natgillin/translations-raw huggingface dataset:
The vaccine works by helping the body to produce its own protection (antibodies) against the disease.
Cepivo deluje tako, da telo spodbudi k proizvajanju lastne zaščite (protiteles) proti bolezni.
This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 14(8) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet v spodaj navedenem časovnem okviru izvesti naslednje ukrepe:
A short summary should be provided in which validated signals and areas of concern are highlighted, taking into account information arising from the prospective cohort study described in 4.5.
Podan mora biti tudi kratek povzetek, v katerem bodo poudarjeni validirani signali in področja, ki so vzrok za zaskrbljenost, z upoštevanjem podatkov, dobljenih iz prospektivne kohortne študije, opisane v poglavju 4.5.
This vaccine complies with the WHO recommendation and EU decision for the pandemic.
Cepivo je skladno s priporočili SZO in Sklepom EU o pandemiji.
Moreover, a 6-monthly cycle may be too long to allow assessment of the safety of a vaccine for which high levels of exposure are expected within a short period of time.
Poleg tega je lahko 6-mesečni ciklus predolg, da bi omogočil ustrezno oceno varnosti cepiva, pri katerem lahko pričakujemo veliko stopnjo izpostavljenosti v kratkem obdobju.
The transient false positive reactions could be due to the IgM response by the vaccine.
Prehodne lažno pozitivne reakcije so lahko posledica odziva IgM na cepivo.
To put the safety report into context, a summary of vaccine distribution should be included and should provide details of the number of doses of vaccine distributed in i) EU member states for the reporting period by batch number, ii) EU member states cumulatively and iii) the rest of the world.
Da bi bilo poročilo o varnosti umeščeno v ustrezen kontekst, mora biti vključen tudi povzetek o distribuciji cepiva, v katerem morajo biti navedene podrobnosti o številu odmerkov cepiva v prometu v i) državah članicah EU za obdobje poročanja s številko serije, ii) državah članicah EU skupaj in iii) preostalem svetu.
Frequency 6 - 35 months 3 - 8 years
Pogostnost 6 - 35 mesecev 3 - 8 let
In the event of multiple signals, signal work-up may be prioritised and appropriate timelines for submission of a full signal evaluation report should be provided.
V primeru več signalov bo lahko obdelava signalov varnosti postala prioritetna in treba bo navesti ustrezne roke za predajo popolnega poročila o vrednotenju signalov.
During the pandemic, the applicant will conduct a prospective cohort study as identified in the Pharmacovigilance plan.
Med pandemijo bo predlagatelj izvedel prospektivno kohortno študijo, ki je določena v Načrtu farmakovigilance.
The Western Blot technique disproves the results.
S tehniko Western Blot so bili ti rezultati ovrženi.
Therefore, 6-monthly or annual PSURs falling within the pandemic period will be replaced by monthly “simplified PSURs” (S-PSUR) accompanied by a summary of vaccine distribution.
Zato bodo 6-mesečna ali letna poročila PSUR med obdobjem pandemije nadomeščena z mesečnimi ”poenostavljenimi poročili PSUR” (S-PSUR), ki jim bo priložen tudi povzetek o distribuciji cepiva.
Those which have not yet been entered should be reported in the following S-PSUR.
Tiste podatke, ki niso bili vneseni, pa je treba prijaviti v okviru naslednjega poročila S-PSUR.
- The clock should start from the first Monday after shipment of the first batch of vaccine.
- Čas začne teči prvi ponedeljek po odpremi prve serije cepiva.
Adults, older people and special risk groups
Odrasli, starejše osebe in skupine s posebnimi tveganji
When it has been agreed by the CHMP that the S-PSUR is no longer necessary, a full PSUR covering the period since the data lock point of the last routine PSUR will be submitted within a time frame to be agreed with the Rapporteur.
Ko bo odbor CHMP soglašal, da poročila S-PSUR niso več potrebna, bo predano celotno poročilo PSUR, ki bo zajemalo obdobje od zaključnega obdobja zbiranja podatkov zadnjega rutinskega poročila PSUR, in sicer v časovnem okviru, ki bo dogovorjen s poročevalcem.
Pandemic influenza vaccine should be used in accordance with official guidance.
Cepivo proti pandemski gripi je treba uporabljati v skladu z uradnimi smernicami.
• if you are having a blood test to look for evidence of infection with certain viruses.
• če ste naročeni za odvzem krvi, da se potrdi okužba z določenimi virusi.
narrow SMQ “Demyelination” (as GBS is also included in this SMQ, there will be an overlap in the number of cases for these two categories).
