (frequency and seriousness) 
4..6 Neželeni učinki (pogostost in resnost)
The dosage was repeated 48 hours later. 
Odmerek je bil ponovno injiciran 48 ur kasneje.
Pharmacotherapeutic group: Penicillins with extended spectrum ATCVet code: QJ01CA04 
Farmakoterapevtska skupina: penicilini z razširjenim spektrom Oznaka ATCVet: QJ01CA04
Escherichia coli resistance has been reported. 
Ugotovljena je odpornost na Escherichia coli.
Several cases of allergic reactions in humans following the ingestion of food containing penicillin residues were reviewed. 
Preučili so več primerov alergijske reakcije pri ljudeh po zaužitju hrane, ki je vsebovala ostanke penicilina.
Do not use in animals with known hypersensitivity to penicillin or other substances of the β-lactam group. 
Ne uporabite pri živalih z znano preobčutljivostjo za penicilin ali druge snovi iz skupine betalaktamov.
It was evident that penicillin residues have caused allergic reactions in consumers and that some of these reactions have been serious. 
Očitno je bilo, da so ostanki penicilina pri uporabnikih povzročili alergijske reakcije, od katerih so bile nekatere precej resne.
06516 CARROS CEDEX FRANCE 
06516 CARROS CEDEX FRANCIJA
However, an ADI for penicillins was not established. 
Kljub temu sprejemljivi dnevni vnos (ADI) za peniciline ni bil ugotovljen.
50 days 
50 dni
The other two kidney samples were below the limit of quantification (25 µg/kg). 
Druga dva vzorca ledvic sta bila pod mejo kvantifikacije (25 µg/kg).
In setting maximum residue limits (MRLs) for the penicillins, the CVMP adopted the same approach as the Joint FAO/WHO Expert Committee on Food Additives (JECFA). 
Pri določanju mejnih vrednosti ostankov zdravila za peniciline je Odbor za zdravila za uporabo v veterinarski medicini sprejel enak pristop kot Skupni strokovni odbor FAO/WHO za aditive za živila (JECFA).
If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. 
Če po izpostavljenosti pride do simptomov, kot je kožni izpuščaj, se posvetujte z zdravnikom in mu pokažite navodilo za uporabo.
Accidental injection is dangerous - see package leaflet before use. 
Nenamerno injiciranje je nevarno - pred uporabo preberite navodilo za uporabo.
The bactericidal effect of amoxicillin is neutralised by simultaneous use of bacteriostatic acting pharmaceuticals (macrolides, sulphonamides and tetracyclines). 
Baktericidni učinek amoksicilina se nevtralizira s hkratno uporabo farmacevtskih izdelkov, ki delujejo bakteriostatično (makrolidi, sulfonamidi in tetraciklini).
In the complementary studies animals that were younger and weighed much less (211 to 249; 206 to 228 kg) were used; otherwise the studies were conducted similarly to the pivotal study. 
Pri komplementarnih študijah so uporabili mlajše in lažje živali (211 do 249; 206 do 228 kg), študije pa so sicer bile izvedene podobno kot glavna študija.
MANUFACTURER'S BATCH NUMBER <Batch> <Lot> <BN> {number} 
IZDELOVALČEVA ŠTEVILKA SERIJE <Serija> <lot> <številka serije> {številka}
Do not use in rabbits, guinea pigs, hamsters or gerbils. 
Ne uporabite pri kuncih, morskih prašičkih, hrčkih ali tekačicah.
Studies performed in laboratory animals (rat, rabbit), did not show a teratogenic, embryotoxic or maternotoxic effect of amoxicillin. 
Z laboratorijskimi študijami na živalih (podgana, zajec) niso bili dokazani teratogeni, embriotoksični ali maternotoksični učinki amoksicilina.
Narrow spectrum antibacterial therapy should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach. 
Antibakterijsko terapijo ozkega spektra je treba uporabiti za prvotno zdravljenje, kjer testiranje dovzetnosti predlaga verjetno uspešnost tega pristopa.
