natgillin/translations-raw huggingface dataset:
This is a summary of the European Public Assessment Report (EPAR) for Raloxifene Teva. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Raloxifene Teva.
This means that Raloxifene Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Evista. 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Evista.
Raloxifene has the same effect as oestrogen in the bone, but it does not have an effect in the breast or the womb. 
Na kosti učinkuje enako kot estrogen, nima pa učinka na prsi ali maternico.
Because Raloxifene Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Raloxifene Teva generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Raloxifene Teva. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Raloxifene Teva is a ‘generic medicine'. 
Raloxifene Teva je „generično zdravilo“.
What are the benefit and risk of Raloxifene Teva? 
Kakšne so koristi in tveganja, povezani z zdravilom Raloxifene Teva?
The Committee recommended that Raloxifene Teva be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Raloxifene Teva izda dovoljenje za promet.
Raloxifene Teva is used for the treatment and prevention of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause. 
Zdravilo Raloxifene Teva se uporablja za zdravljenje in preprečevanje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi.
Other information about Raloxifene Teva 
Druge informacije o zdravilu Raloxifene Teva
Raloxifene acts as an ‘agonist' of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body. 
Raloksifen deluje kot agonist receptorjev estrogena (snov, ki spodbuja receptorje za estrogen) v nekaterih telesnih tkivih.
Because Raloxifene Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Evista. 
Ker je zdravilo Raloxifene Teva generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Evista.
The CHMP concluded that, in accordance with EU requirements, Raloxifene Teva has been shown to have comparable quality and to be bioequivalent to Evista. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Raloxifene Teva primerljivo raven kakovosti kot zdravilo Evista ter da mu je biološko enakovredno.
Raloxifene Teva raloxifene hydrochloride 
Raloxifene Teva raloksifen hidroklorid
The active substance in Raloxifene Teva, raloxifene, is a selective oestrogen receptor modulator (SERM). 
Zdravilna učinkovina zdravila Raloxifene Teva, raloksifen, je selektivni modulator estrogenskih receptorjev (SERM).
Raloxifene Teva is a medicine that contains the active substance raloxifene hydrochloride. 
Raloxifene Teva je zdravilo, ki vsebuje zdravilno učinkovino raloksifen hidroklorid.
Patients may also receive calcium and vitamin D supplements if they do not get enough from their diet. Raloxifene Teva is intended for long-term use. 
Bolnice lahko po potrebi jemljejo tudi dodatek kalcija in vitamina D, če ju ne dobijo dovolj s prehrano.
Raloxifene Teva has been shown to significantly reduce vertebral fractures (breaks in the spine), but not hip fractures. 
Raziskave so pokazale, da zdravilo Raloxifene Teva znatno zmanjša število zlomov vretenc (poškodb hrbtenice), ne pa tudi zlomov kolka.
Therefore, the CHMP's view was that, as for Evista, the benefit outweighs the identified risk. 
Zato je menil, da njegove koristi, tako kot pri zdravilu Evista, odtehtajo znana tveganja.
Why has Raloxifene Teva been approved? 
Zakaj je bilo zdravilo Raloxifene Teva odobreno?
Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall: oestrogen slows down bone breakdown and makes the bones less likely to fracture. 
Osteoporoza je pogostejša pri ženskah v obdobju po menopavzi, ko raven ženskega hormona estrogena upade.
What is Raloxifene Teva? 
Kaj je zdravilo Raloxifene Teva?
How has Raloxifene Teva been studied? 
Kako je bilo zdravilo Raloxifene Teva raziskano?
What is Raloxifene Teva used for? 
Za kaj se zdravilo Raloxifene Teva uporablja?
How is Raloxifene Teva used? 
Kako se zdravilo Raloxifene Teva uporablja?
How does Raloxifene Teva work? 
Kako zdravilo Raloxifene Teva deluje?
The recommended dose should not be exceeded. 
Priporočenega odmerka se ne sme prekoračiti.
If more than 50 broachings are required, the use of a draw-off needle is recommended. 
Če se zahteva več kot 50 prebadanj, je priporočljiva uporaba odtočne igle.
The tablets can be broken into equal halves. 
Tablete lahko prelomite na enaki polovici.
In this case do not use oral follow up treatment. 
V tem primeru ne uporabite peroralnega nadaljevalnega zdravljenja.
Commonly, a reduction in blood albumin concentration will occur during the period of treatment (up to 14 days). 
Znižanje koncentracije krvnega albumina se pogosto pojavi v obdobju zdravljenja (do 14 dni).
Store in the original package in order to protect from light. 
Shranjujte v originalni ovojnini za zaščito pred svetlobo.
