natgillin/translations-raw huggingface dataset:
For pre-exposure prophylaxis of HIV-1 infection, it is expected that Emtricitabine/Tenofovir disoproxil Krka in the blood will stop the virus from multiplying and spreading from the site of infection in case the individual is exposed to the virus.
Pričakuje se, da zdravilo Emtricitabin/dizoproksiltenofovirat Krka v krvi za predekspozicijsko profilakso pred okužbo z virusom HIV-1 v primeru izpostavljenosti posameznika virusu prepreči razmnoževanje in širjenje virusa z mesta okužbe.
Emtricitabine/Tenofovir disoproxil Krka contains two active substances, emtricitabine and tenofovir disoproxil.
Zdravilo Emtricitabin/dizoproksiltenofovirat Krka vsebuje dve zdravilni učinkovini, emtricitabin in dizoproksiltenofovirat.
How is Emtricitabine/Tenofovir disoproxil Krka used?
Kako se zdravilo Emtricitabin/dizoproksiltenofovirat Krka uporablja?
How has Emtricitabine/Tenofovir disoproxil Krka been studied?
Kako je bilo zdravilo Emtricitabin/dizoproksiltenofovirat Krka raziskano?
How does Emtricitabine/Tenofovir disoproxil Krka work?
Kako zdravilo Emtricitabin/dizoproksiltenofovirat Krka deluje?
Your doctor will decide the appropriate dose for your child.
Vaš zdravnik bo določil primeren odmerek za vašega otroka.
In such cases, the Western blot method is negative.
V takšnih primerih je bil izvid na osnovi metode Western blot negativen.
- First data-lock point is 30 days later.
- Prva točka zaključitve zbiranja podatkov je 30 dni pozneje.
This is because the vaccination may not be recommended, or may need to be delayed.
To je zato, ker cepljenje morda ni priporočljivo ali ga je potrebno opraviti kasneje.
• if you have a serious infection with a high temperature (over 38°C).
• če imate resno okužbo z visoko telesno temperaturo (nad 38 °C).
- The clock should start from the first Monday after shipment of the first batch of vaccine.
- Ura steče prvi ponedeljek po odpremljenju prve serije cepiva.
Loss of appetite
izguba apetita
The following principles should be followed when compiling the data:
Pri pripravi podatkov je treba upoštevati naslednja načela:
Those which have not yet been entered should be reported in the following SPSUR.
Tiste, ki še niso bili vneseni, je treba prijaviti v naslednjem
For further information, see sections 4.4, 4.8 and 5.1.
Za dodatne informacije glejte poglavja 4.4, 4.8. in 5.1.
Only spontaneously reported data should be included in the PSUR.
V PSUR je treba vključiti samo spontano prijavljene podatke.
Older (>60 years)
Starejše osebe (>60 let)
For any information about this medicinal vaccine, please contact the local representative of the Marketing Authorisation Holder:
Za vse informacije o tem cepivu se obrnite na lokalnega predstavnika imetnika dovoljenja za promet:
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 multiplih signalov je mogoče obdelavi signalov dati prioriteto in zagotoviti je treba ustrezne časovne okvire za predložitev celotnega poročila o ovrednotenju signalov.
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.
Posredovati je treba kratek povzetek, v katerem so izpostavljeni validirani signali in problematična področja, upoštevaje informacije iz prospektivne kohortne študije, opisane v 4.5.
Very common: headache
Zelo pogosti: glavobol
The following age groups will be used: < 2 years, 2-8 years, > 9 years.
Uporabljene bodo starostne skupine < 2 leti, od 2 do 8 let,
Adjupanrix should be used in accordance with official guidance.
Adjupanrix je treba uporabljati v skladu z uradnimi smernicami.
Warning and precautions:
Opozorila in previdnostni ukrepi:
In the first few weeks after vaccination with Adjupanrix the results of these tests may not be correct.
V prvih nekaj tednih po cepljenju s cepivom Adjupanrix so lahko rezultati teh preiskav napačni.
Date of first authorisation: 19 October 2009 Date of latest renewal: 18 July 2014
Datum zadnjega podaljšanja: 18. julij 2014
Currently available data are described in section 4.4, 4.8 and 5.1 but no recommendation on a posology can be made.
Podatki, ki so trenutno na voljo, so opisani v poglavjih 4.4, 4.8 in 5.1, a priporočil za odmerjanje ni mogoče dati.
• Serious stabbing or throbbing pain along one or more nerves
• resna zbadajoča ali kljuvajoča bolečina vzdolž enega ali več živcev,
These data suggest that the excess risk tends to decline with increasing age at vaccination.
