natgillin/translations-raw huggingface dataset:
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or trace residues (chicken protein, benzonase and gentamicin). 
Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, ali ostanke v sledovih (piščančje beljakovine, benzonazo in gentamicin).
However, your doctor will assess whether the possible benefit in terms of preventing smallpox would outweigh the potential risks of giving you this vaccine. 
Vendar bo zdravnik ocenil, ali bi morebitna korist preprečevanja črnih koz odtehtala morebitna tveganja, povezana s cepljenjem.
If you have never been vaccinated against smallpox: 
Če še nikoli niste bili cepljeni proti črnim kozam:
The following information is intended for healthcare professionals only: Instructions for preparation and administration of the vaccine: 
Naslednje informacije so namenjene samo zdravstvenemu osebju:
If a booster dose is considered necessary then a single dose of 0.5 ml should be administered. 
Če se oceni, da je potreben poživitveni odmerek, je treba uporabiti en 0,5-ml odmerek.
It must not be injected into a blood vessel. 
Cepiva se ne sme injicirati v krvno žilo.
IMVANEX may trigger local rashes or more widespread eruptions. 
Cepivo IMVANEX lahko izzove lokalne izpuščaje ali bolj razširjene kožne izbruhe.
IMVANEX may not fully protect all people who are vaccinated. 
Cepivo IMVANEX morda ne bo v celoti zaščitilo vseh cepljenih oseb.
• influenza like illness, 
• šibkost • gripi podobna bolezen
• increase of cardiac laboratory values (like Troponin I ), liver enzyme increased, white blood cell count decreased, mean platelet volume decreased 
• povečanje laboratorijskih vrednosti za srce (kot je troponin I), povečanje jetrnih encimov, zmanjšanje števila belih krvničk, znižanje povprečnega volumna trombocitov
ACAM2000 was administered via scarification. 
Cepivo ACAM2000 so aplicirali s skarifikacijo.
This vaccine contains trace residues of gentamicin and benzonase. 
Cepivo vsebuje ostanke gentamicina in benzonaze v sledovih.
• Make sure you complete the vaccination course of two injections. 
• Cikel cepljenja z dvema injiciranjema morate zaključiti.
Injury, poisoning and procedural complications 
Poškodbe, zastrupitve in zapleti pri posegih udarnina
The European Medicines Agency has deferred the obligation to submit the results of studies with IMVANEX in all subsets of the paediatric population for prevention of smallpox infection by active immunisation against smallpox infection and disease (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s cepivom IMVANEX za vse podskupine pediatrične populacije za preprečevanje okužbe s črnimi kozami z aktivno imunizacijo proti okužbi s črnimi kozami ali bolezni črnih koz (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Immunocompromised patients (e.g. HIV infected, patients under immunosuppressive therapy) who have been previously vaccinated against smallpox should receive two booster doses. 
Bolniki z oslabljenim imunskim odzivom (npr. bolniki, okuženi z virusom HIV, bolniki, ki se zdravijo z imunosupresivi), ki so bili predhodno cepljeni proti virusu črnih koz, morajo prejeti dve poživitveni cepljenji.
The most common adverse reactions observed in clinical trials were injection site reactions and common systemic reactions typical for vaccines which were mild to moderate in intensity and resolved without intervention within seven days following vaccination. 
Najpogostejši neželeni učinki, ki so jih opazili med kliničnimi preskušanji, so bile reakcije na mestu injiciranja in pogoste sistemske reakcije, običajne za cepiva, ki so bile po intenzivnosti blage do zmerne in so v sedmih dneh po cepljenju izzvenele brez ukrepov.
Booster vaccination (individuals previously vaccinated against smallpox): There are inadequate data to determine the appropriate timing of booster doses. 
Poživitveno cepljenje (posamezniki, ki so že bili cepljeni proti črnim kozam): Podatki ne zadoščajo za določitev ustreznega časovnega obdobja za poživitvene odmerke.
The concomitant administration of the vaccine with any immunoglobulin including Vaccinia Immune Globulin (VIG) has not been studied and should be avoided. 
Sočasne uporabe cepiva s katerim koli imunoglobulinom, vključno z imunoglobulinom vakcinija (VIG = Vaccinia Immune Globulin), niso preučili, zato se ji je treba izogniti.
• if you have HIV infection or any other condition or treatment leading to a weakened immune system. 
