natgillin/translations-raw huggingface dataset:
The CHMP considers that correct insertion is a simple procedure and that the IRRE problems can be prevented or reduced by compliance with updated instructions and training materials. 
CHMP meni, da je pravilno vstavljanje enostaven postopek in da se težave z IRRE lahko preprečijo ali zmanjšajo z upoštevanjem posodobljenih navodil in gradiv za usposabljanje.
The big advantage of implants is the absence of problems with compliance or gastro-intestinal disturbances that negatively affect contraceptive efficacy versus the disadvantages of irregular bleeding being there with all continuous progestogen-only methods that inhibit ovulation. 
Velika prednost implantantov je odsotnost problemov sprejemanja ali gastrointestinalnih motenj, ki negativno vplivajo na učinkovitost kontracepcije, slabost pa neredno krvavenje, ki je prisotno pri vseh neprekinjenih metodah, ki vsebujejo le progestogen in zavirajo ovulacijo.
The main benefit of any contraceptive method is efficacy and the CHMP considered that Implanon shows excellent efficacy with no evidence of decline neither during the 3rd year of use nor in heavy women and that the current text in the SPC regarding efficacy and weight is appropriate. 
Glavna prednost katere koli metode kontracepcije je njena učinkovitost in CHMP je menil, da je zdravilo Implanon izjemno učinkovito brez dokazov o zmanjšanju učinkovitosti med tretjim letom uporabe ali pri ženskah s prekomerno težo ter da je trenutno besedilo v Povzetku glavnih značilnosti zdravila glede učinkovitosti in telesne mase primerno.
Thus, most data pertain to injectable POC, little data exist for other POCs, no data are available for Implanon. 
Zato se večina podatkov nanaša na injicirani POC, malo podatkov je na voljo o ostalih vrstah uporabe POC, ni pa podatkov za zdravilo Implanon.
Strength Pharmaceutical Form Route of administration 
Jakost Farmacevtska oblika
• The body weight at the time of removal will be asked for in case of early removal (including pregnancy) in the AMP. 
• v primeru zgodnje odstranitve (vključno z nosečnostjo) v programu dejavnega spremljanja se ob odstranitvi ugotovi telesna masa;
the CHMP has recommended the renewal of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Implanon. 
CHMP je priporočil obnovitev dovoljenj za promet z zdravilom Implanon, z njim povezani povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo so navedeni v Dodatku III.
Applicant (Invented) Name 
(Lastniško) ime
• An update on bleeding in section 4.8 in the SPC and leaflet as proposed in the draft MAH labelling. 
• posodobitev podatkov o krvavenju v poglavju 4.8 Povzetka glavnih značilnosti zdravila in navodilu za uporabo, kot je predlagano v osnutku označevanja imetnika dovoljenja za promet z zdravilom.
The MAH has compiled data of available relevant studies and overall, the epidemiological data on the association between progestogen-only contraception (POC) and breast cancer risk are sparse and reflect mostly the use of injectable DMPA. 
Imetnik dovoljenja za promet z zdravilom je zbral podatke o razpoložljivih zadevnih študijah in na splošno, epidemiološki podatki o povezavi med kontracepcijo, ki vsebuje le progestogen (POC), in tveganjem raka na dojkah pa so redki in kažejo večinoma na uporabo injiciranega DMPA.
Implanon is a non-biodegradable, long-acting, progestagen-only contraceptive implant inserted subdermally. 
Zdravilo Implanon je biološko nerazgradljiv kontracepcijski implantant z dolgotrajnim delovanjem, ki vsebuje samo progestagen in se vsadi pod kožo.
The Mirena study and reports from the US AMP should be included in the updated RMP. 
Študija o Mireni in poročila iz programa dejavnega spremljanja v ZDA morajo biti vključeni v posodobljenem načrtu za obvladovanje tveganja.
In conclusion, the CHMP considers Implanon to be an effective method of contraception with no apparent safety concerns and that the benefit-risk balance of Implanon is positive. 
Končno CHMP meni, da je zdravilo Implanon učinkovita metoda kontracepcije brez očitnih zadržkov glede varnosti ter da je razmerje med koristmi in tveganji pozitivno.
- Implanon has clearly proven to be an effective method of contraception - including in obese womendespite a low dose, 
- zdravilo Implanon se je kljub majhnim odmerkom jasno dokazalo kot učinkovita metoda kontracepcije, tudi pri ženskah s prekomerno telesno maso.
In conclusion, the CHMP considers Implanon to be an effective method of contraception with no apparent safety concerns and is therefore of the opinion that the benefit-risk profile of Implanon is positive. 