Ti podatki kažejo, da se dodatno tveganje zmanjšuje z naraščajočo starostjo ob cepljenju.
Depending on and after implementation of vaccine when first pandemic will take place.
V odvisnosti od in po uvedbi cepiva ob prvem pojavu pandemije.
If this is not treated it may lead to shock.
Če ta ni zdravljen, lahko povzroči šok.
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 utegnejo biti 6-mesečni ciklusi predolgi za oceno varnosti cepiva, ki mu bo v kratkem časovnem obdobju predvidoma izpostavljenih veliko ljudi.
Prophylaxis of influenza in an officially declared pandemic situation.
Preprečevanje gripe v uradno razglašenih pandemskih razmerah.
The first two injections should be given at the elected date and the two other injections should preferably be given 3 weeks after.
Prvi dve injekciji je treba dati na izbrani datum, drugi dve injekciji pa po možnosti 3 tedne pozneje.
Your doctors know that this might happen and will have emergency treatment ready to use.
Vaš zdravnik ve, da se to lahko zgodi in bo imel nujna zdravila pripravljena za uporabo.
Vaccine distribution report
Poročilo o distribuciji cepiva
Persons not previously vaccinated with Prepandrix Adults from the age of 18 years:
Osebe, ki predhodno niso bile cepljene s cepivom Prepandrix Odrasli, starejši od 18 let:
- However, in a pandemic situation, you may still be given the vaccine.
- V pandemskih razmerah boste še vedno lahko prejeli cepivo.
“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 od uporabe cepiva; učinki, ki niso prijavljeni med proučevanim obdobjem, ne smejo biti vključeni v preglednice.
The report should include the following Tables of aggregate data (using the pre-defined templates attached in Annex 2).
Poročilo mora obsegati naslednje preglednice zbranih podatkov (z uporabo vnaprej opredeljenih predlog, priloženih v Dodatku 2).
It should be noted that the adverse reactions may be intensified.
Zavedati se je treba, da se neželeni učinki lahko stopnjujejo.
During the pandemic, the applicant will conduct a prospective cohort study as identified in the Pharmacovigilance plan.
Med pandemijo bo vlagatelj izvajal perspektivno kohortno študijo, kot je navedeno v načrtu farmakovigilance.
MARKETING AUTHORISATION NUMBER(S) EU/1/09/578/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/578/001
The vaccine contains an ‘adjuvant' AS03.
Cepivo vsebuje "adjuvans" AS03.
The signs of pandemic flu are similar to those of ordinary flu but may be more serious.
Znaki pandemske gripe so podobni simptomom običajne gripe, vendar pa so običajno hujši.
The use of Adjupanrix may be considered during pregnancy if this is thought to be necessary, taking into account official recommendations.
Cepivo Adjupanrix se lahko uporabi med nosečnostjo, če se oceni, da je potrebno in ob upoštevanju uradnih priporočil.
Therefore tell the doctor or nurse if you fainted with a previous injection.
Zato morate zdravniku ali medicinski sestri povedati, če ste omedleli pri kakšni predhodni injekciji.
Allergic reactions which may cause you to have dangerously low blood pressure.
Alergijske reakcije, ki lahko povzročijo nevarno nizek krvni tlak.
Data obtained with the pandemic preparedness vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical immunogenicity, safety and reactogenicity data obtained with pandemic preparedness vaccines are relevant for the pandemic vaccines.
Podatki, pridobljeni s cepivom za pripravljenost na pandemijo, podpirajo strategijo cepljenja, ki bo verjetno uporabljena za pandemsko cepivo: podatki o klinični imunogenosti, varnosti in reaktogenosti, pridobljeni s cepivi za pripravljenost na pandemijo, so relevantni za pandemska cepiva.
These transitory false-positive results may be due to IgM production in response to the vaccine.
Prehodno lažno pozitivni rezultati so lahko posledica tvorbe IgM kot odziv na cepivo.
• if you have problems with your immune system, since your response to the vaccine may then be poor.
• če imate težave z imunskim sistemom, saj bo vaš odziv na cepivo lahko slabši.
It is best to see how Adjupanrix affects you before you try these activities.
Najbolje je, da ugotovite, kako cepivo Adjupanrix vpliva na vas, preden opravljate te dejavnosti.
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines or have recently received any other vaccine.
Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali, boste morda začeli jemati katero koli drugo zdravilo ali pa ste pred kratkim dobili kakršno koli drugo cepivo.
