natgillin/translations-raw huggingface dataset:
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING 
Izgled zdravila in vsebina pakiranja
TAXOTERE 80 mg/4 ml sterile concentrate docetaxel 
TAXOTERE 80 mg/4 ml sterilni koncentrat docetaksel intravenska uporaba
SOLVENT for TAXOTERE 80 mg/2 ml 
KONCENTRAT IN VEHIKEL TAXOTERE 80 mg/2 ml
Epistaxis (G3/4: < 1%) 
S3/4 zvišanje AST (< 1
If TAXOTERE concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. 
Če pride koncentrat, osnovna raztopina ali raztopina za infundiranje zdravila TAXOTERE v stik s kožo, jo je treba takoj in temeljito umiti z milom in vodo.
In TAXOTERE 80 mg /4 ml vial the concentration of docetaxel is 20 mg/ml. 
V viali, ki vsebuje zdravilo Taxotere 80 mg/4 ml, je koncentracija docetaksela 20 mg/ml.
Docetaxel every 3 weeks 
Končna točka docetaksel vsake 3 tedne docetaksel vsak teden
• weight gain or loss 
• povečanje ali zmanjšanje telesne mase
What TAXOTERE looks like and contents of the pack TAXOTERE concentrate for solution for infusion is a pale yellow to brownish-yellow solution. 
Zdravilo TAXOTERE koncentrat za raztopino za infundiranje je bledorumena do rjavo-rumena raztopina.
Hypersensitivity (G3/4: 1.7%) 
Bolezni imunskega sistema preobčutljivost (S3/4: 1,7)
If TAXOTERE concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water. 
Če pride koncentrat, osnovna raztopina ali raztopina za infundiranje zdravila TAXOTERE v stik s sluznicami, jih je treba takoj in temeljito umiti z vodo.
Tabulated list of adverse reactions in high-risk locally advanced or metastatic hormone-sensitive prostate cancer for TAXOTERE 75 mg/m² in combination with prednisone or prednisolone and ADT (STAMPEDE study) 
Splošne težave in spremembe na mestu aplikacije utrujenost (S3/4: 3,9 %), zastajanje tekočine (hudo 0,6 %) Za bolnike z lokalno napredovalim ali metastatskim hormonsko občutljivim rakom prostate z velikim tveganjem so v preglednici prikazani neželeni učinki za zdravilo TAXOTERE 75 mg/m2 v kombinaciji s prednizonom ali prednizolonom in ADT (študija STAMPEDE) Organski sistemi po MedDRA
Hand-foot syndrome (G3/4: 
Očesne bolezni konjunktivitis (S3/4:
Each ml of docetaxel solution contains 40 mg of docetaxel (anhydrous). 
En ml raztopine docetaksela vsebuje 40 mg brezvodnega docetaksela.
Tabulated list of adverse reactions in breast cancer for TAXOTERE 100 mg/m² single agent 
Tabelarični prikaz neželenih učinkov monoterapije z zdravilom TAXOTERE 100 mg/m2 pri raku dojke
Hot flush (G3/4: 0.5%) Hypotension (G3/4: 
hipotenzija (S3/4: 0 %) flebitis (S3/4: 0 %)
Peripheral sensory neuropathy (G3/4: 0.8%) 
periferna motorična nevropatija (S3/4: 0,4 %)
TAXOTERE 80 mg/2 ml concentrate and solvent for solution for infusion docetaxel 
TAXOTERE 80 mg/2 ml koncentrat in vehikel za raztopino za infundiranje docetaksel
Pyrexia (G3/4: NA); Oedema peripheral (G3/4: 0.2%) 
Splošne težave in spremembe na mestu aplikacije astenija (S3/4: 10,0 %), zvišana telesna temperatura (S3/4: NA), periferni edemi (S3/4: 0,2 %)
Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%) 
hipotenzija (S3/4: 0 %) vnetje žile (S 3/4: 0 %)
Tabulated list of adverse reactions in gastric adenocarcinoma cancer for TAXOTERE 75 mg/m² in combination with cisplatin and 5-fluorouracil 
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom TAXOTERE 75 mg/m2 v kombinaciji s cisplatinom in 5-fluorouracilom za adenokarcinom želodca
Febrile neutropenia (G3/4: NA) 
Amenoreja (S3/4: NA)
Description of selected adverse reactions in breast cancer for TAXOTERE 100 mg/m² single agent 
Opis izbranih neželenih učinkov monoterapije z zdravilom TAXOTERE 100 mg/m2 pri raku dojke