GBS tudi vključen v ta SMQ, bo prišlo do prekrivanja pri številu primerov za ti dve kategoriji).
Based on the assumption that product name will not be provided in a significant proportion of cases.
Na podlagi predpostavke, da pri velikem odstotku primerov ime cepiva ne bo navedeno.
Infants, children and adolescents: Adverse Reactions (Infants, Children and Adolescents)
Dojenčki, otroci in mladostniki: Neželeni učinki (dojenčki, otroci in mladostniki)
After first opening, the vial is to be used within a maximum of 3 hours.
Po prvem odprtju uporabite vialo v največ 3 urah.
Uncommon: generalised skin reactions
Občasni: generalizirane kožne reakcije
Infants, children, and adolescents
Dojenčki, otroci in mladostniki
During a pandemic situation, the resources must be concentrated on a timely and effective monitoring of the safety profile of the influenza vaccines used during the pandemic.
V času pandemije morajo biti viri osredotočeni na pravočasno in učinkovito spremljanje profila varnosti cepiv proti gripi, ki se uporabljajo v obdobju pandemije.
- All non-medically confirmed events are those that have been entered into the database by the data-lock point.
- Vsi nemedicinsko potrjeni dogodki oz. učinki so tisti, ki so bili vneseni v podatkovno bazo do zaključnega obdobja zbiranja podatkov.
- “Cumulatively” means since the use of the vaccine; events not reported during the period of interest should not be presented in the tables.
- ”Kumulativno” pomeni v času od uporabe cepiva; morebitni dogodki oz. učinki, ki niso prijavljeni v proučevanem obdobju, pa ne smejo biti podani v preglednicah.
You should tell your doctor before vaccination
Zdravniku pred cepljenjem povejte,
In accordance with Article 114 Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
V skladu s 114. členom Direktive 2001/83/ES z vsemi dopolnitvami in spremembami, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
The results indicate an overall decline in antibody levels over time.
Rezultati kažejo splošno upadanje protiteles v odvisnosti od časa.
Format of the simplified PSUR
Oblika poenostavljenih poročil PSUR
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Med znaki alergijske reakcije so lahko srbeč kožni izpuščaj, težko dihanje in otekanje obraza ali jezika.
• pain in arms and or legs (in the majority of cases reported as pain in the vaccination arm)
• bolečine v rokah ali nogah (v večini primerov je navedena bolečina v roki, v katero je bilo dano cepivo),
Patients with chronic disease conditions
Bolniki s kroničnimi bolezenskimi stanji
• Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed.
• Po cepljenju proti gripi je prišlo do lažno pozitivnih rezultatov seroloških testov, ki so bili izvedeni po metodi ELISA za odkrivanje protiteles proti HIV1, hepatitisu C in še posebej HTLV1.
The MAH shall perfom the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2. dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Adverse Reactions (Adults and Older People)
Neželeni učinki (odrasli in starejše osebe)
• If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile illness or acute infection.
• Če pandemske razmere to dopuščajo, je treba cepljenje odložiti pri bolnikih, ki imajo hujše obolenje s povišano telesno temperaturo ali akutno okužbo.
This means that for scientific reasons, it has been impossible to get complete information on this medicine.
To pomeni, da iz znanstvenih razlogov ni bilo mogoče pridobiti vseh podatkov o cepivu.
Strain A/Indonesia/05/2005
Sev A/Indonesia/05/2005
Children and adolescents aged 3 to 17 years:
Otroci in mladostniki, stari od 3 do 17 let:
21 Days after
21 dni po
Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or foetal or neonatal toxicity.
Podatki pri nosečnicah, cepljenih z različnimi inaktiviranimi sezonskimi cepivi brez adjuvansa, ne kažejo na malformacijsko ali feto/neonatalno toksičnost.
SPECIAL STORAGE CONDITIONS Store in refrigerator.
Shranjujte v hladilniku.
Very common (affects more than 1 user in 10): • pain at the injection site
Zelo pogosti (pojavijo se pri več kot 1 od 10 oseb): • bolečina na mestu injiciranja
• allergic reactions, including severe reactions leading to a dangerous decrease in blood pressure which, if untreated, may lead to shock.
• alergijske reakcije, vključno s hudimi reakcijami, ki povzročijo nevarno znižanje krvnega tlaka,
• As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
• Kot pri vseh cepivih za injiciranje morata biti vedno takoj na voljo ustrezno medicinsko zdravljenje in zdravniški nadzor, če bi po cepljenju prišlo do sicer redke anafilaktične reakcije.
