natgillin/translations-raw huggingface dataset:
Intramuscular Glass bottles 250ml or (hydrolytical subcutaneous Type II) with rubber stopper and aluminium cap
stekleničke (iz stekla tipa II) z gumijastim zamaškom in aluminijasto zaporko
1 bottle
1 steklenička nič dni
HI titre ≥ Emulsion for 6.0 log2 injection per dose
titer HI ≥ 6, 0 log2 v odmerku
Intramuscular or subcutaneous
intramuskularno ali subkutano
Glass bottles 500ml (hydrolytical Type II) with rubber stopper and aluminium cap
stekleničke (iz stekla tipa II) z gumijastim zamaškom in aluminijasto zaporko
PET bottles with rubber stopper and aluminium cap
plastenke iz PET z gumijastim zamaškom in aluminijasto zaporko
Nobilis Influenza H5N2 emulsion for injection for chickens
Nobilis Influenza H5N2, emulzija za injiciranje za piščance
One dose of 0.5ml contains:
En odmerek po 0, 5 ml vsebuje:
Inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/ duck/ Potsdam/ 1402/ 86), inducing an HI titre of ≥ 6.0 log2 as tested according to the potency test.
Inaktivirani antigen podtipa virusa aviarne influence H5N2 (sev A/ raca/ Potsdam/ 1402/ 86), ki vzbudi titer HI ≥ 6, 0 log2 pri preizkusu potentnosti.
Liquid light paraffin 234.8 mg/ 0,5 ml
Tekoči lahki parafin, 234, 8 mg/ 0, 5 ml
Reduction of clinical signs, mortality and excretion of virus after challenge were shown by three weeks after vaccination.
Zmanjšanje kliničnih znakov, umrljivosti in izločanja virusa po provokaciji so dokazali za obdobje treh tednov po cepljenju.
4.6 Adverse Reactions (frequency and seriousness)
Neželeni učinki (pogostost in resnost)
Safety has been assessed on the basis of preliminary results in chickens.
Varnost je ocenjena na podlagi predhodnih izsledkov pri piščancih.
A transient diffuse swelling may occur at the vaccination site in 50% of the animals, which persists for about 14 days.
Pri 50% živali lahko na mestu vboda nastane prehodna, difuzna oteklina, ki traja približno 14 dni.
4.8 Interactions with other medicinal products and other forms of interaction
4. 8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
No information is available on the safety and efficacy from the concurrent use of this vaccine with any other.
Ni podatkov o varnosti ter učinkovitosti ob sočasni uporabi tega cepiva s katerim koli drugim.
From 8-14 days old:
Od 8- 14 dni starosti:
0.25 ml subcutaneously From 14 days to 6 weeks old:
Od 14 dni do 6 tednov starosti:
0.25 or 0.5 ml subcutaneously or intramuscularly 6 weeks and older:
0, 25 ali 0, 5 ml subkutano ali intramuskularno
0.5 ml subcutaneously or intramuscularly Future laying hens and breeders should get a second vaccination 4-6 weeks after first vaccination.
0, 5 ml subkutano ali intramuskularno
No information is available on vaccination in the presence of maternally derived antibodies.
Pri bodočih nesnicah in matičnih jatah moramo cepljenje ponoviti 4 do 6 tednov po prvem cepljenju.
3 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
3 4. 10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno)
Following the administration of a double dose no adverse reactions other than those described in section 4.6 have been observed.
Po vnosu dvojnega odmerka niso zasledili drugačnih neželenih učinkov, kot so opisani v poglavju 4. 6.
Pharmacotherapeutic group: inactivated vaccine, ATC-vet code:
Farmakoterapevtska skupina: inaktivirano cepivo, oznaka ATC vet:
If the circulating avian influenza field virus has a different N component to the N2 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic test to detect Neuraminidase antibodies.
