natgillin/translations-raw huggingface dataset:
The recommended dose at the start of treatment is 2 mg per day, and if it is well tolerated the doctor may progressively increase it by increments of 2 mg/day to a maximum dose of 12 mg per day. 
Priporočeni odmerek ob začetku zdravljenja je 2 mg na dan, če ga pa bolnik dobro prenaša, lahko zdravnik odmerek postopoma povečuje za 2 mg na dan vse do največjega dovoljenega odmerka 12 mg na dan.
Fycompa at doses from 4 mg to 12 mg was shown to be more effective than placebo in reducing the frequency of epileptic seizures. 
Izkazalo se je, da je zdravilo Fycompa v odmerkih od 4 mg do 12 mg učinkovitejše od placeba pri zmanjševanju pogostosti epileptičnih napadov.
Supportive evidence from patients treated for up to 2 years suggested that the benefit was maintained with longer treatment and that some patients could benefit from doses up to 12 mg. 
Podporni dokazi iz evidenc bolnikov, ki so jih zdravili do dve leti, kažejo, da se je učinek zdravila pri daljšem zdravljenju ohranil in da so pri nekaterih bolnikih odmerki do 12 mg pokazali določene koristi.
The most common side effects with Fycompa (seen in more than 1 patient in 10) are dizziness and somnolence (sleepiness). 
Najpogostejša neželena učinka zdravila Fycompa (opažena pri več kot 1 bolniku od 10) sta omotica in zaspanost.
Fycompa is also used in patients from 12 years of age to treat primary generalised tonic-clonic seizures (major fits or convulsions, where the person becomes unconscious, falls down if standing, and jerks or shakes) associated with idiopathic generalised epilepsy (epilepsy with no apparent cause that is thought to have a genetic origin and that affects the whole brain). 
Zdravilo Fycompa se prav tako uporablja pri bolnikih, starejših od 12 let, za zdravljenje primarno generaliziranih napadov s tonično-kloničnimi krči (hujših napadov ali konvulzij, pri katerih lahko pride do nezavesti, padca, če je oseba v stoječem položaju, ter krčev in tresavice), povezanih z idiopatsko generalizirano epilepsijo (epilepsijo brez znanega vzroka, za katero se šteje, da je genetskega izvora in prizadene celotne možgane).
The main measure of effectiveness was the percentage of patients who experienced at least a 50% decrease in seizure frequency. 
Glavno merilo učinkovitosti je bil delež bolnikov, pri katerih je pogostost napadov upadla za vsaj 50 %.
What benefit has Fycompa shown during the studies? 
Kakšne koristi je zdravilo Fycompa izkazalo v študijah?
The CHMP considered that Fycompa, taken together with other anti-epileptic medicines, showed a consistent reduction in the frequency of epileptic fits and that no serious toxicity has been identified. 
CHMP je menil, da je bilo za zdravilo Fycompa, uporabljeno sočasno z drugimi zdravili proti epilepsiji, dokazano, da dosledno zmanjšuje pogostost epileptičnih napadov in ne povzroča resne toksičnosti.
Fycompa is used to treat adults and children from 12 years of age with partial-onset seizures (epileptic fits) with or without secondary generalisation. 
Zdravilo Fycompa se uporablja za zdravljenje odraslih in otrok, starejših od 12 let, ki imajo napade parcialnega izvora (epileptične napade) s sekundarno generalizacijo ali brez nje.
For the full list of all side effects and restrictions with Fycompa, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Fycompa glejte navodilo za uporabo.
In these studies, Fycompa was given at a dose of 2, 4, 8 or 12 mg per day for up to 19 weeks. 
V teh študijah so zdravilo Fycompa bolnikom dajali največ 19 tednov v odmerkih 2, 4, 8 ali 12 mg na dan.
In the management of partial onset seizures, Fycompa has been compared with placebo (a dummy treatment) in three main studies involving a total of 1,491 patients aged 12 years and older with partial-onset seizures who did not respond to other treatments. 