• če ste okuženi z virusom HIV ali imate drugo bolezen oz. se zdravite z zdravili, ki slabijo imunski sistem.
7% of the individuals with AD in clinical trials with IMVANEX experienced a flare-up or worsening of their skin condition during the course of the trial. 
7 % posameznikov z AD je v kliničnih preskušanjih s cepivom IMVANEX v teku preskušanja doživelo izbruh ali poslabšanje kožne bolezni.
• swelling of the ankles, feet or fingers, 
• oteklost gležnjev, stopal ali prstov
ELISA = enzyme-linked immunosorbent assay; GMT= geometric mean titre; N = number of subjects in the specific study group; PRNT = plaque reduction neutralisation test; SCR = seroconversion rate. 
ELISA = encimsko imunski test (enzyme-linked immunosorbent assay); GMT= geometrični povprečni titer (geometric mean titre); N = število oseb v specifični študijski skupini; PRNT = nevtralizacijski test redukcije plakov (plaque reduction neutralisation test); SCR = stopnja serokonverzije (seroconversion rate).
A second dose of 0.5 ml should be administered no less than 28 days after the first dose. 
Drugi odmerek 0,5 ml je treba dati vsaj 28 dni po prvem odmerku.
• sweating, 
• znojenje
The most common side effects reported were at the site of injection. 
Najpogosteje so poročali o neželenih učinkih na mestu injiciranja.
• influenza, 
• gripa
What you need to know before you receive IMVANEX 3. 
Kaj morate vedeti, preden boste dobili cepivo IMVANEX 3.
As seen with traditional smallpox vaccines, a significant reduction in both mortality and morbidity (viral load, weight loss, number of pox lesions, etc.) compared to non-vaccinated controls was demonstrated for NHP vaccinated with IMVANEX. 
Kot pri tradicionalnih cepivih proti črnim kozam se je smrtnost in obolevnost (virusna obremenitev, izguba telesne mase, število lezij zaradi koz itd.) pri primatih, cepljenih s cepivom IMVANEX, močno zmanjšala v primerjavi z necepljeno kontrolno skupino.
There are limited data (less than 300 pregnancy outcomes) from the use of IMVANEX in pregnant women. 
Podatki o uporabi cepiva IMVANEX pri nosečnicah so omejeni (manj kot 300 izidov nosečnosti).
If you have previously been vaccinated against smallpox: 
Če ste predhodno že bili cepljeni proti črnim kozam:
Immunisation should be carried out by subcutaneous injection, preferably into the upper arm (deltoid). 
Način uporabe Imunizacija se opravi s subkutanim injiciranjem, najbolje v nadlaket (v deltoidno mišico).
Events of rash after vaccination (related cases observed in 0.4% of subjects) with IMVANEX tend to occur within the first days after vaccination, are mild to moderate in intensity and usually resolve without sequelae. 
Dogodki z izpuščajem po cepljenju (zadevne primere so opazili pri 0,4 % oseb) s cepivom IMVANEX se pojavljajo v prvih dneh po cepljenju, so po intenzivnosti blagi do zmerni in običajno izzvenijo brez posledic.
The Vaccinia-naïve study population included healthy individuals as well as individuals with HIV infection and AD who received 2 doses of IMVANEX 4 weeks apart. 
Študijska populacija, ki še ni bila cepljena z virusom vakcinija, je vključevala tako zdrave posameznike kot tudi posameznike, okužene z virusom HIV, in posameznike z AD, ki so prejeli 2 odmerka cepiva IMVANEX v časovnem razmiku 4 tednov.
Two clinical studies have demonstrated that IMVANEX is able to boost a pre-existing immunological memory response, induced by either licensed smallpox vaccines a long time ago or two years after IMVANEX. 
Dve klinični študiji sta pokazali, da lahko cepivo IMVANEX poživi obstoječi imunski spominski odziv, ki so ga pred dlje časa izzvala bodisi odobrena cepiva proti črnim kozam ali cepivo IMVANEX dve leti po primarnem cepljenju.