Considering that there is data at an additional time point (90 days) where residues were below the limit of quantification the addition of a 10 % ‘uncertainty factor' was accepted. 
Ob upoštevanju , da obstajajo podatki tudi za dodatno časovno točko (90 dni) ter da so bile tudi takrat vrednosti koncentracije ostankov pod mejnimi vrednostmi, je bil sprejet 10 % dodatek „faktorja negotovosti“.
Do not use in case of known resistance to amoxicillin. 
Ne uporabite v primeru znane odpornosti na amoksicilin.
They inhibit the activity of transpeptidase enzymes which catalyse crosslinkage of the glycopeptide polymer units that form the cell wall. 
Preprečujejo delovanje encimov transpeptidaze, ki katalizirajo navzkrižno povezovanje enot glikopeptidnega polimera, ki oblikujejo celično steno.
Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins and vice versa. 
Preobčutljivost za peniciline lahko povzroči navzkrižne reakcije na cefalosporine in obratno.
The three complementary studies were conducted similarly to the pivotal study but in one of the complementary studies animals were younger and weighing much less (53 to 59 kg) than the ones used in the other studies were used but they did all receive at least the maximum injection volume (5 ml). 
Tri komplementarne študije so bile izvedene podobno kot glavna študija, le da so bile pri eni od teh komplementarnih študij uporabljene mlajše in precej lažje živali (53 do 59 kg) od tistih, uporabljenih pri glavni študiji in vse živali so prejele največjo količino odmerka (5 ml).
Its structure contains the β-lactam ring and thiazolidine ring common to all penicillins. 
Njegova struktura vsebuje beta-laktamski obroč in tiazolidinski obroč, ki sta skupna vsem penicilinom.
On this basis MRLs for amoxicillin and other penicillins were proposed by the CVMP, and amoxicillin is currently entered in Annex I of Council Regulation (EEC) No 2377/90, in accordance with the following table: 
Na podlagi tega je Odbor za zdravila za uporabo v veterinarski medicini predlagal mejne vrednosti ostankov za amoksicilin in druge peniciline, amoksicilin pa je trenutno uvrščen v Prilogo I Uredbe Sveta (EGS) št. 2377/90 v skladu z naslednjo preglednico:
After intramuscular administration amoxicillin is well absorbed and distributed in the tissues. 
Po intramuskularnem dajanju se amoksicilin dobro absorbira in porazdeli v tkivih.
Animals (2 male and 2 female) were slaughtered at 7, 14, 21 and 27 days after the final injection. 
Živali (2 samca in 2 samici) so bile zaklane 7, 14, 21 in 27 dni po zadnjem injiciranju.
In case of accidental contact with eyes, rinse immediately with copious amounts of water. 
V primeru nenamernega stika z očmi takoj sperite z obilo vode.
Being aware of cases of allergic reactions at very low doses, JECFA recommended that the daily intake of benzylpenicillin from food be kept as low as practicable, and in any case below 30 µg parent drug per person. 
Zaradi primerov alergijskih reakcij pri zelo nizkih odmerkih je JECFA priporočil, naj bo dnevni vnos benzilpenicilina s hrano tako nizek, kot je to praktično mogoče, v vsakem primeru pa manjši od 30 µg te ali sorodne kemijske entitete na osebo.
Inappropriate use of the product may increase the prevalence of bacteria resistant to amoxicillin. 
Nepravilna uporaba zdravila lahko poveča razširjenost bakterij, odpornih na amoksicilin.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <{DD/MM/YYYY}> <{DD month YYYY}> 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET <{DD/MM/LLLL}> <{DD mesec LLLL}>
ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET 
DODATEK III POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILA ZA UPORABO
Amoxicillin was previously evaluated by the CVMP together with other penicillins, in order to establish maximum residue limits (MRLs). 
