natgillin/translations-raw huggingface dataset:
As for all medicines, data on the use of Tyverb are continuously monitored.
Kao za sve lijekove, podatci o primjeni lijeka Tyverb kontinuirano se prate.
The active substance in Tyverb, lapatinib, belongs to a group of medicines called protein kinase inhibitors.
Djelatna tvar u lijeku Tyverb, lapatinib, pripada skupini lijekova poznatih pod nazivom inhibitori protein-kinaze.
Side effects reported with Tyverb are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za lijek Tyverb pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
This means that the cancer produces a specific protein called HER2 (also known as ErbB2) in large quantities on the surface of the cancer cells.
To znači da rak proizvodi velike količine specifičnog proteina naziva HER2 (također poznat pod nazivom ErbB2) na površini stanica raka.
An overview of Tyverb and why it is authorised in the EU
Pregled informacija o lijeku Tyverb i zašto je odobren u EU-u
219 of the women had cancer that was producing large quantities of HER2.
Od tih žena, 219 ih je imalo rak s proizvodnjom velikih količina proteina HER2.
The European Medicines Agency decided that Tyverb's benefits are greater than its risks and it can be authorised for use in the EU.
Europska agencija za lijekove zaključila je da koristi od lijeka Tyverb nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
Tyverb contains the active substance lapatinib.
Tyverb sadržava djelatnu tvar lapatinib.
Tyverb in combination with another cancer medicine was shown to be more effective than the comparator treatment in three main studies involving women with breast cancer.
Lijek Tyverb u kombinaciji s drugim lijekom protiv raka pokazao se djelotvornijim od usporednog liječenja u trima glavnim ispitivanjima kojima su bile obuhvaćene žene s rakom dojke.
It involved 408 women with advanced or metastatic disease that was producing large quantities of HER2 who had already been treated with anthracyclines, taxanes and trastuzumab but whose disease had got worse or come back.
Obuhvatilo je 408 žena s uznapredovalom ili metastatskom bolesti koja je proizvodila velike količine proteina HER2, a koje su već bile liječene antraciklinima, taksanima i trastuzumabom, no čija se bolest pogoršala ili se vratila.
For more information about using Tyverb, see the package leaflet or contact your doctor or pharmacist.
Više informacija o primjeni lijeka Tyverb pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
The most common side effects with Tyverb (which may affect more than 1 in 4 patients) are rash and side effects affecting the stomach and gut (such as diarrhoea, nausea (feeling sick) and vomiting).
Najčešće su nuspojave lijeka Tyverb (koje se mogu javiti u više od 1 na 4 osobe) osip i nuspojave koje zahvaćaju želudac i crijeva (kao što su proljev, mučnina i povraćanje).
By blocking HER2 receptors, Tyverb helps to control growth of the cancer.
Inhibirajući te HER2 receptore lijek Tyverb pomaže pri kontroli rasta raka.
The third study compared Tyverb with placebo (a dummy treatment), both of which were taken together with letrozole (an aromatase inhibitor).
Tijekom trećeg ispitivanja lijek Tyverb uspoređen je s placebom (prividnim liječenjem), pri čemu su oba lijeka uzimana zajedno s letrozolom (inhibitorom aromataze).
It involved 1,286 women who had been through the menopause with metastatic breast cancer that was sensitive to hormones.
Obuhvatilo je 1 286 žena u postmenopauzi s metastatskim rakom dojke osjetljivim na hormone.
HER2 is a receptor for a substance called epidermal growth factor which stimulates the cancer cells to grow uncontrollably.
HER2 je receptor tvari naziva faktor epidermalnog rasta koji potiče stanice raka na nekontroliranu diobu.
Tyverb can only be obtained with a prescription and should only be started by a doctor who has experience in giving cancer medicines.
Tyverb se izdaje samo na liječnički recept, a terapiju lijekom mora započeti liječnik koji ima iskustva s primjenom lijekova protiv raka.