Do not exceed the recommended dose or duration of treatment due to the possibility of severe adverse reactions. 
Ne prekoračite priporočenega odmerka ali trajanja zdravljenja, ker so možni hudi neželeni učinki.
Treatment of calves with Loxicom 20 minutes before dehorning reduces post-operative pain. 
Zdravljenje telet z zdravilom Loxicom 20 minut pred odstranitvijo rogov zmanjša pooperativno bolečino.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see section 4.3). 
Varnost zdravila v obdobju brejosti in laktacije ni bila ugotovljena (glejte poglavje 4.3).
The metabolism is qualitatively similar in rats, mini-pigs, humans, cattle and pigs although quantitatively there are differences. 
Presnavljanje je kvalitativno podobno pri podganah, mini prašičih, ljudeh in prašičih, kvantitativno pa se razlikuje.
21 % of the recovered dose is eliminated in urine (2 % as unchanged meloxicam, 19 % as metabolites) and 79 % in the faeces (49 % as unchanged meloxicam, 30 % as metabolites). 
21% odmerjenega odmerka se izloči z urinom (2% kot nespremenjeni meloksikam, 19% v obliki metabolitov) in 79% z blatom (49% kot nespremenjeni meloksikam, 30% v obliki metabolitov).
Sodium chloride Macrogol 300 
Natrijev klorid Makrogol 300
A pale yellow homogenous paste. 
Bledo rumena homogena pasta.
The detection of metabolites from the parent compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 
Detekcija metabolitov iz matične spojine v urinu in blatu, vendar ne v plazmi, nakazuje na njihovo hitro izločanje.
Non-infectious locomotor disorders. 
Neinfekcijske lokomotorne motnje.
Date of first authorisation: 10/02/2009 Date of last renewal: 23/01/2019 
Datum zadnjega podaljšanja dovoljenja za promet: 23/01/2019
Once broached, use by………………………. 
Enkrat načeto, uporabite do…………………….
During anaesthesia, monitoring and fluid therapy should be considered as standard practice. 
Med anestezijo bi morala biti monitoring in tekočinska terapija del običajne prakse.
Do not store above 25°C. 
Ne shranjujte pri temperaturi nad 25 C.
10 tablets 20 tablets 100 tablets 500 tablets 
10 tablet 20 tablet 100 tablet 500 tablet
Due to the loading dose, steady state PK is reached after 2 days (48h). 
Zaradi udarnega odmerka se ravnotežno stanje PK vzpostavi po 2 dneh (48 urah).
The oral paste is available in the following pack sizes: - 1 carton box containing 1 syringe - 1 carton box containing 7 syringes 
Peroralna pasta je na voljo v naslednjih pakiranjih: - 1 kartonska škatla, ki vsebuje 1 brizgo - 1 kartonska škatla, ki vsebuje 7 brizg - 1 kartonska škatla, ki vsebuje 14 brizg
A clinical response is normally seen within 3-4 days. 
Klinični odziv na zdravljenje je običajno opazen po 3 do 4 dneh.
As for other species investigated, the main pathway of meloxicam biotransformation in cat is oxidation. 
Kot pri drugih preiskovanih vrstah je glavna pot biotransformacije meloksikama pri mačkah oksidacija.
Do not exceed 50 broachings per vial. 
Viale ne prebodite več kot 50 krat.
Accidental self injection may cause pain. 
Nenamerno samoinjiciranje lahko povzroči bolečino.
If the animal is fed at the time of dosing, the absorption may be slightly delayed. 
Če žival ob dajanju zdravila nahranimo, se njegova absorpcija nekoliko podaljša.
It reduces leukocyte infiltration into the inflamed tissue. 
Zmanjša infiltracijo levkocitov v vneto tkivo.
Please carefully follow the instructions of the veterinarian. 
Potrebno je natančno slediti navodilom veterinarja.
To ensure correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing or overdosing. 
Za pravilno odmerjanje zdravila je treba kar se da natančno določiti telesno maso, da bi se izognili dajanju premajhnega ali prevelikega odmerka.
See section "Contraindications". 
Glejte poglavje "Kontraindikacije".
Any unused half tablets may be returned to open blister and stored for up to 24 hours. 
Neuporabljene prepolovljene tablete lahko vstavite nazaj v pretisni omot in jih tako shranite za največ 24 ur.
1 syringe 7 syringes 14 syringes 
1 brizga 7 brizg 14 brizg
Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or maternotoxic effects. 
Z laboratorijskimi študijami na govedu niso bili dokazani teratogeni in fetotoksični učinki ter toksični učinki na mater.
