FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: 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 %).
English: Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000)
Slovenian: 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)
English: 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%).
Slovenian: 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
English: The presence of a minor infection and/or low-grade fever should not result in the deferral of vaccination.
Slovenian: Zaradi prisotnosti manjše okužbe in/ali nizke povišane telesne temperature cepljenja ni treba prestaviti.
English: There is no information on the effect of IMVANEX on your ability to drive or use machines.
Slovenian: Podatkov o učinkih cepiva IMVANEX na sposobnost upravljanja vozil in strojev ni.
English: 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.
Slovenian: 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.
English: IMVANEX does not contain smallpox virus (Variola) and cannot spread or cause smallpox.
Slovenian: Cepivo IMVANEX ne vsebuje virusa črnih koz (variola), zato črnih koz ne more širiti ali povzročiti.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: In the absence of compatibility studies, this vaccine must not be mixed with other vaccines.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti cepiva ne smemo mešati z drugimi cepivi.
English: • dizziness, abnormal skin sensations,
Slovenian: • omotica, nenormalni občutki na koži
English: Health status
Slovenian: Zdravstveno stanje
English: Prior vaccination with IMVANEX may modify the cutaneous response (‘take') to subsequently administered replication-competent smallpox vaccine resulting in a reduced or absent take.
Slovenian: 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.
English: It is not known whether IMVANEX is excreted in human milk.
Slovenian: Ni znano, ali se cepivo IMVANEX izloča v materino mleko.
English: IMVANEX is available in pack containing 20 vials.
Slovenian: Cepivo IMVANEX je na voljo v pakiranjih po 20 vial.
English: 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:
Slovenian: 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:
English: IMVANEX suspension for injection Smallpox vaccine (Live Modified Vaccinia Virus Ankara)
Slovenian: IMVANEX suspenzija za injiciranje cepivo proti črnim kozam (živ modificiran virus vakcinija Ankara)
English: 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.
Slovenian: 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.
English: Day 01
Slovenian: Dan 01
English: What IMVANEX is and what it is used for
Slovenian: Kaj je cepivo IMVANEX in za kaj ga uporabljamo
English: Some of the undesirable effects mentioned in section 4.8 may affect the ability to drive or use machines (e.g. dizziness).
Slovenian: Vendar pa se lahko pojavijo nekateri neželeni učinki, našteti v poglavju 4, ki lahko vplivajo na sposobnost vožnje in upravljanja s stroji (npr. omotica).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 20 VIALS
Slovenian: PODATKI NA ZUNANJI OVOJNINI PAKIRANJE Z 20 VIALAMI
English: N Day 01
Slovenian: N Dan 01
English: • The second injection will be given no less than 28 days after the first.
Slovenian: • Drugo injekcijo boste prejeli najmanj 28 dni po prvi.
English: What you need to know before you receive IMVANEX You must not receive IMVANEX:
Slovenian: Kaj morate vedeti, preden boste dobili cepivo IMVANEX Cepiva IMVANEX ne smete dobiti:
English: If you have any further questions on the use of this vaccine, ask your doctor or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi cepiva, se posvetujte z zdravnikom ali medicinsko sestro.
English: Contents of the pack and other information What IMVANEX contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje cepivo IMVANEX
English: • 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]
Slovenian: 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]
English: 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.
Slovenian: Imunski sistem (naravni obrambni sistem telesa) osebe, ki dobi cepivo, začne izločati lastno zaščito v obliki protiteles proti virusu črnih koz.
English: If you get any of the following side effects, tell your doctor.
Slovenian: Če opazite katerega koli od naslednjih neželenih učinkov, se posvetujte z zdravnikom.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Študij medsebojnega delovanja z drugimi cepivi ali zdravili niso izvedli.
English: 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.
Slovenian: Zaradi previdnosti cepiva IMVANEX ne uporabljajte med nosečnostjo, razen če se oceni, da bi morebitna korist preprečevanja črnih koz odtehtala morebitno tveganje.
English: Modified Vaccinia Ankara - Bavarian Nordic Live virus1 no less than 5 x 107 Inf.U * *infectious units
Slovenian: Modificiran živi virus vakcinija Ankara - Bavarian Nordic1, ne manj kot 5 x 107 infektivnih enot 1pridobljeno v celicah piščančjega zarodka
English: The vaccine should be allowed to reach room temperature before use.
