natgillin/translations-raw huggingface dataset:
EU/1/99/126/013 4 pre-filled syringes EU/1/99/126/014 8 pre-filled syringes EU/1/99/126/015 24 pre-filled syringes EU/1/99/126/026 12 pre-filled syringes
EU/1/99/126/013 4 napolnjene injekcijske brizge EU/1/99/126/014 8 napolnjenih injekcijskih brizg EU/1/99/126/015 24 napolnjenih injekcijskih brizg EU/1/99/126/026 12 napolnjenih injekcijskih brizg
Each vial of Enbrel 10 mg should be used on a single occasion in a single patient, and the remainder of the vial should be discarded.
Ena viala z zdravilom Enbrel 10 mg je namenjena za enkratno uporabo pri enem bolniku.
EU/1/99/126/016 2 pre-filled syringes EU/1/99/126/017 4 pre-filled syringes EU/1/99/126/018 12 pre-filled syringes
EU/1/99/126/016 2 napolnjeni injekcijski brizgi EU/1/99/126/017 4 napolnjene injekcijske brizge EU/1/99/126/018 12 napolnjenih injekcijskih brizg
Tell your doctor if you or the child develop any change in the appearance of the skin or growths on the skin.
Pri nekaterih bolnikih, ki so prejemali zdravilo Enbrel, se je pojavil kožni rak. Povejte zdravniku, če se pri vas ali otroku razvije kakšna sprememba videza kože ali rašče na koži.
Serious adverse reactions have also been reported for Enbrel.
Pri uporabi zdravila Enbrel so poročali tudi o pojavu resnih neželenih učinkov.
CARTON TEXT - EU/1/99/126/023-025 (25 mg Pre-filled Pen)
BESEDILO NA ŠKATLI - EU/1/99/126/023-025 (25 mg napolnjeni injekcijski peresnik)
9c
6. mesec c
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR SYRINGE LABEL - EU/1/99/126/003-005
BESEDILO NA NALEPKI NAPOLNJENE INJEKCIJSKE BRIZGE - EU/1/99/126/003-005
28b a: p<0.001, Enbrel vs. placebo b: p = 0.002, Enbrel vs. placebo
ASAS 70 2 tedna 3 meseci 6 mesecev b a: p < 0,001, zdravilo Enbrel proti placebu b: p = 0,002, zdravilo Enbrel proti placebu
Enbrel 25 mg injection etanercept
Enbrel 25 mg injekcija etanercept subkutana uporaba
Purple needle safety shield
beli pokrovček igle vijolični varnostni ščit igle
Each vial of Enbrel 25 mg contains 25 mg of etanercept.
Ena viala zdravila Enbrel 25 mg vsebuje 25 mg etanercepta.
• Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel, and contact your doctor immediately.
Alergijske reakcije: Če se pri vas ali otroku pojavijo alergijske reakcije, na primer tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo Enbrel in nemudoma obvestite zdravnika.
Preparing the injection site and injecting the Enbrel solution
Priprava mesta injiciranja in injiciranje raztopine zdravila Enbrel
The recommended dose is 25 mg Enbrel administered twice weekly, or 50 mg administered once weekly.
Priporočeni odmerek je 25 mg zdravila Enbrel dvakrat na teden ali 50 mg enkrat na teden.
Cartons contain 4, 8, 12 or 24 pre-filled syringes of Enbrel and 4, 8, 12 or 24 alcohol swabs.
Škatle vsebujejo 4, 8, 12 ali 24 napolnjenih injekcijskih brizg zdravila Enbrel in 4, 8, 12 ali 24 alkoholnih blazinic.
Inflammatory bowel disease (IBD) and uveitis in patients with juvenile idiopathic arthritis (JIA) There have been reports of IBD and uveitis in JIA patients being treated with Enbrel (see section 4.8).
Kronična vnetna črevesna bolezen (KVČB): Pri bolnikih z juvenilnim idiopatskim artritisom (JIA), ki so se zdravili z zdravilom Enbrel, so poročali o primerih KVČB.
25 mg Enbrel administered twice weekly is the recommended dose.
Priporočeni odmerek je 25 mg zdravila Enbrel dvakrat na teden.
