natgillin/translations-raw huggingface dataset:
The Committee initially concluded that for the treatment of dementia due to Parkinson's disease, Rivastigmine Sandoz's benefits did not outweigh its risks.
Odbor je prvotno sklenil, da za zdravljenje demence, ki je posledica Parkinsonove bolezni, koristi zdravila Rivastigmine Sandoz ne odtehtajo njegovih tveganj.
For more information about treatment with Rivastigmine Sandoz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Rivastigmine Sandoz preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The CHMP concluded that Rivastigmine Sandoz has a modest effectiveness in treating the symptoms of Alzheimer's dementia, although this does reflect an important benefit in some patients.
CHMP je zaključil, da ima zdravilo Rivastigmine Sandoz pri zdravljenju simptomov Alzheimerjeve demence skromen učinek, čeprav ta pomeni pomembno korist za nekatere bolnike.
Treatment with Rivastigmine Sandoz should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease or dementia in patients with Parkinson's disease.
Zdravljenje z zdravilom Rivastigmine Sandoz mora uvesti in nadzorovati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem Alzheimerjeve bolezni ali demence pri bolnikih s Parkinsonovo boleznijo.
Rivastigmine Sandoz must not be used in people who are hypersensitive (allergic) to rivastigmine, other carbamate derivatives or any of the other ingredients.
Zdravila Rivastigmine Sandoz ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) rivastigmin, druge derivate karbamata ali katero koli drugo sestavino zdravila.
Therefore, the Committee decided that Rivastigmine Sandoz's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zato sklenil, da so koristi zdravila Rivastigmine Sandoz večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
All of the studies lasted six months and compared the effects of Rivastigmine Sandoz with those of placebo (a dummy treatment).
Vse študije so trajale šest mesecev, v njih pa so primerjali učinke zdravila Rivastigmine Sandoz z učinki placeba (zdravila brez zdravilne učinkovine).
Rivastigmine Sandoz was more effective than placebo at controlling symptoms.
Zdravilo Rivastigmine Sandoz je bilo pri obvladovanju simptomov učinkovitejše od placeba.
Rivastigmine Sandoz is used for the treatment of patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Zdravilo Rivastigmine Sandoz se uporablja za zdravljenje bolnikov z blago do zmerno hudo Alzheimerjevo demenco, tj. napredujočo okvaro možganov, ki postopoma prizadene spomin, intelektualne zmožnosti in vedenje.
An additional study in 27 patients was used to show that Rivastigmine Sandoz capsules and oral solution produced similar levels of the active substance in the blood.
Z dodatno študijo s 27 bolniki so dokazali, da kapsule in peroralna raztopina zdravila Rivastigmine Sandoz dosegajo podobne ravni zdravilne učinkovine v krvi.
Rivastigmine Sandoz has been studied in three main studies involving 2,126 patients with mild to moderately severe Alzheimer's disease.
Zdravilo Rivastigmine Sandoz so proučevali v treh glavnih študijah, v katerih je sodelovalo 2 126 bolnikov z blago do zmerno hudo obliko Alzheimerjeve bolezni.
Other information about Rivastigmine Sandoz
Druge informacije o zdravilu Rivastigmine Sandoz
Rivastigmine Sandoz was also studied in 541 patients with dementia due to Parkinson's disease.
Zdravilo Rivastigmine Sandoz so proučevali tudi pri 541 bolnikih z demenco kot posledico Parkinsonove bolezni.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Rivastigmine Sandoz.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Rivastigmine Sandoz, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The global symptom score also improved more in the patients taking Rivastigmine Sandoz.
Tudi rezultat celostne ocene simptomov je bil boljši pri bolnikih, ki so jemali zdravilo Rivastigmine Sandoz.
By blocking these enzymes, Rivastigmine Sandoz allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia and dementia due to Parkinson's disease.
Zdravilo Rivastigmine Sandoz z blokiranjem teh encimov omogoča, da se ravni acetilholina v možganih povečajo, zaradi česar se simptomi Alzheimerjeve demence in demence zaradi Parkinsonove bolezni ublažijo.
In the three studies of Rivastigmine Sandoz in patients with Alzheimer's dementia, patients taking doses of Rivastigmine Sandoz between 6 and 9 mg per day had an average increase in cognitive symptoms of 0.2 points from a baseline of 22.9 points at the start of the study, where a lower score indicates better performance.
V treh študijah zdravila Rivastigmine Sandoz pri bolnikih z Alzheimerjevo demenco je bilo pri tistih, ki so jemali od 6- do 9-miligramske odmerke zdravila Rivastigmine Sandoz, opaziti povprečno povečanje kognitivnih simptomov za 0,2 točke od izhodiščne vrednosti 22,9 točk na začetku študije, pri čemer nižji rezultat pomeni boljšo učinkovitost.