Slovenian: Pred uporabo počakajte, da doseže cepivo sobno temperaturo.
English: Hejreskovvej 10 A, Kvistgård, 3490, Denmark Name and address of the manufacturer(s) responsible for batch release Bavarian Nordic A/S
Slovenian: Hejreskovvej 10 A, Kvistgård, 3490, Danska Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
English: 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.
Slovenian: 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.
English: Adverse reaction rates reported after either vaccination dose (1st, 2nd or booster) were similar.
Slovenian: Stopnje neželenih učinkov, o katerih so poročali po vseh odmerkih cepljenja (1., 2. ali poživitvenem),
English: SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Slovenian: SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
English: There are no data on the immune response to IMVANEX in other immunosuppressed individuals.
Slovenian: Podatkov o imunskem odzivu na cepivo IMVANEX pri drugih posameznikih z oslabljenim imunskim odzivom ni.
English: Seroconversion in Vaccinia-experienced individuals was defined as at least a two-fold increase in base titres following a single vaccination with IMVANEX.
Slovenian: 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.
English: Non-clinical data reveal no special hazard for humans based on repeated dose toxicity, local tolerance, female fertility, embryo-foetal and postnatal toxicity.
Slovenian: 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.
English: The vaccine will be injected under the skin, preferably into the upper arm, by your doctor or a nurse.
Slovenian: To cepivo vam bo injiciral zdravnik ali medicinska sestra pod kožo, po možnosti v nadlaket.
English: • lump in skin,
Slovenian: • zatrdlina v koži
English: 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).
Slovenian: 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).
English: Hejreskovvej 10 A, Kvistgård, 3490, Denmark
Slovenian: Hejreskovvej 10 A, Kvistgård, 3490, Danska
English: IMVANEX should be avoided during breastfeeding unless it is considered that the possible benefit in terms of preventing smallpox would outweigh the potential risk.
Slovenian: Cepiva IMVANEX ne uporabljajte med dojenjem, razen če se oceni, da bi morebitna korist preprečevanja črnih koz odtehtala morebitno tveganje.
English: The protective efficacy of IMVANEX against smallpox has not been studied.
Slovenian: Zaščitnega učinka cepiva IMVANEX proti črnim kozam niso preučili.
English: 2 doses of IMVANEX Licensed smallpox vaccine
Slovenian: 2 odmerka cepiva IMVANEX Odobreno cepivo proti črnim kozam
English: The second booster vaccination should be given no less than 28 days after the first dose.
Slovenian: Drugo poživitveno cepljenje morajo prejeti vsaj 28 dni po prvem odmerku.
English: Immunisation should be postponed in individuals suffering from an acute severe febrile illness or acute infection.
Slovenian: Pri posameznikih, ki imajo akutno resno febrilno bolezen ali akutno okužbo, je treba z imunizacijo počakati.
English: IMVANEX should not be administered by intravascular injection.
Slovenian: Cepiva IMVANEX se ne sme injicirati intravaskularno.
English: • 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
Slovenian: POX-MVA-039: Opazovalna, neintervencijska študija varnosti in učinkovitosti za profilaktično cepljenje s cepivom IMVANEX po ponovnem pojavu okužbe s črnimi kozami med prebivalstvom
English: • 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.
Slovenian: Imvanex (navedene so v poglavju 6) ali piščančje beljakovine, benzonazo ali gentamicin, ki so lahko v cepivu prisotni v zelo majhnih količinah.
English: What IMVANEX looks like and contents of the pack
Slovenian: Izgled cepiva IMVANEX in vsebina pakiranja
English: • underarm swelling, feeling unwell, flushing, chest pain, pain in the armpit,
Slovenian: • oteklina pod pazduho, slabo počutje, pordevanje, bolečine v prsnem košu, bolečine pod pazduho
English: Do not refreeze the vaccine once thawed.
Slovenian: Odmrznjenega cepiva ne zamrzujte ponovno.
English: 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).
Slovenian: 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).