• Allergic reactions: If the child experiences allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel, and contact your doctor immediately.
Alergijske reakcije: Če se pri otroku pojavijo alergijske reakcije, na primer tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo Enbrel in nemudoma obvestite zdravnika.
CARTON TEXT - EU/1/99/126/019-021 (50 mg Pre-filled Pen)
BESEDILO NA ŠKATLI - EU/1/99/126/019-021 (50 mg napolnjeni injekcijski peresnik)
• You will also need the following items: A sterile syringe and needle(s) of 25 gauge x 16 mm or similar A vial or ampoule of water for injections 2 alcohol swabs
sterilno injekcijsko brizgo in iglo(e) velikosti 25 x 16 mm ali podobno,
Preparing the injection site and injecting the Enbrel solution h. Disposing of supplies a.
Priprava mesta injiciranja in injiciranje raztopine zdravila Enbrel h.
Enbrel 50 mg solution for injection in pre-filled syringe The active substance in Enbrel is etanercept.
Enbrel 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Učinkovina zdravila Enbrel je etanercept.
If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel, and contact your doctor immediately.
Če se pri vas ali otroku pojavi alergijska reakcija, npr. tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo Enbrel in nemudoma obvestite zdravnika.
Enbrel 25 mg solution for injection in pre-filled syringe Enbrel 50 mg solution for injection in pre-filled syringe
Enbrel 25 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Enbrel 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
Enbrel 25 mg solution for injection in pre-filled syringe The active substance in Enbrel is etanercept.
Enbrel 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Učinkovina zdravila Enbrel je etanercept.
The solution should be clear and colourless to pale yellow or pale brown, with no lumps, flakes, or particles.
Raztopina mora biti bistra in brezbarvna do bledo rumena oziroma bledo rjava ter ne sme vsebovati kepic, kosmičev ali delcev.
If the child experiences allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel, and contact your doctor immediately.
Če se pri otroku pojavi alergijska reakcija, npr. tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo Enbrel in nemudoma obvestite zdravnika.
Each pack contains 4, 8, 12 or 24 pre-filled syringes and 4, 8, 12 or 24 alcohol swabs.
Eno pakiranje vsebuje 4, 8, 12 ali 24 napolnjenih injekcijskih brizg in 4, 8, 12 ali 24 alkoholnih blazinic.
Pairwise comparison p-values: † = p < 0.05 for comparisons of Enbrel + methotrexate vs methotrexate and φ = p < 0.05 for comparisons of Enbrel + methotrexate vs Enbrel
Vrednosti p za primerjavo po parih: † = p < 0,05 za primerjavo kombinacije zdravila Enbrel + metotreksat z metotreksatom in  = p < 0,05 za primerjavo kombinacije zdravila Enbrel + metotreksat z zdravilom Enbrel.
Enbrel 25 mg solution for injection in pre-filled syringe EU/1/99/126/013
Enbrel 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/99/126/013
Enbrel 25 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 25 mg of etanercept.
Enbrel 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 25 mg etanercepta.
See section 5 for instructions on how to store Enbrel.
Za navodila o shranjevanju zdravila Enbrel glejte poglavje 5.
These include the alcohol swab from the Enbrel carton and a cotton ball or gauze.
Pripravite si še druge stvari, ki jih boste potrebovali pri injiciranju, to sta alkoholna blazinica iz škatle z zdravilom Enbrel in košček vate ali gaze.
Enbrel 50 mg solution for injection in pre-filled syringe EU/1/99/126/016
Enbrel 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/99/126/016
Tell your doctor if the child develops any change in the appearance of the skin or growths on the skin.
Pri nekaterih bolnikih, ki so prejemali zdravilo Enbrel, se je pojavil kožni rak. Povejte zdravniku, če se pri otroku razvije kakšna sprememba videza kože ali rašče na koži.
Enbrel 50 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 50 mg of etanercept.
Enbrel 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 50 mg etanercepta.
Enbrel 25 mg powder for solution for injection Etanercept
Enbrel 25 mg prašek za raztopino za injiciranje etanercept
Detailed instructions on how to prepare and inject Enbrel are provided in section 7, “Instructions for preparing and giving an injection of Enbrel”.