Nazadnje CHMP meni, da je zdravilo Implanon učinkovita metoda kontracepcije, nima očitnih zadržkov glede varnosti in meni, da je razmerje med koristmi in tveganji pozitivno.
From the interim analysis, the study hypothesis of an adverse effect on breast cancer risk has no support. 
Hipoteza študije o neželenem učinku za raka na dojkah tudi ni podprta v vmesni analizi.
However, a number of concerns were raised by the objecting CMS which did not consider the second renewal acceptable. 
Vendar pa so nasprotujoče zadevne države članice, ki druge obnovitve dovoljenja za promet z zdravilom niso ocenile kot primerno, izrazile številne dvome.
Austria 
Avstria
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES 
PRILOGA I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Roche Farmacêutica Química, Lda 
Portugalska Roche Farmacêutica Química, Lda
Roche Hungary Ltd Edison ut 1 
Madžarska Roche Hungary Ltd Edison ut 1
Protection lasts for one year. 
Zaščita traja eno leto.
The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to stimulate a better response. 
Cepivo vsebuje tudi „adjuvansa“ (aluminijev hidroksid in saponin) za spodbujanje boljšega odziva.
The vaccine is used to prevent viraemia (the presence of viruses in the blood) and reduce the signs of the disease. 
Cepivo se uporablja za preprečevanje viremije (prisotnosti virusa v krvi) in zmanjševanje kliničnih znakov bolezni.
Vaccination may be followed by a small local swelling at the injection site (up to 24 cm2) for a short period (up to two weeks). 
Po cepljenju se lahko na mestu injiciranja za kratek čas (največ dva tedna) pojavi manjša lokalizirana oteklina (največ 24 cm2).
Animals may show a slight rise in body temperature, normally no more than 1.1°C on average, in the 24 hours following vaccination. 
Pri živalih so v prvih 24 urah po cepljenju opazili rahlo povečanje telesne temperature, ki pa navadno ne preseže 1,1 °C.
The European Medicines Agency (EMA) reviewed additional information according to an agreed timetable on the quality, safety and efficacy of the vaccine. 
Evropska agencija za zdravila (EMA) je pregledala vse nove podatke o kakovosti, varnosti in učinkovitosti cepiva, ki so bili predloženi po dogovorjenem časovnem razporedu.
The safety and effectiveness studies showed that the vaccine is safe for sheep and that it reduces the signs of the disease and prevents viraemia in animals from one month of age that are infected with bluetongue virus serotypes 2 and 4. 
Študije varnosti in učinkovitosti so pokazale, da je cepivo varno za uporabo pri ovcah ter da zmanjša klinične znake bolezni in preprečuje viremijo pri živalih od enega meseca starosti dalje, ki so okužene z virusom modrega jezika, serotipa 2 in 4.
The vaccine is given to young animals as an injection under the skin. 
Cepivo se injicira mladim živalim v podkožje.
In the future, if the animals are exposed to bluetongue virus, the immune system will be able to produce antibodies more quickly. 
Ob ponovni izpostavitvi virusu bolezni modrega jezika v prihodnosti bo imunski sistem tako hitreje tvoril protitelesa.
The European Commission granted a marketing authorisation valid throughout the EU for BTVPUR AlSap 2-4 on 5 November 2010. 
Evropska komisija je dovoljenje za promet z zdravilom BTVPUR AlSap 2-4, veljavno po vsej Evropski uniji, odobrila 5. novembra 2010.
The injection is given from one month of age in animals that have never been exposed to the disease, and from two-and-a-half months if the animal is likely to have inherited antibodies against the virus from a mother that is already immune to the disease. 
Živalim, ki še nikoli niso bile izpostavljene bolezni, se prva injekcija vbrizga po dopolnjenem enem mesecu starosti, živalim, ki so protitelesa proti virusu verjetno prejele od matere, ki je že imuna na to bolezen, pa po dopolnjenih dveh mesecih in pol starosti.
In 2014 the CVMP considered that the submitted data were adequate for the authorisation of BTVPUR Alsap 2-4 to convert to a normal status. 
Leta 2014 je CVMP menil, da predloženi podatki zadostujejo, da se dovoljenje za promet s cepivom BTVPUR AlSap 2-4 spremeni v običajno dovoljenje.
When it is given to sheep, the animals' immune systems recognise the viruses as ‘foreign' and make antibodies against them. 
Ko ovco cepimo, imunski sistem viruse prepozna kot „tujek“ in proti njim razvije protitelesa.
The studies also showed that the vaccine can be used in pregnant and lactating sheep. 
