natgillin/translations-raw huggingface dataset:
NAME OF THE VETERINARY MEDICINAL PRODUCT Sedadex 0.1 mg/ml solution for injection for dogs and cats 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Sedadex 0,1 mg/ml raztopina za injiciranje za pse in mačke
The dose volume of atipamezole at the concentration of 5 mg/ml is one-half (1/2) the volume of Sedadex 0.5 mg/ml that was given to the cat. 
Volumen odmerka atipamezola pri koncentraciji 5 mg/ml ustreza eni polovici (1/2) volumna zdravila Sedadex 0,5 mg/ml, ki je bil dan mački.
ONLY” 
VALI”
The dose volume of atipamezole at the concentration of 5 mg/ml is one-tenth (1/10) the volume of Sedadex 0.1 mg/ml that was given to the cat. 
Volumen odmerka atipamezola pri koncentraciji 5 mg/ml ustreza eni desetini (1/10) volumna zdravila Sedadex 0,1 mg/ml, ki je bil dan mački.
BY NUMBE 
N DRUGIH
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INDI
by 
VILA
Dogs: in Cats: int Read the 
Psi: intraven Mačke: intr Pred uporab
EDICINAL 
AVILA
ACKAGE S 
AŽENA Z M
PACKAGE LEAFLET FOR Sedadex 0.5 mg/ml solution for injection for dogs and cats 
NAVODILO ZA UPORABO ZA Sedadex 0,5 mg/ml raztopina za injiciranje za pse in mačke
S) 
E)
HT, BY VOL 
MASO, PRO
PACKAGE LEAFLET FOR Sedadex 0.1 mg/ml solution for injection for dogs and cats 
NAVODILO ZA UPORABO ZA Sedadex 0,1 mg/ml raztopina za injiciranje za pse in mačke
(equivalent to dexmedetomidine 
(ki ustreza 0,08 mg deksmedetomidina).
SARY 
INDIKACIJE
MUM PARTI ial of 10 ml AME OF TH x 0.1 mg/ml i etomidine hy 
VEDBA ZDR e: omidinijev kl 0,08 mg deks
AME OF TH x 0.5 mg/ml s etomidine hy 
ZDRAVILA 5 mg/ml razt omidinijev kl
OD 
VILOM OD
ARGET SP d cats 
RABO V VE iciranje za ps
ATCH NUM mber} 
RABO V VE
TH For anim 
AJMANJ N
ECIES 
NAČ
E(S) OF ADM lar use use. 
(I) UPORA amuskularna a uporaba navodilo za u
BSTANCES 
CINI
AME OF TH x 0.1 mg/ml s etomidine hy 
ZDRAVILA 1 mg/ml razt omidinijev kl
IVE AND O 
IKACIJA(E
WITHDRAWAL PERIOD Not applicable. 
Zato uporaba v obdobju brejosti in laktacije ni priporočljiva.
Intramuscularly: up to 500 micrograms/square metre body surface area. 
Za neinvazivne, blago do zmerno boleče posege in preglede, pri katerih so potrebni mirovanje, sedacija in analgezija: intravensko: do 375 mikrogramov/kvadratni meter telesne površine intramuskularno: do 500 mikrogramov/kvadratni meter telesne površine.
SP Read the 
EBNA OPO bo preberite n
There is no experience in children. 
Pri otrocih ni izkušenj.
Adults from the age of 18 years: 
Odrasli, starejši od 18 let:
Vial A 
Viala A
The symptoms of pandemic flu are similar to those of ordinary flu but are usually more severe. 
Simptomi pandemične gripe so podobni simptomom običajne gripe, vendar pa so običajno hujši.
It spreads rapidly around the world. 
Ta oblika gripe se hitro širi po vsem svetu.
Vial B 
Viala B
• if you are having a blood test to look for evidence of infection with certain viruses. 
• če morate opraviti krvne preiskave zaradi testiranja na okužbe z nekaterimi virusi.
Pandemic flu is a type of influenza that occurs at intervals that vary from less than 10 years to many decades. 
Pandemična gripa je oblika gripe, ki se pojavlja v intervalih od manj kot 10 let do nekaj desetletij.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26/09/2008 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 26/09/2008
The vaccine should not usually be given at the same time as other vaccines. 
Cepiva se običajno ne sme uporabljati sočasno z drugimi cepivi.
These reactions usually disappear within 1-2 days without treatment. 
Ti neželeni učinki običajno minejo brez zdravljenja v 1 do 2 dneh.