Podrobna navodila o pripravi in injiciranju zdravila Enbrel so v poglavju 7 “Navodila za pripravo in dajanje injekcije zdravila Enbrel”.
Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of Enbrel."
Obsežna navodila za aplikacijo so navedena v navodilu za uporabo, poglavje 7 "NAVODILA ZA PRIPRAVO IN DAJANJE INJEKCIJE ZDRAVILA ENBREL".
The solution should be clear to slightly opalescent, colourless to pale yellow or pale brown and may contain small translucent or white particles of protein.
Raztopina mora biti bistra do rahlo opalescentna, brezbarvna do bledo rumena oziroma bledo rjava ter lahko vsebuje majhne prosojne ali bele delce beljakovine.
Detailed instructions on how to inject Enbrel are provided in section 7, “Instructions for preparing and giving an injection of Enbrel”.
Podrobna navodila o injiciranju zdravila Enbrel so v poglavju 7 “Navodila za pripravo in dajanje injekcije zdravila Enbrel”.
In this study most psoriatic arthritis patients receiving Enbrel were able to mount effective B-cell immune response to pneumococcal polysaccharide vaccine, but titres in aggregate were moderately lower and few patients had two-fold rises in titres compared to patients not receiving Enbrel.
Večina bolnikov s psoriatičnim artritisom, ki so dobivali zdravilo Enbrel, je v tej študiji zmogla učinkovit imunski odziv celic B na polisaharidno cepivo proti pnevmokokom.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON TEXT - EU/1/99/126/002
BESEDILO NA NALEPKI VIALE - EU/1/99/126/002
Enbrel 10 mg powder and solvent for solution for injection for paediatric use etanercept
Enbrel 10 mg prašek in vehikel za raztopino za injiciranje za uporabo pri otrocih etanercept
Each pre-filled syringe of Enbrel contains 50 mg etanercept.
Ena napolnjena injekcijska brizga zdravila Enbrel vsebuje 50 mg etanercepta.
Each pre-filled syringe of Enbrel contains 25 mg etanercept.
Ena napolnjena injekcijska brizga zdravila Enbrel vsebuje 25 mg etanercepta.
Enbrel 25 mg solution for injection in pre-filled pen EU/1/99/126/023
Enbrel 25 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku EU/1/99/126/023
Enbrela
Dojenje
Enbrel 10 mg powder and solvent for solution for injection for paediatric use
Enbrel 10 mg prašek in vehikel za raztopino za injiciranje za uporabo pri otrocih
Each vial of Enbrel contains 25 mg etanercept.
Ena viala zdravila Enbrel vsebuje 25 mg etanercepta.
Cartons contain 2, 4 or 12 pre-filled syringes of Enbrel with 2, 4 or 12 alcohol swabs.
Škatle vsebujejo 2, 4 ali 12 napolnjenih injekcijskih brizg zdravila Enbrel in 2, 4 ali 12 alkoholnih blazinic.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR SYRINGE LABEL - EU/1/99/126/022 (For paediatric use)
BESEDILO NA NALEPKI INJEKCIJSKE BRIZGE - EU/1/99/126/022 (za uporabo pri otrocih)
Choosing an injection site h. Preparing the injection site and injecting the Enbrel solution i.
Priprava mesta injiciranja in injiciranje raztopine zdravila Enbrel i.
Enbrel did not elicit dose-limiting or target organ toxicity in cynomolgus monkeys following twice weekly subcutaneous administration for 4 or 26 consecutive weeks at a dose (15 mg/kg) that resulted in AUC-based serum drug concentrations that were over 27-fold higher than that obtained in humans at the recommended dose of 25 mg.
Tudi pri opicah cynomolgus, ki so subkutano prejemale odmerek 15 mg/kg 2-krat tedensko 4 ali 26 tednov zapored, zdravilo Enbrel ni povzročilo toksičnosti, ki bi omejevala višino odmerka, niti toksičnosti za tarčne organe.
EU/1/99/126/019 2 pre-filled pens EU/1/99/126/020 4 pre-filled pens EU/1/99/126/021 12 pre-filled pens
EU/1/99/126/019 2 napolnjena injekcijska peresnika EU/1/99/126/020 4 napolnjeni injekcijski peresniki EU/1/99/126/021 12 napolnjenih injekcijskih peresnikov
Each MYCLIC pre-filled pen contains 25 mg of etanercept.