- All tables will be based on generic and not product-specific data1.
- V vseh preglednicah bodo podani generični podatki in ne podatki, ki so specifični za zdravilo1.
PT “Neuritis”
PT ”nevritis“
This should include data from ongoing studies, or actual use if applicable, of the ‘mock-up' strains.
Tu morajo biti vključeni tudi podatki iz študij, ki so v teku, oziroma morebitni podatki iz dejanske uporabe ‘modelnih' sevov cepiva.
Mock-up vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses.
Modelna cepiva vsebujejo antigene gripe, ki se razlikujejo od antigenov v trenutno prisotnih virusih gripe.
Clinically significant alterations in liver enzymes and calcium levels have not been seen to date in human clinical studies.
Klinično pomembnih sprememb ravni jetrnih encimov in kalcija doslej še niso opazili v kliničnih študijah pri ljudeh.
Adults and children from 6 months onwards: One dose of 0.5 ml at an elected date.
Odrasli in otroci, starejši od 6 mesecev: En odmerek 0,5 ml naj bo injiciran na izbran datum.
Tested against
Testiran proti
Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.
Zato mora zdravnik oceniti koristi in morebitna tveganja cepljenja oseb s trombocitopenijo ali motnjami strjevanja krvi, ki bi povzročile kontraindikacije za intramuskularno injiciranje, razen če morebitni koristni učinki odtehtajo tveganje za krvavitve.
The most frequently occurring side effect was injection site pain, which was usually mild.
Najpogostejši neželeni učinek je bila bolečina na mestu injiciranja, ki je bila po navadi blaga.
Such reactions occurred both in patients with a history of multiple allergies and in patients with no known allergy.
Te reakcije so se pojavile pri bolnikih z več alergijami v anamnezi in bolnikih brez znane alergije.
Month 12-15 Month 24
6. mesec 12-15. mesec 24. mesec
PT “Vaccination failure”.
PT ”neuspešnost cepljenja”
A second dose of 0.5 ml should be given after an interval of at least three weeks.
Drugi odmerek 0,5 ml je treba dati po presledku vsaj treh tednov.
However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need.
V pandemskih razmerah je cepljenje morda vseeno upravičeno, vendar ob zagotovitvi opreme za oživljanje, ki mora biti takoj na voljo.
Such reactions have happened both in people who have allergies and in those who do not;
Takšne reakcije so se pojavile pri osebah z alergijami in pri osebah brez alergij;
There were fewer side effects after the second vaccination compared with the first.
Po drugem cepljenju je bilo manj neželenih učinkov kot po prvem.
Prophylaxis of influenza in an officially declared pandemic situation.
Profilaksa gripe pri uradno razglašeni pandemiji.
From post-marketing surveillance with a whole virion, Vero cell derived, H1N1 vaccine, the following adverse reactions have been reported (the frequency of these adverse reactions is not known as it cannot be estimated from the available data):
Med spremljanjem cepiva proti H1N1 s celimi virioni, razmnoženimi v celicah Vero, po pridobitvi dovoljenja za promet so poročali o naslednjih neželenih učinkih (pogostnost teh neželenih učinkov ni znana, saj je iz razpoložljivih podatkov ni možno oceniti):
Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/
Podrobne informacije o cepivu so objavljene na spletni strani Evropske agencije za zdravila (EMA): http://www.ema.europa.eu.
- Vaccination failure:
- neuspešnost cepljenja:
• feeling cold
• občutek mraza.
- Except for Table 1, all tables will be based on number of reactions (presented on PT level, sorted by System Organ Class [SOC] and High Level Term [HLT]) and not number of cases.
- Razen preglednice 1 bo v vseh preglednicah navedeno število učinkov (predstavljenih po stopnji PT in razvrščenih po organskih sistemih [SOC] in terminu visoke stopnje [HLT]) in ne število primerov.
3 - 8 years
3-8 let
Very rare: vasculitis with transient renal involvement.
Zelo redki: vaskulitis s prehodno prizadetostjo ledvic.
In the clinical studies conducted in infants, children and adolescents, the incidence and nature of symptoms after the first and second vaccination were similar to those occurred in adults and older people.
V kliničnih študijah pri dojenčkih, otrocih in mladostnikih sta bili pojavnost in narava simptomov po prvem in drugem cepljenju podobni kot pri odraslih in starostnikih.
During the pandemic, the applicant will collect clinical safety and effectiveness data of the pandemic vaccine and submit this information to the CHMP for evaluation.