• When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities 
• ko se pridobijo novi podatki, ki lahko vplivajo na trenutne varnostne specifikacije, načrt farmakovigilance ali aktivnosti za zmanjševanje tveganja.
For further information, see sections 4.4 and 5.1. 
Za dodatne informacije glejte poglavji 4.4 in 5.1.
1 dose = 0.5 ml 
1 odmerek = 0,5 ml
3.75 micrograms* 
3,75 mikrogramov*
Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or operate machinery. 
Nekateri učinki, navedeni v poglavju 4.8, "Neželeni učinki", lahko vplivajo na sposobnost vožnje in upravljanja s stroji.
During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation (EC) No 726/2004 will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time. 
Med pandemičnimi razmerami pogostnost predložitve periodičnih poročil o varnosti zdravila, ki je določena v 24. členu Uredbe (ES) št. 726/2004, ne bo zadostovala za spremljanje varnosti pandemičnega cepiva, za katerega se v kratkem časovnem obdobju pričakuje visoka stopnja izpostavljenosti.
Allergic reactions, in rare cases leading to shock, have been reported. 
Poročali so o pojavu alergijskih reakcij, ki so v redkih primerih vodile v šok.
MARKETING AUTHORISATION NUMBER(S) EU/1/08/478/001 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/478/001
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR). 
V skladu s smernicami Odbora za zdravila za uporabo v humani medicini za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen načrt za obvladovanje tveganja predložen sočasno z naslednjim periodičnim poročilom o varnosti zdravila (PSUR).
• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached 
• v 60 dneh po pomembnem novem spoznanju (farmakovigilančnem ali povezanem z zmanjševanjem tveganja).
EXP: MM/YYYY 
EXP: MM/LLLL
Healthcare providers need to assess the benefits and potential risks of administering the vaccine to pregnant women taking into consideration official recommendations. 
Zdravnik mora presoditi med koristjo in možnimi tveganji pri cepljenju nosečnic in pri tem upoštevati uradna priporočila.
Immune response to A/Vietnam/1194/2004 (D42) 71 to 80 years 
Imunski odziv proti A/Vietnam/1194/2004 (D42) 71 do 80 let
In addition, duration a pandemic, resources needed for an in-depth evaluation of Periodic Safety Update Reports in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue. 
Poleg tega med trajanjem pandemije, viri, potrebni za poglobljeno vrednotenje periodičnih poročil o varnosti zdravila v obliki, kot je definirana v Pravilih, ki urejajo zdravila v Evropski skupnosti (“Rules Governing Medicinal Product in the European Union” - Volume 9a), morda ne bodo zadostovali za hitro identifikacijo novih varnostnih izsledkov.
If you are not sure, talk to your doctor or pharmacist before having this vaccine. 
Če niste prepričani, se pred cepljenjem posvetujte z zdravnikom ali s farmacevtom.
25 vials x 2: emulsion 
25 vial x 2: emulzija
The vaccine should never be given into a vein or into the skin. 
Cepiva se v nobenem primeru ne sme injicirati v žilo ali v kožo.
From Post-marketing surveillance with interpandemic trivalent vaccines, the following adverse reactions have been reported: 
Med spremljanjem interpandemičnih trivalentnih cepiv po pridobitvi dovoljenja za promet so poročali o naslednjih neželenih učinkih:
Animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonic/fetal development, parturition or post-natal development (see section 5.3). 
Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na plodnost, nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3).
Uncommon: Generalised skin reactions including urticaria 
Občasni: Generalizirane kožne reakcije, vključno z urtikarijo.
When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease. 
Po cepljenju imunski sistem (naravni obrambni sistem telesa) ustvari lastno zaščito (protitelesa) pred boleznijo.
Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection. 
Vsak 0,5-ml odmerek cepiva izvlecite v injekcijsko brizgo.
In consequence, as soon as the pandemic is declared (Phase 6 of the WHO global Influenza preparedness plan) and the prepandemic vaccine is used, the MAH shall submit more frequent simplified periodic safety update reports with a format and a periodicity defined in the "CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context" (EMEA/49993/2008), and any subsequent update. 
Imetnik dovoljenja za promet z zdravilom mora zato takoj po razglasitvi pandemije (faza 6 globalnega načrta SZO o pripravljenosti na gripo) in začetku uporabe prepandemičnega cepiva pogosteje predajati redna posodobljena poročila o varnosti zdravila v obliki in s pogostnostjo, kot je opisano v "CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context" (EMEA/49993/2008) in vseh nadaljnjih dopolnitvah.
Adjuvants are used to improve the body's response to the vaccine. 
Adjuvans se uporablja zato, da okrepi telesni imunski odziv na cepivo.