En napolnjeni injekcijski peresnik MYCLIC vsebuje 25 mg etanercepta.
Each pack contains 4, 8 or 24 pens and 4, 8 or 24 alcohol swabs.
Eno pakiranje vsebuje 4, 8 ali 24 injekcijskih peresnikov in 4, 8 ali 24 alkoholnih blazinic.
Enbrel 50 mg solution for injection in pre-filled syringe etanercept
Enbrel 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku etanercept
EU/1/99/126/023 4 pre-filled pens EU/1/99/126/024 8 pre-filled pens EU/1/99/126/025 24 pre-filled pens
EU/1/99/126/023 4 napolnjeni injekcijski peresniki EU/1/99/126/024 8 napolnjenih injekcijskih peresnikov EU/1/99/126/025 24 napolnjenih injekcijskih peresnikov
A 25 mg strength of Enbrel is available for doses of 25 mg.
Predpisali so vam zdravilo Enbrel v jakosti 50 mg. Za 25 mg odmerek je na voljo zdravilo Enbrel jakosti 25 mg.
Enbrel 50 mg solution for injection in pre-filled pen EU/1/99/126/019
Enbrel 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku EU/1/99/126/019
Enbrel 25 mg solution for injection in pre-filled syringe etanercept
Enbrel 25 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku etanercept
Enbrel 25 mg powder and solvent for solution for injection
Enbrel 25 mg prašek in vehikel za raztopino za injiciranje
Adding solvent
Dodajanje vehikla
Enbrel 25 mg powder and solvent for solution for injection Etanercept
Enbrel 25 mg prašek in vehikel za raztopino za injiciranje etanercept
Comprehensive instructions for the preparation and administration of the reconstituted Enbrel vial are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of Enbrel."
Obsežna navodila za pripravo in aplikacijo rekonstituirane viale zdravila Enbrel so navedena v navodilu za uporabo, poglavje 7 "NAVODILA ZA PRIPRAVO IN DAJANJE INJEKCIJE ZDRAVILA ENBREL".
Comprehensive instructions for the preparation and administration of the reconstituted Enbrel vial are given in the package leaflet, section 7, “INSTRUCTIONS FOR PREPARATION AND GIVING AN INJECTION OF ENBREL”.
Obsežna navodila za pripravo in aplikacijo rekonstituirane viale zdravila Enbrel so navedena v navodilu za uporabo, poglavje 7 "Navodila za pripravo in dajanje injekcije zdravila Enbrel".
Methotrexate Enbrel
--Zdravilo Enbrel
Do not use this medicine after the expiry date which is stated on the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake ''Uporabno do'' ali ''Upor.
Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with Enbrel use.
Pri uporabi zdravila Enbrel so poročali o redkih primerih demielinizacije centralnega in zelo redkih primerih demielinizacije perifernega živčevja.
• Hepatitis B: Tell your doctor if you or the child have or have ever had hepatitis B. Your doctor should test for the presence of hepatitis B infection before you or the child begin treatment with Enbrel.
Hepatitis B: Če ste vi ali vaš otrok kdaj imeli hepatitis B, o tem obvestite zdravnika.
How to store Enbrel
Shranjevanje zdravila Enbrel
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR PRE-FILLED SYRINGE - EU/1/99/126/016-018 (50 mg Pre-filled Syringe)
BESEDILO NA NAPOLNJENI INJEKCIJSKI BRIZGI - EU/1/99/126/016-018 (50 mg napolnjena injekcijska brizga)
Setting up for an injection
Priprava na injiciranje
In this study, most psoriatic arthritis patients receiving Enbrel were able to mount effective B-cell immune response to pneumococcal polysaccharide vaccine, but titres in aggregate were moderately lower, and few patients had two-fold rises in titres compared to patients not receiving Enbrel.
Toda celokupno so bili titri zmerno nižji in malo bolnikov je imelo dvakraten porast titrov v primerjavi z bolniki, ki niso dobivali zdravila Enbrel.
