natgillin/translations-raw huggingface dataset:
Aripiprazole Mylan was expected to be used to treat schizophrenia in patients aged 15 years or over.
Aripiprazole Mylan trebao se koristiti za liječenje shizofrenije u bolesnika u dobi od 15 ili više godina.
Aripiprazole Mylan was developed as a ‘generic medicine'.
Aripiprazole Mylan razvijen je kao „generički lijek”.
What is Aripiprazole Mylan?
Što je Aripiprazole Mylan?
It was also expected to be used to treat moderate to severe manic episodes and to prevent new manic episodes in adults with bipolar I disorder who have responded to the medicine in the past, and for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over with bipolar I disorder.
Također se trebao koristiti za liječenje maničnih epizoda umjerenog do teškog stupnja te za sprječavanje novih maničnih epizoda u odraslih osoba s bipolarnim poremećajem tipa I. koji su u prošlosti pozitivno reagirali na lijek i za liječenje, u trajanju do 12 tjedana, maničnih epizoda umjerenog do teškog stupnja u bolesnika u dobi od 13 ili više godina s bipolarnim poremećajem tipa I.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Aripiprazole Mylan.
Sukladno navedenome, u vrijeme povlačenja CHMP je smatrao kako tvrtka nije dostavila dostatne podatke koji bi poduprli zahtjev za Aripiprazole Mylan.
The CHMP considered that the dissolution tests required for the biowaiver had not been carried out according to existing recommendations and thus, bioequivalence for all the different strengths of tablets and orodispersible tablets had not been demonstrated.
CHMP je smatrao da ispitivanja otapanja potrebna za izuzeće od ispitivanja bioekvivalencije nisu provedena sukladno postojećim preporukama i da stoga nije dokazana bioekvivalencija za sve različite jačine tableta i orodisperzibilne tablete.
Aripiprazole's action alters dopamine and 5-hydroxytryptamine activity, which is abnormal in schizophrenia and bipolar disorder.
Djelovanje aripiprazola mijenja aktivnost dopamina i 5-hidroksitriptamina koja je abnormalna u slučaju shizofrenije i bipolarnog poremećaja.
agonist' on the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin).
aripiprazol djeluje kao „parcijalni agonist” za receptore neurotransmitera dopamina i 5hidroksitriptamina (koji se također naziva serotonin).
The biowaiver removes the need to repeat bioequivalence studies for all the other strengths of Aripiprazole Mylan tablets.
Izuzeće od ispitivanja bioekvivalencije otklanja potrebu za ponavljanjem ispitivanja bioekvivalentnosti za sve druge jačine tableta Aripiprazole Mylan.
The active substance in Aripiprazole Mylan, aripiprazole, is an antipsychotic medicine.
Djelatna tvar u lijeku Aripiprazole Mylan, aripiprazol, jest antipsihotik.
The CHMP considered that the tests to support a biowaiver were not acceptable.
CHMP je smatrao da ispitivanja provedena radi potpore izuzeću od ispitivanja bioekvivalencije nisu bila prihvatljiva.
Based on the review of the data, at the time of the withdrawal, the CHMP was of the provisional opinion that Aripiprazole Mylan could not have been approved for the treatment of schizophrenia and for the treatment and prevention of manic episodes in patients with bipolar I disorder.
Na temelju pregleda podataka, u trenutku povlačenja privremeno mišljenje CHMP-a bilo je da nije moguće dati odobrenje za Aripiprazole Mylan za liječenje shizofrenije te liječenje i sprječavanje maničnih epizoda u bolesnika s bipolarnim poremećajem tipa I.
What was Aripiprazole Mylan expected to be used for?
Za što se Aripiprazole Mylan trebao koristiti?
Because Aripiprazole Mylan is a generic medicine, the company had presented results of studies in volunteers to show that Aripiprazole Mylan 10-mg tablet and the 10-mg orodispersible tablet were bioequivalent to the corresponding tablets of the reference medicine, Abilify.
Mylan generički lijek, tvrtka je dostavila rezultate ispitivanja provedenih na dobrovoljcima kako bi dokazala da su tableta od 10 mg i orodisperzibilna tableta od 10 mg lijeka Aripiprazole
How is Aripiprazole Mylan expected to work?
Kako je Aripiprazole Mylan trebao djelovati?
Aripiprazole Mylan is a medicine that contains the active substance aripiprazole.
