natgillin/translations-raw huggingface dataset:
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). 
Hiperodzivnim bolnikom se ne sme predpisati režima terapevtskega odmerka Bronchitol (glejte poglavje 4.3).
The most commonly observed adverse reaction associated with the use of Bronchitol is cough (see section 4.4). 
Najpogosteje ugotovljeni neželeni učinek, povezan z uporabo zdravila Bronchitol, je bil kašelj (glejte poglavje 4.4).
- Never take your inhaler apart. 
- Inhalatorja ne razstavljajte.
Store in the original blister in order to protect from moisture. 
Hranite v originalnem pretisnem omotu, da preprečite vdor vlage.
Use your bronchodilator; 
1. bronhodilatator ;
Mannitol was shown not to be an irritant in an isolated bovine eye assay or when introduced into rabbit eyes. 
V testu izoliranega govejega očesa ali pri vnosu v oči kunca se manitol ni pokazal kot dražljiva snov.
• recurrent bleeding ≥100 ml/day over several days The reinstitution or withholding of Bronchitol following smaller episodes of haemoptysis should be based on clinical judgement. 
O ponovni uvedbi ali zadržanju zdravila Bronchitol po manjših epizodah hemoptize presodi zdravnik.
- Never place a capsule directly into the mouth-piece of your inhaler. 
- Kapsule na vstavljajte v ustnik inhalatorja.
- If you do not hear the rattling, hold the inhaler with the mouth-piece facing downwards, and tap the bottom firmly. 
- V tem primeru primite inhalator z ustnikom navzdol in po spodnji strani močno potrkajte.
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 
, astma, bronhospazem, zmanjšan forsirani ekspiracijski volumen, rinoreja, dispneja disfonija, hiperventilacija, obstruktivna bolezen dihal, kongestija dihal, obarvan sputum, hipoksija bolezni prebavil pogosti bruhanje po kašljanju, bruhanje občasni navzea, driska, spahovanje, vetrovi, gastroezofagealna refluksna bolezen, glosodinija, siljenje na bruhanje, stomatitis, bolečine v zgornjem predelu trebuha, aftozni stomatitis, bolečine pri požiranju bolezni kože in podkožja občasni
- The powder in the capsules must only be inhaled using the inhaler included in the pack. 
- Prašek v kapsulah je le za inhalacijo z inhalatorjem, priloženim v pakiranju zdravila.
Bronchitol 40 mg inhalation powder, hard capsules 
Bronchitol 40 mg prašek za inhaliranje, trde kapsule
Impaired lung function 
Okvarjeno delovanje pljuč
Animal reproduction studies have not been carried out with inhaled mannitol. 
Študije učinka inhaliranega manitola na razmnoževanje živali niso bile opravljene.
Bronchitol should not be used by children and adolescents under the age of 18. 
Otroci in mladostniki, mlajši od 18 let, zdravila Bronchitol ne smejo uporabljati, ker je v tej populaciji premalo informacij o zdravilu.
In this leaflet we call making the hole ‘piercing'. 
V tem navodilu se za predrtje kapsule uporablja pojem „prediranje“.
If you think you have used too much medicine, tell your doctor or pharmacist straight away. 
Če ste vzeli večji odmerek zdravila Bronchitol, kot bi smeli Če menite, da ste vzeli preveč zdravila, se nemudoma posvetujte z zdravnikom ali farmacevtom.
- The usual dose is 10 capsules (400 mg) inhaled in the morning, and 10 capsules inhaled in the evening. 
Odmerek za zdravljenje (pakiranje za dvotedensko zdravljenje) - Zdravilo Bronchitol morate uporabljati vsak dan. - Običajni odmerek je inhalacija 10 kapsul (400 mg) zjutraj in 10 kapsul zvečer.
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). 