• night sweats, 
• nočno znojenje
Adverse Reactions Reported in Completed Clinical Trials with IMVANEX (N = 7,082 subjects) 
Preglednica 1: Neželeni učinki, o katerih so poročali v zaključenih kliničnih preskušanjih s cepivom IMVANEX (N = 7.082 oseb)
In a non-placebo controlled clinical trial that compared the safety of IMVANEX in individuals with AD to healthy individuals, individuals with AD reported erythema (61.2%) and swelling (52.2%) at the injection site with a higher frequency than healthy individuals (49.3% and 40.8%, respectively). 
V kliničnem preskušanju, ki ni bilo kontrolirano s placebom, v katerem so primerjali varnost cepiva IMVANEX pri posameznikih z AD in zdravih posameznikih, so posamezniki z AD pogosteje poročali o eritemu (61,2 %) in oteklini (52,2 %) na mestu injiciranja kot zdravi posamezniki (49,3 % oz. 40,8 %).
Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) 
Zelo pogosti (≥ 1/10) Pogosti (≥1/100 do <1/10) Občasni (>1/1.000 do <1/100) Redki (≥1/10.000 do <1/1.000)
The following general symptoms were reported more frequently in individuals with AD compared to healthy individuals: headache (33.1% vs. 24.8%), myalgia (31.8% vs. 22.3%), chills (10.7% vs. 3.8 %), nausea (11.9% vs. 6.8%), and fatigue (21.4% vs. 14.4%). 
O naslednjih splošnih simptomih so pogosteje poročali pri posameznikih z AD kot pri zdravih posameznikih: glavobol (33,1 % v primerjavi s 24,8 %), mialgija (31,8 % v primerjavi z 22,3 %), mrzlica (10,7 % v primerjavi s 3,8 %), navzea (11,9 % v primerjavi s 6,8 %) in utrujenost
The presence of a minor infection and/or low-grade fever should not result in the deferral of vaccination. 
Zaradi prisotnosti manjše okužbe in/ali nizke povišane telesne temperature cepljenja ni treba prestaviti.
There is no information on the effect of IMVANEX on your ability to drive or use machines. 
Podatkov o učinkih cepiva IMVANEX na sposobnost upravljanja vozil in strojev ni.
The second co-primary endpoint evaluated if vaccination with Imvanex (n = 165) prior to administration of ACAM2000 results in an attenuation of the cutaneous reaction to ACAM2000 (n = 161) as measured by maximum lesion area in mm2. 
Drugi sestavljeni primarni opazovani dogodek učinkovitosti je ocenjeval, ali cepljenje s cepivom IMVANEX (n = 165) pred cepljenjem s cepivom ACAM2000 privede do zmanjšanja kožnih reakcij na cepivo ACAM2000 (n = 161), izmerjenih pri največjem področju lezije v mm2.
IMVANEX does not contain smallpox virus (Variola) and cannot spread or cause smallpox. 
Cepivo IMVANEX ne vsebuje virusa črnih koz (variola), zato črnih koz ne more širiti ali povzročiti.
Imvanex induced a peak neutralizing antibody geometric mean titer (GMT) of 153.5 (n = 185; 95% CI 134.3, 175.6), which was noninferior to the GMT of 79.3 (n = 186; 95% CI 67.1, 93.8) obtained after scarification with ACAM2000. 
Cepivo IMVANEX je sprožilo največji geometrični povprečni titer (GMT) nevtralizirajočega protitelesa 153,3 (n = 185, 95% IZ 134,3; 175,6), ki je bil neinferioren v primerjavi z GMT 79,3 (n = 186; 95-% IZ 67,1; 93,8), dobljenega po skarifikaciji s cepivom ACAM2000.
Non-human primate (NHP) studies have demonstrated that vaccination with IMVANEX induced a comparable immune response and protective efficacy to traditional smallpox vaccines used to eradicate smallpox and protected NHP from severe disease associated with a lethal challenge of monkeypox virus. 
Študije na primatih so pokazale, da je cepljenje s cepivom IMVANEX povzročilo primerljiv imunski odziv in zaščitni učinek na tradicionalna cepiva proti črnim kozam, ki se uporabljajo za izkoreninjenje črnih koz, in so zaščitile primate pred hudimi boleznimi, povezanimi s smrtnim izzivom z virusom opičjih koz.
In the absence of compatibility studies, this vaccine must not be mixed with other vaccines. 
Zaradi pomanjkanja študij kompatibilnosti cepiva ne smemo mešati z drugimi cepivi.