English: • spinning sensation (vertigo),
Slovenian: • občutek vrtenja (vrtoglavica)
English: Seroconversion rates in Vaccinia-experienced healthy and special populations
Slovenian: Stopnje serokonverzije pri zdravi populaciji in posebnih populacijah, ki so že bile cepljene z virusom vakcinija
English: 1 dose (0.5 ml) has a titre of no less than 5 x 107 Inf.U (Inf.U = infectious units)
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 odmerek (0,5 ml) ima titer najmanj 5 x 107 infektivnih enot
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: How to store IMVANEX 6.
Slovenian: Shranjevanje cepiva IMVANEX 6.
English: • bleeding, irritation, scaling, inflammation, abnormal skin sensation, reaction at the injection iste,
Slovenian: • krvavitev, draženje, luščenje kože, vnetje, nenormalni občutki na koži, reakcije na mestu injiciranja
English: Once the frozen vaccine has been thawed, IMVANEX is a pale milky coloured homogeneous suspension for injection.
Slovenian: Odtaljeno zamrznjeno cepivo IMVANEX je homogena suspenzija za injiciranje bledo mlečne barve.
English: Hyperhidrosis Ecchymosis Night sweats Subcutaneous nodule Angioedema
Slovenian: Bolezni kože in podkožja izpuščaj pruritus dermatitis obarvanje kože urtikarija hiperhidroza ekhimoza nočno znojenje subkutani vozlič angioedem
English: IMVANEX contains sodium
Slovenian: Cepivo IMVANEX vsebuje natrij
English: In case of any particles and/or abnormal appearance, the vaccine should be discarded.
Slovenian: Če v cepivu opazite delce in/ali je njegov videz neobičajen, ga zavrzite.
English: In the event of any damage to the vial, foreign particulate matter and/or variation of physical aspect being observed, discard the vaccine.
Slovenian: Če opazite kakršne koli poškodbe viale, če v cepivu opazite vidne delce in/ali drugo odstopanje od pričakovanega fizičnega izgleda,
English: 1Day 0 corresponding to day of booster vaccination with IMVANEX (pre-booster); Day 7 and 14 corresponding to 1 or 2 weeks after booster vaccination with IMVANEX; N = number of subjects in the specific study group; ELISA = enzymelinked immunosorbent assay; PRNT = plaque reduction neutralization test; S+ = Seropositivity rate; GMT = geometric mean titre.
Slovenian: 1Dan 0 ustreza dnevu cepljenja s poživitvenim odmerkom s cepivom IMVANEX (pred-poživitveni odmerek); 7. in 14. dan ustrezata 1 ali 2 tednoma po cepljenju s poživitvenim odmerkom s cepivom IMVANEX; N = število oseb v specifični študijski skupini; ELISA = encimsko imunski test (enzyme-linked immunosorbent assay); PRNT = nevtralizacijski test redukcije plakov (plaque reduction neutralisation test); S+ = stopnja seropozitivnosti; GMT= geometrični povprečni titer (geometric mean titre).
English: IMVANEX is a vaccine used to prevent smallpox infection in adults.
Slovenian: Kaj je cepivo IMVANEX in za kaj ga uporabljamo Cepivo IMVANEX se uporablja za preprečevanje okužbe s črnimi kozami pri odraslih.
English: • sinus infection,
Slovenian: • okužba sinusov
English: Imvanex was compared to ACAM2000 (a 'second generation' live attenuated smallpox vaccine produced in cell culture and licenced in the United States of America) in a randomized, open-label non-inferiority clinical trial in healthy adults (US military personnel) aged 18 to 42 years and who were naïve to smallpox vaccine (Study POX-MVA-006).
Slovenian: V randomiziranem, odprtem preskušanju neinferiornostipri zdravih odraslih (pripadniki vojske ZDA), starih od 18 do 42 let, ki še niso bili celjeni s cepivom proti črnim kozam (študija POX-MVA-006), so cepivo IMVANEX primerjali s cepivom ACAM2000 (živo atenuirano cepivo "druge generacije" proti črnim kozam, proizvedeno v celični kulturi in licencirano registrirano v ZDA).
English: 5 years at -80°C +/-10°C
Slovenian: 5 let pri -80 °C +/-10 °C
English: After thawing, the vaccine should be used immediately or if previously stored at -20°C +/-5°C, the vaccine can be stored at 2°C-8°C in the dark for up to 8 weeks prior to use.