Pri uporabnikih rhDNaze v študiji 301 je bila v 26 tednih relativna sprememba odstotkovne vrednosti FEV1, napovedane v izhodišču, 2,83 (95-odstotni IZ: -0,62; 6,27).
For the full list of excipients, see section 6.1. 
Povprečni vneseni odmerek na kapsulo je 32,2 mg. Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Bronchitol is for inhalation use, using the inhaler provided in the pack. 
Zdravilo Bronchitol se inhalira z inhalatorjem, priloženim v pakiranju.
Order of using this medicine 
NAČIN IZDAJANJA ZDRAVILA
The following steps explain how to use the inhaler. 
Uporaba inhalatorja je razložena po korakih v nadaljevanju.
Bronchitol 40 mg, inhalation powder, hard capsules mannitol 
Bronchitol 40 mg, prašek za inhaliranje, trde kapsule manitol
Bronchitol 40 mg inhalation powder, hard capsules Mannitol 
Bronchitol 40 mg prašek za inhaliranje, trde kapsule manitol
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. 
Če bolnik ne more opravljati spirometrije ali dokončati oceno začetne količine odmerka, se Bronchitola ne sme predpisati.
Make a hole in the capsule - This lets the powder in the capsule be released when you breathe in. 
- To omogoči izhajanje praška iz kapsule med vdihom.
How to store Bronchitol 
Shranjevanje zdravila Bronchitol
Reproduction and developmental toxicity studies have not been carried out with inhaled mannitol. 
Študije učinka inhaliranega manitola na sposobnost razmnoževanja in razvoj niso bile opravljene.
Talk to your doctor if the cough won't go away or worries you. 
Če kašelj ne izzveni ali vas skrbi, se posvetujte s svojim zdravnikom.
Uncommon Musculoskeletal chest pain, Arthralgia, Back pain, Joint stiffness, Musculoskeletal pain Renal and urinary disorders Uncommon Urinary incontinence General disorders and administration site conditions 
Akne, mrzel pot, srbenje, izpuščaj, srbeč izpuščaj bolezni mišično-skeletnega sistema in vezivnega tkiva občasni mišično-skeletne bolečine v prsnem košu, bolečine v sklepih, bolečina v hrbtu, otrdelost sklepov, mišično-skeletne bolečine bolezni sečil občasni urinska inkontinenca splošne težave in spremembe na mestu aplikacije pogosti stanje je poslabšano, nelagodje v prsnem košu občasni
The educational pack should contain the following: 
Navodilo vsebuje:
- Then twist the mouth-piece into the closed position - when it is closed you will hear a ‘click'. 
- Nato zavrtite ustnik v zaprti položaj.
The most commonly observed adverse reaction associated with the use of Bronchitol is cough. 
Terapevtski režim odmerjanja (starost od 6 do 17 let) Najpogosteje ugotovljeni neželeni učinek, povezan z uporabo zdravila Bronchitol, je kašelj.
Dornase alfa (Pulmozyme) if this is part of your treatment routine Inhaled antibiotics if this is part of your treatment routine 
Priporočeni vrstni red je naslednji, razen če vam zdravnik naroči drugače: uporabite bronhodilatator, počakajte 5 do 15 minut, vzemite zdravilo Bronchitol pred fizioterapijo, če je ta del vašega običajnega dnevnega zdravljenja, dornaza alfa (Pulmozyme), če je del vašega običajnega dnevnega zdravljenja, antibiotiki za inhaliranje, če so del vašega običajnega dnevnega zdravljenja.
Refer to enclosed leaflet for inhaler device instructions. 
Glejte navodilo za uporabo inhalatorja v navodilu za uporabo.
For instructions on how to use the inhaler, see the end of the leaflet. 
Podrobno navodilo za uporabo inhalatorja je na kocu tega navodila.
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%. 
V teh preskušanjih ni bilo dovoljeno sočasno dajanje hipertonične fiziološke raztopineV študiji DPM-CF-303 (N = 432) je odstotkovna vrednost FEV1, napovedana v izhodišču, znašala 63,17 (SD: 15,15) in 62,98 (SD: 13,65).