Mylan je lijek koji sadrži djelatnu tvar aripiprazol.
officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Aripiprazole Mylan, for the treatment of schizophrenia and the treatment and prevention of manic episodes in patients with bipolar I disorder.
Dana 8. siječnja 2016. tvrtka Mylan S.A.S. službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) da želi povući svoju zahtjev za odobrenje za stavljanje u promet lijeka Aripiprazole Mylan za liječenje shizofrenije te liječenje i sprječavanje maničnih epizoda u bolesnika s bipolarnim poremećajem tipa I.
To support an application for a ‘biowaiver', the company also presented laboratory tests to show that other strengths of Aripiprazole Mylan tablets dissolve in an identical way to the reference medicine.
Kako bi poduprla zahtjev za izuzeće od ispitivanja bioekvivalencije, tvrtka je također dostavila rezultate laboratorijskih ispitivanja koji pokazuju da se druge jačine tableta Aripiprazole
Date of first autorisation: 06.11.2001 / Date of last renewal: 21.11.2006
Datum prvog odobrenja 06.11.2001 / Datum zadnje obnove: 21.11.2006.
These clinical signs disappear within 7 days without any particular treatment.
Ovi simptomi nestaju u roku od 7 dana bez ikakvog posebnog tretmana.
Αθηνών - Λαμίας, T.K.14452, Μεταμόρφωση, Ελλάδα
13o χλμ Ε.Ο. Αθηνών - Λαμίας, T.K.14452, Μεταμόρφωση, Ελλάδα
EXP: {month/year}
EXP {mjesec/godina}
1515 Tsutsui, Masaki-Cho, Iyogun
1515 Tsutsui, Masaki-Cho, lyogun
These parameters return to normal in the week following the last injection.
Ove se vrijednosti vraćaju u normalu kroz tjedan dana nakon posljednje aplikacije.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Za bilo kakve informacije o ovom veterinarsko-medicinskom proizvodu molimo da kontaktirate lokalnog zastupnika, nositelja odobrenja za stavljanje u promet.
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
a) će primjena veterinarsko-medicinskog proizvoda na životinjama interferirati s provedbom nacionalnog programa otkrivanja, kontrole i suzbijanja bolesti životinja ili će izazvati poteškoće u certificiranju odsutnosti zaraze u živim životinjama ili hrani ili drugim proizvodima dobivenim od tretiranih životinja.
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.
Ako primjetite nuspojave, čak i ako nisu već navedene na ovom pakiranju ili ako mislite da lijek nije djelovao, molimo potražite pomoć vašeg veterinara.
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
Sukladno članku 71 Direktive 2001/82/EZ i Europskog Parlamenta i Vijeća koja je dopunjena, države članice zabranjuju ili mogu zabraniti uvoz, prodaju, opskrbu i/ili primjenu veterinarsko-medicinskog proizvoda na cijelom teritoriju ili na jednom njegovom dijelu ako je utvrđeno da:
Store and transport refrigerated (2 °C - 8 °C).
Čuvati i prevoziti na hladnom (2 C - 8 C).
No information on the induction of long-term side effects is available in dog and cat, especially for autoimmune disorders.
Nema informacija o dugoročnim nuspojavama kod pasa i mačaka naročito glede autoimunih poremećaja.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme graviditeta i laktacije.
• in anaemic cats, mortality rate of about 60% at 4, 6, 9 and 12 months was reduced by approximately 30% following treatment with interferon.
• kod anemičnih mačaka stopa smrtnosti od 60% u 4., 6., 9., i 12. mjesecu bila je smanjena približno oko 30% po tretmanu interferonom.
The use of supplementary supportive treatments improves prognosis.
Korištenje dodatne potporne terapije tijekom liječenja popravlja prognozu.
*MU : Million Units
MJ* : Milijun jedinica
Sodium hydroxide 0.2 M Sodium chloride D-Sorbitol
Natrijev hidroksid 0,2 M Natrijev klorid D-sorbitol
Sodium chloride Water for injections
Natrijev klorid Voda za injekcije
Do not use after the expiry date stated on the label.
Ne koristiti poslije isteka roka valjanosti označenog na etiketi.
• slight increase of body temperature.
• blagi porast tjelesne temperature.
Interaction with other medicinal products and other forms of interaction
Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija
After injection it is quickly bound to specific receptors of a large variety of cells.
U kratkom vremenu poslije aplikacije brzo se veže na specifične receptore različitih stanica.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://emea.europa.eu/.
Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.>
In cats infected by FIV, mortality was low (5%) and was not influenced by the treatment.
