natgillin/translations-raw huggingface dataset:
The additional data provided from the open-label phase, a 4-year period of treatment, do not allow to convincingly conclude on a relevant effect of eteplirsen in this population. 
Dodatni podatki iz odprte faze, štiriletnega obdobja zdravljenja, ne omogočajo prepričljivega sklepa o zadevnem učinku eteplirsena pri tej populaciji.
Therefore, the CHMP has recommended the refusal of the granting of the conditional marketing authorisation for Exondys. 
Odbor CHMP je zato priporočil zavrnitev vloge za pridobitev pogojnega dovoljenja za promet z zdravilom Exondys.
During the initial CHMP assessment, three additional clinical studies were being conducted, in order to provide additional data to support the application. 
Med prvotnim ocenjevanjem odbora CHMP so potekale tri dodatne klinične študije, da bi vlogo podprli z dodatnimi podatki.
The Applicant has defined post-hoc several external controls that have been used for different comparisons. 
Predlagatelj je naknadno opredelil več zunanjih kontrolnih skupin, ki jih je uporabil za različne primerjave.
The assessment of the safety profile of eteplirsen was hampered by the limitations of the safety database. 
Oceno varnostnega profila eteplirsena so ovirale omejitve zbirke podatkov o varnosti.
The potential sources of bias, using this strategy, seriously affect the reliability of the subsets and comparisons, and the conclusions made thereof. 
Možni viri pristranskosti pri tej strategiji resno vplivajo na zanesljivost podskupin in primerjav ter na oblikovane sklepe.
Separation between curves is apparent at Year 3 (Year 3 - 144 metres, p=0.0055; Year 4 - 161 metres, p=0.0007). 
Ločitev krivulj je opazna pri tretjem letu (tretje leto - 144 metrov, p = 0,0055; četrto leto - 161 metrov, p = 0,0007).
Regarding the laboratory findings the main concern is proteinuria that has already been observed in nonclinical studies. 
Kar zadeva laboratorijske izvide, vzbuja največjo zaskrbljenost proteinurija, ki je bila opažena že v predkliničnih študijah.
Physicochemical and biological aspects relevant to the uniform clinical performance of the product have been investigated and are controlled in a satisfactory way. 
Proučeni so bili fizikalno-kemični in biološki vidiki, pomembni za enotno klinično učinkovitost zdravila, ki so zadovoljivo nadzorovani.
Without an appropriate concurrent control it is not possible to conclude that the results are reflecting a true and clinically meaningful change (slowing the progression) in the course of the condition. 
Brez ustrezne sočasne kontrole ni mogoče skleniti, da izidi izražajo pravo in klinično pomembno spremembo (upočasnitev napredovanja) med potekom bolezni.
• Due to the limited number of patients exposed to eteplirsen the safety profile remains not thoroughly characterised. 
• zaradi omejenega števila eteplirsenu izpostavljenih bolnikov varnostni profil še vedno ni popolnoma določen.
This small and acquired in a non-comparative manner, dataset makes the assessment of the long-term safety impossible. 
Ta manjši nabor podatkov, pridobljen na neprimerjalen način, onemogoča oceno dolgoročne varnosti.
In general, this strategy increases the uncertainty about the results rather than providing reassuring comparisons. 
Ta strategija na splošno povečuje negotovost glede rezultatov in ne omogoča zanesljivih primerjav.
Therefore, safety data have to be interpreted with caution, precluding any firm conclusions on the safety profile of the product. 
Podatke o varnosti je zato treba razlagati previdno in brez sprejemanja dokončnih sklepov o varnostnem profilu zdravila.
As the minimum amount of truncated dystrophin expression that is needed to achieve a clinically relevant benefit remains unknown, the value of these data is mainly to serve as supportive for the proposed mechanism of action of the product. 
Ker najmanjša količina zaznanega izražanja skrajšanega distrofina, potrebnega za dosego klinično pomembne koristi, ostaja neznana, so ti podatki pomembni predvsem zato, ker podpirajo predlagani mehanizem delovanja zdravila.