Breastfeeding 
Mouthpiece
- To get the best results from Bronchitol, inhale each capsule one after another. 
- Da bo zdravljenje čim bolj učinkovito, inhalirajte kapsulo za kapsulo.
Study 303 did not show a superior treatment effect of Bronchitol on FEV1 for female patients, in whom the underlying cystic fibrosis disease course may be worse than males for reasons that are not fully understood. 
Učinek zdravljenja z Bronchitolom na FEV1 je bil manj opazen v podskupini bolnikov, ki so prejemali sočasno rhDNase.
Use immediately after preparation. 
Uporabite takoj po pripravi.
Proceed immediately to next step. 
Nato takoj nadaljujte z naslednjim korakom.
Repeat the rinsing operation once or twice. 
Postopek izpiranja ponovite enkrat ali dvakrat.
Each dose of vaccine contains: 
Vsak odmerek cepiva vsebuje:
It should be used immediately after the preparation (all of the diluted vaccine should be used up within one hour). 
Uporabiti ga je treba takoj po pripravi (celotno količino razredčenega cepiva morate porabiti v eni uri).
A single vaccination is sufficient to provide protection during the risk period. 
Enkratno cepljenje zadostuje za zaščito v obdobju tveganja.
The instructions for use of this device should be strictly followed. 
Strogo je treba upoštevati navodila za uporabo takih naprav.
Date of first authorisation: 09/08/2002 Date of last renewal: 06/07/2012 
Datum pridobitve dovoljenja za promet: 09/08/2002 Datum zadnjega podaljšanje DzP: 06/07/2012
Reconstitution of the vaccine 
Rekonstitucija cepiva
This is why the vaccine suspension should only be prepared as and when required. 
Prav zato je treba suspenzijo cepiva pripraviti ko in kadar je potrebna.
Do not re-freeze under any circumstances. 
Pod nobenimi pogoji je ponovno ne zamrzujte.
ADVICE ON CORRECT ADMINISTRATION Frozen vaccines: 
NASVET O PRAVILNI UPORABI ZDRAVILA Zamrznjena cepiva:
This diluent may be used with the following products: Vaxxitek HVT+IBD (EU/2/02/032/001-002) 
Vehikel se lahko uporablja z naslednjimi proizvodi: Vaxxitek HVT+IBD (EU/2/02/032/001-002)
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) bi uporaba zdravila ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
Day-old chickens and 18 days embryonated eggs. 
Enodnevni piščanci in jajca z 18 dnevnimi embriji.
• The diluted vaccine prepared as described is mixed by gentle agitation so as to be ready for use. 
• Razredčeno cepivo, ki je pripravljeno, kot je bilo opisano, zmešajte z rahlim pretresanjem in že je pripravljeno za uporabo.
• Remove from the liquid nitrogen container only those ampoules which are to be used immediately. 
• Iz vsebnika s tekočim dušikom vzemite le ampule, ki jih boste takoj uporabili.
For active immunisation of chickens: 
Za aktivno imunizacijo piščancev:
the disease to which the product is intended to confer immunity is largely absent from the territory in question. 
bolezen, za katero se z zdravilom pridobi imunost, na zadevnem območju skoraj ni prisotna.
Casein hydrolysate Phenol red 1% solution Salts 
Vehikel: saharoza hidrolizat kazeina fenol rdeče, 1% raztopina soli
The onset of protection is from 2 weeks and the protection extends to 9 weeks. 
Zaščita nastopi od 2. tedna dalje in traja do 9 tednov.
The device should be proven to safely and effectively deliver the appropriate dose. 
Naprava mora biti preverjeno varna in učinkovita za uporabo, ter mora zagotoviti ustrezno odmerjanje.
• Once the ampoule is opened, draw up the contents into a 5 ml sterile syringe. 