Pri uravnavanju napadov parcialnega izvora so zdravilo Fycompa primerjali s placebom (zdravilom brez zdravilne učinkovine) v treh glavnih študijah, v katerih je skupno sodelovalo 1 491 bolnikov, starejših od 12 let, z napadi parcialnega izvora, ki se niso odzivali na druga zdravila.
The third study showed a significant decrease in seizure frequency only in patients taking 4 mg and 8 mg Fycompa but not in patients taking a dose of 2 mg. 
Tretja študija je pokazala znatno zmanjšanje pogostosti napadov samo pri bolnikih, ki so jemali 4- in 8-miligramski odmerek zdravila Fycompa, ne pa pri bolnikih, ki so jemali 2-miligramski odmerek.
What is the risk associated with Fycompa? 
Kakšna tveganja so povezana z uporabo zdravila Fycompa?
For patients with primary generalised tonic-clonic seizures Fycompa was also more effective than placebo: 47 of 81 patients (58%) given Fycompa had at least a 50% reduction in frequency of seizures, compared with 29 of 81 (36%) of those given the dummy treatment. 
Pri bolnikih s primarno generaliziranimi tonično-kloničnimi napadi je bilo zdravilo Fycompa učinkovitejše od placeba: do najmanj 50-odstotnega zmanjšanja pogostosti napadov je prišlo pri 47 od 81 (58 %) bolnikov, ki so prejemali zdravilo Fycompa, medtem ko je pri bolnikih, ki so prejemali placebo, do takšnega zmanjšanja prišlo pri 29 od 81 (36 %) bolnikov.
Treatment was started at a dose of 2 mg of Fycompa and gradually increased over 4 weeks to a maximum of 8 mg if tolerated, then continued for a further 13 weeks. 
Zdravljenje se je začelo z 2-miligramskim odmerkom zdravila Fycompa, ki so ga v obdobju štirih tednov povečali na največji dovoljeni odmerek 8 mg, če so bolniki zdravilo dobro prenašali, nato pa dajanje zdravila nadaljevali nadaljnjih 13 tednov.
Fycompa is taken by mouth once a day at bedtime. 
Zdravilo Fycompa se jemlje peroralno enkrat dan pred spanjem.
Fycompa is a medicine that contains the active substance perampanel. 
Fycompa je zdravilo, ki vsebuje zdravilno učinkovino perampanel.
Why has Fycompa been approved? 
Zakaj je bilo zdravilo Fycompa odobreno?
The active substance in Fycompa, perampanel, is an anti-epileptic medicine. 
Zdravilna učinkovina v zdravilu Fycompa, perampanel, je zdravilo proti epilepsiji.
Fycompa was compared with placebo as an addition to patients' existing epilepsy treatment. 
Zdravilo Fycompa so primerjali s placebom, pri čemer so ju dodajali bolnikovim obstoječim zdravilom proti epilepsiji.
Fycompa must only be used as an ‘add-on' therapy to other anti-epileptic medicines. 
Zdravilo Fycompa se lahko uporablja samo kot dodatek k drugim zdravilom proti epilepsiji.
In the first study, the percentage of patients who experienced a decrease in seizure frequency of at least 50% was 37.6% for patients taking 8 mg Fycompa and 36.1% for patients taking 12 mg Fycompa, compared with 26.4% of patients taking placebo. 
V prvi študiji je delež bolnikov, pri katerih je prišlo do najmanj 50-odstotnega upada pogostosti napadov, znašal 37,6 % pri bolnikih, ki so jemali 8-miligramski odmerek zdravila Fycompa, ter 36,1 % pri bolnikih, ki so jemali 12-miligramski odmerek, medtem ko je ta delež pri bolnikih, ki so jemali placebo, znašal 26,4 %.
The dose should not exceed 8 mg per day in patients with mildly or moderately reduced liver function. 
Pri bolnikih z blažjo ali zmerno okvaro jeter odmerek ne sme preseči 8 mg na dan.
How has Fycompa been studied? 
Kako je bilo zdravilo Fycompa raziskano?
In the second study, 33.3% and 33.9% of patients taking 8 mg and 12 mg Fycompa respectively showed a decrease in seizure frequency of at least 50%, compared with 14.7% of patients taking placebo. 