• dizziness, abnormal skin sensations, 
• omotica, nenormalni občutki na koži
Prior vaccination with IMVANEX may modify the cutaneous response (‘take') to subsequently administered replication-competent smallpox vaccine resulting in a reduced or absent take. 
Predhodno cepljenje s cepivom IMVANEX lahko spremeni dermalni odziv ("take") na naslednje injicirano cepivo proti črnim kozam, sposobno razmnoževanja, kar povzroči manjši odziv ali odsotnost odziva.
It is not known whether IMVANEX is excreted in human milk. 
Ni znano, ali se cepivo IMVANEX izloča v materino mleko.
IMVANEX is available in pack containing 20 vials. 
Cepivo IMVANEX je na voljo v pakiranjih po 20 vial.
Limited data on long-term immunogenicity covering a period of 24 months following primary vaccination of Vaccinia-naïve individuals with IMVANEX are currently available as shown below: 
Trenutno razpoložljivi omejeni podatki o dolgoročni imunogenosti zajemajo 24-mesečno obdobje po primarnem cepljenju posameznikov, ki predhodno še niso bili cepljeni z virusom vakcinija, s cepivom IMVANEX, so prikazani spodaj:
IMVANEX suspension for injection Smallpox vaccine (Live Modified Vaccinia Virus Ankara) 
IMVANEX suspenzija za injiciranje cepivo proti črnim kozam (živ modificiran virus vakcinija Ankara)
The safety of IMVANEX has been assessed in 20 clinical trials in which 5,261 Vaccinia-naïve individuals received two doses of no less than 5 x 107 Inf.U four weeks apart while 534 Vaccinia- and IMVANEX-experienced individuals received a single booster dose. 
Povzetek varnostnega profila Varnost cepiva IMVANEX so ocenili v 20 kliničnih preskušanjih, v katerih je 5.261 posameznikov, ki predhodno še niso bili cepljeni z virusom vakcinija, prejelo dva odmerka po najmanj 5 x 107 infektivnih enot v časovnem razmiku štirih tednov, 534 posameznikov, ki so bili z virusom vakcinija in cepivom IMVANEX že cepljeni, pa je prejelo en poživitveni odmerek.
Day 01 
Dan 01
What IMVANEX is and what it is used for 
Kaj je cepivo IMVANEX in za kaj ga uporabljamo
Some of the undesirable effects mentioned in section 4.8 may affect the ability to drive or use machines (e.g. dizziness). 
Vendar pa se lahko pojavijo nekateri neželeni učinki, našteti v poglavju 4, ki lahko vplivajo na sposobnost vožnje in upravljanja s stroji (npr. omotica).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 20 VIALS 
PODATKI NA ZUNANJI OVOJNINI PAKIRANJE Z 20 VIALAMI
N Day 01 
N Dan 01
• The second injection will be given no less than 28 days after the first. 
• Drugo injekcijo boste prejeli najmanj 28 dni po prvi.
What you need to know before you receive IMVANEX You must not receive IMVANEX: 
Kaj morate vedeti, preden boste dobili cepivo IMVANEX Cepiva IMVANEX ne smete dobiti:
If you have any further questions on the use of this vaccine, ask your doctor or nurse. 
Če imate dodatna vprašanja o uporabi cepiva, se posvetujte z zdravnikom ali medicinsko sestro.
Contents of the pack and other information What IMVANEX contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje cepivo IMVANEX
• Non-interventional post-authorisation safety study (PASS) POX-MVA-038: An observational, non-interventional postauthorisation safety study for the prophylactic vaccination with IMVANEX for [insert description of target vaccinee population] 
POX-MVA-038: Opazovalna, neintervencijska študija varnosti po pridobitvi dovoljenja za promet z zdravilom za profilaktično cepljenje s cepivom IMVANEX za [vstavite opis ciljne populacije za cepljenje]
When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection in the form of antibodies against the smallpox virus. 
Imunski sistem (naravni obrambni sistem telesa) osebe, ki dobi cepivo, začne izločati lastno zaščito v obliki protiteles proti virusu črnih koz.
If you get any of the following side effects, tell your doctor. 
Če opazite katerega koli od naslednjih neželenih učinkov, se posvetujte z zdravnikom.
4.5 Interaction with other medicinal products and other forms of interaction 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Študij medsebojnega delovanja z drugimi cepivi ali zdravili niso izvedli.