Predhodno je Odbor za zdravila za uporabo v veterinarski medicini amoksicilin ovrednotil skupaj z drugimi penicilini, da bi določil najvišje mejne vrednosti ostankov zdravila (MRL).
Amoxicillin is active against susceptible Gram positive and Gram negative bacteria. 
Amoksicilin deluje zoper dovzetne po Gramu pozitivne in po Gramu negativne bakterije.
However, there are data to show residue depletion from at least one injection site which received the maximum volume and therefore the studies could be accepted for the purposes of setting the meat withdrawal period in cattle. 
Kljub temu pa obstajajo podatki, ki kažejo na izločanje ostankov na vsaj enem mestu injiciranja, na katerem je bila injicirana največja količina odmerka, zato se študije lahko upoštevajo pri določitvi karence za meso govedi.
Assessment of residue depletion studies 
Ocena študije izločanja ostankov
Another possible mode of resistance to β-lactam antibiotics can be associated with chromosomal mutations in bacteria resulting either in modification of the penicillin binding proteins (PBPs) or in modification of the cellular permeability to β-lactams. 
Drugi možen način odpornosti na beta-laktamske antibiotike je lahko povezan s kromosomskimi mutacijami bakterij, kar povzroča modifikacijo proteinov, ki vežejo peniciline (PBP), ali pa modifikacijo celične prepustnosti beta-laktamov.
Meat and offal: - Cattle: 
Meso in drobovina: - Govedo:
2.5 days 
2,5 dni
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. 
Penicilini in cefalosporini lahko povzročijo preobčutljivost (alergija) po injiciranju, vdihavanju, zaužitju ali stiku s kožo.
ROUTE(S) OF ADMINISTRATION Intramuscular injection 
NAČIN IN POT(I) UPORABE Intramuskularno injiciranje
In animals with hepatic and renal failure, the dosage regimen should be carefully evaluated. 
Pri živalih z odpovedjo jeter in ledvic je treba način odmerjanja previdno določiti.
The safety of the product has not been assessed in pregnant and lactating targets species. 
Varnost izdelka ni ocenjena pri ciljnih živalskih vrstah v obdobju brejosti in laktacije.
Suramox 15% LA and its associated name Stabox 15% LA is presented as an injectable suspension containing amoxicillin, which is a β-lactam antibiotic, belonging to the group of penicillins intended for the treatment of respiratory infections caused by Pasteurella multocida and Mannheimia haemolytica in cattle and for the treatment of respiratory infections due to Pasteurella multocida in pigs. 
Zdravilo Suramox 15 % LA in z njim povezano ime Stabox 15 % LA sta na voljo v obliki raztopine za injiciranje, ki vsebujeta amoksicilin, ki je beta-laktamski antibiotik iz skupine penicilinov, namenjenih zdravljenju okužb dihal, ki jih povzročata Pasteurella multocida in Mannheimia haemolytica pri govedu, ter za zdravljenje okužb dihal, ki jih povzroča Pasteurella multocida pri prašičih.
It is recommended that the maximum volume administered per site of injection should not exceed 20 ml in cattle and 5 ml in swine. 
Priporočamo vam, da ne prekoračite največje količine, odmerjene na kraju injiciranja, ki pri govedu znaša 20 ml in pri prašičih 5 ml.
The use of heavier animals would have given extra assurance about residues levels at the injection site and would have made all studies homogenous. 
Uporaba težjih živali pri teh študijah bi zagotovila večjo potrditev vrednosti ostankov na mestih injiciranja, študije pa bi tako bile tudi homogene.
50 days - Milk: 2.5 days BATCH NUMBER <Batch> <Lot> <BN> {number} EXPIRY DATE <EXP {month/year}> Shelf-life after first opening the container: 28 days. 
2,5 dni ŠTEVILKA SERIJE <Serija> <lot> <številka serije> {številka} DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA <EXP {mesec/leto}> Rok uporabnosti po prvem odpiranju ovojnine: 28 dni.