V drugi študiji je najmanj 50-odstotni upad pogostosti napadov imelo 33,3 % bolnikov, ki so jemali 8-miligramski odmerek zdravila Fycompa, in 33,9 % bolnikov, ki so jemali 12-miligramski odmerek, medtem ko je ta delež pri bolnikih, ki so prejemali placebo, znašal 14,7 %.
What is Fycompa? 
Kaj je zdravilo Fycompa?
What is Fycompa used for? 
Za kaj se zdravilo Fycompa uporablja?
How is Fycompa used? 
Kako se zdravilo Fycompa uporablja?
Therefore by blocking glutamate's actions, Fycompa is thought to stop epileptic seizures from occurring. 
Zdravilo Fycompa naj bi tako posledično z zaviranjem delovanja glutamata ustavilo pojav epileptičnih napadov.
How does Fycompa work? 
Kako zdravilo Fycompa deluje?
It is currently difficult to explain if this phenomenon is treatment related or not. 
Trenutno je težko razložiti, ali je ta pojav povezan z zdravljenjem ali ne.
In this case, your doctor will postpone the vaccination. 
V tem primeru bo vaš zdravnik odložil cepljenje.
Tell your doctor: 
Obvestite svojega zdravnika:
Dispose of in accordance with local requirements. 
Zavrzite v skladu z lokalnimi zahtevami.
You and your child may need to read it again. 
Morda ga boste želeli vi ali vaš otrok ponovno prebrati.
1 produced in Vero cells 
1 proizvedeno v celicah Vero
If the vaccine has been frozen it should not be used. 
Če je bilo cepivo zamrznjeno, ga ne smete uporabiti.
Safety and tolerability was evaluated in the entire study population. 
Varnost in prenašanje so ocenili v celotni študijski populaciji.
4.5 Interaction with other medicinal products and other forms of interaction 
4.5 Medsebojno delovanje z drugimi zdravili in ostale oblike interakcij
Please note that: 
Upoštevajte naslednje:
The pre-filled syringe is for single use only and should not be used for more than one person. 
Napolnjena injekcijska brizga je samo za enkratno uporabo in je ne smete uporabiti za več kot eno osebo.
◊Negative Pre-Vaccination titers were imputed to 5. 
◊Negativnim titrom pred cepljenjem je bilo prišteto 5.
Mathematical modelling was applied to project the average duration of protection. 
Matematični model je bil uporabljen za napovedovanje povprečnega trajanja zaščite.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. 
Ker študije kompatibilnosti niso bile izvedene, se to zdravilo ne sme mešati z drugimi zdravili.
All of the 198 subjects treated were included in the ITT and Safety Populations. 
Vseh 198 zdravljenih oseb je osodelovalo v populaciji ITT in varnostni populaciji.
The vaccine causes the body to produce its own protection (antibodies) against this disease. 
Cepivo vzpodbudi telo k proizvajanju lastne zaščite (protiteles) proti tej bolezni.
This virus is mainly found in Asia and is transmitted to humans by mosquitoes that have bitten an infected animal (like pigs). 
Ta virus običajno najdemo v Aziji in se na ljudi prenaša prek komarjev, ki so pičili okuženo žival (kot so prašiči).
Non-clinical toxicity data are limited. 
Nekliničnih podatkov o toksičnosti ni veliko.
Date of first authorisation: 31 March 2009 Date of latest renewal: 22 November 2018 
Datum prve odobritve: 31. marec 2009 Datum zadnjega podaljšanja: 28. februar 2014
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 
Za izboljšanje sledljivosti bioloških zdravil, je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
If the primary immunization of two injections is not completed, full protection against the disease might not be achieved. 
Če primarna imunizacija z dvema odmerkoma ni zaključena, popolna zaščita proti bolezni morda ne bo dosežena.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
Zahteve glede periodično posodobljenih poročil o varnosti tega zdravila so opredeljene na seznamu referenčnih datumov Unije (seznamom EURD), ki je naveden v členu 107c(7) Direktive 2001/83/ES in vseh naknadnih posodobitvah ter objavljen na spletnem portalu Evropske agencije za zdravila.
Long-term seroprotection following a booster-dose is not known. 