Pokazale so tudi, da se cepivo lahko uporabi pri brejih ovcah in ovcah v laktaciji.
It is available as a suspension for injection that contains inactivated (killed) bluetongue serotype 2 and 4 viruses. 
Na voljo je v obliki suspenzije za injiciranje, ki vsebuje inaktivirane (uničene) viruse modrega jezika, serotipa 2 in 4.
BTVPUR AlSap 2-4 was initially authorised under ‘exceptional circumstances'. 
Cepivo BTVPUR AlSap 2-4 je prvotno pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
The effectiveness of the vaccine in sheep was studied in a pivotal laboratory trial using the vaccine in sheep from a young age. 
Učinkovitost cepiva pri ovcah so raziskovali v ključnem laboratorijskem preskušanju, v katerem so ovce cepili že od zgodnje starosti dalje.
The withdrawal period for BTVPUR Alsap 2-4 for meat and milk for sheep is zero days. 
Obdobje karence za cepivo BTVPUR AlSap 2-4 za meso in mleko pri ovcah je nič dni.
The safety of the vaccine was studied in an overdose laboratory safety study carried out with BTVPUR AlSap 2-4 in sheep. 
Varnost cepiva je bila raziskana v laboratorijskih študijah varnosti prevelikega odmerjanja z uporabo cepiva BTVPUR AlSap 2-4 pri ovcah.
Bluetongue vaccine serotype 2 and 4 
Cepivo proti bolezni modrega jezika, serotip 2 in 4
The studies on the monovalent vaccines containing bluetongue virus serotypes 2 or 4 showed that the period of protection is 12 months for both serotypes. 
Študije monovaletnih cepiv z virusom modrega jezika serotipa 2 ali 4 so pokazale, da zaščita pri obeh serotipih traja 12 mesecev.
BTVPUR AlSap 2-4 contains bluetongue viruses of two types (serotypes 2 and 4). 
Zdravilo BTVPUR AlSap 2-4 vsebuje dva tipa virusov modrega jezika (serotipa 2 in 4).
The CVMP concluded that the benefits of BTVPUR AlSap 2-4 exceed the risks for active immunisation of sheep to prevent infection, viraemia and clinical signs caused by the bluetongue virus serotypes 2 and 4, and recommended that BTVPUR AlSap 2-4 be given marketing authorisation. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi cepiva BTVPUR AlSap 2-4 za aktivno imunizacijo ovac za preprečitev okužbe, viremije in kliničnih znakov, ki jih povzročata serotipa 2 in 4 virusa bolezni modrega jezika, večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Protection starts three and five weeks after the injection for serotype 4 and serotype 2, respectively. 
Zaščita nastopi tri tedne po cepljenju za serotip 4 in pet tednov po cepljenju za serotip 2.
Results also from a series of laboratory safety trials performed with vaccines of similar composition but including only one of the two serotypes of BTVPUR AlSap 2-4 or different bluetongue serotypes were presented in order to extrapolate safety conclusions. 
Predstavljeni so bili tudi rezultati niza laboratorijskih preskušanj varnosti z uporabo cepiva s podobno sestavo, ki pa je vsebovalo bodisi le enega od dveh serotipov cepiva BTVPUR AlSap 2-4 bodisi različne serotipe bolezni modrega jezika, da bi tako pridobili zaključke o varnosti.
The company also presented results from a series of trials conducted with vaccines of similar composition but including only one of the two serotypes of BTVPUR AlSap 2-4 in order to extrapolate further efficacy conclusions. 
Družba je predstavila tudi rezultate niza preskušanj cepiv podobne sestave, ki vsebujejo le enega od dveh serotipov zdravila BTVPUR AlSap 24, da bi tako pridobili nadaljnje zaključke o učinkovitosti.
BTVPUR AlSap 2-4 contains bluetongue viruses that have been inactivated so that they cannot cause the disease. 
Cepivo BTVPUR AlSap 2-4 vsebuje inaktivirane viruse modrega jezika, ki ne povzročajo bolezni.
What benefit has BTVPUR AlSap 2-4 shown during the studies? 
Kakšne koristi je zdravilo BTVPUR AlSap 2-4 izkazalo med študijami?
Other information about BTVPUR AlSap 2-4: 
Druge informacije o zdravilu BTVPUR AlSap 2-4:
BTVPUR ALSap 2-4 is used in sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges. 
Cepivo BTVPUR ALSap 2-4 se uporablja pri ovcah za zaščito pred boleznijo modrega jezika, tj. okužbo, ki jo povzroča virus modrega jezika, prenašajo pa jo krvosesi insekti.