It involved 296 women with metastatic disease that was producing large quantities of HER2 and got worse despite treatment with trastuzumab and other cancer medicines (including anthracyclines and taxanes).
Obuhvatilo je 296 žena s metastatskom bolesti koja je proizvodila velike količine proteina HER2 i pogoršavala se unatoč liječenju lijekom trastuzumab i drugim lijekovima protiv raka (uključujući antracikline i taksane).
Women taking Tyverb with capecitabine survived for an average of 75 weeks, and those taking capecitabine alone survived for an average of 64.7 weeks.
Žene koje su uzimale Tyverb s kapecitabinom preživjele su prosječno 75 tjedana, a one koje su uzimale monoterapiju kapecitabina preživjele su prosječno 64,7 tjedana.
The company that markets Tyverb will evaluate ways to predict resistance (the medicine becoming less effective) in breast cancer patients taking Tyverb with other cancer medicines.
Tvrtka koja stavlja na tržište Tyverb također će procijeniti načine predviđanja otpornosti (smanjene djelotvornosti lijeka) u osoba s rakom dojke koje primaju lijek Tyverb u kombinaciji s drugim lijekovima protiv raka.
How is Tyverb used?
Kako se Tyverb koristi?
These medicines work by blocking enzymes known as protein kinases, which can be found in some receptors (targets) on the surface of cancer cells including HER2.
Ti lijekovi djeluju inhibirajući enzime poznate pod nazivom protein-kinaze koji se nalaze u nekim receptorima na površini stanica raka, uključujući HER2.
• in combination with trastuzumab for metastatic cancer that does not respond to hormones (hormone receptor-negative disease), and which got worse when previously treated with a combination of trastuzumab and other cancer medicines (chemotherapy);
• u kombinaciji s trastuzumabom za metastatski rak koji ne odgovara na hormone (bolest s negativnim hormonskim receptorima) i koji se pogoršao tijekom prethodnog liječenja trastuzumabom u kombinaciji s drugim lijekovima protiv raka (kemoterapijom);
How does Tyverb work?
Kako djeluje Tyverb?
Tyverb is a cancer medicine used to treat patients with breast cancer that has been shown to be ‘expressing' large amounts of HER2.
Tyverb je lijek protiv raka koji se koristi za liječenje bolesnika s rakom dojke koji „izlučuje” velike količine proteina HER2.
Tyverb in combination with other cancer medicines has been shown to improve survival of patients with breast cancer that produces large quantities of HER2, and its side effects are considered acceptable.
Dokazano je da Tyverb u kombinaciji s drugim lijekovima protiv raka poboljšava stopu preživljenja bolesnica s rakom dojke koji proizvodi velike količine HER2 te se njegove nuspojave smatraju prihvatljivima.
The women whose cancer was producing large quantities of HER2 taking Tyverb in combination with letrozole survived for an average of 35.4 weeks without their disease getting worse.
Žene u kojih je rak proizvodio velike količine proteina HER2, a koje su uzimale lijek Tyverb u kombinaciji s letrozolom, preživjele su u prosjeku 35,4 tjedna bez pogoršanja bolesti.
What benefits of Tyverb have been shown in studies?
Koje su koristi lijeka Tyverb utvrđene u ispitivanjima?
• in combination with capecitabine (another cancer medicine) when the cancer is advanced or metastatic and got worse following previous treatment including an anthracycline and a taxane (other types of cancer medicine), and following treatment of the patient's metastatic disease with trastuzumab (another cancer medicine).
• u kombinaciji s kapecitabinom (drugim lijekom protiv raka) ako je riječ o uznapredovalom ili metastatskom raku ili o raku koji se pogoršao nakon prethodnog liječenja koje je uključivalo antraciklin i taksan (druge vrste lijekova protiv raka) te nakon liječenja metastatske bolesti trastuzumabom (drugim lijekom protiv raka).