Dolgoročna serološka zaščita po obnovitvenem odmerku ni znana.
However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route. 
Vendar pa je treba pripomniti, da ni podatkov o klinični učinkovitosti, ki bi podprli subkutano dajanje.
Immunogenicity data were evaluated in 64 subjects. 
Podatki o imunogenosti so bili ocenjeni pri 64 preiskovancih.
In patients receiving immunosuppressive therapy or patients with immunodeficiency an adequate immune response may not be obtained. 
Pri bolnikih, ki so prejeli imunosupresijsko zdravljenje, ali bolnikih z oslabljenim imunskim odgovorom morda ne bo mogoče doseči primernega imunskega odgovora.
Administration must be postponed in persons with acute severe febrile conditions. 
Uporabo cepiva je treba pri osebah z akutnimi hudimi febrilnimi stanji odložiti.
Many infected people develop mild symptoms or no symptoms at all. 
Pri mnogih okuženih ljudeh se pojavijo le blagi simptomi ali pa teh sploh ni.
The majority of the side effects listed below have been observed during clinical trials. 
Večino neželenih učinkov, ki so navedeni spodaj, so opazili med kliničnimi preskušanji.
Confusion and agitation also occur in the early stage of disease. 
V zgodnji fazi bolezni se lahko pojavita tudi zmedenost in razdražljivost.
This product might contain traces of residual sodium metabisulfite which is below detection limit. 
To zdravilo lahko vsebuje sledove ostankov natrijevega metabisulfita, ki so pod mejo zaznavanja.
corresponding to a potency of ≤ 460 ng ED50 
ki ustreza jakosti ≤ 460 ng ED50
Blank white foil without any printed information. 
Prazen bel omot brez natisnjenih podatkov.
Data are limited but there were no differences in the safety profile between the 0.25 ml and the 0.5 ml dose in this age group. 
Podatki so omejeni, vendar razlik v profilu varnosti med odmerkoma 0,25 ml in 0,5 ml v tej starostni skupini ni bilo.
ATC code: J07BA02 
Oznaka ATC: J07BA02
Time point after primary immunization 
Časovna točka po primarni imunizaciji
If you have any further questions, ask your doctor. 
• Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom.
Email: infoixiaro@valneva.com 
E-pošta: infoixiaro@valneva.com
In animal studies findings of unclear clinical relevance have been identified (see section 5.3). 
Klinični pomen ugotovitev v študijah pri živalih je nejasen (glejte poglavje 5.3).
As with any other vaccine, vaccination with IXIARO may not result in protection in all cases. 
Kot pri drugih cepivih, cepljenje s cepivom IXIARO morda ne bo dalo zaščite v vseh primerih.
Your doctor will discuss with you the possible risks and benefits of receiving IXIARO. 
Vaš zdravnik se bo z vami pogovoril o morebitnih tveganjih in koristih cepljenja s cepivom IXIARO.
Longterm immunogenicity data were evaluated in 23 children, mean age 14.3 years, range 3 - 18 years). 
Podatki o dolgoročni imunogenosti so bili ocenjeni pri 23 otrocih, povprečna starost 14,3 leta, razpon 3-18 let.
Pre-Vaccination 30% (3/10) Day 56 Month 7 
Pred cepljenjem 30% (3/10) 56. dan 7. mesec
Do not use this medicine after the expiry date which is stated on the carton and label after “EXP”. 
• Tega zdravila ne smete uporabiti po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki za besedo „EXP“.
If not, you and/or your child may not be fully protected against the disease. 
nasprotnem primeru morda vi in/ali vaš otrok ne boste popolnoma zaščiteni pred boleznijo.
If a needle is not provided, use a sterile needle. 
Če igla ni priložena, uporabite sterilno iglo.
Upon storage, a fine white deposit with a clear colourless supernatant can be observed. 
Pri shranjevanju se lahko pojavi fina bela usedlina s čistim, brezbarvnim supernatantom.
The safety and efficacy of IXIARO in children younger than 2 months has not been established. 
Varnost in učinkovitost cepiva IXIARO pri otrocih, mlajših od 2 mesecev, nista bili dokazani.