Tabulated list of adverse reactions in non-small cell lung cancer for TAXOTERE 75 mg/m² single agent 
Tabelarični prikaz neželenih učinkov monoterapije z zdravilom TAXOTERE 75 mg/m2 pri nedrobnoceličnem pljučnem raku
Lethargy (G3-4: 2%) Flu-like symptoms (G3: 0%) Asthenia (G3: 0%) Fluid retention 
Srčne bolezni aritmija (S3/4: 2, 0 %) ishemija miokarda
Infusion site reaction; Non-cardiac chest pain (severe: 0.4%) 
febrilna nevtropenija, trombocitopenija (S4: 0,8 %)
PREPARATION GUIDE FOR USE WITH TAXOTERE 80 mg/4 ml CONCENTRATE FOR SOLUTION FOR INFUSION 
NAVODILA ZA UPORABO GLEDE PRIPRAVE KONCENTRATA ZA RAZTOPINO ZA INFUNDIRANJE ZDRAVILA TAXOTERE 80 mg/ 4 ml
Alopecia (G3/4: 4.0%); Rash pruritic 
Srčne bolezni aritmija (S3/4: 2,0 %) ishemija miokarda
Dysgeusia/Parosmia (G3/4: 0.4%); 
bolečine v trebuhu (S3/4: 0,4 %)
Oesophagitis/dysphagia/odynop hagia (G3/4: 0.7%) 
Bolezni živčevja disgevzija/parozmija, periferna senzorična nevropatija (S3/4:0,6 %)
Neutropenia (G3/4: 32%); Anaemia (G3/4: 4.9%) 
Infekcijske in parazitske bolezni okužba (S3/4): 3,3 %) Bolezni krvi in limfatičnega sistema nevtropenija (S3/4: 32 %), anemija (S3/4: 4,9 %)
Skin reaction (no severe) 
Pogosti neželeni učinki spremembe nohtov (nobenih hudih)
The addition of the entire contents of the solvent vial to the contents of the TAXOTERE 20 mg/0.5 ml vial ensures a premix concentration of 10 mg/ml docetaxel. 
Dodatek celotne vsebine viale z vehiklom vsebini viale zdravila TAXOTERE 20 mg zagotavlja koncentracijo 10 mg/ml docetaksela v osnovni raztopini.
24.4 mg/0.61 ml). 
z 9 meseci, p = 0,01).
Diarrhoea (G3/4: 2.9%); Vomiting (G3/4: 0.6%) 
Bolezni prebavil navzea (S3/4: 0,6 %), stomatitis (S3/4: 4,0 %), driska (S3/4: 2,9 %), bruhanje (S3/4: 0,6 %)
2.1 TAXOTERE 80 mg/2 ml vial 
2.1 Viala zdravila TAXOTERE 80 mg/2 ml:
Tabulated list of adverse reactions in non-small cell lung cancer for TAXOTERE 75 mg/m² in combination with cisplatin 
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom TAXOTERE 75 mg/m2 pri nedrobnoceličnem pljučnem raku v kombinaciji s cisplatinom Organski sistemi po
60 mg/m². 
stopnje, moramo odmerek zmanjšati na 60 mg/m2.
Diabetes (G3-4: 1%) 
Bolezni endokrinega sistema sladkorna bolezen (3.-4. st.: 1 %)
Dehydration (G3/4: 2%) 
Srčne bolezni aritmija (S3/4: 0,2 %)
ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES 
DODATEK I SEZNAM IZMIŠLJENIH IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POT UPORABE IN IMETNIKI DOVOLJENJ ZA PROMET
Member State Marketing Authorisation Holder Invented Name 
Imetnik dovoljenja za promet
2 bottles of 240 
2 plastenki po 240
240 ml (15 mg/ml) 1 bottle + 20 ml measuring cup 
1 plastenka + 20 ml odmerni lonček
Package size 
Vsebnost (koncentracija) Velikost pakiranja
Invented name Strength Pharmaceutical form Route of administration Packaging 
Farmacevtska oblika Način uporabe Ovojnina
15 mg/ml Oral solution 
EU/1/00/148/004 AGENERASE 15 mg/ml Peroralna raztopina Peroralna uporaba Plastenka (HDPE) 240 ml (15 mg/ml)
Locomotor disorders: 
Lokomotorne motnje:
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/).
Cattle and pigs 
Goveda in prašiči
Novem alone will not provide adequate pain relief during the dehorning procedure. 
Samo zdravilo Novem ne zagotavlja ustreznega lajšanja bolečine med postopkom odstranjevanja rogov.
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the relase of the concerned batch. 
V natisnjenem navodilu za uporabo zdravila mora biti navedeno ime in naslov proizvajalca, odgovornega za sproščanje zadevne serije.
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)