Če ima divji virus aviarne influence sestavino N, ki se razlikuje od sestavine N2 v cepivo, lahko cepljene ptice razlikujemo od okuženih z diagnostičnim testom za odkrivanje protiteles proti nevraminidazi.
Do not mix with any other medicinal product.
Ne mešajte z nobenim drugim zdravilom.
PET vials:
Viale iz PET:
2 years Glass vials:
2 leta Steklene viale:
After broaching use within 8 hours, provided the product is not subject to extreme temperatures or contaminated.
Načeto zdravilo porabite v 8 urah, če izdelek ni bil izpostavljen zelo visoki temperaturi ali kontaminiran.
Store and transport refrigerated (2°C to 8°C).
Shranjujte in prevažajte v hladilniku (2 °C – 8 °C).
The bottles are closed with a nitryl rubber stopper and sealed with a coded aluminium cap.
Stekleničke in plastenke so zaprte z zamaški iz nitrilne gume in zatesnjene z aluminijasto zaporko s šifro.
4 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
The import, sale, supply and/ or use of Nobilis Influenza H5N2 is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Uvoz, prodaja, oskrba in/ ali uporaba Nobilisa Influenza H5N2 je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
Any person intending to import, sell, supply and/ or use Nobilis Influenza H5N2 must consult the relevant Member State’ s competent authority on the current vaccination policies prior to the import, sale, supply and/ or use.
Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ ali uporabljati Nobilis Influenza H5N2 se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred uvozom, prodajo, oskrbo in/ ali uporabo
Intervet International BV Wim de Korverstraat 35 NL-5831 AN Boxmeer The Netherlands
Wim de Körverstraat 35 5831 AN Boxmeer Nizozemska
Laboratorios Intervet SA Poligono El Montalvo Apartado 3006 Salamanca 37080 Spain
Laboratorios Intervet SA Poligono El Montalvo apartado 3006 Salanca 37080 Španija
Intervet International BV, site De Bilt Ambachtstraat 4 3732 CN De Bilt The Netherlands
Intervet International IBV site De Bilt Ambachtstratt 43732 CN De Bilt Nizozemska
Intervet International BV Wim de Korverstraat 35 NL-5831 AN Boxmeer The Netherlands
Intervet International BV Wim de Korverstraat 35 NL- 5831 AN Boxmeer Nizozemska
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals
a) bi uporaba zdravila za uporabo v veterinarski medicini 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.
The following substances contained in the final product are included in Annex II of Council Regulation (EEC) No 2377/ 90:
Naslednje snovi v končnem izdelku so vključene v Dodatek II Uredbe Sveta (EES) No 2377/ 90:
Pharmacologically active substance Light liquid paraffin Polysorbate 80 Sorbitan mono oleate (E494) Glycine
lahki tekoči parafin polisorbat 80 sorbitan monooleat (E494) glicin
Animal Species All food producing species All food producing species All food producing species All food producing species
vse vrste, namenjene prehrani ljudi vse vrste, namenjene prehrani ljudi vse vrste, namenjene prehrani ljudi vse vrste, namenjene prehrani ljudi
The Marketing Authorisation Holder shall complete the following programme of studies, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile.
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem obdobju izvesti naslednji program študij, katerih rezultati služijo kot osnova za vsakoletno ponovno oceno razmerja korist/ tveganje.
More detailed information on the specific obligations is set out in the CVMP assessment report.
Podrobnejšo informacijo o specifičnih zahtevah vsebuje poročilo CVMP.
The Applicant should provide a list of suitable source countries for the pigs used as a source of the porcine starting material in tryptose.
Vlagatelj mora navesti seznam ustreznih izvornih držav za prašiče, uporabljene kot vir prašičjega vhodnega materiala pri triptozi.
Tryptose and NZ-Amines:
Triptoza in amini NZ:
The use of unspecified countries of origin of the cows providing the milk and unspecified suppliers of the tryptose and NZ-Amine is not considered acceptable.