The women taking Tyverb in combination with capecitabine lived for an average of 23.9 weeks without their disease getting worse, as assessed by their doctors, compared with 18.3 weeks in the women taking capecitabine alone.
Žene koje su uzimale lijek Tyverb u kombinaciji s kapecitabinom živjele su u prosjeku 23,9 tjedana bez pogoršanja bolesti, prema procjeni njihovih liječnika, dok je u žena koje su primale monoterapiju kapecitabinom to razdoblje trajalo 18,3 tjedna.
In addition, women taking the combination survived for 14.0 months on average, compared with 9.5 months in those taking Tyverb alone.
Osim toga, žene koje su uzimale kombinaciju lijekova preživjele su u prosjeku 14,0 mjeseci, a one koje su uzimale samo lijek Tyverb 9,5 mjeseci.
This compared with 13.0 weeks in those taking placebo in combination with letrozole.
U onih koje su uzimale placebo u kombinaciji s letrozolom to je razdoblje trajalo 13,0 tjedana.
Women taking Tyverb with trastuzumab lived without their disease getting worse for 12.0 weeks on average, compared with 8.1 weeks in those taking Tyverb alone.
Žene koje su uzimale lijek Tyverb u kombinaciji s trastuzumabom živjele su u prosjeku 12,0 tjedana bez pogoršanja bolesti, a one koje su uzimale samo lijek Tyverb 8,1 tjedan.
For the full list of side effects and restrictions with Tyverb, see the package leaflet.
Potpuni popis nuspojava i ograničenja pri primjeni lijeka Tyverb potražite u uputi o lijeku.
The second study compared Tyverb alone with a combination of Tyverb plus trastuzumab.
U drugom je ispitivanju monoterapija lijekom Tyverb uspoređena s kombinacijom lijeka Tyverb i trastuzumaba.
• in combination with an aromatase inhibitor (another type of cancer medicine) in women who have been through the menopause, when the cancer is metastatic and responds to hormones.
• u kombinaciji s inhibitorom aromataze (drugim lijekom protiv raka) u žena u postmenopauzi s metastatskom bolesti uz pozitivne hormonske receptore.
The first study compared Tyverb in combination with capecitabine, with capecitabine taken alone.
U prvom je ispitivanju uspoređena kombinacija lijeka Tyverb i kapecitabina s monoterapijom kapecitabinom.
Portugal capsule
Portugal kapsula
Unit 34/35, Block A Dunboyne Business Park Dunboyne
Unit 34/35, Block A Dunboyne Business Park Dunboyne Co.
Sopharma AD 16"Iliensko shose" Str. Sofia
Sopharma AD 16"Iliensko shose" Str.
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for bromocriptine-containing medicinal products indicated in the “prevention or suppression of physiological lactation in the immediate post-partum period and in the late post-partum period”
Dodatak I Popis imena, farmaceutskih oblika, jačina lijekova, puta primjene, nositelja odobrenja u zemljama članicama
United Kingdom Meda Pharmaceuticals Limited,
Meda Pharmaceuticals Limited
MEDA PHARMA 25, boulevard de l'Amiral Bruix,
MEDA PHARMA 25, boulevard de l'Amiral Bruix 75016 Paris France
Skyway House,
Skyway House Parsonage Road
Medochemie Ltd., 1-10 Astronafton Str. Limassol
Medochemie Ltd. 1-10 Astronafton Str.
MEDA PHARMA, S.A.U.
MEDA PHARMA, S.A.U. Avda.
Lek farmacevtska družba d.d.,
Lek farmacevtska družba d.d. Verovškova 57
MEDOCRIPTINE 2,5 mg
MEDOCRIPTINE 2,5 mg 2,5 mg
Bromocriptin AbZ 2,5 mg
Bromocriptin AbZ 2,5 mg 2,5 mg
Co. Meath
Meath Ireland
CT Arzneimittel GmbH Graf-Arco-Str. 3
AbZ-Pharma GmbH Graf-Arco-Str.