However, the CHMP concluded that the medicinal product did not fulfil all of the criteria set out in Article 4(1) of the Regulation, such as, the current benefit-risk balance could not be considered positive based on the available, submitted data. 
Odbor CHMP pa je sklenil, da zdravilo ne izpolnjuje vseh meril iz člena 4(1) navedene uredbe, kot na primer, da na podlagi razpoložljivih in predloženih podatkov trenutnega razmerja med tveganji in koristmi ni mogoče šteti za pozitivnega.
• It remains unknown whether expression of the observed very low amount of truncated dystrophin after treatment with eteplirsen can translate into any clinical benefit to patients. 
• še vedno ni pojasnjeno, ali se lahko izražanje opažene zelo majhne količine skrajšanega distrofina po zdravljenju z eteplirsenom izrazi v klinični koristi za bolnike.
At time of Opinion, there are no outstanding issues on the quality of the active substance or the medicinal product. 
V času izdaje mnenja ni bilo nobenih odprtih vprašanj o kakovosti učinkovine ali zdravila.
• The provided additional comparative data from a variety of external controls, derived from different studies and populations, suffer from important limitations related to the nature of the methodology used (non-concurrent, retrospectively selected, post-hoc defined). 
• predloženi dodatni primerjalni podatki iz različnih zunanjih kontrolnih skupin, pridobljeni v različnih študijah in pri različnih populacijah, so pomembno omejeni, kar zadeva vrsto uporabljenih metod (nesočasne, izbrane retrospektivno, določene naknadno).
In terms of the pharmacodynamic proof of concept, a modest increase in dystrophin (truncated) production has been shown in some patients, while in a number of them no production was detected. 
Z vidika farmakodinamične potrditve zasnove je bilo pri nekaterih bolnikih dokazano manjše povečanje tvorbe (skrajšanega) distrofina, pri številnih pa tvorba ni bila zaznana.
The main limitations in the dataset arise from the limited number of patients by arm (which hinder the interpretability of the study results), and from the duration of the placebo-controlled phase (6 months). 
Glavne omejitve nabora podatkov so povezane z omejenim številom bolnikov v posameznem kraku (kar ovira razlago rezultatov študije) in trajanjem s placebom nadzorovane faze (šest mesecev).
Other findings already seen for other antisense oligonucleotides, like elevation of transaminases have also been identified. 
Ugotovljene so bile tudi druge nepravilnosti, ki so bile opažene tudi pri drugih protismiselnih oligonukleotidih, npr. zvišanje ravni transaminaz.
The quality of this product is considered to be acceptable when used in accordance with the conditions defined in the proposed SmPC. 
Kakovost zdravila Exondys je bila ocenjena za sprejemljivo, če se zdravilo uporablja skladno s pogoji, opredeljenimi v predlaganem povzetku glavnih značilnosti zdravila.
Although the evidence of truncated dystrophin production may support the mechanism of action of the product, convincing demonstration of sustained functional effect is necessary to support the claim for efficacy of the medicinal product in the intended indication. 
Čeprav bi lahko dokaz tvorbe skrajšanega distrofina podprl mehanizem delovanja zdravila, je treba za podprtje trditve o učinkovitosti zdravila pri izbrani indikaciji prepričljivo dokazati njegov dolgotrajni funkcionalni učinek;
The CHMP considered that with the currently available data it is not possible to conclude that the benefit/risk balance of eteplirsen is positive in DMD patients with mutations amenable to exon 51 skipping, since: 
Odbor CHMP je menil, da na podlagi trenutno razpoložljivih podatkov ni mogoče zaključiti, da je razmerje med koristmi in tveganji eteplirsena pri bolnikih z DMD z mutacijami, odzivnimi na preskok eksona 51, pozitivno, saj:
Comparison with untreated patients is challenging as only 4 patients were on placebo for 24 weeks. 
Primerjavo z nezdravljenimi bolniki je težko narediti, saj so bili 24 tednov s placebom zdravljeni le štirje bolniki.
There are no comparative data with patients on placebo beyond 24 weeks, and the available data for patients on treatment are derived from only a limited number of patients (n=12). 