Uporaba nespecificiranih držav porekla krav, ki služijo kot vir mleka, in nespecificiranih dobaviteljev triptoze in amina NI sprejemljiva.
Up- to-date information should be provided on the source countries of origin of the animals supplying the milk for preparation of the Tryptose from BD Biosciences and for the preparation of the casein, and lactose where appropriate, for manufacture of the NZ-Amines purchased from Quest/ Kerry.
Navesti je treba sodobne podatke o izvornih državah za živali, ki služijo kot vir mleka za pripravo triptoze iz BD Biosciences in za pripravo kazeina ter laktoze, kadar je primerno, za izdelavo aminov NZ, kupljenih pri Quest/ Kerry.
The Applicant should agree to only source Tryptose and (specified) NZ-Amines from specified companies from whom suitable ‘ milk statements’ have been submitted in the dossier, together with details of the countries of origin of the source animals.
Vlagatelj mora soglašati, da bo pridobil triptozo in (specificirane) amine NZ samo od specificiranih podjetij, ki so predala ustrezne 'izjave o mleku' v dokumentaciji, skupaj s podrobnimi podatki o državah porekla živali, ki so služile kot vir.
Revised supporting TSE compliance tables will be required.
Zahtevane bodo revidirane tabele skladnosti za TSE.
Test for identification:
Preskus za identifikacijo:
A final product batch test should be introduced to identify the neuraminidase component and confirm that the vaccine has the correct composition.
Opraviti je treba preskus končne serije izdelka, da bi odkrili sestavino nevraminidaze in potrdili pravilno sestavo cepiva.
A proposal is required.
Zahtevan je predlog.
The antigen should be stored for no longer than 12 months at 2-8ºC pending the provision of data supporting a longer period of storage.
Antigena ni dovoljeno shranjevati dlje kot 12 mesecev pri temperaturi 2- 8 ºC, ker niso navedeni podatki o daljšem shranjevanju.
8 EFFICACY ASPECTS
8 VIDIKI UČINKOVITOSTI
As far as possible batch protocols, and especially potency test results, should be provided for all batches of H5N2 vaccine used in the efficacy trials presented in the dossier.
Kolikor je mogoče, morajo biti predloženi protokoli o seriji in zlasti rezultatih preskusov potentnosti za vse serije cepiva H5N2, ki so bili uporabljeni v študijah učinkovitosti, navedenih v dokumentaciji.
The response should indicate which trials the various batches were used for.
Odziv mora kazati, v katerih preskušanjih so bile uporabljene različne serije.
On the basis of this, a justification should be provided for the minimum potency specified for the product.
Na podlagi tega mora biti navedena upravičenost najmanjše potentnosti izdelka.
The applicant is required to submit 3-montly Periodic Update Safety reports for the first 2 years following the initial use in the field and is additionally required to present a protocol that would ensure adequate recording and reporting of field data in relation to suspected adverse reactions including suspected lack of efficacy.
Vlagatelj mora izročiti 3- mesečna periodična poročila o varnosti za prvi 2 leti po začetni uporabi na terenu, poleg tega pa še protokol, ki bo zagotovil ustrezno dokumentiranje in poročanje o podatki s terena, ki se nanašajo na sum na neželene učinke in sum na neučinkovitost.
CARTON {250ml Bottle / 500ml Bottle}
ŠKATLA {steklenička po 250 ml / steklenička po 500 ml}
Nobilis Influenza H5N2 Emulsion for injection
Nobilis Influenza H5N2 Emulzija za injiciranje
One dose of 0.5 ml contains:
En odmerek po 0, 5 ml vsebuje:
Liquid light paraffin 234.8 mg/ 0.5 ml
Tekoči lahki parafin, 234, 8 mg/ 0, 5 ml
Intramuscular or subcutaneous injection of 0.25 to 0.5 ml, depending on the age.