Each ml contains: 
Vsak ml vsebuje:
Dose scheme for the maintenance dose: 
Shema odmerjanja za vzdrževalni odmerek:
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age. 
Pri zdravljenju driske pri govedih ne uporabite pri živalih, mlajših od enega tedna.
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of 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 product. 
Pomožne snovi, navedene v poglavju 6.1 SPC so bodisi dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
Body weight (kg) 
Telesna masa (kg)
Chronic musculoskeletal disorders: Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon. 
Kronična mišično-skeletna obolenja: Veterinar naj v rednih razmikih spremlja odzivanje na dolgotrajno zdravljenje.
Acute respiratory infection. 
Akutne okužbe dihal.
Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at relatively small overdose levels. 
Meloksikam ima pri mačkah ozko terapevtsko varnostno območje, zato se lahko klinični znaki prevelikega odmerjanja pojavijo pri razmeroma majhnih prekoračitvah odmerka.
If skin and/or eye contact occurs, wash the affected parts immediately with water. 
V primeru stika s kožo in/ali očmi si to mesto takoj sperite z vodo.
Loxicom alone will not provide adequate pain relief during the dehorning procedure. 
Samo zdravilo Loxicom ne zagotavlja ustreznega lajšanja bolečine med postopkom odstranjevanja rogov.
To be administered directly into the mouth over the back of the tongue keeping the animal's head raised until swallowed. 
Daje se direktno v usta na zadnji del zgornje strani jezika, konj pa naj ima dvignjeno glavo dokler ne pogoltne zdravila.
Maximal plasma concentrations are obtained after approximately 2 - 3 hours. 
Največjo koncentracijo v plazmi doseže približno po 2-3 urah.
Bovine, caprine 
Govedo, koze
The recommended maximum volume to be administered at a single injection site is 10 ml. 
Največja priporočena količina, ki se daje na enem mestu vbrizgavanja je 10 ml.
When the product is used according to the recommended dosage regime the oral bioavailability is approximately 98%. 
Če dajemo zdravilo po priporočenem režimu odmerjanja, je njegova peroralna biološka uporabnost približno 98%.
This veterinary medicinal product for dogs should not be used in cats as it is not suitable for use in this species. 
Tega zdravila za pse ne uporabite pri mačkah, ker ni primerno za to živalsko vrsto.
The recommended maximum volume to be administered at a single injection site is 2 ml. 
Največja priporočena količina, ki se daje na enem mestu vbrizgavanja je 2 ml.
For post-operative pain relief in cats, safety has only been documented after thiopental/halothane anaesthesia. 
Za pooperativno lajšanje bolečine pri mačkah je bila varnost dokumentirana samo po anesteziji s tiopentalom in halotanom.
To be administered with food or directly into the mouth. 
Dajemo s hrano ali direktno v usta.
Co. Down, BT35 6PU United Kingdom 
Co. Down, BT35 6PU Združeno kraljestvo
Advice on correct administration To be administered with food or directly into the mouth. 
Nasvet o pravilni uporabi zdravila Dajemo s hrano ali direktno v usta.
Particular care should be taken with regard to the accuracy of dosing. 
Posebno skrb je treba nameniti natančnemu odmerjanju.
CONTENT BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injection 
Natrijev hidroksid (za uravnavanje pH ) Klorovodikova kislina (za uravnavanje pH ) Voda za injekcije
For the full list of excipients, see section 6.1 
Za celoten seznam pomožnih snovi, glejte poglavje 6.1
Pregnancy and lactation: See section "Contraindications". 
Brejost in laktacija: Glejte poglavje »Kontraindikacije«.
In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically. 
Zelo redko se lahko pojavijo anafilaktoidne reakcije, ki so lahko resne (tudi smrtne) in jih je treba zdraviti simptomatsko.
-Sodium starch glycolate, type A -Spray dried pork liver -Lactose monohydrate -Povidone K30 -Sucrose -Microcrystalline cellulose and guar gum -Microcrystalline cellulose -Wheatgerm defatted flour -Yeast extract (dried) -Magnesium stearate 
- natrijev karboksimetil škrob (vrsta A) - prašičja jetra (pripravljena z razprševalnim sušenjem) - laktoza monohidrat - povidon K30 - saharoza - celuloza, mikrokristalna in gumi semena cijamopsisa, uprašenega - celuloza, mikrokristalna - razmaščena moka pšeničnih kalčkov - ekstrakt kvasa (sušen) - magnezijev stearat
The suspension can be given using either of the two measuring syringes provided in the package (depending on weight of dog). 
Suspenzijo je treba odmeriti z merilno brizgo, ki je sestavni del pakiranja (odvisno od teže psa).