Parlodel 5mg Tablets capsule
Parlodel 5mg Tablets kapsula
S.C. BIOFARM S.A. Str. Logofăt Tăutu nr. 99, sector 3,
Logofăt Tăutu nr. 99 sector 3, Bucureşti
Bishops Stortford
Skyway House Parsonage Road Takeley Bishops Stortford
Parlodel 10mg Tablets capsule
Parlodel 10mg Tablets 10 mg kapsula
Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
3 89079 Ulm Germany
Gyömröi út 19-21 1103 Budapest, Hungary
Gedeon Richter Plc. Gyömröi út 19-21 1103 Budapest Hungary
Pravidel 2,5 mg Tabletten
Pravidel 2,5 mg Tabletten 2,5 mg
Slovak Republic MEDA Pharma s.r.o.
Meda Pharma s.a.
Kodaňská 1441/46
MEDA Pharma s.r.o. Kodaňská 1441/46 100 00 Praha 10
Annex I
Castilla 2
TEVA ITALIA S.R.L.
Medochemie Ltd.
Parlodel 2.5mg Tablets
Parlodel 2.5mg Tablets 2,5 mg
16 December 2016 EMA/822769/2016 EMEA/H/C/004342
EMA/822769/2016 EMEA/H/C/004342
What is Cavoley?
Što je Cavoley?
Cavoley was developed as a ‘biosimilar' medicine.
Cavoley je razvijen kao „biosličan” lijek.
On 16 November 2016, Gedeon Richter Plc officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cavoley, for reducing neutropenia.
Dana 16. studenog 2016., tvrtka Gedeon Richter Plc službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Cavoley za liječenje neutropenije.
This means that Cavoley was intended to be highly similar to a biological medicine (the ‘reference medicine') already authorised in the European Union called Neulasta.
To znači da je Cavoley trebao biti vrlo sličan biološkom lijeku („referentnom lijeku”) koji je već odobren u Europskoj uniji (EU) pod nazivom Neulasta.
What was Cavoley expected to be used for?
Za što se Cavoley trebao koristiti?
A further study in patients receiving cancer medicines compared the safety and effectiveness of Cavoley and Neulasta.
U dodatnom ispitivanju na bolesnicima koji su dobivali lijekove za liječenje raka uspoređena je sigurnost i učinkovitost lijekova Cavoley i Neulasta.
Withdrawal of the marketing authorisation application for Cavoley (pegfilgrastim)
Povlačenje zahtjeva za davanje odobrenja za stavljanje u promet lijeka Cavoley (pegfilgrastim)
How does Cavoley work?
Kako djeluje Cavoley?
The company presented results of studies in healthy people designed to show that Cavoley is highly similar to its reference medicine Neulasta in terms of chemical structure, purity, the way it works and how the body handles the medicine.
Tvrtka je predstavila rezultate ispitivanja u zdravih ljudi koja su provedena kako bi se dokazalo da je lijek Cavoley vrlo sličan svojem referentnom lijeku Neulasta u smislu kemijske strukture, čistoće, djelovanja i načina na koji tijelo podnosi lijek.
After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Nakon što je CHMP ocijenio odgovore tvrtke na posljednji popis pitanja, još su uvijek postojale neke nedoumice.
Neutropenia is a side effect of certain cytotoxic (cell-killing) cancer treatments because the treatments also kill white blood cells.
Neutropenija je nuspojava određenih citotoksičnih (koji ubijaju stanice) načina liječenja raka jer se takvim liječenjem ubijaju i bijele krvne stanice.
Cavoley is a medicine that contains the active substance pegfilgrastim, which stimulates the production of neutrophils (a type of white blood cell that fights infections).
Cavoley je lijek koji sadrži djelatnu tvar pegfilgrastim, koja potiče stvaranje neutrofila (vrsta bijelih krvnih stanica koje se bore protiv infekcija).