As a precautionary measure the use of IMVANEX should be avoided during pregnancy unless it is considered that the possible benefit in terms of preventing smallpox would outweigh the potential risk. 
Zaradi previdnosti cepiva IMVANEX ne uporabljajte med nosečnostjo, razen če se oceni, da bi morebitna korist preprečevanja črnih koz odtehtala morebitno tveganje.
Modified Vaccinia Ankara - Bavarian Nordic Live virus1 no less than 5 x 107 Inf.U * *infectious units 
Modificiran živi virus vakcinija Ankara - Bavarian Nordic1, ne manj kot 5 x 107 infektivnih enot 1pridobljeno v celicah piščančjega zarodka
The vaccine should be allowed to reach room temperature before use. 
Pred uporabo počakajte, da doseže cepivo sobno temperaturo.
Hejreskovvej 10 A, Kvistgård, 3490, Denmark Name and address of the manufacturer(s) responsible for batch release Bavarian Nordic A/S 
Hejreskovvej 10 A, Kvistgård, 3490, Danska Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
A total of 433 subjects were randomized in a 1 : 1 ratio to receive either two doses of Imvanex followed by a single dose of ACAM2000 at four weeks intervals or to receive a single dose of ACAM2000. 
Skupno 433 preiskovancev so naključno v razmerju 1 : 1 razporedili v dve skupini, ena je prejela dva odmerka cepiva IMVANEX in nato en odmerek cepiva ACAM2000 v 4-tedenskih intervalih, druga skupina pa je prejela enkratni odmerek cepiva ACAM2000.
Adverse reaction rates reported after either vaccination dose (1st, 2nd or booster) were similar. 
Stopnje neželenih učinkov, o katerih so poročali po vseh odmerkih cepljenja (1., 2. ali poživitvenem),
SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES 
SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
There are no data on the immune response to IMVANEX in other immunosuppressed individuals. 
Podatkov o imunskem odzivu na cepivo IMVANEX pri drugih posameznikih z oslabljenim imunskim odzivom ni.
Seroconversion in Vaccinia-experienced individuals was defined as at least a two-fold increase in base titres following a single vaccination with IMVANEX. 
Serokonverzija pri posameznikih, ki so že bili cepljeni z virusom vakcinija, je bila opredeljena kot vsaj dvakratno povečanje osnovnih titrov po enkratnem cepljenju s cepivom IMVANEX.
Non-clinical data reveal no special hazard for humans based on repeated dose toxicity, local tolerance, female fertility, embryo-foetal and postnatal toxicity. 
Predklinični podatki na osnovi običajnih študij toksičnosti pri ponavljajočih odmerkih, lokalnega prenašanja, plodnosti žensk, toksičnosti za zarodek/plod in postnatalne toksičnosti ne kažejo posebnega tveganja za človeka.
The vaccine will be injected under the skin, preferably into the upper arm, by your doctor or a nurse. 
To cepivo vam bo injiciral zdravnik ali medicinska sestra pod kožo, po možnosti v nadlaket.
• lump in skin, 
• zatrdlina v koži
At day 13-15, the median maximum lesion area for subjects who were administered ACAM2000 was 75mm2 (95% CI 69.0, 85.0) and for those who received Imvanex it was 0.0 (95% CI 0.0, 2.0). 
Od 13. do 15. dneva je mediano področje lezije pri preiskovancih, ki so bili cepljeni s cepivom ACAM2000, merilo 75 mm2 (95-% IZ 69,0; 85,0), pri preiskovancih, ki so bili cepljeni s cepivom IMVANEX, pa je merilo 0,0 (95-% IZ 0,0; 2,0).
IMVANEX should be avoided during breastfeeding unless it is considered that the possible benefit in terms of preventing smallpox would outweigh the potential risk. 
Cepiva IMVANEX ne uporabljajte med dojenjem, razen če se oceni, da bi morebitna korist preprečevanja črnih koz odtehtala morebitno tveganje.
The protective efficacy of IMVANEX against smallpox has not been studied. 
Zaščitnega učinka cepiva IMVANEX proti črnim kozam niso preučili.
2 doses of IMVANEX Licensed smallpox vaccine 
2 odmerka cepiva IMVANEX Odobreno cepivo proti črnim kozam
The second booster vaccination should be given no less than 28 days after the first dose. 