Avoid skin and eye contact with the product. 
Izogibajte se stiku zdravila s kožo ali očmi.
Hydrochloric acid Sodium hydroxide Water for injections 
Klorovodikova kislina Natrijev hidroksid Voda za injekcije
Cattle, pigs and horses. 
Govedo, prašiči in konji.
Each vial is closed with a bromobutyl bung and sealed with an aluminium cap. 
Vsaka viala je zaprta z bromobutilnim zamaškom in aluminijasto zaporko.
The major metabolites found in all species were the 5-hydroxyand 5-carboxy-metabolites and the oxalyl-metabolite. 
Glavni presnovki, ki so jih odkrili pri vseh vrstah so 5-hidroksi- in 5-karboksipresnovki ter oksalil-presnovek.
The active substance in Loxicom 20 mg/ml solution for injection for cattle, pigs and horses 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) Učinkovina v Loxicom 20 mg/ml raztopina za injiciranje za govedo, prašiče in konje je dovoljena količina, kot je navedena v tabeli 1( dovoljene snovi) priloge Uredbe Komisije (EU) št. 37/2010: Farmakološko aktivna snov
The oral follow-up dose may be administered once daily (at 24-hour intervals) for up to four days. 
Peroralni nadaljevalni odmerek lahko dajemo enkrat dnevno (v 24 urnih presledkih), največ štiri dni.
For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculoskeletal disorders, a suitable oral therapy containing meloxicam, administered in accordance with label recommendations, may be used for continuation of treatment. 
Za uporabo pri zmanjševanju vnetja in lajšanje bolečine pri akutnih in kroničnih mišično-kostnih obolenjih se lahko za nadaljevanje zdravljenja, v skladu s priporočili na ovojnini, uporabi ustrezno peroralno zdravljenje, ki vsebuje meloksikam.
This product for dogs should not be used in cats due to the different dosing devices. 
To zdravilo za pse se ne sme uporabljati pri mačkah zaradi različnih odmernih brizg.
Dosing procedure: 
Postopek odmerjanja:
To a minor extent it also inhibits collagen-induced thrombocyte aggregation. 
V manjši meri zavira tudi agregacijo trombocitov, ki jo povzroča kolagen.
Puerperal septicaemia and toxaemia (MMA syndrome) with antibiotic therapy. 
Puerperalna septikemija in toksemija (sindrom MMA), ob antibiotičnem zdravljenju.
Dosage for each species: 
Odmerki za različne živalske vrste:
15 µg/kg Milk 
15 µg/kg Mleko
Light brown oval biconvex tablet with a score line on one face and plain on the other. 
Svetlo rjava ovalna bikonveksna tableta z zarezo na eni strani.
Co. Down, 
Pol. Ind.
Number of chewable tablets 1 mg 
Število žvečljivih tablet 1 mg
See also section 4.3. 
Glejte tudi poglavje 4.3.
Reduction of post-operative pain (over a period of 24 hours): single intravenous or subcutaneous injection before surgery, for example at the time of induction of anaesthesia. 
Lajšanje pooperativne bolečine (v 24 urnem obdobju): enkratno intravensko ali podkožno dajanje pred operacijo, naprimer ob indukciji anestezije.
NO ENTRY 
NI VNOSA
The tablets can be administered with or without food, are flavoured and are taken by most dogs voluntarily. 
Tablete lahko dajete s hrano ali brez nje, so okusne in jih večina psov rada poje.
The metabolism in horses was not investigated. 
Presnavljanje pri konjih ni bilo raziskano.
Blister packs of 10 tablets per strip in cartons containing 10, 20, 100 or 500 tablets. 
Pretisni omoti po 10 tablet na traku, pakirani v škatle po 10, 20, 100 ali 500 tablet.
15 μg/kg Milk 
15 μg/kg Mleko
In animals at anaesthetic risk (e.g. aged animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration. 
Pri živalih, pri katerih obstaja tveganje ob anesteziji (npr. pri starejših živalih), je treba presoditi o uporabi intravenskega ali podkožnega dajanja tekočine med anestezijo.
Norbrook Laboratories Limited 
Norbrook laboratiries Limited
Hydroxypropyl cellulose Glycerol 
Hidroksipropilceluloza Glicerol
Meloxicam Meloxicam Bovine, caprine, porcine, rabbit, 
Meloksikam Meloksikam Govedo, koze, prašiči, kunci,
Meloxicam is eliminated with a half-life of 24 hours in dogs and 15 hours in cats. 
Pri psih je razpolovna doba izločanja meloksikama 24 ur, pri mačkah pa 15 ur.