The active substance in Cavoley, pegfilgrastim, consists of filgrastim that has been 'pegylated' (attached to a chemical called polyethylene glycol).
Djelatna tvar lijeka Cavoley, pegfilgrastim, sastoji se od filgrastima koji je „pegiliran” (spojen s kemijskom tvari pod nazivom polietilen glikol).
Cavoley was to be used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).
Cavoley se trebao primjenjivati za smanjenje trajanja neutropenije i pojave febrilne neutropenije (neutropenija praćena vrućicom).
The company informed the CHMP that there are no ongoing clinical trials or compassionate-use programmes for Cavoley.
Tvrtka je obavijestila CHMP da nema kliničkih ispitivanja ni programa milosrdnog davanja lijeka Cavoley koji su u tijeku.
In its letter notifying the Agency of the withdrawal of the application, the company stated that having considered the CHMP's conclusion, it has decided to withdraw the application but to continue developing the product and follow the CHMP's advice to eliminate the remaining uncertainty.
U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva, tvrtka je navela da je nakon razmatranja zaključka CHMP-a donijela odluku o povlačenju zahtjeva i daljnjem razvijanju lijeka u cilju uklanjanja preostalih nejasnoća, sukladno savjetu CHMP-a.
The CHMP was concerned that study results had not shown that Cavoley was handled by the body in the same way as the reference medicine Neulasta.
CHMP je izrazio zabrinutost da rezultati ispitivanja nisu pokazali da tijelo podnosi lijek Cavoley na isti način kao i referentni lijek Neulasta.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Cavoley could not have been approved for reducing neutropenia.
Na temelju pregleda podataka te odgovora tvrtke na popise pitanja CHMP-a, u trenutku povlačenja CHMP je smatrao da postoje razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Cavoley za liječenje neutropenije.
Cavoley was to be used in cancer patients to reduce neutropenia (low levels of neutrophils).
Lijek Cavoley trebao se primjenjivati u bolesnika oboljelih od raka za smanjenje neutropenije (niske razine neutrofila).
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not demonstrated that Cavoley is highly similar to Neulasta.
Sukladno navedenome, CHMP je u vrijeme povlačenja smatrao da tvrtka nije dostavila dostatne podatke kojima bi potkrijepili tvrdnju da je Cavoley vrlo sličan lijeku Neulasta.
Filgrastim is very similar to a human protein called
Filgrastim je vrlo sličan ljudskom proteinu pod nazivom faktor stimulacije kolonije granulocita (G-CSF).
ATCvet code: QI01BD03.
ATC vet kod: QI01BD03.
The vaccine is then ready to use.
Cjepivo je spremno za korištenje.
Do not use in birds in lay (see section 4.3).
Ne primjenjivati pticama kad nesu (vidi odjeljak 4.3).
Store and transport refrigerated (2° C - 8° C).
Čuvati i prevoziti na hladnom (2 °C - 8 °C).
Date of last renewal:
Datum zadnjeg produljenja:
Concentrate:
Koncentrat:
ANNEX IV GROUNDS FOR ONE ADDITIONAL RENEWAL
DODATAK IV RAZLOZI ZA JEDNO DODATNO PRODULJENJE
Due to the limited period the veterinary medicinal product Parvoduk has been placed on the market and the consequently limited post-marketing safety information, the CVMP at their meeting on 6-8 November 2018 decided that one five-year renewal is required.
Zbog ograničenog razdoblja u kojem je veterinarska-medicinski proizvod Parvoduk stavljen u promet i stoga ograničenih informacije o neškodljivosti , na sastanku CVMP dana 6.-8. studenoga 2018. odlučeno je da je potrebna petogodišnja obnova odobrenja.
b) the disease to which the product is intended to confer immunity is largely absent from the territory in question
b) je bolest, za koju je proizvod namijenjen da pruži imunost, u velikoj mjeri odsutna s odnosnog područja.