No fertility data are available.
Podatkov o plodnosti ni.
71 to 80 years
71 do 80 let
OTHER Storage (2ºC-8ºC), do not freeze, protect from light
Shranjevanje (2°C-8°C), ne zamrzujte, zaščitite pred svetlobo.
• Allergic reactions leading to a dangerously low blood pressure.
• Alergijske reakcije, ki nevarno znižajo krvni tlak.
Read all of this leaflet carefully before you start receiving this vaccine because it contains important information for you.
Preden dobite to cepivo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
After one priming dose
Po enem primarnem odmerku
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 možna tveganja uporabe cepiva pri posameznikih s trombocitopenijo ali kakršnokoli motnjo strjevanja krvi, ki bi bila kontraindikacija za intramuskularno injiciranje, razen če možna korist odtehta tveganje krvavitve.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this vaccine.
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden dobite to cepivo.
Frequency of submission
Pogostnost oddajanja
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.
Med pandemijo je treba vire usmeriti v pravočasno in učinkovito spremljanje varnostnih značilnosti cepiv proti gripi, ki se uporabljajo med pandemijo.
This can cause bleeding or bruising
To lahko povzroči krvavitve ali modrice.
When a person is given the vaccine, the body's natural defence system (immune system) produces its own protection (antibodies) against the disease.
Po cepljenju naravni obrambni sistem telesa (imunski sistem) ustvari lastno zaščito (protitelesa) proti bolezni.
Available epidemiological data in adults aged over 20 years have indicated approximately 1 additional case per 100,000 vaccinated subjects.
Epidemiološki podatki, ki so na voljo za odrasle, starejše od 20 let, so nakazali približno 1 dodaten primer na 100.000 cepljenih oseb.
Format of the simplified PSUR
Struktura poenostavljenega PSUR
The side effects listed below have happened in the days or weeks after vaccination with vaccines given routinely every year to prevent flu.
Neželeni učinki, ki so navedeni spodaj, so se pojavili v dnevih ali tednih po cepljenju s cepivi, s katerimi se vsako leto cepi proti gripi.
Pandemic flu is a type of influenza that happens at intervals that vary from less than 10 years to many decades.
Pandemska gripa je vrsta gripe, ki se pojavi v presledkih, ki trajajo od manj kot 10 let do več desetletij in se hitro širi po vsem svetu.
The frequency of side effects was lower in the group of children who received half of the adult dose.
Pogostnost neželenih učinkov je bila nižja v skupini otrok, ki so prejeli polovični odmerek za odrasle.
PT “Vaccination failure”.
PT “neuspeh cepljenja”
This should include data from ongoing studies, or actual use if applicable, of the pandemic preparedness strains and any safety data relevant to the adjuvant system.
Vključeni morajo biti podatki o potekajočih študijah ali dejanski uporabi (če pride v poštev) seva za pripravljenost na pandemijo in vsi podatki o varnosti, relevantni v zvezi z adjuvantnim sistemom.
- Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
- Znaki alergijske reakcije so lahko srbeč izpuščaj na koži, težko dihanje in otekanje obraza ali jezika.
• Generalised skin reactions including urticaria (hives)
• Generalizirane kožne reakcije, vključno z urtikarijo (koprivnico).
Product-specific data can be evaluated during signal work-up.
Za cepivo specifične podatke je mogoče oceniti med obdelavo signalov.
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.
Če je s CHMP dogovorjeno, da S-PSUR niso več potrebna, bo v časovnem okviru, dogovorjenem s poročevalcem, predloženo celotno PSUR; to PSUR bo zajelo obdobje od točke zaključitve zbiranja podatkov za zadnje redno PSUR.
All tables will be based on generic and not product-specific data1.
- Vse preglednice bodo temeljile na generičnih podatkih, ne na podatkih, specifičnih za cepivo.1
In the unadjuvanted control group, as well as in the adjuvant control group, all animals died or had to be euthanized as they were moribund, three to four days after the start of challenge.
V kontrolnih skupinah so vse živali - tako tiste, ki niso dobile adjuvansa, kot tiste, ki so ga - poginile ali so jih morali žrtvovati, ker so bile tik pred poginom, od tri do štiri dni po začetku provokacije.
In children/adolescents (aged up to 20 years), these studies have indicated an additional 1.4 to 8 cases in 100,000 vaccinated subjects.
Pri otrocih/mladostnikih (starih do 20 let) so te študije nakazale od 1,4 do 8 dodatnih primerov na 100.000 cepljenih oseb.