Rivastigmine Sandoz is a medicine containing the active substance rivastigmine.
Rivastigmine Sandoz je zdravilo, ki vsebuje zdravilno učinkovino rivastigmin.
For the global score, patients taking Rivastigmine Sandoz had an increase in symptoms of 4.1 points, compared with 4.4 in those taking placebo.
Kar zadeva rezultat celostne ocene simptomov so imeli bolniki, ki so jemali zdravilo Rivastigmine Sandoz, povečanje v simptomih za 4,1 točke v primerjavi s 4,4 točke pri tistih, ki so jemali placebo.
The patients with dementia due to Parkinson's disease taking Rivastigmine Sandoz capsules showed an improvement in cognitive symptoms of 2.1 points, compared with a worsening of 0.7 points in those taking placebo, from a baseline of around 24 points.
Pri bolnikih z demenco zaradi Parkinsonove bolezni, ki so jemali kapsule zdravila Rivastigmine Sandoz, je bilo opaziti izboljšanje kognitivnih simptomov za 2,1 točke, v primerjavi s poslabšanjem za 0,7 točke pri tistih, ki so jemali placebo, od izhodiščne vrednosti približno 24 točk.
What benefit has Rivastigmine Sandoz shown during the studies?
Kakšne koristi je zdravilo Rivastigmine Sandoz izkazalo med študijami?
In patients who tolerate this dose, it can be increased in 1.5-mg steps no more frequently than every two weeks, to a regular dose of 3 to 6 mg twice a day.
Pri bolnikih, ki prenašajo navedeni odmerek, se lahko ta postopoma povečuje za 1,5 mg, vendar ne pogosteje kot vsaka dva tedna, dokler se ne doseže stalni odmerek 3 do 6 mg dvakrat na dan. Za dosego največje učinkovitosti se uporabi največji odmerek, ki ga bolnik še prenaša, vendar ta ne sme preseči 6 mg dvakrat na dan.
The active substance in Rivastigmine Sandoz, rivastigmine, is an antidementia medicine.
Zdravilna učinkovina zdravila Rivastigmine Sandoz, rivastigmin, je zdravilo proti demenci.
The types of side effects seen with Rivastigmine Sandoz depend on the type of dementia it is being used to treat.
Vrste neželenih učinkov, opaženih pri zdravilu Rivastigmine Sandoz, so odvisne od tipa demence, ki se zdravi.
For the full list of all side effects reported with Rivastigmine Sandoz, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rivastigmine Sandoz, glejte navodilo za uporabo.
Rivastigmine Sandoz is also used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Zdravilo se lahko uporablja tudi za zdravljenje blage do zmerno hude demence pri bolnikih s Parkinsonovo boleznijo.
What is the risk associated with Rivastigmine Sandoz?
Kakšna tveganja so povezana z zdravilom Rivastigmine Sandoz?
Why has Rivastigmine Sandoz been approved?
Zakaj je bilo zdravilo Rivastigmine Sandoz odobreno?
What is Rivastigmine Sandoz used for?
Za kaj se zdravilo Rivastigmine Sandoz uporablja?
What is Rivastigmine Sandoz?
Kaj je zdravilo Rivastigmine Sandoz?
How does Rivastigmine Sandoz work?
Kako zdravilo Rivastigmine Sandoz deluje?
How has Rivastigmine Sandoz been studied?
Kako je bilo zdravilo Rivastigmine Sandoz raziskano?
How is Rivastigmine Sandoz used?
Kako se zdravilo Rivastigmine Sandoz uporablja?
A proposal should be provided.
Zahtevan je predlog.
4.6 Adverse Reactions (frequency and seriousness)
4.6 Neželeni učinki (pogostost in resnost)
PET vials: 2 years Glass vials: 1 year
Viale iz PET: 2 leti Steklene viale: 1 leto
Special warning for the user:
Posebno opozorilo za uporabnika:
The specified timeframe for all specific obligations is that a first update on the progress of the fulfilment of the specific obligations is expected to be received by the CVMP by 1 October 2007.
Časovni okvir, določen za vse specifične obveznosti je opredeljen tako, da prejme Odbor za zdravila za uporabo v veterinarski medicini (CVMP) prvo posodobljeno poročilo o izpolnjevanju specifičnih obveznosti do 1. oktobra 2007.
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:
MARKETING AUTHORISATION NUMBER(S) EU/2/07/076/001-004
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/07/076/001-004
Do not freeze.
Zdravilo ne sme zmrzniti
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Imetnik dovoljenja za promet z zdravilom mora obvestiti Evropsko komisijo o načrtih trženja z zdravilom, za katerega je izdana ta odločba.
It is recommended to use a closed multidose vaccination system.