A 50 mg strength of Enbrel is available for doses of 50 mg.
Napolnjeni injekcijski peresnik Enbrel je na voljo v jakostih 25 mg in 50 mg.
Treatment with Enbrel may result in reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus.
Če je bolnik pozitiven na HBV, je pred uvedbo zdravljenja z zdravilom Enbrel priporočljivo posvetovanje z zdravnikom specialistom za zdravljenje hepatitisa B. Pri dajanju zdravila Enbrel bolnikom, ki so že bili okuženi s HBV, je potrebna previdnost.
You have been prescribed a 25 mg strength of Enbrel.
Predpisali so vam zdravilo Enbrel v jakosti 25 mg. Za 50 mg odmerek je na voljo zdravilo Enbrel jakosti 50 mg.
With your free hand, hold the syringe near its base to stabilise it. Then push the plunger to inject all of the solution at a slow, steady rate (see Diagram 11).
Nato potisnite bat tako, da počasi in enakomerno injicirate vso raztopino (glejte sliko 11).
Pre-filled pen (MYCLIC) containing a 25 mg pre-filled syringe of Enbrel.
25 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Napolnjen injekcijski peresnik (MYCLIC), ki vsebuje 25 mg napolnjeno injekcijsko brizgo zdravila Enbrel.
Do not shake the pen.
Peresnika ne stresajte.
1 Enbrel vial
gumijasti zamašek viala
Infect ions and infestations
invazivnih glivičnih okužb.
Pre-filled pen (MYCLIC) containing a 50 mg pre-filled syringe of Enbrel.
50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Napolnjen injekcijski peresnik (MYCLIC), ki vsebuje 50 mg napolnjeno injekcijsko brizgo zdravila Enbrel.
Laboratory workers are also at risk.
Tveganju so izpostavljeni tudi laboratorijski delavci.
Of the 10 cases, 7 were in contacts, and 3 in contacts-of-contacts.
Od teh 10 primerov jih je bilo 7 med kontakti in 3 med kontakti kontaktov.
Duration of protection
Trajanje zaščite
What is Ebola?
Kaj je ebola?
n = Number of subjects contributing to the analysis.
n = število preiskovancev, ki so prispevali k analizi.
Proper hand washing methods are described below.
Pravilni načini umivanja rok so opisani spodaj.
Transmission to animals and livestock
Prenos na živali in živino
Your healthcare worker might need to do another test.
Zdravstveni delavec bo morda moral narediti drug test.
Efficacy in children has not been assessed.
Učinkovitost pri otrocih ni bila ocenjena.
• Excessive sweating.
• prekomerno znojenje.
A progress report has to be included in the annual renewal application.
Poročilo o napredku mora biti vključeno v vlogi za letno podaljšanje.
This does not mean that you have Ebola.
To ne pomeni, da imate ebolo.
It reduces the number of germs on the hands and so reduces their spread from person to person.
Zmanjša število klic na rokah in tako zmanjša njihovo širjenje z ene osebe na drugo.
It is not known if it is safe and works in children and adolescents.
Ni znano, ali je za otroke in mladostnike varno in ali pri njih deluje.
Are in contact with vulnerable individuals
Če ste v stiku z ranljivimi osebami
If you or your child is under 18 years old, talk to your healthcare worker.
Če ste vi ali vaš otrok mlajši od 18 let, se posvetujte z zdravstvenim delavcem.
One dose (1 mL) contains:
En odmerek (1 ml) vsebuje:
A total of 1,197 healthy subjects 18 to 65 years of age were enrolled in the US, Canada, and Spain.
Vključenih je bilo skupaj 1.197 zdravih oseb, starih od 18 do 65 let, v ZDA, Kanadi in Španiji.
While in an area affected by Ebola, it is important to avoid the following:
Medtem ko ste na območju, ki ga je prizadela ebola, se morate izogibati naslednjemu:
Most side effects go away within a few days.
Večina neželenih učinkov mine v nekaj dneh.
The reasons for differences in arthritis reporting across trials are not known but may be due to differences in study populations or outcome reporting.
Razlogi za razlike v poročanju o artritisu med preskušanji niso znani, a morda gre za posledico razlik v študijskih populacijah ali razlik v poročanju o izidih.