Med pandemijo bo predlagatelj zbiral klinične podatke o varnosti in učinkovitosti cepiva s pandemskim sevom in jih predložil CHMP v ovrednotenje.
The report should include the following Tables of aggregate data (using the pre-defined templates attached in Annex 2).
To poročilo naj vključuje naslednje preglednice sestavljenih podatkov (z uporabo vnaprej opredeljenih predlog,
However, in a pandemic situation, your doctor may recommend to give the vaccine.
V pandemskih razmerah vam bo zdravnik morda vseeno svetoval cepljenje s cepivom.
Outside of the pandemic period, the normal PSUR periodicity and format will be maintained, with a specific review of AESI.
V času zunaj obdobja pandemije bosta ohranjena običajna periodičnost in oblika predajanja poročil PSUR, s posebnim pregledom neželenih učinkov posebnega pomena (AESI).
• reduced blood pressure, feeling faint (syncope)
• znižan krvni tlak, izguba zavesti (sinkopa),
The vaccine is available in a multidose container (see section 6.5 for the number of doses per vial).
Cepivo je na voljo v večodmernem vsebniku (število odmerkov na vialo je navedeno v poglavju 6.5).
These antigens can be considered as ‘novel' antigens and simulate a situation where the target population for vaccination is immunologically naïve.
Te antigene lahko obravnavamo kot ”nove” antigene, ki posnemajo pogoje, v katerih ciljna populacija še ni bila cepljena.
Immunization should be carried out by intramuscular injection into the deltoid muscle or anterolateral thigh, depending on the muscle mass.
Cepivo je treba injicirati intramuskularno, v deltoidno mišico ali anterolateralni predel stegna, odvisno od mišične mase.
6 - 35 months
6-35 mesecev
Data obtained with the mock-up vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical immunogenicity, safety and reactogenicity data obtained with mock-up vaccines are relevant for the pandemic vaccines.
Podatki, pridobljeni z uporabo modelnega cepiva, bodo uporabljeni pri oblikovanju strategije cepljenja, ki bo najverjetneje uporabljena za cepivo proti pandemski gripi: podatki o klinični imunogenosti, varnosti in reaktogenosti, pridobljeni z modelnimi cepivi,
It should be noted that the adverse reactions may be intensified.
Pri tem se lahko okrepijo neželeni učinki.
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, PANDEMIC INFLUENZA VACCINE H5N1 BAXTER can still be given but your response to the vaccine may be poor.
Če jemljete zdravila, ki zmanjšajo imunost na okužbe, ali prejemate drugo vrsto terapije (radioterapijo), ki vpliva na imunski sistem, boste še vedno lahko cepljeni s cepivom PANDEMIC INFLUENZA VACCINE H5N1 BAXTER, vendar bo lahko vaš odziv na cepivo oslabljen.
This section describes the clinical experience with the mock-up vaccine following a two-dose administration.
V tem poglavju so opisane klinične izkušnje pri cepljenju z dvema odmerkoma modelnega cepiva.
Product-specific data can be evaluated during signal work-up.
Podatki, specifični za zdravilo, pa bodo lahko ovrednoteni med obdelavo signalov o varnosti.
- Guillain-Barré syndrome:
- Guillain-Barréjev sindrom:
• insomnia (difficulty sleeping)
• nespečnost (težave pri spanju),
9 - 17 years
9 - 17 let
The side effects listed below have occurred with a similar influenza vaccine (Celvapan) in adults and children during the H1N1 pandemic flu vaccination programme.
Neželeni učinki, navedeni v nadaljevanju, so se pojavili pri podobnem cepivu proti gripi (Celvapan) pri odraslih in otrocih v programu cepljenja proti pandemski gripi H1N1.
Only spontaneously reported data should be included in the S-PSUR.
V poenostavljeno poročilo PSUR morajo biti vključeni le spontano prijavljeni podatki.
Immunogenicity in immunocompromised subjects (N=122) and in patients with chronic disease conditions (N=123)
Imunogenost pri preiskovancih, ki so imunsko kompromitirani (N=122) ali bolnikih s kroničnimi bolezenskimi stanji (N=123)
Depending on and after implementation of vaccine when first pandemic will take place.
Odvisno od uporabe cepiva ob nastopu prve pandemije in kasneje, po prvi uporabi.
The incidence and nature of symptoms after the first and second vaccination were similar to those observed in the healthy adults and older subjects.
Pojavnost in narava simptomov po prvem in drugem odmerku cepiva sta bili podobni kot pri zdravih odraslih in starejših osebah.