• Ko je ampula odprta, vsebino napolnite v 5-ml sterilno brizgo.
Merial Laboratoire Lyon Gerland, 254 rue Marcel Merieux 69007 Lyon 
MERIAL Laboratory of Lyon Gerland 254 rue Marcel Mérieux 69007 Lyon
• Transfer the suspension into the diluent (Do not use if cloudy). 
• Suspenzijo prenesite v vehikel (Ne uporabite, če je vsebina motna).
Interaction with other medicinal products and other forms of interaction: 
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij: Za subkutano dajanje:
Safety and reversion to virulence trials have shown that the strain is safe for turkeys. 
Preskusi varnosti in povrnitve virulence so pokazali, da je ta sev varen za purane.
However, precautionary measures have to be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys. 
Toda, potrebno je slediti vsem varnostnim ukrepom, da bi se izognili neposrednemu ali posrednemu stiku med cepljenimi piščanci in purani.
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. 
Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerimkoli drugim zdravilom za uporabo v veterinarski medicini razen s prej omenjenimi.
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 mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini razen s tistimi, navedenimi v poglavju 4.8. in vehiklom, ki je priložen za uporabo s tem cepivom.
Name and address of the manufacturers of the biological active substance(s) 
Ime in naslov izdelovalcev biološke zdravilne učinkovine (zdravilnih učinkovin).
1 bottle of 200 ml 
1 steklenica s po 200 ml
1000 doses 2000 doses 
1000 odmerkov 2000 odmerkov
Do not use after the expiry date stated on the ampoule. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ampuli.
Do not re-use opened containers of diluted vaccine. 
Odprtih vsebnikov z razredčenim cepivom ne uporabite ponovno.
Ampoule carriers are stored in canister, and in liquid nitrogen containers. 
Nosilci ampul so shranjeni v pločevinast škatli in v vsebnikih s tekočim dušikom.
• Thaw the contents of the ampoules rapidly by agitation in water at 25°C-30°C. 
• Vsebino ampule odtajajte hitro s pretresanjem v vodi pri 25 °C do 30 °C.
For in ovo administration, an automated egg injection machine can be used. 
Za in ovo injiciranje se lahko uporablja avtomatične naprave za injiciranje v jajca.
The vaccine induces an active immunity and a serological response against Infectious Bursal Disease and Marek's Disease in chickens. 
Cepivo spodbudi aktivno imunost in serološki odgovor proti bolezni Gumboro in Marekovi bolezni pri piščancih.
As a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys. 
Ker je cepivo živo, lahko cepljene ptice izločajo cepni sev virusa, ki se lahko prenese na purane.
Store the reconstituted vaccine at a temperature below 25°C. 
Rekonstituirano cepivo hranite pri temperaturi do 25 °C.
Vaccinate only healthy birds. 
Cepite samo zdrave živali.
For subcutaneous route: 
Za subkutano dajanje:
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 uporabnosti nerekonstituiranega cepiva: 36 mesecev pri -196 oC Rok uporabnosti po rekonstituciji: do dve uri pri temperaturi do 25 °C.
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. 
Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno aplicirati na isti dan vendar ne zmešano z Merialovimi atenuiranimi cepivi proti atipični kokošji kugi in infekcioznemu bronhitisu.
Use sterile and antiseptic-free and/or disinfectant-free equipment for injections purposes. 
Za injiciranje uporabljajte le sterilne instrumente, brez aseptikov in/ali dezinficiensov.
The onset of protection is from 4 days. 
Zaščita nastopi od 4. dneva dalje.
Open ampoules holding them at arm's length in order to prevent any risk of injury should an ampoule break. 
Ampule odpirajte tako, da jih držite na oddaljenosti dolžine roke, da bi lahko preprečili možnost poškodbe, če bi se ampula zlomila.