Information on outcomes from estimated more than 200,000 women who have been vaccinated during pregnancy is currently limited.
Trenutno je malo informacij o izidih pri okvirno več kot 200.000 ženskah, cepljenih med nosečnostjo.
If this applies to you then your vaccination will usually be postponed until you are feeling better.
V tem primeru, bo zdravnik cepljenje običajno odložil, dokler ne boste ozdraveli.
If your child receives the vaccine, you should be aware that the side effects may be more intense after the second dose, especially temperature over 38°C.
Če vaš otrok dobi cepivo, morate vedeti, da so lahko neželeni učinki po drugem odmerku izrazitejši, zlasti zvišanje telesne temperature nad 38 °C.
If you have not previously received doses of Prepandrix
Če predhodno niste prejeli odmerkov cepiva Prepandrix
One dose of 0.5 ml at an elected date.
En odmerek 0,5 ml na izbrani dan.
PT “Neuritis”
PT “nevritis”
All non-medically confirmed events are those that have been entered into the database by the data-lock point.
- Učinki, ki niso medicinsko potrjeni, so vsi učinki, ki niso bili vneseni v podatkovno bazo do točke zaključitve zbiranja podatkov.
Pharmacotherapeutic group: Influenza vaccines, ATC Code: J07BB02.
Farmakoterapevtska skupina: Cepiva proti gripi, oznaka ATC: J07BB02
Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or foetal or neonatal toxicity.
Podatki, pridobljeni pri nosečnicah, ki so bile cepljene z drugačnimi inaktiviranimi sezonskimi cepivi brez adjuvansa, ne nakazujejo na malformacije ali toksične učinke na plod ali novorojenca.
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 bodo vse preglednice temeljile na številu učinkov (predstavljeni po nivoju PT, razvrščeni po organskem sistemu [SOC] in visokonivojskem têrminu [HLT]), ne na številu primerov.
If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile illness or acute infection.
Če pandemske razmere dopuščajo, je treba cepljenje odložiti pri bolnikih, ki imajo hujše obolenje s povišano telesno temperaturo ali akutno okužbo.
Based on the assumption that product name will not be provided in a significant proportion of cases.
Glede na predpostavko, da v velikem deležu primerov ime cepiva ne bo posredovano.
Adjupanrix can only be marketed when there is an official WHO/EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Adjupanrix takes due account of the officially declared pandemic strain.
Cepivo Adjupanrix se lahko sprosti v promet le, če SZO/EU uradno razglasi pandemijo gripe in pod pogojem, da imetnik dovoljenja za promet s cepivom Adjupanrix upošteva uradno razglašen pandemski sev.
An AS03-containing vaccine containing HA from H1N1v has been administered to women in each trimester of pregnancy.
Cepivo z AS03, ki je vsebovalo HA iz H1N1v, je bilo uporabljeno pri nosečnicah v vseh trimesečjih nosečnosti.
If a double dose is given, the injections should be given into opposite limbs preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Če je uporabljen dvojni odmerek, je treba injekciji dati v nasprotni okončini, po možnosti v deltoidno mišico ali anterolateralni del stegna (odvisno od mišične mase).
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA): http://www.ema.europa.eu/
Outside of the pandemic period, the normal PSUR periodicity and format will be maintained, with a specific review of AESI and possible adverse events related to adjuvants.
Zunaj obdobja pandemije bosta ohranjena normalni razpored in struktura PSUR s specifičnim pregledom posebej zanimivih neželenih učinkov in možnih neželenih učinkov, povezanih z adjuvansi.
Pandemic preparedness vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses.
Cepiva za pripravljenost na pandemijo vsebujejo antigene virusa influence, ki se razlikujejo od antigenov virusa influence, ki trenutno kroži med prebivalstvom.
Prior to administration, the two components should be mixed.
Pred uporabo morate obe komponenti zmešati skupaj.
What you need to know before you receive Adjupanrix
Kaj morate vedeti, preden boste dobili cepivo Adjupanrix
There is currently no evidence to indicate that Adjupanrix may be associated with a risk of narcolepsy.
Trenutno ni dokazov, da bi bilo cepivo Adjupanrix morda povezano s tveganjem za narkolepsijo.
A line listing of fatal cases will be provided in an Annex.
- V Dodatku bo priložen vrstični izpis smrtnih primerov.
At day 42, the anti-HA antibody seroconversion rate was 98%, all subjects were seroprotected and the seroconversion factor was 88.6.