Very rare (these may occur with up to 1 in 10,000 doses of the vaccine): • Temporary inflammation of the brain and nerves causing pain, weakness and paralysis that may 
Zelo redki (pojavijo se lahko pri do 1 od 10.000 odmerkov cepiva): • Prehodno vnetje možganov in živcev, kar lahko povzroči bolečino, šibkost in ohromelost, ki
Your doctor needs to assess the benefits and potential risks of giving you the vaccine if you are pregnant or breastfeeding. 
Zdravnik mora presoditi o koristih in možnih tveganjih, povezanih s cepljenjem med nosečnostjo ali dojenjem.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine. 
Uporaba drugih zdravil ali cepiv Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
There are no data on administration of AS03-adjuvanted vaccines before or following other types of influenza vaccines intended for pre-pandemic or pandemic use. 
Na voljo ni podatkov o cepljenju s cepivi z adjuvansom AS03, pred ali po cepljenju z drugimi vrstami cepiv proti gripi, ki so namenjena za prepandemično ali pandemično uporabo.
After mixing, the vaccine should be used within 24 hours. 
Po mešanju morate cepivo uporabiti v 24 urah.
Excipients: It contains 5 micrograms thiomersal 
Pomožne snovi: Vsebuje 5 mikrogramov tiomersala.
The MAH must ensure that the system of pharmacovigilance, as described in version V03 (dated 19 November 2007) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market. 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici V03 (z dne 19. november 2007), predstavljen v modulu 1.8.1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
If you have any further questions on the use of this product, ask your doctor or nurse. 
Če imate dodatna vprašanja o uporabi cepiva, se posvetujte z zdravnikom ali z medicinsko sestro.
In addition, an updated RMP should be submitted 
Poleg tega je posodobljen načrt za obvladovanje tveganja treba predložiti
The seroprotection rate against A/Indonesia 21 days after booster vaccination was 92% and 69.2% at day 180. 
Delež serološke zaščite proti A/Indonesia je bil 21 dni po obnovitvenem cepljenju 92% in 180. dan 69,2 %.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version RMPv6 (dated March 2009) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP. 
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil študije in dodatne farmakovigilančne aktivnosti, ki so podrobno opisane v načrtu farmakovigilance, sprejetem v različici RMPv6 (marec 2009) načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1.8.2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah načrta za obvladovanje tveganja v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
• Increased sweating, shivering, flu-like symptoms 
• močnejše znojenje, drgetanje, gripi podobni simptomi.
The vaccine is mixed by withdrawing the contents of the vial containing the emulsion (Vial B) by means of a syringe and by adding it to the vial containing the suspension (Vial A). 
Cepivo zmešate tako, da z injekcijsko brizgo izvlečete vsebino viale z emulzijo (Viala B) in jo dodate v vialo s suspenzijo (Viala A).
Outside of the pandemic period, the normal PSUR periodicity and format will be maintained. 
Izven pandemicnega obdobja se bodo periodicna porocila o varnosti zdravila (PSUR) predajala v obicajni obliki in casovnih obdobjih.
A second dose of 0.5 ml should be given after an interval of at least three weeks. 
Drugi odmerek 0,5 ml morajo prejeti najmanj 3 tedne po prvem odmerku.
Immune response to A/Indonesia/5/2005 0, 6 months schedule 7 days after 2nd dose 
Imunski odziv na A/Indonesia/5/2005 shema 0, 6 mesecev 7 dni po drugem odmerku n=47
Uncommon (these may occur with up to 1 in 100 doses of the vaccine): • Generalised skin reactions including urticaria (hives) 
Občasni (pojavijo se lahko pri do 1 od 100 odmerkov cepiva): • Generalizirane kožne reakcije, vključno z urtikarijo (koprivnico).
After mixing, one dose (0.5 ml) contains 3.75 micrograms of haemagglutinin from the following influenza virus strain: 
Po premešanju en odmerek (0,5 ml) vsebuje 3,75 mikrogramov hemaglutinina naslednjega seva virusa gripe:
The mixed vaccine is a whitish emulsion. 
Zmešano cepivo je belkasta emulzija.
• Narrowing or blockage of blood vessels with kidney problems 
• Zoženje ali zapora krvnih žil z ledvičnimi težavami.
Acute severe febrile illness. 
Hujša akutna bolezen z zvišano telesno temperaturo.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/. 
DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http://www.emea.europa.eu/.
Clinical studies have evaluated the incidence of adverse reactions listed below in approximately 5,000 subjects 18 years old and above who received formulations containing at least 3.75 microgram HA/AS03. 