Intramuskularno ali subkutano odmerek po 0, 25 to 0, 5 ml, glede na starost.
< EXP {month/year} > Once broached, use within 8 hours.
< EXP {mesec/ leto} > Načeto zdravilo uporabite v 8 urah.
For disposal read the package leaflet.
Za odstranjevanje glejte navodilo za uporabo.
13 MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING
13 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
BOTTLE LABEL {250ml/ 500ml}
NALEPKA NA STEKLENIČKI {250 ml/ 500 ml}
Intramuscular or Subcutaneous injection Read the package leaflet before use.
Intramuskularna ali subkutana uporaba Pred uporabo preberite navodilo za uporabo.
Zero days
Karenca: nič dni
Intervet International BV Wim de Körverstraat 35 NL-5831 AN Boxmeer The Netherlands
Intervet International BV Wim de Körverstraat 35 NL- 5831 AN Boxmeer Nizozemska
Nobilis Influenza H5N2 Emulsion of injection
Nobilis Influenza H5N2 Emulzija za injiciranje
On dose of 0.5 ml contains:
En odmerek po 0, 5 ml vsebuje:
Liquid paraffin
Adjuvans: tekoči parafin
0.25 ml subcutaneously
0, 25 ml subkutano
From 14 days to 6 weeks old:
Od 14 dni do 6 tednov starosti:
0.25 or 0.5ml subcutaneously or intramuscularly
0, 25 ali 0, 5 ml subkutano ali intramuskularno
6 weeks and older:
6 tednov in starejši:
0.5ml subcutaneously or intramuscularly
0, 5 ml subkutano ali intramuskularno
Allow the vaccine to reach a temperature of 15°C-25°C and shake well before use.
Cepivo ogrejte na 15 °C – 25 °C in ga pred uporabo dobro pretresite.
Do not freeze.
Shranjujte in prevažajte v hladilniku (2 °C – 8 °C).
After broaching, use within 8 hours, provided the product is not subject to extreme temperatures or contaminated.
Zdravilo ne sme zmrzniti Načeto zdravilo porabite v 8 urah, če izdelek ni bil izpostavljen zelo visoki temperaturi ali kontaminiran.
It is therefore recommended that no other vaccines should be administered 14 days before or after vaccination with the product.
Zato odsvetujemo uporabo katerega koli cepiva v obdobju 14 dni pred ali po cepljenju s tem izdelkom.
18 Pack sizes:
18 Velikosti pakiranja:
Reproduction is authorised provided the source is acknowledged How has Nobilis Influenza H5N6 been studied?
Reproduction is authorised provided the source is acknowledged Kako je bilo zdravilo Nobilis Influenza H5N6 raziskano?
When compared, the subcutaneous and intramuscular routes were shown to produce the same responses. • The vaccine has been shown to prevent clinical signs and mortality and reduce virus shedding in infected chickens. • The vaccine is able to induce antibodies in a wide range of birds. • If the circulating avian influenza field virus has a different N component to the N6 included in the vaccine, it may be possible to differentiate between vaccinated from infected birds by using a diagnostic test to detect Neuraminidase antibodies.
Ob primerjavi subkutanega in intramuskularnega načina dajanja zdravila se je izkazalo, da so bili odzivi enaki. • Dokazano je bilo, da cepivo preprečuje klinične znake in umrljivost ter zmanjšuje izločanje virusa pri okuženih piščancih. • Cepivo je sposobno spodbuditi nastajanje protiteles pri številnih vrstah ptic. • Če ima krožeči divji virus aviarne influence sestavino N, ki se razlikuje od sestavine N6 v cepivu, lahko cepljene ptice razlikujemo od okuženih z diagnostičnim testom za odkrivanje protiteles proti nevraminidazi.
Page 2/ 3 ©EMEA 2008 Why has Nobilis Influenza H5N6 been approved?