Hypersensitity reactions unrelated to dose can be observed. 
Ugotoviti je mogoče reakcije preobčutljivosti, kar ni povezano z odmerkom.
All samples were analysed for amoxicillin concentrations using a validated HPLC-MS/MS method with a limit of quantification of 25 µg/kg for all tissues. 
Pri vseh vzorcih so analizirali koncentracije amoksicilina z metodo HPLC-MS/MS z mejo kvantifikacije 25 µg/kg za vsa tkiva.
Amoxicillin belongs to β-lactams antibiotic family. 
Amoksicilin spada v skupino beta-laktamskih antibiotikov.
A withdrawal period of 88 days is therefore established for cattle. 
Za govedo je tako bila določena 88-dnevna karenca.
The animals were slaughtered at 7, 14, 46 and 57 days after the final injection. 
Živali so bile zaklane 7, 14, 46 in 57 dni po zadnjem odmerku.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI Zdravilna(e) učinkovina(e):
With the exception of one animal after 36 days which had high residues (core sample 339.4 µg/kg), residue levels were below the MRL after 30, 38 and 46 days. 
Z izjemo ene živali, pri katerih so bile 36 dni po zakolu vrednosti ostankov zelo visoke (osnovni vzorec 339,4 µg/kg), so bile pri vseh drugih vzorcih koncentracije ostankov po 30, 38 in 46 dneh pod mejno vrednostjo ostankov.
β-lactam antibiotics prevent the bacterial cell wall synthesis by interfering with the final stage of peptidoglycan synthesis. 
Beta-laktamski antibiotiki preprečujejo sintezo bakterijske celične stene, pri čemer onemogočajo končno stopnjo sinteze peptidoglikana.
Shelf-life after first opening the container: 28 days. 
Rok uporabnosti po prvem odpiranju stične ovojnine: 28 dni.
In view of the weight of the animals only one injection site sample (core plus surrounding) was available for analysis unlike in the pivotal study where there were three samples per animal. 
Ob upoštevanju mase živali je bil za analizo na voljo samo en vzorec tkiva na mestu injiciranja (mesto injiciranja in okolica), za razliko od glavne študije, pri kateri so bili pri vsaki živali analizirani trije vzorci tkiv.
The CVMP set MRLs such that consumer intake from all foods would not exceed this 30 µg threshold. 
Odbor za zdravila za uporabo v veterinarski medicini je določil take mejne vrednosti ostankov, da vnos z vso hrano pri potrošniku ne preseže meje 30 µg.
Target tissue 
Ciljna tkiva
The results from the study were used to design the pivotal residue study to include time points at 7, 14, 21 and 27 days after the last injection. 
Na podlagi rezultatov študije je bila oblikovana glavna študija izločanja ostankov s časovnimi točkami 7, 14, 21 in 27 dni po zadnjem injiciranju.
2.1 Residue studies in cattle 
2.1 Študije izločanja ostankov pri govedu
2.3 Residue studies in pigs 
2.3 Študije izločanja ostankov pri prašičih
The first residue depletion study in cattle was performed to identify the time points to be used in the pivotal residue depletion study. 
Prva študija izločanja ostankov pri govedu je bila izvedena za opredelitev časovnih točk za uporabo pri glavni študiji izločanja ostankov.
The statistical approach could not be used for the calculation of the withdrawal period as the test for log-linearity (F-test) was not met and therefore the ‘alternative approach' as set out in the CVMP guideline (EMEA/CVMP/036/95-Final) was used. 
Statistični pristop se ni mogel uporabiti za izračun karence na mestu injiciranja, saj test logaritemske linearnosti (F-test) ni bil izpolnjen, tako da je bil uporabljen „alternativni pristop“ v skladu z navodili Odbora za zdravila za uporabo v veterinarski medicini (EMEA/CVMP/036/95-Končni).
Stearic acid 
Stearinska kislina
Use during pregnancy or lactation 
Uporaba med brejostjo ali laktacijo