• Ebola is not spread through the air, water or food.
• Ebola se ne širi po zraku, z vodo ali s hrano.
Impact to serological testing
Vpliv na serološko testiranje
29 May 2020
29. maj 2020
• babies who are less than 1 year old,
• dojenčki, mlajšimi od 1 leta starosti,
• Children <1 year of age.
• otroci, stari < 1 leto.
Have had allergic reactions to vaccines or medicines
Če ste imeli alergijske reakcije na cepiva ali zdravila
It is not known if Ervebo will harm you or your unborn baby.
Ni znano, ali cepivo Ervebo škoduje vam ali vašemu nerojenemu otroku.
The use of other Ebola control measures should therefore not be interrupted.
Uporabe drugih ukrepov za nadzor nad ebolo se zato ne sme prekiniti.
Serious side effects are rare.
Resni neželeni učinki so redki.
Do not thaw the vial in a refrigerator.
Viale ne odtajajte v hladilniku.
This exemption is subject to annual review and in any case ceases to be valid on 31 July 2022.
Ta izjema je predmet letnega pregleda in ne more biti daljša kot do 31. julija 2022.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega cepiva.
As there are limitations to available data, including the small number of cases, caution should be exercised in drawing conclusions.
Ker obstajajo omejitve glede razpoložljivih podatkov, ki vključujejo majhno število primerov, je pri sprejemanju odločitev potrebna previdnost.
Both may present compelling needs that should be considered before vaccination of the mother.
Oboje lahko predstavlja nujno potrebo in o tem je treba razmisliti pred cepljenjem matere.
No immune correlates of protection have been defined to date.
Imunološki korelati zaščite doslej niso bili opredeljeni.
High-risk individuals include:
Med osebami z velikim tveganjem so:
Get medical care right away if you have symptoms of an allergic reaction, which may include:
Nemudoma poiščite zdravniško pomoč, če se vam pojavijo simptomi alergijske reakcije, med katerimi so lahko:
The clinical relevance of the immunogenicity data is currently not known.
Klinični pomen teh podatkov o imunogenosti trenutno ni znan.
• you have HIV infection or AIDS,
• Če imate okužbo z virusom HIV ali imate aids,
Tell your healthcare worker if you are taking, have recently taken or might take any other medicines or vaccines.
Obvestite zdravstvenega delavca, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo ali cepivo.
The median age of consenting CCCs was 35 years old.
Mediana starost vključenih KKK je bila 35 let.
Vaccine virus RNA was mainly detected from Day 1 to Day 7.
RNA cepilnega virusa so v glavnem zaznali od 1. do 7. dne.
If your immune system is weak (which means your body is less able to fight off diseases), you might not be able to receive Ervebo.
Če imate šibek imunski sistem (to pomeni, da je vaše telo manj sposobno premagovati bolezni), morda ne boste mogli prejeti cepiva Ervebo.
The median durations reported were between 6 to 18 days.
Mediano trajanje je bilo med 6 do 18 dni.
Instructions on the handling of the vaccine before administration
Navodila za ravnanje s cepivom pred uporabo
Individuals 18 years of age or older: one dose (1 mL) (see section 5.1).
Osebe, stare 18 let ali več: 1 odmerek (1 ml) (glejte poglavje 5.1).
At the end of 14 days, the vaccine should be used or discarded.
Ob koncu 14-dnevnega obdobja je treba cepivo ali uporabiti ali zavreči.
The use of Ervebo should be in accordance with official recommendations.
Cepivo Ervebo je treba uporabljati v skladu z uradnimi priporočili.
Have a fever (high temperature)
Če imate zvišano telesno temperaturo (vročino)
To avoid unintended exposure to livestock, ensure medical waste and other cleaning materials do not come in contact with livestock.
Za preprečitev nenamerne izpostavljenosti živine je treba zagotoviti, da medicinski odpadki in drugi materiali za čiščenje ne pridejo v stik z živino.
Your healthcare worker will talk to you and then together you can decide if you should receive this vaccine.
Zdravstveni delavec se bo pogovoril z vami in skupaj se bosta odločila, ali naj prejmete cepivo.