Stran 2. od 3 ©EMEA 2008 Zakaj je bilo zdravilo Nobilis Influenza H5N6 odobreno?
Nobilis Influenza H5N6 has been authorised under “ Exceptional Circumstances”.
Zdravilo Nobilis Influenza H5N6 je bilo odobreno v » izjemnih okoliščinah «.
The European Commission granted a marketing authorisation valid throughout the European Union, for Nobilis Influenza H5N6 to Intervet International BV on 31.01.2008.
Evropska komisija je dovoljenje za promet z zdravilom Nobilis Influenza H5N6, veljavno po vsej Evropski uniji, odobrila družbi Intervet International BV dne 31. 01. 2008.
This summary was last updated on 31.01.2008.
Ta povzetek je bil nazadnje posodobljen 31. 01. 2008.
Page 3/ 3 ©EMEA 2008
Stran 3. od 3 ©EMEA 2008
HI titre ≥ 6.0 log2
titer HI ≥ 6. 0 log2
Glass bottles (hydrolytical class II) with rubber stopper and aluminium cap
stekleničke (steklo tipa II) z gumijastimi zamaški in aluminijasto zaporko
PET bottles with rubber stopper and aluminium cap
plastenke iz PET z gumijastimi zamaški in aluminijasto zaporko
Inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/ duck/ Potsdam/ 2243/ 84), inducing an HI titre of ≥ 6.0 log2 as tested according to the potency test.
Inaktivirani antigen podtipa virusa aviarne influence H5 (sev H5N6, A/ raca/ Potsdam/ 2243/ 84), ki vzbudi titer HI ≥ 6, 0 log2 pri preizkusu učinkovitosti.
Liquid light paraffin 234.8 mg/ 0.5 ml
Redko tekoči parafin, 234, 8 mg/ 0, 5 ml
This vaccine has been tested for safety in chickens and some supportive data for safety in ducks are available.
Raven dosežene učinkovitosti je lahko različna glede na stopnjo antigenske homologije med cepnim sevom in sevi na terenu.
If used in other avian species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of birds prior to mass vaccination.
Varnost cepiva je testirana pri piščancih, o njegovi varnosti pri racah pa je na voljo nekaj spremljajočih podatkov.
The level of efficacy for other species may differ from that observed in chickens.
Če ga uporabljamo pri drugih vrstah ptic, za katere menimo, da je pri njih povečano tveganje okužbe, ga moramo uporabljati previdno, pred množičnim cepljenjem pa ga je priporočljivo preskusiti na majhnem številu ptic.
The level of efficacy attained may vary depending on the degree of antigenic homology between the vaccine strain and circulating field strains.
Učinkovitost pri drugih vrstah ptic se lahko razlikuje od učinkovitosti pri piščancih.
Chickens From 8-14 days old:
Piščanci Od 8 do 14 dni starosti:
0.25 ml subcutaneously From 14 days to 6 weeks old:
0, 25 ali 0, 5 ml subkutano ali intramuskularno
0.25 or 0.5 ml subcutaneously or intramuscularly 6 weeks and older:
0, 5 ml subkutano ali intramuskularno
0.5 ml subcutaneously or intramuscularly Future laying hens and breeders should get a second vaccination 4-6 weeks after first vaccination.
Pri bodočih nesnicah in matičnih jatah moramo cepljenje ponoviti 4 do 6 tednov po prvem cepljenju.
2 years Glass vials:
2 leti Steklene viale:
The import, sale, supply and/ or use of Nobilis Influenza H5N6 is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Uvoz, prodaja, oskrba in/ ali uporaba Nobilisa Influenza H5N6 je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
Any person intending to import, sell, supply and/ or use Nobilis Influenza H5N6 must consult the relevant Member State’ s competent authority on the current vaccination policies prior to the import, sale, supply and/ or use.
Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ ali uporabljati Nobilis Influenza H5N6, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred uvozom, prodajo, oskrbo in/ ali uporabo.
