FrancophonIA/ELRC3.0 huggingface dataset:
English: If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose should be increased to 1 to 2 mg/kg/day methylprednisolone equivalents and nivolumab must be permanently discontinued.
Croatian: Ako unatoč uvođenju kortikosteroida nastupi pogoršanje ili izostane poboljšanje, dozu kortikosteroida treba povećati na 1 do 2 mg/kg/dan ekvivalenata metilprednizolona, a liječenje
English: Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Tel: + 372 6827 400
Croatian: Bristol-Myers Squibb Polska Sp. z o.o. Tel.: + 48 22 5796666
English: The use of systemic corticosteroids and other immunosuppressants at baseline, before starting nivolumab, should be avoided because of their potential interference with the pharmacodynamic activity.
Croatian: Treba izbjegavati primjenu sistemskih kortikosteroida i drugih imunosupresiva na početku liječenja,
English: Most patients
Croatian: Starije osobe
English: For Grade 4 diarrhoea or colitis, nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Croatian: U slučaju proljeva ili kolitisa 4. stupnja, liječenje nivolumabom mora se trajno prekinuti i treba uvesti liječenje kortikosteroidima u dozi ekvivalentnoj 1 do 2 mg/kg/dan metilprednizolona.
English: Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Tel: + 40 (0)21 272 16 00
Croatian: Česká republika Bristol-Myers Squibb spol. s r.o. Tel: + 420 221 016 111
English: For Grade 3 diarrhoea or colitis, nivolumab should be withheld and corticosteroids initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Croatian: U slučaju proljeva ili kolitisa 3. stupnja, potrebno je odgoditi primjenu nivolumaba i uvesti liječenje kortikosteroidima u dozi ekvivalentnoj 1 do 2 mg/kg/dan metilprednizolona.
English: Eight patients, including the 4 patients with a Grade 3 case, required permanent discontinuation of nivolumab due to pneumonitis.
Croatian: U osam bolesnika, uključujući 4 bolesnika sa slučajem 3. stupnja, liječenje nivolumabom moralo se trajno prekinuti zbog pneumonitisa.Nuspojave su se povukle u svih 13 bolesnika, a medijan vremena do njihova povlačenja iznosio je 3,9 tjedana (raspon: 0,6-13,4).
English: These additional biomarker analyses are occurring in the context of Study CA209-038 and Study CA209-066.
Croatian: Te će se analize provoditi u ispitivanjima CA 209037 i
English: If applicable, dilute with the required volume of sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection.
Croatian: Nakon primjene doze nivolumaba isperite liniju otopinom natrijeva klorida za injekciju od 9 mg/ml (0,9%) ili otopinom glukoze za injekciju od 50 mg/ml (5%).
English: No Grade 4 or 5 rash was reported in these studies.
Croatian: U tim ispitivanjima nije prijavljen nijedan slučaj osipa 4. ili 5. stupnja.
English: Hazard ratio 96.85% CI p-value Median (95% CI) months Rate (95% CI) at 12 months Confirmed objective response (95% CI)
Croatian: Ukupno preživljenje Događaji Omjer hazarda 96,85% CI p-vrijednost
English: Manufacturer Bristol-Myers Squibb S.r.l.
Croatian: Bristol-Myers Squibb spol. s r.o.
English: Vistor hf.
Croatian: PK analizama.
English: Hepatic impairment
Croatian: Imunološki uzrokovan osip
English: One of the active substances, palonosetron, has been authorised on its own in the EU since 2005.
Croatian: Jedna od djelatnih tvari, palonosetron, odobrena je samostalno u EU od 2005.
English: Akynzeo netupitant / palonosetron hydrochloride
Croatian: Akynzeo netupitant / palonosetron hidroklorid
English: The patient takes one capsule one hour before starting each chemotherapy cycle.
Croatian: Bolesnici uzimaju jednu kapsulu jednom na dan prije početka svakog ciklusa kemoterapije.
English: The Committee therefore concluded that the medicine's benefits are greater than its risk and recommended that it be approved for use in the EU.
Croatian: Odbor je stoga zaključio da koristi lijeka nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u Europskoj uniji.
English: This is a summary of the European public assessment report (EPAR) for Akynzeo.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Akynzeo.
English: Netupitant works by blocking neurokinin-1 (NK1)
Croatian: Netupitant djeluje inhibirajući neurokinin-1
English: Akynzeo is available as capsules containing 300 mg of netupitant and 0.5 mg of palonosetron.
Croatian: Akynzeo je dostupan kao kapsule koje sadrže 300 mg netupitanta i 0,5 mg palonosetrona.
English: Other information about Akynzeo
Croatian: Ostale informacije o lijeku Akynzeo
English: The most common side effects reported with Akynzeo are headache (seen in 3.6% of patients), constipation (3.0%) and fatigue (1.2%).
Croatian: Najčešće nuspojave povezane s lijekom Akynzeo su glavobolja (uočeno u 3,6% bolesnika, zatvor (3,0%) i iscrpljenost (1,2%).
English: Why is Akynzeo approved?
Croatian: Zašto je Akynzeo odobren?
English: This study involved 1,455 patients and the patients took dexamethasone, another medicine used to prevent vomiting, as an additional treatment.
Croatian: Ovo ispitivanje obuhvatilo je 1.455 bolesnika, te su bolesnici uzimali deksametazon, drugi lijek koji sprječava povraćanje kao dodatnu terapiju.
English: What measures are being taken to ensure the safe and effective use of Akynzeo?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Akynzeo?
English: The figures for day 2 to day 5 were 77% for patients in the Akynzeo group and 70% for those in the palonosetron group.
Croatian: Brojke za 2. do 5. dan glase kako slijedi 77% za bolesnike u grupi koja je uzimala Akynzeo i 70% u grupi koja je uzimala palonosetron.
English: Around 88% of patients taking Akynzeo experienced no vomiting on day 1 following the first chemotherapy cycle, compared with 85% of patients taking palonosetron.
Croatian: Otprilike 88% bolesnika koji su uzimali lijek Akynzeo nije iskusilo povraćanje na 1. nakon prvog ciklusa kemoterapije, u usporedbi s 85% bolesnika koji su uzimali palonosetron.
English: What is Akynzeo and what is it used for?
Croatian: Što je Akynzeo i za što se koristi?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Akynzeo on 27 May 2015
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Akynzeo na snazi u Europskoj uniji od 27. svibnja 2015.
English: In a main study comparing Akynzeo with palonosetron alone, 90% of patients taking Akynzeo (121 out of 135) experienced no vomiting within 5 days of starting highly emetogenic chemotherapy compared with 77% of patients taking palonosetron alone (104 out of 136).
Croatian: U glavnom ispitivanju koje je usporedilo Akynzeo s monoterapijom palonosetrona, 90% bolesnika koji su uzimali Akynzeo (121 od 135() nije povraćalo unutar 5 dana od početka emetogene kemoterapije u usporedbi sa 77% bolesnika koji su uzimali samo monoterapiju palonosetrona (104 od 136).
English: receptors, which are found in the nervous system and are responsible for the delayed phase of nausea and vomiting (that occurs after the first 24 hours); palonosetron, on the other hand, blocks 5HT3 receptors in the gut, which are responsible for the immediate phase (that occurs within the first 24 hours).
Croatian: (NK1)-receptore, koji se nalaze u živčanom sustavu i odgovorni su za odgođenu fazu mučnine i povraćanje (koje nastupa nakon prvih 24 sata); palonosetron s druge strane inhibira 5HT, receptore u crijevima, koji su odgovorni za neposrednu fazu (koja nastupa unutar prvih 24 sata).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Akynzeo, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za Akynzeo nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: It is not intended to provide practical advice on how to use Akynzeo.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Akynzeo.
English: Akynzeo is a medicine used to prevent nausea (feeling sick) and vomiting in adult patients with cancer who are receiving chemotherapy (medicines to treat cancer).
Croatian: Akynzeo je lijek koji se koristi za sprječavanje mučnine (osjećaja slabosti) i povraćanja u odraslih bolesnika s rakom, koji primaju kemoterapiju (lijekovi za liječenje raka).
English: What are the risks associated with Akynzeo?
Croatian: Koji su rizici povezani s lijekom Akynzeo?
English: A risk management plan has been developed to ensure that Akynzeo is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Akynzeo.
English: For practical information about using Akynzeo, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Akynzeo bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Akynzeo was effective at preventing both the immediate and delayed phases of nausea and vomiting following chemotherapy, and that the medicine has a favourable safety profile.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da je lijek Akynzeo djelotvoran u sprječavanju kako neposredne tako i odgođene mučnine nakon kemoterapije, te da lijek ima povoljan sigurnosan profil.
English: The two active substances in Akynzeo work by blocking two different mechanisms involved in inducing nausea and vomiting during chemotherapy.
Croatian: Dvije djelatne tvari lijeka Akynzeo djeluju blokirajući dva različita mehanizma koja su uključena u izazivanje mučnine i povraćanje tijekom kemoterapije.
English: Some chemotherapy is known to induce severe nausea and vomiting, and Akynzeo is used in patients receiving either highly emetogenic (vomit-inducing) chemotherapy based on the cancer medicine cisplatin, or other chemotherapies that are moderately emetogenic.
Croatian: Pojedine kemoterapije mogu uzrokovati ozbiljnu mučninu i povraćanje, a Akynzeo se koristi u bolesnika koji primaju visoko emetogenu (izaziva povraćanje) kemoterapiju koja se temelji na antitumorskom lijeku cisplatinu ili druge kemoterapije koje su umjereno emetogene.
English: A second main study looked at the benefits of Akynzeo in patients undergoing moderately emetogenic chemotherapy.
Croatian: Drugo glavno ispitivanje istražilo je koristi lijeka Akynzeo u bolesnika koje se podvrgavaju umjereno emetogenoj kemoterapiji.
English: Akynzeo contains the active substances netupitant and palonosetron.
Croatian: Akynzeo sadrži djelatnu tvar netupitant i palonosetron.
English: The full EPAR and risk management plan summary for Akynzeo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Akynzeo nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o terapiji lijekom Akynzeo pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: What benefits of Akynzeo have been shown in studies?
Croatian: Koje su koristi lijeka Akynzeo utvrđene u ispitivanjima?
English: By having both active substances together, Akynzeo helps provide control for both the immediate and delayed phases of nausea and vomiting than occur following chemotherapy.
Croatian: Budući da sadrži obje djelatne tvari, lijek Akynzeo pomaže pri uspostavi kontrole za obje faze neposrednu i odgođenu fazu mučnine i povraćanja koje nastupaju tijekom kemoterapije.
English: How does Akynzeo work?
Croatian: Kako djeluje Akynzeo?
English: How is Akynzeo used?
Croatian: Kako se Akynzeo koristi?
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administra
Croatian: (Zaštićeno) ime Doza Farmaceutski oblik Put primjene Unutarnje pakiranje
English: The following side effects have also been reported:
Croatian: Zabilježene su i sljedeće nuspojave:
English: Adopted at the 8-11 January 2018 PRAC
Croatian: Usvojeno na sjednici PRAC-a 8. - 11. siječnja 2018.
English: Respiratory system
Croatian: Dišni sustav
English: If you experience symptoms of spitting or coughing up blood you should contact your doctor immediately.
Croatian: Ako iskusite pljuvanje ili iskašljavanje krvi, odmah se obratite svom liječniku.
English: Frequency ‘not known': Non-mechanical intestinal obstruction
Croatian: Učestalost „nepoznato”: Ne-mehanička intestinalna opstrukcija
English: Symptoms typically include dyspnoea, cough (especially a dry nonproductive cough), thoracic pain and fever for which patients should be monitored at each follow-up visit.
Croatian: Simptomi obično uključuju dispneju, kašalj (osobito suhi, neproduktivni kašalj), bol u prsištu i vrućicu, zbog čega bolesnike treba nadzirati kod svakog kontrolnog pregleda.
English: Many of the patients in whom these occurred had underlying risk factors for the development of renal events including dehydration or pre-existing hypertension or diabetes.
Croatian: Mnogi bolesnici kod kojih se to dogodilo imali su podležeće čimbenike rizika za razvoj bolesti bubrega, uključujući dehidraciju, postojeću hipertenziju ili dijabetes.
English: Not known: frequency cannot be estimated from the available data Increased urine output
Croatian: Nepoznato: učestalost se ne može procijeniti na temelju dostupnih podataka Povećano stvaranje mokraće
English: Patients should be informed of the risk of pneumonitis and advised to contact their doctor immediately should they develop persistent cough or dyspnoea.
Croatian: Bolesnike treba upozoriti na rizik od pneumonitisa i savjetovati da se odmah obrate liječniku ako razviju uporni kašalj ili dispneju.
English: Questioning the patient with regard to possible pulmonary dysfunctions, if necessary lung function test.
Croatian: Ispitati bolesnika o mogućim poremećajima funkcije pluća i, ako je potrebno, testirati funkciju pluća.
English: The following side effects have also been reported: Frequency not known (cannot be estimated from the available data): bleeding from the lungs
Croatian: Zabilježene su i sljedeće nuspojave: Nepoznato (učestalost se ne može procijeniti na temelju dostupnih podataka): krvarenje iz pluća
English: Dulaglutide - Gastrointestinal stenosis and obstruction (EPITT no 18931)
Croatian: Dulaglutid - Stenoza i opstrukcija probavnog sustava (EPITT br. 18931)
English: Acute or chronic interstitial pneumonitis, often associated with blood eosinophilia, may occur and deaths have been reported.
Croatian: Može se pojaviti akutni ili kronični intersticijski pneumonitis, često povezan s eozinofilijom u krvi, a zabilježeni su i smrtni ishodi.
English: Bowel obstruction - a severe form of constipation with additional symptoms such as stomach ache, bloating or vomiting
Croatian: Začepljenje (opstrukcija) crijeva - težak oblik zatvora s dodatnim simptomima kao što su bol u trbuhu, nadutost ili povraćanje
English: Uncommon cases of acute renal failure have been reported with pemetrexed alone or in association with other chemotherapeutic agents (see section 4.4).
Croatian: Slučajevi akutnog zatajenja bubrega prijavljeni su manje često pri primjeni pemetrekseda samog ili u kombinaciji s drugim kemoterapeuticima (vidjeti dio 4.4.).
English: Assessment of respiratory system
Croatian: Procjena stanja dišnog sustava
English: Thirst and increased water consumption Hypernatraemia - increased sodium in blood
Croatian: Hipernatremija - povećana razina natrija u krvi
English: Frequency not known (cannot be estimated from the available data): bleeding from the lungs* *(has been reported for methotrexate used in patients with underlying rheumatologic disease).
Croatian: Nepoznato (učestalost se ne može procijeniti na temelju dostupnih podataka): krvarenje iz pluća* *(zabilježeno pri primjeni metotreksata u bolesnika s podležećom reumatskom bolešću).
English: Pemetrexed - Nephrogenic diabetes insipidus (EPITT no
Croatian: Pemetreksed - Nefrogeni dijabetes insipidus (EPITT br.
English: Respiratory, thoracic and mediastinal disorders Not known: Epistaxis, Pulmonary alveolar haemorrhage* *(has been reported for methotrexate used in rheumatologic and related indications)
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Nepoznato: Epistaksa, Plućna alveolarna hemoragija* *(zabilježena pri primjeni metotreksata u reumatološkim i njima povezanim indikacijama)
English: Respiratory, thoracic and mediastinal disorders Not known: Epistaxis, Pulmonary alveolar haemorrhage
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Nepoznato: Epistaksa, Plućna alveolarna hemoragija
English: Frequency ‘not known'
Croatian: Učestalost „nepoznato”:
English: For methotrexate-containing medicinal products with oncologic indications
Croatian: Za lijekove koji sadrže metotreksat s onkološkim indikacijama
English: Methotrexate - Pulmonary alveolar haemorrhage (EPITT no 18850)
Croatian: Metotreksat - Plućna alveolarna hemoragija (EPITT br.
English: For methotrexate-containing medicinal products with both nononcologic and oncologic indications
Croatian: Za lijekove koji sadrže metotreksat s neonkološkim i onkološkim indikacijama
English: Acute bleeding from the lungs in patients with underlying rheumatologic disease has been reported with methotrexate.
Croatian: Pri primjeni metotreksata u bolesnika s podležećom reumatskom bolešću zabilježeno je akutno krvarenje iz pluća.
English: Undesirable effects
Croatian: Moguće nuspojave
English: If you develop any of the following side effects, contact your doctor immediately: - inflammation of the lungs (symptoms may be general illness, dry, irritating cough, shortness of breath, breathlessness at rest, chest pain, or fever) - spitting or coughing blood
Croatian: − upala pluća (simptomi mogu biti opće loše osjećanje, suh, nadražajni kašalj, nedostatak zraka,
English: ATCvet code: QI01AD16.
Croatian: ATCvet kod: QI01AD16.
English: SC In ovo
Croatian: s.c. in ovo
English: MD: entire risk period.
Croatian: MD: tijekom cijelog rizičnog perioda.
English: Date of first authorisation: 22/08/2017
Croatian: Datum prvog odobrenja: 22/08/2017
English: Do not thaw in hot water or ice cold water.
Croatian: Ne otapati u vrućoj vodi ili ledeno hladnoj vodi.
English: The vaccine is now ready for use.
Croatian: Cjepivo je spremno za upotrebu.
English: Suspension: off-red to red suspension.
Croatian: Suspenzija: crvenkasta do crvena suspenzija.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove ( http://www.ema.europa.eu/ ).
English: THE NETHERLANDS
Croatian: NIZOZEMSKA
English: 5831 AN Boxmeer
Croatian: 5831 AN Boxmeer NIZOZEMSKA
English: 1 PFU - plaque forming units.
Croatian: 1PFU: jedinice koje tvore plak.
English: MSD Animal Health Logo
Croatian: MSD Animal Helath Logo
English: (number of doses per ampoule is presented on the colour coded clip attached to each cane containing the ampoule)
Croatian: (broj doza po ampuli je navedena na obojenoj oznaci priloženoj na svakoj kutiji koja sadrži ampule)
English: The excipients (including adjuvants) 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 considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Croatian: Pomoćne tvari (uključujući adjuvanse) navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 naznačeno da određivanje MRL nije nužno, ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EZ) br. 470/2009 kada se primjenjuju u tim veterinarsko-medicinskim proizvodima.
English: If frozen suspension is situated in the tip of the ampoule this indicates that the suspension has been thawed and must not be used.
Croatian: Ako je suspenzija smrznuta na vrhu ampule znači da je suspenzija bila odmrznuta i ne smije se upotrijebiti.
English: Duration of immunity: ND: 8 weeks, IBD: 8 weeks,
Croatian: Trajanje imunosti: ND: 8 tjedana, IBD: 8 tjedana,
English: Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Croatian: Svaka osoba koja namjerava proizvesti, uvesti, prodavati, opskrbljivati i/ili primjenjivati ovaj veterinarsko medicinski proizvod mora prethodno konzultirati nadležno tijelo odnosne države članice u pogledu važećih odredbi o cijepljenju jer ove aktivnosti mogu biti zabranjene u državi članici na cijelom teritoriju ili jednom njezinom dijelu, sukladno nacionalnom propisu.
English: After adding the contents of the ampoule to the solvent, the ready to use product is a clear, red coloured suspension for injection.
Croatian: Nakon dodavanja sadržaja ampule u otapalo, proizvod spreman za upotrebu je bistra, crveno obojena suspenzija za injekciju.
English: Control of correct storage:
Croatian: Kontrola pravilnog načina čuvanja:
English: The solvent must be clear, red coloured, without sediment and at room temperature (15-25 °C) at the time of mixing.
Croatian: Otapalo treba biti bistro, crveno obojeno, bez taloga i na sobnoj temperaturi (15-25 °C) za vrijeme miješanja.
English: Suspension and solvent for suspension for injection.
Croatian: Suspenzija i otapalo za suspenziju za injekciju.
English: Bovine serum Veggie medium Dimethyl sulfoxide
Croatian: Goveđi serum „Veggie“ medij Dimetil sulfoksid
English: Solvent: clear, red solution.
Croatian: Otapalo: bistra, crvena otopina.
English: Dry the ampoule, then break the ampoule at its neck and immediately proceed as described below.
Croatian: Osušiti ampulu, zatim prelomiti je na vratu i odmah postupiti kako je opisano u nastavku.
English: 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.
Croatian: Djelatna tvar koja se sastoje od tvari biološkog podrijetla, namijenjene za izazivanje aktivne imunosti na koje se ne primjenjuju odredbe Uredbe (EZ) br. 470/2009.
English: EU/2/17/213/001-002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/17/213/001-002
English: Care should be exercised to prevent contaminating the hands, eyes and clothing with the suspension.
Croatian: Posebno obratiti pozornost sprečavanju zagađenja ruku, očiju i odjeće suspenzijom.
English: Remove the syringe and invert the bag (6-8 times) to mix the vaccine.
Croatian: Maknuti brizgalicu i preokrenuti vrećicu (6-8 puta) radi miješanja cjepiva.
English: If you notice any serious effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Croatian: Ako zamijetite ozbiljne nuspojave ili druge nuspojave koje nisu opisane u uputi o VMP ili smatrate da veterinarsko-medicinski proizvod nije djelotvoran, molimo javite veterinaru.
English: It is recommended to handle a maximum of 5 ampoules (from one cane only) at a time.
Croatian: Preporučeno je rukovati sa maksimalno 5 ampula (iz jedne kutije).
English: CAUTION: The ampoules have been known to explode on exposure to sudden temperature changes.
Croatian: UPOZORENJE: ampule mogu eksplodirati prilikom naglih promjena temperature.
English: In ovo: One single injection of 0.05 ml per chicken egg.
Croatian: In ovo: jedna injekcija od 0,05 ml po kokošjem jajetu.