Drugo poživitveno cepljenje morajo prejeti vsaj 28 dni po prvem odmerku.
Immunisation should be postponed in individuals suffering from an acute severe febrile illness or acute infection. 
Pri posameznikih, ki imajo akutno resno febrilno bolezen ali akutno okužbo, je treba z imunizacijo počakati.
IMVANEX should not be administered by intravascular injection. 
Cepiva IMVANEX se ne sme injicirati intravaskularno.
• Non-interventional post-authorisation efficacy study (PAES) POX-MVA-039: An observational, non-interventional postauthorisation safety and efficacy study for the prophylactic vaccination with IMVANEX following re-emergence of circulating smallpox infections 
POX-MVA-039: Opazovalna, neintervencijska študija varnosti in učinkovitosti za profilaktično cepljenje s cepivom IMVANEX po ponovnem pojavu okužbe s črnimi kozami med prebivalstvom
• if you have previously had a sudden life-threatening allergic reaction to any ingredient of Imvanex (these are listed in section 6) or chicken protein, benzonase or gentamicin which may be present in the vaccine in very small amounts. 
Imvanex (navedene so v poglavju 6) ali piščančje beljakovine, benzonazo ali gentamicin, ki so lahko v cepivu prisotni v zelo majhnih količinah.
What IMVANEX looks like and contents of the pack 
Izgled cepiva IMVANEX in vsebina pakiranja
• underarm swelling, feeling unwell, flushing, chest pain, pain in the armpit, 
• oteklina pod pazduho, slabo počutje, pordevanje, bolečine v prsnem košu, bolečine pod pazduho
Do not refreeze the vaccine once thawed. 
Odmrznjenega cepiva ne zamrzujte ponovno.
1Day 0 corresponding to day of vaccination with IMVANEX; Day 7/14 corresponding to 1 or 2 weeks after vaccination with IMVANEX (first post vaccination analysis at Day 7 in study POX-MVA-011, and at Day 14 in studies POX-MVA-005 and POX-MVA-024); Day 28 corresponding to 4 weeks after vaccination with IMVANEX; SCR = Seroconversion rate; 2 Full Analysis Set (FAS). 
1Dan 0 ustreza dnevu cepljenja s cepivom IMVANEX; dan 7/14 ustreza 1 ali 2 tednoma po cepljenju s cepivom IMVANEX (prva analiza po cepljenju na 7. dan v študiji POX-MVA-011 in na 14. dan v študijah POX-MVA-005 in POX-MVA-024); 28. dan ustreza 4 tednom po cepljenju s cepivom IMVANEX; SCR = stopnja serokonverzije; 2celotna množica za analizo (FAS, Full Analysis Set).
• spinning sensation (vertigo), 
• občutek vrtenja (vrtoglavica)
Seroconversion rates in Vaccinia-experienced healthy and special populations 
Stopnje serokonverzije pri zdravi populaciji in posebnih populacijah, ki so že bile cepljene z virusom vakcinija
1 dose (0.5 ml) has a titre of no less than 5 x 107 Inf.U (Inf.U = infectious units) 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 odmerek (0,5 ml) ima titer najmanj 5 x 107 infektivnih enot
Seroconversion rates in Vaccinia-naïve individuals were defined as appearance of antibody titers equal or greater than the assay cut-off value following receipt of two doses of IMVANEX. 
Stopnje serokonverzije pri posameznikih, ki še niso bili cepljeni z virusom vakcinija, so bile opredeljene kot pojav titrov protiteles, ki je bil enak ali večji kot mejna vrednost testa po injiciranju dveh odmerkov cepiva IMVANEX.
If previously stored at -20°C +/-5°C, the vaccine can be stored short-term in a refrigerator at 2°C-8°C for up to 8 weeks prior to use. 
Če je bilo cepivo prej shranjeno pri temperaturi -20 °C +/-5 °C, se ga za kratek čas lahko shrani v hladilniku pri temperaturi med 2 °C in 8 °C do 8 tednov pred uporabo.
How to store IMVANEX 6. 
Shranjevanje cepiva IMVANEX 6.
• bleeding, irritation, scaling, inflammation, abnormal skin sensation, reaction at the injection iste, 
• krvavitev, draženje, luščenje kože, vnetje, nenormalni občutki na koži, reakcije na mestu injiciranja