The use of this veterinary medicinal product is only allowed under the particular conditions established by the European Community legislation on the control of Avian Influenza.
Uporaba tega zdravila za uporabo v veterinarski medicini je dovoljena samo v posebnih razmerah, ki so opredeljene v zakonodaji Evropske skupnosti za nadzor nad aviarno influenco.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMEA) http: // www. emea. europa. eu.
Laboratorios Intervet SA Poligono El Montalvo Apartado 3006 Salamanca 37080 Spain
Laboratorios Intervet SA Poligono El Montalvo Apartado 3006 Salamanca 37080 Španija
Intervet International BV, site De Bilt Ambachtstraat 4 3732 CN De Bilt The Netherlands
Intervet International BV, site De Bilt Ambachtstraat 4 3732 CN De Bilt Nizozemska
According to Article 71 of Directive 2001/ 82/ EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/ or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
Skladno z 71. členom Direktive 2001/ 82/ ES Evropskega parlamenta in Sveta in dopolnili, države članice prepovejo ali lahko prepovejo uvoz, prodajo, oskrbo in/ ali uporabo zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če se ugotovi da:
Pharmacologically active substance Light liquid paraffin Polysorbate 80 Sorbitan mono oleate (E494) Glycine
Farmakološko aktivna snov redko tekoči parafin polisorbat 80 sorbitan monooleat (E494) glicin
Animal Species All food producing species All food producing species All food producing species All food producing species
Živalska vrsta vse živali za proizvodnjo živil vse živali za proizvodnjo živil vse živali za proizvodnjo živil vse živali za proizvodnjo živil
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile.
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem obdobju izvesti naslednji program študij, katerih rezultati služijo kot osnova za vsakoletno ponovno oceno razmerja korist/ tveganje.
II. A.1 Composition
ANALITIČNI VIDIKI
STARTING MATERIALS
II. A. 1 Sestava
Embryonated chicken eggs (for vaccine production):
Za izdelavo cepiva je dovoljeno uporabiti samo antigen H5N6, pridobljen iz jajc.
The Applicant should confirm that the country of origin of the source flock(s) is Spain and that there will be no change to the source (or changes to the disease control measures applied to the flocks) without informing the CVMP.
METODA PRIPRAVE
H5N6 Working Seed Viruses:
Količina antigena pri pripravi zmesi:
There is no mention of any WSV testing for subtype H5N6 and the Applicant should accept a specific obligation to provide information on the tests conducted on each batch of Working Seed Virus.
Iz preglednice o pripravi zmesi, navedeni kot primer, je razvidno, da je zmes za serije cepiva pripravljena tako, da vsebuje najmanj 13, 4 log10 EID50 na 1, 000 kg.
The Applicant should provide a list of suitable source countries for the pigs used as a source of the porcine starting material in tryptose.
Za študijo kinetike inaktivacije je bila uporabljena serija antigena H5N6, katere predinaktivacijski titer je bil 9. 8 log10 EID50 / ml, kar mora biti največji predinaktivacijski titer za serije antigena.
Specific Measures concerning the prevention of the transmission of animal spongiform encephalopathies
II. C. 1 Navedene v farmakopeji
Tryptose and NZ-Amines:
Jajca, prosta specifičnih antigenov (SPF):
The use of unspecified countries of origin of the cows providing the milk and unspecified suppliers of the tryptose and NZ-Amine is not considered acceptable.
Navedeni morajo biti podrobni podatki o jatah, prostih specifičnih antigenov, ki so uporabljene kot vir za jajca za pripravo WSV (Working Seed Viruses).
Up-to- date information should be provided on the source countries of origin of the animals supplying the milk for preparation of the Tryptose from BD Biosciences and for the preparation of the casein, and lactose where appropriate, for manufacture of the NZ-Amines purchased from Quest/ Kerry.
8 II. C. 2 Niso navedene v farmakopeji