Suspension and solvent for suspension for injection 
Suspenzija in vehikel za suspenzijo za injiciranje
• To reduce mortality, clinical signs and lesions of Marek's disease. 
• Za zmanjšanje smrtnosti, ublažitev kliničnih znakov in poškodb zaradi Marekove bolezni.
In ovo route: one single injection of 0.05 ml per egg at 18 days of embryonation. 
Pri in ovo vnosu - enkratno injiciranje 0,05 ml pripravljenega cepiva na jajce 18. dan embrionalnega razvoja.
• Repeat the thawing, opening, transfer and rinsing operations for the appropriate number of ampoules to be reconstituted in the diluent; either 1 ampoule of 1,000 doses of vaccine per 200 ml of diluent (or 1 ampoule of 2,000 doses of vaccine per 400 ml of diluent) for subcutaneous administration, or 4 ampoules of 1,000 doses of vaccine per 200 ml of diluent (or 4 ampoules of 2,000 doses of vaccines per 400 ml of diluent) for in ovo administration. 
• Odtajanje, odpiranje in izpiranje vsebine ampule z vehiklom ponovite glede na potrebno število ampul, ali 1 ampulo s 1,000 odmerki cepiva za 200 ml vehikla (ali 1 ampulo z 2,000 odmerki cepiva za 400 ml vehikla) za vnos v podkožje ali 4 ampule s 1,000 odmerki cepiva za 200 ml vehikla (ali 4 ampule z 2,000 odmerki cepiva za 400 ml vehikla) za vnos in ovo.
• To prevent mortality and to reduce clinical signs and lesions of Infectious Bursal disease. 
• Za preprečevanje smrtnosti, ublažitev kliničnih znakov in poškodb, ki so posledica bolezni Gumboro.
Lay: Do not use in breeding birds and birds in lay. 
Nesnost: Ne uporabite pri vzrejnih pticah in pticah v obdobju valjenja.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
- (polypropylene) bottle of 200ml of diluent. 
- (polipropilenska) steklenica z 200 ml vehikla.
Read the package leaflet supplied with the vaccine vial. 
Preberite Navodilo za uporabo, ki je priloženo viali s cepivom.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial attenuated vaccines against Marek's disease Rispens strain. 
Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno mešati z Merialovim atenuiranim cepivom proti Marekovi bolezni, sev Rispens.
- (polyvinylchloride) bag of 200ml, 400ml, 600ml, 800ml, 1000ml, 1200ml, 1400ml, 1600ml, 
- (polivinilkloridna) vrečka z 200 ml, 400 ml, 600 ml, 800 ml, 1000 ml, 1200 ml, 1400 ml, 1600 ml,
1800ml or 2400ml of diluent. 
1800 ml ali 2400 ml vehikla.
- (glass) ampoule of 1,000 doses of vaccine, 5-ampoule carrier. 
- (steklena) ampula s 1,000 odmerki cepiva, nosilec s 5 ampulami.
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 mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini, razen z navedenimi zgoraj in vehiklom, ki je priložen za uporabo s tem cepivom.
Shelf life of the diluent in polyvinylchloride bags: 36 months at a temperature below 30°C. 
Rok uporabnosti vehikla v polivinilkloridnih vrečkah: 36 mesecev pri temperaturi do 30 °C.
Do not use in breeding birds and birds in lay. 
Ne uporabite pri vzrejnih pticah in pticah v obdobju valjenja.
• Rinse the ampoule with these 2 ml and then transfer the rinsing liquid into the diluent. 
• S tema dvema mililitroma izperite ampulo in nato ta izpirek prenesite v vehikel.
Subcutaneous route: one single injection of 0.2 ml per chicken at the age of one day. 
Pri subkutani uporabi - enkratno injiciranje 0,2-ml pripravljenega cepiva v podkožje piščanca, starega en dan.
The active substance being a principle of biological origin intended to active immunity is not within the scope of Regulation (EC) No 470/2009. 