Make sure you and/or your child finish the complete vaccination course of 2 injections. 
Poskrbite, da boste vi in/ali vaš otrok dokončali cikel cepljenja z dvema injekcijama.
The pre-filled syringe is ready to use. 
Napolnjena injekcijska brizga je pripravljena za uporabo.
IXIARO has no or negligible influence on the ability to drive and use machines. 
Cepivo IXIARO nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
As with all injectable vaccines, appropriate medical treatment and supervision should always be available to treat rare cases of anaphylactic reactions following the administration of the vaccine. 
Kot pri vseh cepivih, ki se injicirajo, morajo biti vedno na voljo ustrezni terapevtski ukrepi in nadzor za zdravljenje redkih primerov anafilaktičnih reakcij po uporabi cepiva.
Subcutaneous administration could lead to a suboptimal response to the vaccine (see section 4.4). 
Subkutano dajanje lahko povzroči manj optimalen odziv na cepivo (glejte poglavje 4.4).
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 receiving this vaccine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden se cepite s tem cepivom.
Booster dose 12 months after primary immunization N = 149 
Obnovitveni odmerek 12 mesecev po primarni imunizaciji N = 149
The immune responses to further doses at different time points after complete or incomplete primary immunization are shown in table 6. 
Imunski odzivi na nadaljnje odmerke v različnih časovnih obdobjih po zaključeni ali nezaključeni primarni imunizaciji so prikazani v preglednici 6.
Aluminium hydroxide is included in this vaccine as an adjuvant. 
Aluminijev hidroksid je v zdravilu vključen kot adjuvans.
If you and/or your child are allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine (listed in section 6). 
• če ste vi in/ali vaš otrok alergični (preobčutljivi) na zdravilno učinkovino ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Tell your doctor if you and/or your child are taking or have recently taken, or might take any other medicines, including medicines obtained without a prescription or have recently received any other vaccine. 
Obvestite svojega zdravnika, če vi in/ai vaš otrok jemljete, ste pred kratkim jemali ali nameravate jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta, ali ste se pred kratkim cepili z drugimi cepivi.
The observed decline in GMT is as expected and compares well with data from other inactivated JE vaccines. 
Opaženi padec v geometričnem srednjem titru je pričakovan in dobro primerljiv s podatki drugih cepiv z inaktiviranim virusom JE.
If your or your child's immune system does not work properly (immunodeficiency) or you and/or your child are taking medicines affecting your immune system (such as a medicine called cortisone or cancer medicine). 
• če vaš imunski sistem ali imunski sistem vašega otroka ne deluje pravilno (imunodeficienca) ali če vi in/ali vaš otrok jemljete zdravila, ki vplivajo na imunski sistem (na primer zdravilo, ki ga imenujemo kortizon ali zdravila proti raku).
n.a. 95% Confidence Interval could not be established (single-subject data) 
NP 95-odstotnega intervala zaupanja ni bilo mogoče vzpostaviti (podatki za enega preizkušanca).
No symptoms related to overdose were reported. 
O simptomih, povezanih s prekomernim odmerkom, ni bilo poročil.
1 dose (0.5 ml) of IXIARO contains: 
1 odmerek (0,5 ml) cepiva IXIARO vsebuje:
0.5 ml N=628 3 to <18 years 
0,5 ml n = 628 3 do < 18 let
Month 2 98.9 (179/181) Month 6 95.0 (172/181) Month 12 83.4 (151/181) Month 24 81.8 (148/181) Month 36 84.9 (129/152) 
12. mesec 83,4 (151/181) 24. mesec 81,8 (148/181) 36. mesec 84,9 (129/152)
Adults (18 to ≤ 65 years of age) 
Odrasli (18 do ≤ 65 let)
Studies in animals have shown that the vaccine triggers the immune system to produce antibodies against Japanese encephalitis virus that are most often protective. 
Študije pri živalih so pokazale, da cepivo vzpodbudi imunski sistem tako, da proizvaja tista protitelesa, ki najpogosteje ščitijo proti virusu japonskega encefalitisa.