S kliničnimi študijami so ocenili pojavnost spodaj navedenih neželenih učinkov pri približno 5.000 preiskovancih, starih 18 let in več, ki so prejeli cepiva z vsaj 3,75 mikrograma HA/AS03.
After the addition of the emulsion to the suspension, the mixture should be well shaken. 
Potem, ko emulzijo dodate suspenziji, morate mešanico dobro pretresti.
Suspension for emulsion for injection 50 vials: suspension 
Suspenzija za emulzijo za injiciranje 50 vial: suspenzija
Neuralgia, convulsions, transient thrombocytopenia. 
Nevralgija, konvulzije, prehodna trombocitopenija.
Immunisation should be postponed. 
V tem primeru je treba cepljenje odložiti.
Blood and lymphatic system disorders Common: lymphadenopathy 
Bolezni krvi in limfatičnega sistema Pogosti: limfadenopatija
Immune response to A/Vietnam/1194/2004 0, 21 days schedule 
Imunski odziv proti A/Vietnam/1194/2004 shema 0, 21 dni shema 0, 6 mesecev
Split influenza virus inactivated, containing antigen* equivalent to: 
Inaktivirane delce virusa gripe z vsebnostjo antigena*, ki ustreza:
Very common: headache Uncommon: paraesthesia, somnolence, dizziness 
Zelo pogosti: glavobol Občasni: parestezije, somnolenca, omotica
Please tell your doctor if you are/may be pregnant or intend to become pregnant, or if you are breast-feeding and follow his advice. 
Če ste noseči, mislite, da ste noseči, nameravate zanositi ali dojite to povejte svojemu zdravniku.
• Diarrhoea, vomiting, stomach pain, feeling sick 
• driska, bruhanje, bolečine v želodcu, siljenje na bruhanje.
After two doses administered 6 months apart all subjects had a titre of at least 1:80. 
Po dveh odmerkih uporabljenih v razmaku 6 mesecev so vsi preiskovanci imeli titer vsaj 1:80.
Vial A: multidose vial containing the antigen (suspension), Vial B: multidose vial containing the adjuvant (emulsion). 
Viala A: večodmerna viala z antigenom (suspenzija) Viala B: večodmerna viala z adjuvansom (emulzija)
QUALITATIVE AND QUANTITATIVE COMPOSITION After mixing, 1 dose (0.5 ml) contains: 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Po premešanju 1 odmerek (0,5 ml) vsebuje:
Emulsion for emulsion for injection 25 vials: emulsion 
Emulzija za emulzijo za injiciranje 25 vial: emulzija
After two doses given 21 days or 6 months apart, 96.0% of subjects had a 4-fold increase in serum neutralising antibody titres and 98-100% had a titre of at least 1:80. 
Po dveh odmerkih apliciranih 21 dni ali 6 mesecev narazen je 96,0 % preiskovancev imelo 4-krat večji titer nevtralizacijskih protiteles v serumu in 98-100 % preiskovancev je imelo titer vsaj 1:80.
The day 180 seroprotection rates in subjects aged >60 years were 52.9% for those who received two single doses and 69.5% of subjects for those who had received two double doses at day 0 and day 21. 
180. dan je bila serološka zaščita preiskovancev, starejših od 60 let, 52,9%, če so prejeli na dan 0 in 21. dan dva enojna odmerka in 69,5%, če so prejeli dva dvojna odmerka.
The suspension is a colourless light opalescent liquid. 
Suspenzije je brezbarvna, rahlo opalescentna tekočina.
This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared from A/VietNam/1194/2004 NIBRG-14 (H5N1) (see section 5.1). 
Indikacija temelji na podatkih o imunogenosti pri zdravih prostovoljcih, starejšiih od 18 let, po cepljenju z dvema odmerkoma cepiva, pripravljenega iz A/VietNam/1194/2004 NIBRG-14 (H5N1) (glejte poglavje 5.1).
A 4-fold increase in serum neutralising antibody titres from day 0 was observed in 85.7% at day 42 and 72% at day 180. 
Od dneva 0 so 4-kraten porast titra nevtralizirajočih protiteles v serumu ugotovili 42. dan pri 85,7 % oseb, 180. dan pri 72 % oseb.
Against A/Vietnam 21 days after boosting with A/Vietnam 
anti-HA protitelesa Proti A/Vietnam 21 dni po obnovitvi Proti A/Indonesia 21 dni po obnovitvi z A/Vietnam n = 46
To be mixed with Vial A before administration 
Pred uporabo zmešajte skupaj z vialo A
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 10 doses (2.5 ml) 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 10 odmerkov (2,5 ml)
1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40; 
1Delež serološke zaščite: delež preiskovancev s titrom inhibicije hemaglutinacije (HI) ≥ 1:40.