The concentrate is opalescent and homogeneous.
Koncentrat je opalescentan i homogen.
Then remove the trocar from both containers.
Potom izvucite trokar iz oba spremnika.
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Sukladno članku 71. Direktive 2001/82/EZ i Europskog Parlamenta i Vijeća s izmjenama i dopunama, države članice, u skladu s nacionalnim zakonodavstvom mogu zabraniti proizvodnju, uvoz, posjedovanje, prodaju, opskrbu i/ili primjenu imunoloških veterinarsko-medicinskih proizvoda na cijelom ili na dijelu svog teritorija ako je utvrđeno da:
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.
Pomoćne tvari navedene u odjeljku 6.1 su dopuštene tvari za koje je u tablici 1. Dodatka Uredbe Komisije (EU) br. 37/2010 naznačeno da se za njih ne zahtijeva određivanje DNK (MRL) ili nisu obuhvaćene odredbama Uredbe (EK) br. 470/2009, kada se koriste u ovom veterinarskom medicinskom proizvodu.
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Djelatna tvar je biološkog podrijetla namijenjena za poticanje aktivne imunosti na koju se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 500 doses
SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU DOZA 500 doza
Casein hydrolysate Aluminium hydroxide
Kazein hidrolizat Aluminij hidroksid
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11/04/2014
Datum prvog odobrenja: 11/04/2014
SPECIAL STORAGE CONDITIONS Store below 25° C.
11. POSEBNI UVJETI ČUVANJA Čuvati na temperaturi ispod 25°C.
Eleven genetic markers (nucleotides) in the VP1 gene allow differentiation of the Parvoduk vaccine strain from the field strains of duck and goose parvovirus, as shown below:
Jedanaest genetskih markera (nukleotida) u VP1 genu omogućavaju diferencijaciju Parvoduk vakcinalnog soja od terenskog soja parvovirusa pataka i gusaka, kako je niže prikazano:
Overdose (symptoms, emergency procedures, antidotes): No adverse reactions were observed after the administration of an overdose (10x the dose).
Predoziranje (simptomi, hitni postupci, antidoti): Nisu zabilježene nuspojave nakon primjene uvećane doze (10 x veće doze).
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Detaljne informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na web stranici Europske agencije za lijekove http://www.emea.europa.eu/.
EXP Once diluted, use within 4 hours.
EXP Jednom pripremljen upotrijebiti unutar 4 sata.
- First vaccination: at 1 day of age.
- Primarno cijepljenje: na 1. dan starosti.
In ducklings free of maternally derived antibodies a single vaccination at day 1 will lead to an onset of immunity after 14 days.
U pačića slobodnih od protutijela prenesenih od majke, jednokratno cijepljenje prvog dana starosti potiče stvaranje imuniteta nakon 14 dana.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadne materijale dobivene primjenom tih veterinarsko-medicinskih proizvoda treba odlagati u skladu s lokalnim propisima.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
U nedostatku ispitivanja kompatibilnosti, ovaj veterinarsko-medicinski proizvod ne smije se miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom.
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
ODGOVORAN ZA PUŠTANJE SERIJE U PROMET B. UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE C. IZVJEŠĆE O MRL
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Odluka o korištenju ovog cjepiva prije ili nakon bilo kojeg drugog veterinarsko-medicinskog proizvoda stoga treba biti donesena od slučaja do slučaja.
After mixing, connect the bag to a high-speed, automated or semi-automated injection system.
Nakon toga, spojite vrećicu na automatsku ili poluautomatsku brizgalicu.
Duration of immunity: 26 days after the primary vaccination course
Trajanje imunosti: 26 dana nakon prve injekcije.
Sodium chloride Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dehydrate Water for injections.
Kalij dihidrogen fosfat Dinatrijev fosfat dehidrat Voda za injekcije