Phosphate Buffered Saline 0.0067 M (in PO4) has the following saline composition: NaCl - 9mg/mL 
Fosfatni pufer s soljo 0,0067 M (v PO4) ima naslednjo sestavo: NaCl - 9 mg/ml
Individuals who show hypersensitivity reactions after receiving the first dose of the vaccine should not be given the second dose. 
Posamezniki, pri katerih se po prejemu prvega odmerka cepiva pokažejo preobčutljivostne reakcije, ne smejo prejeti drugega odmerka.
They usually occur within the first 3 days after vaccination, are usually mild and disappear within a few days. 
Ti se običajno pojavijo v prvih treh dneh po cepljenju, so običajno blagi in izzvenijo v nekaj dneh.
Push the plunger stopper up to the edge of the red line on the syringe barrel, indicated by a red arrow (see Figure 1)*, to discard excess volume. 
Bat potisnite do roba rdeče črte na telesu brizge, ki ga označuje rdeča puščica (glejte sliko 1)*, da iztisnete odvečno količino
Approximately 40% of treated subjects experienced systemic adverse reactions and approximately 54% experienced injection site reactions. 
Sistemski neželeni učinki so se pojavili pri približno 40 % cepljenih oseb, pri približno 54 % pa so se pojavile reakcije na mestu injiciranja.
First dose at Day 0. 
Prvi odmerek na 0. dan.
Signs of an allergic reaction may include an itchy rash, shortness of breath and swelling of the face and tongue. 
Znaki alergijske reakcije lahko vključujejo srbeč izpuščaj, zadihanost in otekanje obraza ter jezika,
As with many vaccines, the immune response in elderly persons to IXIARO is lower than in younger adults. 
Kot pri mnogih cepivih je imunski odziv starostnikov na cepivo IXIARO slabši kot pri mlajših odraslih.
The booster dose led to a pronounced increase in GMTs and seroprotection rate remained at 100% two years after the booster. 
Obnovitveni odmerek je povzročil izrazito zvišanje GMT, stopnja serološke zaščite pa je ostala 100 % dve leti po obnovitvenem odmerku.
Frequency of adverse reactions(%) by dose/age 
Pogostnost neželenih učinkov (%) po odmerku/starosti
The vaccine should be administered by intramuscular injection into the deltoid muscle. 
Cepivo je treba injicirati intramuskularno, v deltoidno mišico.
Pharmacotherapeutic group: Vaccines, Viral vaccines, Encephalitis vaccines. 
Farmakoterapevtska skupina: Cepiva, virusna cepiva, cepiva proti virusom encefalitisa.
If you and/or your child have any other known allergies. 
• če imate vi in/ali vaš otrok druge znane alergije;
Studies in humans to evaluate the effectiveness and safety of medicines (clinical trials) have shown that IXIARO can be given at the same time with hepatitis A vaccine and rabies vaccine. 
Študije pri ljudeh za oceno učinkovitosti in varnosti zdravil (klinične študije) so pokazale, da se lahko cepivo IXIARA odmerja sočasno s cepivom proti hepatitisu A in steklini.
For elderly persons (>65 years) the first booster dose may be given earlier. 
Starejši odrasli (≥ 65 let) lahko prvi obnovitveni odmerek prejmejo prej.
Read all of this leaflet carefully before you or your child receive this vaccine because it contains important information for you. 
Preden vi ali vaš otrok prejmete to cepivo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
There was also no interference with the immune response to Rabipur. 
Prav tako ni bil moten imunski odziv na cepivo Rabipur.
Group C: IXIARO + HAVRIX1440 Group A: IXIARO + Placebo 
Skupina C: IXIARO + HAVRIX1440 Skupina A: IXIARO + Placebo
Parents or subjects were asked for any unsolicited AEs on the day of the second vaccination and at in-person visits including a medical exam 28 days (Day 56) and 6 months (Month 7) after the second dose. 
Starši ali osebe so bili naprošeni, da spontano navedejo vse neželene učinke na dan drugega cepljenja in na dan osebnega obiska, vključno z zdravniškim pregledom 28. dne (56. dne) in 6 mesecev (7 mesecev) po drugem odmerku.
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. 
Uradna sprostitev serije: 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.