Ferrets vaccinated with the 7.5 µg dose of the A/Vietnam/1203/2004 vaccine demonstrated a high rate of seroconversion.
Dihurji, cepljeni z odmerkom 7,5 µg cepiva A/Vietnam/ 1203/2004, so pokazali visoko stopnjo serokonverzije.
Similar to the homologous challenge, vaccination against a heterologous challenge reduced virus burden, and reduced haematological (leukopenia) changes associated with highly pathogenic avian influenza infection.
Podobno kot pri injiciranju homolognega virusa je tudi pri cepljenju proti heterolognemu virusu prišlo do zmanjšanja virusnega bremena in do manj izraženih hematoloških sprememb (levkopenija), povezanih z izjemno patogeno okužbo s ptičjo gripo.
The side-effects are generally similar to those related to the influenza vaccine.
Neželeni učinki so po navadi podobni učinkom, ki jih povzroči cepivo proti gripi.
• Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
• Pri bolnikih z endogeno ali jatrogeno zmanjšanim imunskim odzivom je protitelesni odziv lahko nezadosten.
BLOOD AND LYMPHATIC SYSTEM DISORDERS
BOLEZNI KRVI IN LIMFATIČNEGA SISTEMA
The symptoms (signs) of pandemic flu are similar to those of an ‘ordinary' flu but are usually more severe.
Simptomi (znaki) pandemske gripe so podobni znakom ”navadne”
The European Agency (EMA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
Evropska agencija za zdravila (EMA) bo vsako leto pregledala vse nove podatke,
21 days after 2nd dose
21 dni po drugem odmerku
• abnormal, reduced sensation
• nenormalno oz. zmanjšano čutenje,
If your are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor for advice if you should receive PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, ali ste lahko cepljeni s cepivom PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
Animal reproductive and developmental toxicity studies do not indicate direct or indirect harmful effects with respect to female fertility, pregnancy, embryonal/ foetal development parturition or post natal development.
Študije vpliva na sposobnost razmnoževanja in razvoj pri živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na plodnost samic, brejost, razvoj zarodka/plodu, kotitev ali postnatalni razvoj.
* SRH area ≥ 25 mm²
* površina SRH ≥ 25 mm²
Sensory disturbance (paresthesia, dysesthesia, oral dysesthesia, hypoesthesia, dysgeusia, and burning sensation)
glavobol omotica somnolenca nenormalnosti čutil (parestezija, disestezija, oralna disestezija, hipestezija, disgevzija in pekoč občutek)
The following serious adverse reactions have been reported from post-marketing surveillance with egg-derived interpandemic trivalent vaccines:
O naslednjih resnih neželenih učinkih so poročali med spremljanjem interpandemskih trivalentnih cepiv, razmnoženih v jajcih, po pridobitvi dovoljenja za promet:
18 - 59 years
18 - 59 let
Male fertility was not investigated in the reproductive and developmental toxicity studies, however there were no findings in the repeat-dose toxicity studies to indicate any vaccine-related changes to the tissues of the male reproductive tract.
Plodnosti samcev v študijah vpliva na sposobnost razmnoževanja in razvoj niso raziskovali, vendar rezultati študij toksičnosti pri ponavljajočih odmerkih ne kažejo s cepivom povezanih sprememb na tkivih moških spolovil.
• if you have a poor immune response (for example because of immunosuppressive therapy, e.g. corticosteroid treatments or chemotherapy for cancer);
• če imate oslabljen imunski sistem (na primer zaradi imunosupresivnega zdravljenja z zdravili,
In the first few weeks after vaccination with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER the results of these tests may not be correct.
V prvih tednih po cepljenju s cepivom PANDEMIC INFLUENZA VACCINE H5N1 BAXTER izvidi teh preiskav morda ne bodo pravilni.
Immunogenicity in adults aged 18 to 59 years (N=961) and in subjects aged 60 years and older (N=391)
in 21. dan. Imunogenost pri odraslih, starih od 18 do 59 let (N=961), in osebah, starih 60 let in več (N=391)
• sudden hearing loss, ear pain
• nenadna izguba sluha, bolečine v ušesu,
The safety profile in immunocompromised subjects and patients with chronic disease conditions is similar to the safety profile in healthy adults and older subjects.
Varnostni profil pri preiskovancih, ki so imunsko kompromitirani in pri bolnikih s kroničnimi bolezenskimi stanji, je podoben kot pri zdravih odraslih in starejših preiskovancih.
The vaccine is available in a single dose pre-filled syringe.
Cepivo je na voljo v enoodmerni napolnjeni injekcijski brizgi