To be mixed with Vial B before administration 
Pred uporabo zmešajte skupaj z vialo B
Based on very limited data, adults aged >80 years may require a double dose of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg on an elected date and again after an interval of at least three weeks in order to achieve an immune response (see section 5.1). 
Na podlagi zelo omejenih podatkov kaže, da lahko odrasli, starejši od 80 let, potrebujejo za doseganje imunskega odziva dvojni odmerek cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg na izbrani datum in znova po presledku vsaj treh tednov (glejte poglavje 5.1).
Very common (these may occur with more than 1 in 10 doses of the vaccine): 
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 odmerkov cepiva):
The needle used for withdrawal must be replaced by a needle suitable for intramuscular 
Pred aplikacijo morate iglo, ki ste jo uporabili pri izvleku cepiva, zamenjati z iglo, primerno za
If you take any medicines that reduce immunity to infections or have any other type of treatment (such as radiotherapy) that affects the immune system, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg can still be given but your response to the vaccine may be poor. 
Če jemljete katerokoli zdravilo, ki zmanjšuje imunost proti okužbam, ali se zdravite s katerokoli drugo obliko zdravljenja, ki vpliva na imunski sistem (npr. obsevanje), ste s cepivom Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg lahko cepljeni, vendar pa je odziv na cepivo lahko slabši.
However, if coadministration with another vaccine is considered to be essential, the vaccines should be injected into separate limbs. 
Če je sočasno cepljenje nujno, je treba drugo cepivo injicirati v drugo okončino.
3booster factor: ratio of the post-booster geometric mean titre (GMT) and the pre-booster GMT. 
3Obnovitveni dejavnik: razmerje geometrijske sredine (GMS) titra po obnovitvenem odmerku in GMS titra pred obnovitvenim odmerkom.
- two packs of 25 vials (type I glass) of 2.5 ml emulsion (10 x 0.25 ml doses) with a stopper (butyl rubber). 
- dve pakiranji s 25 vialami (steklo tipa I) po 2,5 ml emulzije (10 x 0,25 ml odmerki) z zamaškom iz butilne gume.
Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1): 
Navzkrižni imunski odziv na cepivo z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz A/Vietnam/1194/2004 (H5N1):
• two packs containing 25 vials of 2.5 ml emulsion (adjuvant) for 10 doses 
• dve pakiranji s 25 vialami po 2,5 ml emulzije (adjuvans) za 10 odmerkov
If any of these side effects occur, please tell your doctor or pharmacist immediately. 
Če opazite katerikoli neželeni učinek od the, nemudoma obvestite svojega zdravnika ali farmacevta.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 50 VIALS OF SUSPENSION 
PODATKI NA ZUNANJI OVOJNINI PAKIRANJE S 50 VIALAMI SUSPENZIJE
OTHER SPECIAL WARNING(S), IF NECESSARY Emulsion to be exclusively mixed with suspension before administration 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Emulzijo morate pred uporabo zmešati izključno s suspenzijo.
After the vaccine is mixed: After mixing, use the vaccine within 24 hours and do not store above 25°C. 
Po premešanju cepiva: Po premešanju morate cepivo uporabiti v 24 urah.
• Warmth, itching or bruising at the injection site 
• občutek toplote, srbenje ali modrica na mestu injiciranja.
0, 6 months schedule 
6.3 Rok uporabnosti
In the event of either being observed, discard the vaccine. 
Če opazite eno ali drugo, morate cepivo zavreči.
Caution is needed when administering this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal and to residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate). 
Previdnost je potrebna pri cepljenju oseb z znano preobčutljivostjo (poleg anafilaktične reakcije) za zdravilno učinkovino, katerokoli pomožno snov, tiomersal ali zaostanke (jajčne ali piščančje proteine, ovalbumin, formaldehid, gentamicinijev sulfat ali natrijev deoksiholat).
Gastrointestinal disorders Uncommon: gastro-intestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea) 
Bolezni prebavil Občasni: prebavni simptomi (kot so driska, bruhanje, bolečine v trebuhu, navzea)
Before mixing the two components, the emulsion and suspension should be allowed to reach room temperature, shaken and inspected visually for any foreign particulate matter and/or abnormal physical appearance. 
Preden obe komponenti zmešate skupaj, morate pustiti, da se emulzija in suspenzija segrejeta na sobno temperaturo.