To be administered orally either mixed with food or directly into the mouth using the measuring syringe provided. 
Dajemo peroralno, s hrano ali direktno v usta s priloženo merilno brizgo.
In very rare cases anaphylactoid reactions may occur and should be treated symptomatically. 
Zelo redko se lahko pojavijo preobčutljivostne reakcije, ki jih je treba zdraviti simptomatsko.
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Citric acid anhydrous Simethicone emulsion Purified water 
Ksantanski gumi Natrijev hidrogenfosfat dihidrat Natrijev dihidrogenfosfat dihidrat Citronska kislina, brezvodna Emulzija simetikona Prečiščena voda
Diarrhoea in calves of over one week of age and young, non-lactating cattle. 
Driska pri teletih, starejših od enega tedna in mladih govedih, ki niso v obdobju laktacije.
Benzyl alcohol Saccharin sodium powder Purified water 
Benzilalkohol Natrijev saharinat, prah
meloxicam2. 
meloksikam2.
The volume of distribution is 0.3 l/kg in dogs and 0.09 l/kg in cats. 
Porazdelitveni volumen pri psih je 0,3 l/kg, pri mačkah pa 0,09 l/kg.
Loxicom 0.5 mg/ml Oral Suspension for Cats is available in bottle of 5 ml, 15 ml and 30 ml volumes. 
PakiranjeLoxicom 0,5 mg/ml peroralna suspenzija za mačke je na razpolago v plastenkah po 5 ml, 15 ml in 30 ml.
Administer 0.6 mg/kg body weight, once daily for up to 14 days. 
Odmerek 0,6 mg/kg telesne mase se daje enkrat dnevno, do 14 dni.
Blister packs of 10 tablets per strip composed of PVC/PVDC base foil and aluminium lidding foil in cartons containing 10, 20, 100 or 500 tablets. 
Pretisni omoti po 10 tablet na traku (PVC/PVDC bazna folija in prekrivna folija iz aluminija), pakirani v škatle po 10, 20, 100 ali 500 tablet.
To be supplied on veterinary prescription. 
Na veterinarski recept.
Carton Box labelling 
Kartonska škatla
For dogs weighing less than 4 kg the use of meloxicam containing oral suspension for dogs is recommended. 
Za pse z manjšo telesno maso od 4 kg priporočamo uporabo peroralne suspenzije za pse, ki vsebuje meloksikam.
Reduction of post-operative pain in cats when administration of meloxicam is to be continued as an oral follow-up therapy: 
Lajšanje pooperativne bolečine pri mačkah, kjer se bo dajanje meloksikama nadaljevalo v obliki peroralnega nadaljevalnega zdravljenja:
For use in 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. 
Za umirjanje kliničnih znakov driske, v kombinaciji s peroralnim rehidracijskim zdravljenjem, pri teletih, starejših od enega tedna, in mladih govedih, ki niso v obdobju laktacije.
Do not use in animals less than 6 weeks of age nor in cats of less than 2 kg. 
Ne uporabite pri živalih, mlajših od 6 tednov, niti pri mačkah, lažjih od 2 kg.
Antiinflammatory agents/ Nonsteroidal antiinflammatory agents 
Protivnetna zdravila/ Nesteroidna protivnetna zdravila
The oral follow-up dose may be administered for up to a total of four doses at 24 hour intervals. 
Peroralni nadaljevalni odmerek se lahko da največ štiri krat v 24-urnih intervalih.
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/. 
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/.
The following clinical signs (some of which may be serious) have been reported in clinical studies following administration of the product at 5x overdose: dull behaviour, diarrhoea, oedema, buccal mucosal ulceration and/or dark coloured urine. 
V kliničnih študijah so po 5-kratnem prekomernem odmerjanju zdravila poročali o naslednjih kliničnih znakih (nekateri so lahko resni): otopelost, driska, edem, razjeda bukalne sluznice in/ali temno obarvan urin.
Use during pregnancy and lactation: Do not use in pregnant or lactating mares 
Uporaba v obdobju brejosti in laktacije: Ne uporabite pri brejih kobilah ali kobilah v obdobju laktacije.
Pale yellow suspension. 
Bledo rumena suspenzija.
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 bila dosežena Cmax pri prašičih po 1 uri 1,9 µg/ml.
Cattle: Single subcutaneous or intravenous injection. 
Govedo: Enkratna podkožna ali intravenska injekcija.
EXP {month/year} Shelf-life of the halved tablet: 24-hours 
EXP mesec/leto Rok uporabnosti prepolovljene tablete: 24 ur
QUANTITY OF THE ACTIVE SUBSTANCE 
KOLIČINA UČINKOVINE