Priporočamo uporabo zaprtega sistema za cepljenje z večtočkovnim vbrizgom.
BATCH NUMBER <Lot> {number}
ŠTEVILKA SERIJE <Lot> {številka}
Pharmacotherapeutic group: inactivated vaccine, ATC-vet code: QI01AA23
Farmakoterapevtska skupina: inaktivirano cepivo, oznaka ATC vet: QI01AA23
ANALYTICAL ASPECTS
ANALITIČNI VIDIKI
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 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.
Predlagatelj mora predložiti 3-mesečna periodična poročila o varnosti za prvi 2 leti po prvi uporabi na terenu in protokol, ki zagotavlja ustrezno zapisovanje podatkov in poročanje o podatkih s terena o sumu na neželene učinke, tudi sumu na odsotnost učinkovitosti.
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
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.
For a full list of excipients see section 6.1
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
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.
The level of efficacy for other species may differ from that observed in chickens.
Učinkovitost pri drugih vrstah ptic se lahko razlikuje od učinkovitosti pri piščancih.
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.
Tryptose: The Applicant should provide a list of suitable source countries for the pigs used as a source of the porcine starting material in tryptose.
Triptoza: Predlagatelj mora predložiti seznam primernih držav izvora za prašiče, uporabljene kot vir prašičje vhodne snovi v triptozi.
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 se ne sme shranjevati dlje kot 12 mesecev pri temperaturi 2-8 ºC, dokler ne bo na voljo nadaljnjih podatkov, na podlagi katerih bo možno daljše obdobje shranjevanja.
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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Following the administration of a double dose no adverse reactions other than those described in section 4.6 have been observed.
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Po vnosu dvojnega odmerka niso zasledili drugačnih neželenih učinkov, kot so opisani v poglavju 4.6. 4.11 Karenca
Do not use after the expiry date which is stated on the label.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini.
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.
PHARMACOVIGILANCE ASPECTS
FARMAKOVIGILANČNI VIDIKI
Immunisation of progeny from vaccinated birds should therefore be delayed until such antibodies have declined.
Imunizacijo potomcev cepljenih ptic je zato treba odložiti, dokler se količina protiteles ne zmanjša.
The level of efficacy attained may vary depending on the degree of antigenic homology between the vaccine strain and circulating field strains.
Raven dosežene učinkovitosti je lahko različna glede na stopnjo antigenske homologije med cepnim sevom in sevi na terenu.
Reduction of clinical signs, mortality and excretion of virus after challenge with a virulent H5N1 strain, were shown by two weeks after a single dose vaccination.
Klinični znaki, umrljivost in izločanje virusa so se po provokaciji z virulentnim sevom H5N1 zmanjšali v dveh tednih po cepljenju z enim odmerkom.
Up-todate 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.
Navedeni morajo biti posodobljeni podatki o državah izvora za živali, ki služijo kot vir mleka za pripravo triptoze iz BD Biosciences in za pripravo kazeina ter laktoze, kadar je primerno, za izdelavo NZ-aminov, kupljenih pri Quest/Kerry.
Stability
F. STABILNOST
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.
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.
NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Influenza H5N6
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Nobilis Influenza H5N6
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 aluminijastimi zaporkami s šifro.
MANUFACTURER'S BATCH NUMBER Lot {number}
IZDELOVALČEVA ŠTEVILKA SERIJE Lot{številka}
The use of this veterinary medicnal 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.
PACKAGE SIZE 250 ml
VELIKOST PAKIRANJA 250 ml
No information is available on vaccination in the presence of maternally derived antibodies.
Ni podatkov o cepljenju v prisotnosti materinih protiteles.
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Če vam je bil ta izdelek nenamerno injiciran, se takoj posvetujte z zdravnikom, čeprav je bila injicirana le majhna količina, in mu pokažite navodilo za uporabo.
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.
All food producing species All food producing species
vse živali za proizvodnjo živil vse živali za proizvodnjo živil glicin vse živali za proizvodnjo živil
The Applicant should agree to specify the NZ-Amine(s) used in production and only to source Tryptose and these specified NZ-Amine(s) 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.
Predlagatelj mora soglašati, da bo podrobno navedel NZ-amin(e), ki jih bo uporabil v proizvodnji in kot vir za triptozo in podrobno naveden(e) NZamin(e) uporabljal samo podjetja, za katera so v dokumentaciji primerne 'izjave o mleku' in podrobni podatki o državah izvora živali, ki služijo kot vir.
ADVICE ON CORRECT ADMINISTRATION Allow the vaccine to reach a temperature of 15°C-25°C and shake well before use.
NASVET O PRAVILNI UPORABI ZDRAVILA Cepivo ogrejte na 15 °C-25 °C in ga pred uporabo dobro pretresite.