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo(ES) št.
- (glass) ampoule of 2,000 doses of vaccine, 4-ampoule carrier. 
- (steklena) ampula z 2,000 odmerki cepiva, nosilec s 4 ampulami.
Shelf life of the diluent in polypropylene bottles: 12 months at a temperature below 30°C. 
Rok uporabnosti vehikla v polipropilenskih stekleničkah: 12 mesecev pri temperaturi do 30 °C.
Discard any ampoules that have been accidentally thawed. 
Vsako ampulo, ki je bila nenamerno odtaljena, zavrzite.
Live recombinant vaccine against Infectious Bursal Disease and Marek's Disease. 
Živo rekombinantno cepivo proti bolezni Gumboro in Marekovi bolezni.
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. 
Sev virusa v cepivu je rekombinantni puranji herpesvirus (HVT), ki izraža zaščitne antigene (VP2)
Manufacturer responsible for batch release 
Izdelovalec odgovoren za sprostitev serije
Live vHVT013-69 recombinant virus, at least ......................................................... 3.6 to 5.0 log10 PFU Excipient ...................................................................................................................................... qs 1 dose Diluent: 
živi rekombinantni virus vHVT013-69, najmanj ............................................................... 3,6 log10 PFU Pomožna snov ..................................................................................................................... q.s 1 odmerek
Read the package leaflet supplied with the vaccine vial before use. 
Pred uporabo preberite navodilo, priloženo viali s cepivom.
Marketing authorisation holder Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY 
Imetnik dovoljenja za promet z zdravilom Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
• Wear protective gloves and spectacles during the ampoule thawing and opening operations. 
• Pri odtajanju in odpiranju ampule nosite zaščitne rokavice in očala.
- (polypropylene) bottle of 200ml of diluent - (polyvinylchloride) bag of 200ml, 400ml, 600ml, 800ml, 1000ml, 1200ml, 1400ml, 1600ml, 
(polipropilenska) steklenica z 200 ml. - (polivinilkloridna) vrečka z 200 ml 400 ml, 600 ml, 1000 ml, 1200 ml, 1400 ml, 1600 ml, 1800 ml ali 2400 ml vehikla.
Active ingredient: 
Zdraviln učinkovina:
For in ovo route: 
Za in ovo dajanje:
Wear protective gloves and spectacles during the ampoule thawing and opening operations. 
Pri odtajanju in odpiranju ampule nosite zaščitne rokavice in očala.
Do not use if cloudy. 
Ne uporabljajte, če je vsebina motna.
PACKAGE LEAFLET FOR: Vaxxitek HVT+IBD suspension and solvent for suspension for injection 
NAVODILO ZA UPORABO ZA: Vaxxitek HVT+IBD suspenzija in vehikel za suspenzijo za injiciranje
Vaxxitek HVT+IBD Suspension and solvent for suspension for injection 
Vaxxitek HVT+IBD suspenzija in vehikel za suspenzijo za injiciranje
Shelf life of the reconstituted vaccine: up to 2 hours at a temperature below 25°C. 
Rok uporabnosti po rekonstituciji: do dve uri pri temperaturi do 25 oC.
Apply the usual aseptic precautions to all administration procedures. 
Pri vseh postopkih vnosa cepiva ravnajte v skladu s pravili asepse.
Store the vaccine in liquid nitrogen. 
Cepivo shranjujete v tekočem dušiku.
STERILE DILUENT 
STERILNI VEHIKEL
PACKAGE LEAFLET FOR STERILE DILUENT 
NAVODILO ZA UPORABO STERILNI VEHIKEL
Dimethyl sulfoxide Dilution medium 
Suspenzija: dimetilsulfoksid razrečilo
Merial Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest France 
MERIAL, Laboratoire Porte des Alpes Rue de l'Aviation
Subcutaneous or in ovo route. 
Subkutana in in ovo uporaba