U mačaka inficiranih sa FIV stopa uginuća bila je mala (5%) i tretman na nju nije utjecao.
STATEMENT OF THE MRLs
IZJAVA O MRL
Pharmacotherapeutic group: Interferons ATCvet code : QL03AB
Farmakoterapijska grupa: Interferoni ATCvet kod: QL03 AB
It is mainly in cells infected by virus that the mechanism of replication is stopped both by destruction of mRNA and by inactivation of translation proteins (2'5' oligo-adenylate synthetase activation).
U stanicama zaraženim virusom dolazi do prekida mehanizma razmnožavanja virusa uništavanjem mRNA i inaktivacijom translacijskih proteina (aktivacija 2'5' oligo adenilat sintetaze).
Detailed information on this product is available on the website of the European Medicines Agency http://emea.europa.eu/.
Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
The exact mechanism of action of interferon omega is not perfectly known, but may involve enhancement of the non-specific defence of the body, in particular in the dog against canine parvovirosis and in the cat against feline retrovirosis (FeLV, FIV).
Točan mehanizam djelovanja interferona omega nije sasvim poznat ali može uključivati pojačavanje nespecifičnih obrambenih mehanizama organizma, posebice kod pasa protiv parvoviroze i kod mačaka protiv retroviroze (FeLV, FIV).
Lyophilisate: white pellet.
Liofilizat: bijela peleta.
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
b) bolest za koju je dotični veterinarsko-medicinski proizvod predviđen za pružanje imuniteta, nije nazočna na tom području.
However, as specific information on possible interactions of interferon with other products are missing, supplementary supportive treatments should be used cautiously and after a thorough risk/benefit analysis.
Ipak, pošto nema specifičnih informacija o interakcijama interferona s ostalim proizvodima, potpornu terapiju treba koristiti oprezno i nakon podrobne analize koristi i rizika.
Purified gelatin of porcine origin
Pročišćena svinjska želatina
Any person intending to import, sell, supply and/or use VIRBAGEN OMEGA must consult the relevant Member State's competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Svaka osoba koja namjerava uvoziti, prodavati, opskrbljivati i/ili primjenjivati VIRBAGEN OMEGA mora se prethodno konzultirati s nadležnim tijelom odnosne države članice u pogledu važećih odredbi o cijepljenju prije uvoza, prodaje, opskrbe i/ili primjene.,
Interferon does not act directly and specifically on the pathogenic virus, but exerts its effect by inhibition of the internal synthesis mechanisms of the infected cells.
Interferon ne djeluje direktno i specifično na patogeni virus ali djeluje na unutrašnje mehanizme sinteze u zaraženim stanicama.
Name and address of the manufacturer of the biological active substance
Naziv i adresa proizvođača biološki djelatne tvari
No information is available on the safety and efficacy from the concurrent use of this product with any vaccine.
Nema informacija o neškodljivosti i djelotvornosti istovremenog korištenja ovog proizvoda s bilo kojim cjepivom.
• slight increase of respiratory rate
• blagi porast frekvencije disanja
Such side effects have been described after multiple and long-term administration of type I interferon in man.
Takve nuspojave su bile opisane poslije višestrukog i dugoročnog unošenja interferona tipa i kod ljudi.
• in non-anaemic cats, mortality rate of 50 % in cats infected by FeLV was reduced by 20% following treatment with interferon.
• kod neanemičnih mačaka stopa smrtnosti od 50% kod mačaka inficiranih sa FeLV smanjena je za 20% po tretmanu interferonom.
For dogs, it is recommended that no vaccines should be administered until the animal appears to have recovered.
Za pse se ne preporuča koristi niti jedno cjepivo dok životinja ne oporavi.
SPECIAL WARNING(S) Special warnings for each target species
12. POSEBNO(A) UPOZORENJE(A) Posebna upozorenja za svaku od ciljnih vrsta životinja
Type I glass vial closed with stopper made with butyl rubber polymer coated with a fluorocarbon polymer resin.
I zatvorena čepom od gumenog butil polimera presvučena smolom od fluorkarbon polimera.
For the full list of excipients, see section 6.1.
Pomoćne tvari: Potpuni popis pomoćnih tvari vidi u djelu 6.1.