Slovenian: Odmrznjeno cepivo je treba uporabiti takoj ali, če je bilo cepivo prej shranjeno pri temperaturi -20 °C +/-5 °, shraniti pri temperaturi med 2 °C in 8 °C v temnem prostoru do 8 tednov pred uporabo.
English: Rare (may affect up to 1 in 1000 people):
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
English: Peripheral sensory neuropathy Somnolence
Slovenian: Bolezni živčevja glavobol omotica parestezija migrena periferna senzorična nevropatija somnolenca
English: Pale milky coloured homogeneous suspension.
Slovenian: FARMACEVTSKA OBLIKA suspenzija za injiciranje Bledo mlečno obarvana homogena suspenzija.
English: NA
Slovenian: N
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
English: Denmark tel fax +45 3326 8380 e-mail regulatory@bavarian-nordic.com
Slovenian: e-pošta regulatory@bavarian-nordic.com
English: • sore throat, runny nose, cough,
Slovenian: • vneto žrelo, izcedek iz nosu, kašelj
English: 20 single dose vials.
Slovenian: 20 vial z enim odmerkom
English: The active substance is Modified Vaccinia Ankara - Bavarian Nordic Live virus1, no less than 5 x 107 Inf.U* *infectious units
Slovenian: Učinkovina je modificiran živi virus vakcinija Ankara - Bavarian Nordic1, ne manj kot
English: • faster heart beat,
Slovenian: • hitrejši srčni utrip
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Kot pri vseh cepivih, ki se injicirajo, je treba pri cepljenju zagotoviti ustrezno obliko zdravljenja in zdravniškega nadzora, ki bi bila v primeru redke anafilaktične reakcije na cepljenje, nemudoma na voljo.
English: (≥1/1,000 to <1/100)
Slovenian: Občasni (≥1/1.000 do <1/100)
English: Bavarian Nordic A/S Hejreskovvej 10A,
Slovenian: Bavarian Nordic A/S
English: How IMVANEX is given
Slovenian: Kako se daje cepivo IMVANEX
English: The suspension should be visually inspected for particulate matter and discoloration before use.
Slovenian: Vizualno preglejte suspenzijo, ali so v njej delci in ali je obarvana.
English: The other ingredients are: trometamol, sodium chloride, and water for injections.
Slovenian: 1pridobljeno v celicah piščančjega zarodka Druge sestavine cepiva so: trometamol, natrijev klorid in voda za injekcije.
English: • lump, discolouration, bruising or warmth at the injection site.
Slovenian: • otrdlina, obarvanje, oteklina ali občutek vročine na mestu injiciranja
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 odmerek (0,5 ml)
English: Store in a freezer (at -20°C +/-5°C or -50°C +/-10°C or -80°C +/-10°C).
Slovenian: Shranjujte v zamrzovalniku (pri -20 °C +/-5 °C ali -50 °C +/-10 °C ali -80 °C +/-10 °C).
English: (≥1/100 to <1/10)
Slovenian: Pogosti (≥1/100 do <1/10)
English: • weakness,
Slovenian: • omotica,
English: Store in a freezer (at -20°C +/-5°C or -50°C +/-10°C or -80°C +/-10°C) protected from light.
Slovenian: DRUGI PODATKI Shranjujte v zamrzovalniku (pri -20 °C +/-5 °C ali -50 °C +/-10 °C ali -80 °C +/-10 °C), zaščiteno pred svetlobo.
English: • muscle stiffness, back pain, neck pain,
Slovenian: • togost, bolečine v hrbtu, bolečina v vratu
English: How to store IMVANEX
Slovenian: Shranjevanje cepiva IMVANEX
English: The first co-primary endpoint compared vaccinia-specific neutralizing antibody responses at the peak visits (Day 42 after first vaccination for Imvanex where the subjects received two doses according to the standard vaccination schedule and Day 28 for ACAM2000).
Slovenian: Prvi sestavljeni primarni opazovani dogodek je primerjal za cepivo specifične odzive nevtralizirajočega protitelesa ob ključnih obiskih (42 dan po prvem cepljenju s cepivom
English: Suspension for injection.
Slovenian: cepivo zavrzite.
English: • joint pain, pain in extremities,
Slovenian: • bolečine v sklepih, bolečine v okončinah