Two further studies were conducted to determine the period of protection of the monovalent vaccines each containing either bluetongue virus serotype 2 or 4 respectively. 
Dve dodatni študiji sta bili izvedeni, da bi določili obdobje zaščite, ki ga nudita monovalentni cepivi, od katerih eno vsebuje virus modrega jezika serotip 2, drugo pa serotip 4.
BTVPUR AlSap 2-4 is a vaccine. 
BTVPUR AlSap 2-4 je cepivo.
Two more laboratory studies with BTVPUR AlSap 2-4 were presented to support the efficacy of the vaccine. 
V podporo učinkovitosti cepiva sta bili predstavljeni dve nadaljnji laboratorijski študiji s cepivom BTVPUR AlSap 2-4.
What is the risk associated with BTVPUR AlSap 2-4? 
Kakšna tveganja so povezana z zdravilom BTVPUR AlSap 2-4?
Why has BTVPUR AlSap 2-4 been approved? 
Zakaj je bilo zdravilo BTVPUR AlSap 2-4 odobreno?
In both studies lambs were exposed to either bluetongue virus serotype 2 or bluetongue virus serotype 4, 12 months after vaccination. 
V obeh študijah so bila jagnjeta 12 mesecev po cepljenju izpostavljena bodisi virusu modrega jezika serotipa 2 bodisi virusu modrega jezika serotipa 4.
What is BTVPUR AlSap 2-4? 
Kaj je zdravilo BTVPUR AlSap 2-4?
What is BTVPUR AlSap 2-4 used for? 
Za kaj se zdravilo BTVPUR AlSap 2-4 uporablja?
The virus exists in several forms (serotypes) throughout the world; the types used in BTVPUR Alsap 2-4 are serotypes 2 and 4. 
Virus obstaja v različnih oblikah (serotipih) po vsem svetu.
How has BTVPUR AlSap 2-4 been studied? 
Kako je bilo zdravilo BTVPUR AlSap 2-4 raziskano?
This means that it was not possible to obtain complete information about BTVPUR AlSap 2-4 at the time of the initial authorisation. 
To pomeni, da ob prvotni odobritvi ni bilo mogoče pridobiti vseh podatkov o njem.
Incompatibilities None known. 
Inkompatibilnosti Niso znane.
Please carefully follow the instructions of the veterinarian. 
Upoštevajte navodila veterinarja.
Five major metabolites have been identified. 
Zaznali so pet glavnih presnovkov.
Reduction of post-operative pain (over a period of 24 hours): 
Zmanjševanje pooperativne bolečine ( čez obdobje 24 ur ):
The active substance in Meloxidyl is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010: 
Zdravilna učinkovina v zdravilu Meloxidyl je dovoljena učinkovina, kot je navedena v tabeli 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št. 37/2010:
One ml contains: 
1 ml vsebuje:
Lungomare Pirandello, 8 92014 Porto Empedocle (AG) Italy 
Lungomare Pirandello, 8 92014 Porto Empedocle (AG) Italija
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.
If the animal is fed at the time of dosing, the absorption may be slightly delayed. 
Če žival ob prejemu zdravila ni tešča, je lahko absorpcija nekoliko odložena.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/. 
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
Treatment of calves with Meloxidyl 20 minutes before dehorning reduces post-operative pain. 
Zdravljenje telet z zdravilom Meloxidyl 20 minut pred odstranitvijo rogov zmanjša pooperativno bolečino.
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% vnesenega odmerka se odstrani iz telesa z urinom (2 % v obliki nespremenjenega meloksikama, 19 % v obliki presnovkov) in 79 % z blatom (49 % v obliki nespremenjenega meloksikama, 30 % v obliki presnovkov).
Name and address of the manufacturer of the biological active substances Not applicable. 
Ime in naslov proizvajalca(proizvajalcev) biološke (bioloških)učinkovine (učinkovin) Ni smiselno.
Reduction of post-operative pain: 
Zmanjševanje pooperativne bolečine:
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 na dan (v 24-urnih presledkih) največ do štiri dni.
Oral suspension. 
Bledorumena suspenzija.
The recommended dose should not be exceeded. 
Ne prekoračite priporočenega odmerjanja.
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon . 
Če opazite kakršne koli stranske učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
Thus, for the first day, twice the maintenance volume will be required. 
Prvi dan zdravljenja je torej potreben dvakratni volumen vzdrževalnega odmerka.
In case of overdose, adverse reactions, as listed in Section 4.6, are expected to be more severe and more frequent. 
V primeru prevelikega odmerka so neželeni učinki navedeni v poglavju 4.6 lahko močnejši in pogostejši.
Do not use in horses producing milk for human consumption. 