After a tenfold overdose in both dog and cat the following clinical signs have been observed:
Poslije predoziranja desetorostrukom dozom i u pasa i u mačaka zabilježeni su sljedeći klinički simptomi:
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
14. DATUM KADA JE UPUTA O PROIZVODU ZADNJI PUT ODOBRENA
Dispose of waste material in accordance with local requirements
Odlaganje otpadnih materijala u skladu s lokalnim propisima
Shelf life after reconstitution according to directions: use immediately.
Rok valjanosti poslije rekonstitucije prema uputi: primijeniti odmah.
Store and transport refrigerated.
Čuvati i prevoziti na hladnom mjestu.
Pregnancy and lactation
Graviditet i laktacija:
Solvent: colourless liquid.
Otapalo: bezbojna tekućina.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
OSNOVNI PODACI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKIRANJA
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI)
The import, possession, sale, supply and/or use of this veterinary medicinal product may be prohibited in a Member State on the whole or part of its territory, see package leaflet for further information.
Uvoz, posjedovanje, prodaja, opskrba i/ili primjena ovog veterinarsko-medicinskog proizvoda je ili može biti zabranjena u određenim državama članicama na cijelom ili na dijelu njihovog teritorija, za daljnje informacije vidi uputu o proizvodu.
• mild lethargy and drowsiness
• blaga letargija i dremljivost
The possibility of occurrence of autoimmune disorders in treated animals cannot therefore be ruled out and has to be balanced with the risk associated with FeLV/FIV infections.
Mogućnost pojave autoimunih poremećaja u tretiranih životinja ne može se isključiti i treba s njom računati prilikom procjene rizika kod FeLV/FIV infekcija.
• slight sinus tachycardia.
• blaža sinusna tahikardija.
Read the package leaflet before use.
Pročitati uputu o proizvodu prije primjene.
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the product.
Ne miješati s bilo kojim drugim veterinarskim medicinskim proizvodom, osim otapalom priloženim za primjenu s proizvodom.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
U slučaju nehotičnog samo injiciranja, odmah potražiti pomoć liječnika i pokazati mu uputu o proizvodu ili etiketu.
Dogs: Intravenous route Cats: Subcutaneous route
Psi: intravenozna primjena Mačke: subkutana primjena
Overdose (symptoms, emergency procedures, antidotes)
Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - 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)
Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e) ) - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja)
Three separate 5-day treatments must be performed at day 0, day 14 and day 60.
Potrebna su tri odvojena 5-dnevna tretmana, primjenjena nultog, četrnaestog i šezdesetog dana.
Cat vaccination during and after VIRBAGEN OMEGA treatment is contra-indicated as both FeLV and FIV infections are known to be immunosuppressive.
Cijepljenje mačaka tijekom i nakon tretmana VIRBAGEN-om OMEGA je kontraindicirano jer su i FeLV i FIV infekcije poznate kao imunosupresivne.
The import, sale, supply and/or use of VIRBAGEN OMEGA is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Uvoz, prodaja, opskrba i primjena VIRBAGEN OMEGA, je ili može biti zabranjena u određenoj državi članici u cijelosti ili samo na djelu njezinog teritorija, u skladu s nacionalnim zakonodavstvom.
Dispose of waste material in accordance with local requirements.
Odlaganje otpadnih materijala u skladu s lokalnim propisima.
Slight and transient clinical signs such as hyperthermia (3-6 hours after injection) lethargy and digestive signs ( vomiting and soft faeces to mild diarrhoea, in cats only) were commonly observed in safety studies.
Blaži i privremeni klinički znakovi kao što su hipertermija (36 sati nakon injekcije) letargija i probavni znakovi (povraćanje i mekši feces do blagog prolijeva samo kod mačaka.) zabilježeni su u ispitivanjima neškodljivosti.
A slight decrease in white blood cells, platelets and red blood cells, and rise in the concentration of alanine aminotransferase were observed very commonly in safety studies.
Dodatno je moguće zabilježiti blaži pad leukocita, trombocita i eritrocita, te porast koncentracije alanin aminotransferaze što je jako uobičajeno u ispitivanjima neškodljivosti.
1055 Budapest Magyarország Teл: +36703387177
VIRBAC Hungary KFT Szent Istvàn krt.11.II/21. 1055 Budapest Magyarország Teл: +36703387177
Store in the original carton.
Držati u originalnom pakovanju.
Cats.
Mačke
In some cases, during treatment, the following transitory clinical signs may be observed in dogs and cats:
U nekim slučajevima tijekom tretmana pasa i mačaka mogu se primijetiti sljedeći prolazni klinički simptomi:
Dogs and cats: it was shown that strict compliance with the recommended posology is compulsory to achieve clinical benefit.