Na 42. dan je bil delež serokonverzije anti-HA protiteles 98 %, vsi preiskovanci so bili serološko zaščiteni in faktor serokonverzije je bil 88,6.
Adults from the age of 18 years onwards: one dose of 0.5 ml at an elected date.
Odrasli, starejši od 18 let: en odmerek 0,5 ml na izbrani dan.
The second dose should be given after an interval of at least three weeks and up to twelve months after the first dose.
Drugi odmerek je potrebno dati po presledku najmanj treh tednov in do dvanajst mesecev po prvem odmerku.
Sächsisches Serumwerk Dresden Branch of GlaxoSmithKline Biologicals Zirkusstraße 40, D-01069 Dresden Germany
Sächsisches Serumwerk Dresden Branch of GlaxoSmithKline Biologicals Zirkusstraße 40, D-01069 Dresden
As with all vaccines, Adjupanrix may not fully protect all persons who are vaccinated.
Kot druga cepiva tudi cepivo Adjupanrix morda ne bo popolnoma zaščitilo vseh cepljenih oseb.
Adjupanrix can still be given but your response to the vaccine may be poor.
Cepivo Adjupanrix lahko dobite kljub temu, a vaš odziv nanj je lahko šibek.
After two priming doses
Po dveh primarnih odmerkih
2.5 ml per vial.
2,5 ml na vialo.
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 vlagatelj zbiral podatke o klinični varnosti in učinkovitosti pandemskega cepiva in te podatke posredoval v vrednotenje Odboru za zdravila za uporabo v humani medicini (CHMP).
In addition, from post-marketing surveillance with interpandemic trivalent vaccines, the following adverse reactions have been reported:
Med spremljanjem interpandemskih trivalentnih cepiv po pridobitvi dovoljenja za promet so poročali tudi o naslednjih neželenih učinkih:
Before the vaccine is given, the two parts will be mixed together.
Pred uporabo cepiva je treba oba dela zmešati skupaj.
The European Medicines Agency will review any new information on the medicine every year and this leaflet will be updated as necessary.
Evropska agencija za zdravila bo vsako leto ponovno pregledala vse nove podatke o zdravilu in posodobila navodilo za uporabo, če bo potrebno.
At day 180, the seroprotection rate was 13%.
180. dan je bil delež serokonverzije 13 %.
The side effects listed below have happened with H1N1 AS03-containing vaccines.
Neželeni učinki, našteti spodaj, so se pojavili pri cepivih s H1N1, ki vsebujejo AS03.
4.7 Effects on ability to drive and use machines Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or operate machinery.
Nekateri učinki, navedeni v poglavju 4.8, "Neželeni učinki", lahko vplivajo na sposobnost vožnje in upravljanja s stroji.
Adjupanrix contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose.
Cepivo Adjupanrix vsebuje manj kot 1 mmol natrija (23 mg) in manj kot 1 mmol kalija (39 mg) na odmerek.
Viral shedding into the upper respiratory tract was also reduced in vaccinated animals relative to controls, suggesting a reduced risk of viral transmission.
Pri cepljenih živalih se je v primerjavi s kontrolnimi zmanjšalo tudi izločanje virusa iz zgornjih dihal, kar kaže na manjše tveganje za prenos virusa.
Persons previously vaccinated with one or two doses of Prepandrix containing HA derived from a different clade of the same influenza subtype as the pandemic influenza virus:
Osebe, ki so bile predhodno cepljene z enim ali dvema odmerkoma Prepandrixa, ki vsebuje HA iz druge gruče (clade) istega podtipa gripe, kot je pandemski virus influence:
Musculoskeletal and connective tissue disorders Very common: arthralgia, myalgia
Bolezni mišično-skeletnega sistema in vezivnega tkiva Zelo pogosti: artralgija, mialgija
Furthermore, in the group of children that received a half dose of vaccine, the rate of subjects with a titre of neutralising antibodies above 1:80 remained high up to 24 months after the first dose.
Poleg tega je v skupini otrok, ki so dobili pol odmerka cepiva, delež preiskovancev s titrom nevtralizirajočih protiteles nad 1:80 ostal visok do 24 mesecev po prvem odmerku.
Seroprotection rate*1
Delež serološke zaščite*1
• They will give Adjupanrix as an injection into a muscle.
• Cepivo Adjupanrix vam bodo injicirali v mišico.
However, following two administrations of a double dose of vaccine, the seroprotection rate at day 42 was 75%.
Po dvakratni uporabi dvojnega odmerka cepiva pa je bil delež serološke zaščite na 42. dan 75 %.