Ni dovoljena uporaba pri konjih, katerih mleko je namenjeno prehrani ljudi.
As for other species investigated, the main pathway of meloxicam biotransformation in cat is oxidation and there are no pharmacologically active metabolites. 
Tako kot pri drugih raziskanih vrstah, je glavna pot biološke transformacije meloksikama pri mačkah oksidacija in ni farmakološko aktivnih presnovkov.
To be administered orally either mixed with food or directly into the mouth. 
Zdravilo dajemo peroralno pomešano s hrano ali direktno v gobec živali.
Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at relatively small overdose levels. 
Meloksikam ima ozko mejo terapevtske varnosti pri mačkah in se lahko klinični znaki prevelikega odmerka pojavijo že pri relativno nizkem prekoračenju odmerka.
Do not store above 25° C. 
Ne shranjujte pri temperaturi nad 25 °C
Date of first authorisation: 15.01.2007 Date of last renewal: 19.12.2011 
Datum podaljšanja dovoljenja za promet: 19.12.2011
Meloxidyl alone will not provide adequate pain relief during dehorning procedure. 
Samo zdravilo Meloxidyl ne zagotavlja ustreznega lajšanja bolečine med samim postopkom odstranjevanja rogov.
Two measuring syringes are provided per each presentation. 
V vsakem pakiranju sta priloženi dve merilni brizgi.
Material of the primary container 
Material primarne ovojnine
Do not store above 25°C. 
Ne shranjujte pri temperaturi nad 25 C
Cattle, pigs and horses 
Govedo, prašiči in konji.
The metabolism in horses has not been investigated. 
Presnova pri konjih ni bila ugotavljana.
D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM>
For post-operative pain relief in cats, safety has only been documented after thiopental/halothane anaesthesia. 
Pri lajšanju pooperativnih bolečin pri mačkah je varnost uporabe zdravila dokumentirana samo po narkozi z tiopentalom/halotanom.
The volume of distribution is 0.3 l/kg in dogs and 0.09 l/kg in cats. 
Porazdelitveni volumen je 0,3 l/kg pri psih in 0,09 l/kg pri mačkah.
Ceva Santé Animale ensures that the system of pharmacovigilance, as described in Part I of the marketing authorisation application, is in place and functioning before and whilst the veterinary medicinal product is on the market. 
D. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM Ceva Santé Animale zagotavlja, da je sistem farmakovigilance, predložen kot je opisan v delu I vloge za pridobitev dovoljenja za promet, vzpostavljen in deluje, preden je zdravilo v prometu in ves čas trženja zdravila.
Meloxicam is eliminated with a half-life of 24 hours in dogs and 15 hours in cats. 
Razpolovna doba izločanja meloksikama je 24 ur pri psih in 15 ur pri mačkah.
If the animal is fasted when dosed, the maximal plasma concentrations are obtained after approximately 3 hours. 
Če je žival ob prejemu zdravila tešča, je največja koncentracija v plazmi dosežena v približno 3 urah.
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, lactating cows and pigs. 
Deluje tudi antiendotoksično, saj so dokazali, da zavira nastajanje tromboksana B2, izzvano z vnosom endotoksina E. coli pri teletih, kravah v laktaciji in prašičih.
The detection of metabolites from the parent compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 
Dejstvo, da so presnovke matične spojine odkrili v urinu in blatu, ne pa tudi v plazmi, kaže na hitro izločanje presnovkov.
Post-operative pain and inflammation following surgical procedures: In case additional pain relief is required, multimodal pain therapy should be considered. 
Postoperativna bolečina in vnetje po kirurških postopkih: Če je potrebno dodatno lajšanje bolečine, je treba razmisliti o zdravljenju z dodatnim zdravilom.
In case of overdose, adverse reactions, as listed in Section “Adverse reactions” are expected to be more severe and more frequent. 
V primeru prevelikega odmerka so neželeni učinki navedeni v poglavju ''Neželeni učinki'' lahko močnejši in pogostejši.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation (See section 4.3). 
Varnost zdravila med brejostjo in laktacijo ni raziskana (glejte 4.3).
Très le Bois - 22600 Loudéac - France Vetem SpA - Lungomare Pirandello, 8 - 92014 Porto Empedocle (AG) - Italy 
Très le Bois - 22600 Loudeac - Francija VETEM SpA - Lungomare Pirandello, 8 - 92014 Porto Empedocle (AG) - Italija Meloxidyl 5 mg/ml
Musculo-skeletal disorders: single subcutaneous injection. 
Mišično - skeletna obolenja: enkratna podkožna injekcija.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND 
A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE