natgillin/translations-raw huggingface dataset:
Step 1: Patients baseline FEV1 and SpO2 is measured prior to the initiation dose Step 2: Patient inhales 40 mg (1x40 mg capsules) and SpO2 is monitored Step 3: Patient inhales 80 mg (2x40 mg capsules) and SpO2 is monitored Step 4: Patient inhales 120 mg (3x40 mg capsules), FEV1 is measured and SpO2 is monitored
1. korak: Prije primjene početne doze pacijentu su izmjerene početne vrijednosti FEV1 i SpO2 2. korak: Pacijent inhalira 40 mg (1 kapsula od 40 mg) i prati se SpO2
The powder is inhaled into the lungs using the inhaler provided in the pack.
Prašak se inhalira u pluća uz pomoć inhalatora priloženog u pakiranju.
Uncommon Dizziness
- Nekontrolirano mokrenje
Hyperresponsive patients should not be prescribed the therapeutic dose regimen of Bronchitol (see section 4.3).The usual precautions regarding bronchial hyperresponsiveness monitoring apply (see section 4.2).
Hiperreaktivnim pacijentima ne smije se propisati terapijska doza Bronchitola (vidi dio 4.3.).
If you think you have used too much medicine, tell your doctor or pharmacist straight away.
Ako uzmete više Bronchitola nego što ste trebali Ako mislite da ste uzeli previše lijeka, odmah se obratite liječniku ili ljekarniku.
How Bronchitol works
Način djelovanja Bronchitola
Reproduction and developmental toxicity studies have not been carried out with inhaled mannitol.
Ispitivanja toksičnosti inhalacijskog manitola na reprodukciju i razvoj nisu provedena.
Note: There were some differences in analysis methods across the 3 studies.
Apsolutna promjena % predviđene vrijednosti Relativna promjena % predviđene vrijednosti Napomena: postojale su neke razlike u metodama analize u 3 ispitivanja.
Condition aggravated, Chest discomfort Uncommon Pyrexia, Fatigue, Influenza like illness, Hernia pain, Malaise, Chest pain
Često pogoršanje stanja, nelagoda u prsištu Manje često pireksija, umor, bolest nalik gripi, bol zbog hernije, malaksalost, bol u prsištu
Expiratory Volume in first second of expiration (FEV1) is usually less than 30%.
- ako imate teški oblik cistične fibroze, posebice ako Vam je funkcija pluća izmjerena forsiranim ekspiracijskim volumenom zraka u prvoj sekundi izdisaja (FEV1) obično manja od 30%.
Pharmaxis Europe Limited Teл.
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Pharmaxis Europe Limited
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet: België/Belgique/Belgien
Uncommon Musculoskeletal chest pain
Manje često mišićno-koštana bol prsišta
Uncommon Pyrexia
Manje često pireksija
Special populations
Posebne populacije pacijenata
Prepare for inhalation - Tilt the inhaler so that the mouth-piece faces slightly downward.
- Nagnite inhalator tako da nastavak za usta bude okrenut malo prema dolje.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - PAKIRANJE ZA POČETNU DOZU
Infections and infestations Uncommon Bacterial disease carrier, Bronchitis, Bronchopneumonia, Lung infection, Oral candidiasis, Pharyngitis, Staphylococcal infection, Upper respiratory tract infection
Manje često kliconoša bakterijskih bolesti, bronhitis, bronhopneumonija, infekcija pluća, oralna kandidijaza, faringitis, infekcija uzrokovana stafilokokom, infekcija gornjih dišnih puteva
In DPM-CF-303 imputation of missing data was performed using a baseline observation carried forward (BOCF) approach whereas no imputation was performed in DPM-CF-301 or DPM-CF-302.
U DPM-CF-303 nedostajućih podaci imputirani su korištenjem prenošenja podataka s početka promatranja (engl. baseline observation carried forward,
Do not remove capsules from blister until immediately before use.
Kapsule se smiju izvaditi iz blistera isključivo netom prije uporabe.
Capsules contain powder for oral inhalation using the inhaler device enclosed.
Kapsule sadrže prašak za inhalaciju kroz usta uz pomoć priloženog inhalatora.
- The powder in the capsules must only be inhaled using the inhaler included in the pack.
- Prašak iz kapsula smije se samo inhalirati uz pomoć inhalatora isporučenog u paketu.
- Then open it by turning the mouth-piece in the direction of the arrow on the inhaler.
- Okrenite nastavak za usta u smjeru strelice na inhalatoru kako biste otvorili inhalator.
The primary pre-specified endpoint i.e. the change from baseline in FEV1 (ml) in the modified ITT (mITT) population (n=269, 297 and 423 in studies DPM-CF-301,DPM-CF-302 and DPM-CF-303, respectively) compared to control over the 26 weeks period is provided in Table 3 alongside FEV1 presented as absolute and relative change % predicted.
Primarna prethodno specificirana mjera ishoda tj. promjena FEV1 (ml) u odnosu na početnu vrijednost u modificirane ITT (mITT) populacije (n = 269, 297 i 423 u ispitivanjima DPM-CF-301, DPM-CF
For more advice on how to look after your inhaler, please see the end of the instructions.
Savjete o održavanju inhalatora potražite na kraju uputa.
Below is a diagram that shows what the inhaler looks like.
U nastavku se nalazi dijagram inhalatora.
Cough, Condition aggravated, Haemoptysis, Oropharyngeal pain, Chest discomfort, Wheezing, Asthma, Productive cough
Često kašalj, pogoršanje stanja, hemoptiza, orofaringealna bol, nelagoda u prsištu, piskanje, astma, produktivni kašalj
<20% within 15 minutes; - FEV1 has fallen ≥50% (from baseline) at the end of the assessment.
- vrijednost FEV1 pala je za 20- < 50% (u odnosu na početnu vrijednost) na kraju procjene i nije se vratila na < 20% unutar 15 minuta - smanjenje vrijednosti FEV1 za ≥ 50% (u odnosu na početnu vrijednost) na kraju procjene.
Inhaler device
Inhalator
Each hard capsule contains 40 mg mannitol.
NAVOĐENJE DJELATNE(IH) TVARI Jedna tvrda kapsula sadrži 40 mg manitola.
The excretion of mannitol in milk has not been studied in animals.
Nema podataka o izlučivanju manitola u mlijeko životinja.
Medicare Pharma S.L.C Tel: +34 91 848 9534
Tel: +34 91 848 9534
The potential risk of cough related sequelae during treatment o The need to train the patient to minimise cough during administration in using the correct inhalation technique.
o Potreba da se pacijenta nauči kako smanjiti kašalj tijekom primjene lijeka korištenjem ispravne tehnike inhalacije.
Make a hole in the capsule - This lets the powder in the capsule be released when you breathe in.
To omogućuje da se tijekom udisanja oslobodi prašak iz kapsule.
Bronchitol 40 mg inhalation powder, hard capsules
Bronchitol 40 mg prašak inhalata, tvrde kapsule
Cartons containing 10 or 280 capsules for initial dose and treatment use respectively.
Kutije sadrže 10 kapsula za početno doziranje ili
What Bronchitol is and what it is used for What you need to know before you use Bronchitol How to use Bronchitol
Što morate znati prije nego počnete primjenjivati Bronchitol Kako primjenjivati Bronchitol Moguće nuspojave
Cough was commonly reported with use of Bronchitol in clinical studies (see section 4.8).
Kašalj Klinička ispitivanja pokazala su učestalu pojavu kašlja kod primjene Bronchitola (vidjeti dio 4.8).
No mutagenic or genotoxic effect has been revealed when mannitol was assayed in a standard battery of genotoxicity tests.
U standardnom nizu testova genotoksičnosti nisu otkriveni mutageni ni genotoksični učinci manitola.
The 2-week treatment pack is for treatment use.
Pakiranje za 2-tjedno liječenje namijenjeno je liječenju (nakon procjene početne doze).
Haemoptysis has been commonly reported with Bronchitol in clinical studies.
Klinička ispitivanja pokazala su učestalu pojavu hemoptize kod primjene Bronchitola.
IMED Poland Sp. z o. o. Tel: +48 22 663 43 10
Tel: +48 22 663 43 10
Patients must be monitored for bronchial hyperresponsiveness to inhaled mannitol during their initiation dose assessment before commencing the therapeutic dose regimen of Bronchitol.If the patient is unable to perform spirometry or complete the initiation dose assessment, they must not be prescribed Bronchitol.
Pacijente se mora nadzirati zbog hiperreaktivnosti na inhalirani manitol tijekom procjenjivanja učinka početne doze, a prije nego se započne s uzimanjem terapijske doze Bronchitola.
EU/1/12/760/001
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/760/001
The treatment effect of Bronchitol on FEV1 was less evident in the subgroup of patients who were receiving concomitant rhDNase.In rhDNase users in study 301 the relative change in FEV1 % predicted from baseline across 26 weeks of treatment was 2.83 (95% CI -0.62, 6.27).
Za osobe koje uzimaju rhDNase u ispitivanju 301, procijenjena relativna postotna promjena FEV1 % u odnosu na početnu vrijednost tijekom 26 tjedana iznosila je 2,83 (95% CI -0,62, 6,27).
Before you are started on Bronchitol, your doctor will check whether your airways are too sensitive to mannitol.
Prije no što počnete uzimati Bronchitol, liječnik će provjeriti jesu li
EU/1/12/760/002
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/760/002
Animal reproduction studies have not been carried out with inhaled mannitol.
Ispitivanja učinka inhalacije manitola na reprodukciju u životinja nisu provedena.
Once removed from the blister a capsule should be used immediately.
Kapsula se mora upotrijebiti odmah nakon vađenja iz blistera.
For instructions on how to use the inhaler, see the end of the leaflet.
Upute o uporabi inhalatora potražite na kraju Upute.
In study 302 the most frequent adverse reaction reported during the MTT was cough in seven patients (2.1%),and in study 303 the most frequently reported adverse reaction from the MTT was also cough in eight patients (1.6%).
U ispitivanju 302, najučestalija nuspojava zabilježena tijekom MTT-a bio je kašalj u sedam pacijenata (2,1 %), a u ispitivanju 303
CARTON - 2-WEEK TREATMENT PACK
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - PAKIRANJE ZA 2-TJEDNO LIJEČENJE
Renal or hepatic impairment
- Prehlada i vrućica
Treatment dose (2-week packs) - You must use Bronchitol every day.
- Bronchitol morate uzimati svaki dan.
Uncommon Bronchitis, Bronchopneumonia, Dysphonia, Hyperventilation, Sputum Discoloured, Throat irritation, Pharyngitis, Upper respiratory tract infection, Bronchospasm, Dyspnoea, Chest pain
nadraženost grla, faringitis, infekcija gornjih dišnih putova, bronhospazam, dispneja, bol u prsištu
Post-tussive vomiting, Vomiting Uncommon Nausea, Diarrhoea, Eructation, Flatulence, Gastrooesophageal reflux disease, Glossodynia, Retching, Stomatitis, Abdominal pain upper, Aphthous Stomatitis, Odynophagia
Poremećaji probavnog sustava Često povraćanje uzrokovano kašljem, povraćanje Manje često mučnina, proljev, podrigivanje, flatulencija, gastroezofagealna refluksna bolest, glosodinija,
Pharmaxis Europe Limited Tél/Tel: + 353 (0) 1431 9816
PharmaxisEurope Limited Tél/Tel: + 353 (0) 1431 9816
Bronchitol 40 mg, inhalation powder, hard capsules mannitol
Bronchitol 40 mg, prašak inhalata, tvrde kapsule manitol
Bronchitol 40 mg inhalation powder, hard capsules mannitol
Bronchitol 40 mg prašak inhalata, tvrde kapsule manitol
Take off the cap - Using both hands, hold the inhaler upright and take off the cap.
Skinite zatvarač - Držite inhalator u uspravnom položaju objema rukama i skinite zatvarač.
In study DPM-CF-303 (N=423) the baseline FEV1 percent predicted was 63.17 (SD: 15.15) and 62.98 (SD: 13.65).In study DPM-CF-301 64.4 % of the patient population were adults while in study DPM-CF302 this figure was 49.5%.
U ispitivanju DPM-CF-301, 64,4 % populacije pacijenata činile su odrasle osobe, dok je ta brojka u ispitivanju DPM-CF-302 bila 49,5 %.
Oropharyngeal pain, Wheezing Uncommon Productive cough, Throat irritation, Asthma, Bronchospasm, Forced expiratory volume decreased, Rhinorrhoea, Dyspnoea Dysphonia, Hyperventilation, Obstructive airways disorder, Respiratory tract congestion, Sputum discoloured, Hypoxia
bronhospazam, smanjen forsirani ekspiracijski volumen zraka, rinoreja, dispneja, disfonija,
Uncommon Initial insomnia, Morbid thoughts
Manje često početna nesanica, morbidne misli Poremećaji živčanog sustava Često glavobolja
Cough, Haemoptysis,
hiperventilacija, promjena boje sputuma,
Non-CF Bronchiectasis
Bronhiektazije nepovezane s cističnom fibrozom
Cough
- Kašalj
Refer to enclosed leaflet for inhaler device instructions.
Upute o inhalatoru potražiti u priloženoj uputi o lijeku.
4.7 Effects on ability to drive and use machines
4.7 Utjecaj na sposobnost upravljanja vozilima i rada na strojevima Bronchitol ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada na strojevima.
EXP
FEV1
Repeat the rinsing operation once or twice.
Postupak ispiranja ponovite jednom ili dvaput.
Protect from light.
Zaštititi od svjetla
Do not re-freeze under any circumstances.
Ne zamrzavati ponovo ni u kojim okolnostima.
Each dose of vaccine contains:
Svaka doza cjepiva sadrži:
Date of first authorisation: 09/08/2002 Date of last renewal: 06/07/2012
Datum prvog odobrenja: 09/08/2002 Datum posljednje obnove: 06/07/2012
Use immediately after preparation.
Primijeniti odmah nakon pripremanja.
ATCvet code QI01AD15
ATCvet kod QI01AD15
Proceed immediately to next step.
Odmah prijeđite na slijedeći korak.
Vaccinate only healthy birds.
Cijepiti samo zdrave ptice.
EXP {month/year}
EXP{mjesec/godina}
The instructions for use of this device should be strictly followed.
Treba se strogo pridržavati uputa za uporabu uređaja.
A single vaccination is sufficient to provide protection during the risk period.
Jednokratno cijepljenje je dostatno za osiguravanje zaštite tijekom rizičnog razdoblja.
The device should be proven to safely and effectively deliver the appropriate dose.
Naprava treba biti provjerena za sigurno i djelotvorno davanje odgovarajuće doze.
The onset of protection is from 2 weeks and the protection extends to 9 weeks.
Početak zaštite je nakon 2 tjedna, a zaštita traje do 9 tjedana.
It should be used immediately after the preparation (all of the diluted vaccine should be used up within one hour).
Mora se primijeniti odmah nakon pripreme (svo razrijeđeno cjepivo mora se upotrijebiti u roku od jednog sata).
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/EV i Europskog Parlamenta i Vijeća koja je dopunjena, država članica može, u skladu sa svojim nacionalnim zakonodavstvom, zabraniti proizvodnju, uvoz, posjedovanje, prodaju, opskrbu i/ili primjenu imunološkog veterinarsko-medicinskog proizvoda na cijelom ili na jednom njenom dijelu ako je utvrđeno da:
Apply the usual aseptic precautions to all administration procedures.
Primijenite uobičajene aseptičke mjere opreza u svim postupcima primjene.
Casein hydrolysate Phenol red 1% solution Salts
Kazein hidrolizat Fenol crvena 1% solucija Soli
For active immunisation of chickens:
Za aktivnu imunizaciju pilića:
1 bottle of 200 ml
1 bočica od 200 ml
However, precautionary measures have to be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys.
Međutim, potrebno je poduzeti mjere opreza kako bi se izbjegao izravni ili neizravni kontakt cijepljenih pilića i purana.
the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or 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 proizvoda na životinjama interferirati s provedbom nacionalnog programa otkrivanja, kontrole ili eradikacije bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živim životinjama ili hrani ili drugim proizvodima dobivenim od tretiranih životinja.
The onset of protection is from 4 days.
Početak zaštite je nakon 4 dana.
Day-old chickens and 18 days embryonated eggs.
Jednodnevni pilići i 18-dnevna embrionirana jaja.
1000 doses 2000 doses
1000 doza: 2000 doza:
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.
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 (EK) br. 470/2009 kada se primjenjuju u tim veterinarsko medicinskim proizvodima.
Do not re-use opened containers of diluted vaccine.
Ne koristiti ponovo otvorene spremnike s razrijeđenim cjepivom.
Merial Laboratoire Lyon Gerland, 254 rue Marcel Merieux 69007 Lyon
Merial, Laboratoire Lyon Gerland 254, rue Marcel Mérieux 69007 Lyon
• Transfer the suspension into the diluent (Do not use if cloudy).
• Prenesite suspenziju u razrjeđivač (Ne koristite ako je mutna).
Interaction with other medicinal products and other forms of interaction:
Interakcija sa ostalim veterinarsko medicinskim preparatima i ostale vrste interakcija:
The active substance being a principle of biological origin intended to active immunity is not within the scope of Regulation (EC) No 470/2009.
Djelatna tvar koja se sastoji od tvari biološkog podrijetla, namijenjene za stvaranje aktivne imunosti na koje se ne primjenjuju odredbe Uredbe (EK) 470/2009.
• Remove from the liquid nitrogen container only those ampoules which are to be used immediately.
• Iz spremnika s tekućim dušikom izvadite samo one ampule koje će se odmah upotrijebiti.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above.
Ne postoje dostupni podaci o neškodljivosti i djelotvornosti ovog cjepiva kada se primjenjuje s bilo kojim drugim veterinarsko-medicinskim proizvodom osim gore navedenim proizvodom.
As a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys.
Kao živo cjepivo, cjepni soj se izlučuje iz cijepljenih ptica i može se proširiti na purane.
For in ovo administration, an automated egg injection machine can be used.
Za primjenu in ovo treba koristiti uređaj za automatsko injiciranje jaja.
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 odnosni proizvod namijenjen da pruži imunost, odsutna s tog područja.
Use sterile and antiseptic-free and/or disinfectant-free equipment for injections purposes.
Za davanje cjepiva koristite sterilne materijale bez antiseptičkog i/ili dezinfekcijskog sredstva.
Do not mix with any other veterinary medicinal product except those mentioned in section 4.8 and the diluent supplied for use with the product.
Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim onih navedenih u dijelu 4.8 i razrjeđivačem koji je isporučen s proizvodom.
The vaccine strain is a recombinant Herpesvirus of turkeys (HVT) expressing the protective antigen (VP2) of the Infectious Bursal Disease Virus (IBDV) strain Faragher 52/70.
Cjepni soj je rekombinantni herpes virus purana (HVT) koji izražava zaštitni antigen (VP2) virusa zarazne bolesti burze (IBDV) soj Faragher 52/70.
• The diluted vaccine prepared as described is mixed by gentle agitation so as to be ready for use.
• Razrijeđeno cjepivo pripremljeno kako je opisano lagano se mućka kako bi bilo spremno za primjenu.
• As soon as they are thawed, open ampoules holding them at arm's length in order to prevent any risk of injury should an ampoule break.
• Čim su otopljene, otvarajte ampule tako da ih držite na udaljenosti dužine ruke kako bi se spriječila opasnost od povrede ako se ampula slomi.
• Once the ampoule is opened, draw up the contents into a 5 ml sterile syringe.
• Nakon otvaranja ampule navucite sadržaj u sterilnu špricu od 5 ml.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Svaki neiskorišteni veterinarski lijek ili otpadni materijal dobiven iz tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s lokalnim propisima.
Do not use if cloudy.
Ne primjenjivati ako je mutno.
In the absence of specific studies, no other veterinary medicinal product should be administered concurrently with the product.
U nedostatku određenih ispitivanja, nijedan drugi veterinarsko-medicinski proizvod se ne smije primjenjivati s ovim veterinarsko-medicinskim proizvodom.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Merial attenuated vaccines against Newcastle disease and Infectious bronchitis.
Podaci o neškodljivosti i djelotvornosti su dostupni, što je dokaz da ovo cjepivo smije biti primijenjeno istog dana, ali ne pomiješano s atenuiranim cjepivom tvrtke Merial protiv Newcastleske bolesti i zaraznog bronhitisa.
The vaccine induces an active immunity and a serological response against Infectious Bursal Disease and Marek's Disease in chickens.
Cjepivo inducira aktivni imunitet i serološki odgovor protiv zarazne bolesti burze i Marekove bolesti u pilića.
OTHER INFORMATION
12. OSTALE INFORMACIJE
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {AMPOULE 1000 and 2000 doses}
OSNOVNI PODACI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA AMPULA s 1000 i 2000 doza
Name and address of the manufacturers of the biological active substance(s)
Naziv i adresa proizvođača biološki djelatne(ih) tvari
• Transfer the suspension into the diluent.
• Prenesite suspenziju u razrjeđivač.
This diluent may be used with the following products: Vaxxitek HVT+IBD (EU/2/02/032/001-002)
Vaxxitek HVT+IBD (EU/2/02/032/001-002)
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Ako zamijetite ozbiljne nuspojave ili druge nuspojave koje nisu opisane u uputi o VMP, molimo da javite veterinaru.
Open ampoules holding them at arm's length in order to prevent any risk of injury should an ampoule break.
Otvarajte ampule tako da ih držite na udaljenosti dužine ruke kako bi se spriječila opasnost od povrede ako se ampula slomi.
Suspension and solvent for suspension for injection
Suspenzija i razrjeđivač za suspenziju za injekcije.
Do not use after the expiry date stated on the ampoule.
Ne koristiti poslije isteka roka valjanosti naznačenog na ampuli.
This is why the vaccine suspension should only be prepared as and when required.
Zato suspenziju cjepiva treba pripremiti kako i kada je potrebno.
Shelf life of the non-reconstituted vaccine: 36 months at -196°C Shelf life of the reconstituted vaccine: up to 2 hours at a temperature below 25°C.
Rok valjanosti nerekonstituiranog cjepiva: 36 mjeseci na -196 °C Rok valjanosti rekonstituiranog cjepiva: do 2 sata na temperaturi ispod 25 C.
This is why the vaccine suspension should only be prepared as and when required
Zato suspenziju cjepiva treba pripremiti kako i kada je potrebna
Do not mix with any other veterinary medicinal product except those mentioned in the above paragraph and the diluent supplied for use with the product.
Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim onih navedenih u u gornjem odlomku i razrjeđivačem isporučenim s proizvodom.
STERILE DILUENT
STERILNI RAZRJEĐIVAČ
Safety and reversion to virulence trials have shown that the strain is safe for turkeys.
Ispitivanja neškodljivosti i povrata virulencije su pokazala da soj nije škodljiv za purane.
Store the vaccine in liquid nitrogen.
Cjepivo čuvati u tekućem dušiku.