Serum antibodies have been shown to persist in chickens for at least 7 months and studies performed with other vaccine strains show that serum antibodies would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine.
Pokazalo se je, da trajajo pri piščancih zaščitne ravni protiteles v serumu najmanj 7 mesecev, študije z drugimi cepnimi sevi pa so pokazale, da bi bila pri piščancih po dveh odmerkih cepiva protitelesa v serumu predvidoma prisotna najmanj 12 mesecev.
NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Influenza H5N6 emulsion for injection for chickens
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Nobilis Influenza H5N6, emulzija za injiciranje za piščance
This vaccine has been tested for safety in chickens and only some supportive data for safety in ducks are available.
Varnost cepiva je testirana pri piščancih, o njegovi varnosti pri racah pa je na voljo nekaj spremljajočih podatkov.
SPECIAL STORAGE CONDITIONS Store refrigerated (2°C to +8°C).
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte v hladilniku (2 °C do +8 °C).
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 250 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 250 ml
E. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
E. POSEBNE ZAHTEVE, KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
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 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 N6 v cepivu, lahko cepljene ptice razlikujemo od okuženih z diagnostičnim testom za odkrivanje protiteles proti nevraminidazi.
From 8-14 days old: 0.25 ml subcutaneously
Od 8 do 14 dni starosti: 0,25 ml subkutano
ROUTE(S) OF ADMINISTRATION Intramuscular or subcutaneous injection Read the package leaflet before use.
POT(I) UPORABE ZDRAVILA Intramuskularno ali subkutano Pred uporabo preberite navodilo za uporabo.
From 14 days to 6 weeks old: 0.25 or 0.5 ml subcutaneously or intramuscularly 6 weeks and older: 0.5 ml subcutaneously or intramuscularly Future laying hens and breeders should get a second vaccination 4-6 weeks after first vaccination.
Od 14 dni do 6 tednov starosti: 0,25 ali 0,5 ml subkutano ali intramuskularno Stari 6 tednov in starejši: 0,5 ml subkutano ali intramuskularno Pri bodočih nesnicah in matičnih jatah moramo cepljenje ponoviti 4 do 6 tednov po prvem cepljenju.
Liquid light paraffin 234.8 mg/0.5 ml
Redko tekoči parafin, 234,8 mg/0,5 ml
METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular or subcutaneous injection of 0.25 or 0.5 ml, depending on the age.
Intramuskularno ali subkutano odmerek po 0,25 ali 0,5 ml, glede na starost.
Adjuvant: Liquid light paraffin 234.8 mg/0.5 ml
Adjuvans: Redko tekoči parafin, 234,8 mg/0,5 ml
The following substances contained in the final product are included in Annex II of Council Regulation (EEC) No 2377/90:
D. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) Naslednje snovi, ki jih vsebuje končni izdelek, so vključene v Dodatek II Uredbe Sveta (ES) št.
250 or 500 ml multidose glass bottle 250 or 500 ml multidose PET bottle The bottles are closed with a rubber stopper and an aluminium cap.
Večodmerna steklenička po 250 ali 500 ml Večodmerna plastenka iz PET po 250 ali 500 ml Steklenička in plastenka sta zaprti z gumijastim zamaškom in aluminijasto zaporko.
250 ml or 500 ml bottles of glass, hydrolytical class type II or of polyethylene terephthalate (PET).
Stekleničke po 250 ml ali 500 ml iz stekla tipa II ali plastenke po 250 ml ali 500 ml iz polietilen tereftalata (PET).
Test for identification: A final product batch test should be introduced to identify the neuraminidase component and confirm that the vaccine has the correct composition.
KONTROLA KAKOVOSTI KONČNEGA IZDELKA II.E.2 Istovetnost in vsebnost zdravilnih učinkovin Preskus istovetnosti: Vpeljati je treba končni preskus serije izdelka za istovetnost sestavine nevraminidaze in potrditev, da ima cepivo pravilno sestavo.
Polysorbate 80 Sorbitan mono oleate (E494)
Druge določbe redko tekoči parafin vse živali za proizvodnjo živil polisorbat 80 sorbitan monooleat (E494)
MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
The vaccine stimulates active immunity against Avian Influenza virus type A, subtype H5.
Cepivo vzbudi aktivno imunost proti virusu aviarne influence tipa A, podtip H5.
Adjuvant: Liquid paraffin
Adjuvans: redko tekoči parafin
QUALITATIVE AND QUANTITATIVE COMPOSITION One dose of 0.5ml contains:
KAKOVOSTNA IN KOLIČINSKA SESTAVA En odmerek po 0,5 ml vsebuje:
Liquid light paraffin Polysorbate 80
Seznam pomožnih snovi redko tekoči parafin polisorbat 80 sorbitan monooleat glicin