Psi i mačke: Radi postizanja kliničkog učinka važno je točno se pridržavati preporučenog doziranja.
The product should be used with the accompanying solvent only.
Proizvod se koristi samo s pripadajućim otapalom.
The product should be used immediately after reconstitution.
Proizvod primijeniti odmah nakon rekonstitucije.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
13. RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVJETI ILI OGRANIČENJA
Reduction of mortality and clinical signs of parvovirosis (enteric form) in dogs from one month of age.
Smanjenje smrtnosti i kliničkih simptoma parvoviroze (crijevni oblik) kod pasa starijih od jednog mjeseca.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
UVJETI ILI OGRANIČENJA ODOBRENJA ZA PUŠTANJE U PROMET S OBZIROM NA SIGURNU I DJELOTVORNU UPOTREBU
5 MU
5 MJ
Each dose of 1 ml contains:
Svaka doza od 1 ml sadrži:
4.5 Special precautions for use Special precautions for use in animals
4.5 Posebne mjere opreza prilikom primjene Posebne mjere opreza prilikom primjene na životinjama
Slight and transient clinical signs such as hyperthermia (3-6 hours after injection) lethargy and digestive signs (vomiting and soft faeces to mild diarrhoea, in cats only. )
Lagani i kratkotrajni klinički znakoci kao što je hipertermija (36 sati nakon primjene) letargija i probavni znakovi (povraćanje i mekana stolica do laganog proljeva kod mačaka).
In the case of intravenous administration in cats, increased adverse reactions may be seen, e.g. hyperthermia, soft faeces, anorexia, decreased drinking or collapse.
mekši feces, anoreksija, manji unos vode ili kolaps.
Omega interferon of feline origin, produced by genetic engineering, is a type Ι interferon closely related to alpha interferon.
5.1 Farmakodinamička svojstva Omega interferon mačjeg podrijetla dobiven genetskim inženjeringom je interferon tipa
Each dose of 1ml contains:
Svaka doza od 1 mL sadrži:
EXP {month/year} The product should be used immediately after reconstitution.
EXP {mjesec/godina} Proizvod primijeniti odmah nakon rekonstitucije.
10 MU
10 MJ
For the 10MU presentation:
Pakovanje od 10 MJ:
VIRBAGEN OMEGA 10 MU for dogs and cats
VIRBAGEN OMEGA 10 MJ za pse i mačke
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
I SAŽETAK OPISA SVOJSTAVA PROIZVODA
VIRBAGEN OMEGA 5 MU for dogs and cats VIRBAGEN OMEGA 10 MU for dogs and cats
VIRBAGEN OMEGA 5 MJ za pse i mačke VIRBAGEN OMEGA 10 MJ za pse i mačke
Cats: In case of repeated treatments of chronic diseases associated with hepatic, cardiac and renal failure, the corresponding disease has to be monitored prior to administration of VIRBAGEN OMEGA.
Mačke: u slučaju ponovljenih tretmana kroničnih bolesti kod kojih su prisutni hepatitis, te slabost srca i bubrega postojeća bolest mora biti praćena prije nego se pristupi aplikaciji VIRBAGEN OMEGA.
In a field study conducted, it was observed that there was: - a reduction of clinical signs during the symptomatic phase (4 months) - a reduction of mortality :
- smanjenja kliničkih znakova tijekom simptomatske faze (4 mjeseca)
No interaction has been observed during the treatment with VIRBAGEN OMEGA together with antibiotics, solution for rehydration, vitamins and non steroidal anti-inflammatory agents.
VIRBAGEN-om OMEGA nisu zabilježene interakcije sa antibioticima, rehidracijskim otopinama,
VIRBAGEN OMEGA 5 MU for dogs and cats
VIRBAGEN OMEGA 5 MJ za pse i mačke
Dogs: Vaccination during and after VIRBAGEN OMEGA treatment is contra-indicated, until the dog appears to have recovered.
Psi: cijepljenje tijekom i nakon tretmana sa VIRBAGEN OMEGA je kontraindicirano sve dok se pas ne oporavi.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
UVJETI ILI OGRANIČENJA ODOBRENJA ZA STAVLJANJE U PROMET U POGLEDU OPSKRBE I PRIMJENE
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) BIOLOŠKI DJELATNE(IH) TVAR(I) I VLASNICI ODOBRENJA
Dogs.
Psi
Batch {number}
Serija{broj}