Primerjalni podatki za bolnike, ki so bili zdravljeni s placebom dlje kot 24 tednov, niso na voljo, za zdravljene bolnike pa so podatki na voljo samo za omejeno število bolnikov (n = 12).
The limitation derived from the small numbers is acknowledged, but the fact that it is a result of the small number of patients does not reduce the uncertainty related to the results observed. 
Čeprav je bila upoštevana omejitev zaradi majhnega števila vključenih bolnikov, se zaradi dejstva, da gre za majhno število bolnikov, nezanesljivost opazovanih izidov ne zmanjša.
The limitation of the database size does not allow for the identification of frequent AEs (≥10%) and the lack of a comparator placebo arm makes it impossible to distinguish between AEs related to the disease or the age of the population and those related to the drug. 
Zaradi omejene velikosti podatkovnih zbirk ni mogoče prepoznati pogostih neželenih učinkov (≥ 10 %), pomanjkanje primerjalnega kraka s placebom zdravljenih bolnikov pa onemogoča razlikovanje med neželenimi učinki, povezanimi z boleznijo ali starostjo populacije, in tistimi, ki so povezani z zdravilom.
In conclusion, the safety profile of eteplirsen has not been thoroughly characterized. 
Zaključiti je mogoče, da varnostni profil eteplirsena ni popolnoma določen.
For this application clinical data were provided from a randomized, double-blinded, placebo controlled 24week Phase IIb study (study 201) and its open label extension Study 202 in a total of 12 DMD patients. 
Klinični podatki za to vlogo so bili pridobljeni iz randomizirane, dvojno slepe, s placebom nadzorovane 24-tedenske študije faze IIb (študije 201) in njene odprte podaljšane študije 202 s skupno 12 bolniki z Duchennovo mišično distrofijo (DMD).
Additional post-hoc comparisons with other external controls also have their limitations, as previously mentioned. 
Kot omenjeno, dodatno omejitev pomenijo tudi naknadne primerjave z drugimi zunanjimi kontrolnimi skupinami.
Longer comparisons (up to 4 years) with 12 DMD patients on eteplirsen were subsequently performed versus two post-hoc defined, external and non-concurrent cohorts (Italian Telethon DMD Registry and Leuven Neuromuscular Reference Center Registry) in an open label extension study. 
Nato so bile v odprti podaljšani študiji opravljene daljše (do štiriletne) primerjave med zdravljenjem 12 bolnikov z DMD, ki so prejemali eteplirsen, in zdravljenjem dveh naknadno opredeljenih, zunanjih in nesočasnih kohort (italijanskega registra bolnikov z DMD fundacije Telethon in registra referenčnega centra za živčno-mišične bolezni v Leuvnu).
This increases the uncertainty about the reliability of such comparisons rather than providing confirmatory data for efficacy. 
Tovrstni podatki povečujejo dvom o zanesljivosti primerjav in ne potrjujejo njihove učinkovitosti;
The primary analysis of this pivotal trial provided a 24-week comparison of only 4 patients on eteplirsen exposed to the proposed dose of 30mg/kg/week versus placebo (n=4), and additionally 4 patients exposed to 50 mg/kg/week, in which no difference was observed in the 6MWD. 
Primarna analiza tega ključnega preskušanja je omogočila 24-tedensko primerjavo med samo štirimi bolniki, zdravljenimi z eteplirsenom v predlaganem odmerku 30 mg/kg/teden, in bolniki (n = 4), zdravljenimi s placebom, in naknadno še štirimi bolniki, izpostavljenimi odmerku 50 mg/kg/teden, pri katerih pri šestminutnem preizkusu hoje ni bila opažena nobena razlika.
The comparison was done with an untreated control arm of DMD patients amenable to exon skipping of an exon other than exon 51. 
Primerjava je bila opravljena z nezdravljenim kontrolnim krakom bolnikov z DMD, dovzetnih za preskok eksona, ki ni ekson 51.
The only comparative data comes from study 201 (n=12) in which 4 subjects were randomized to 30 mg/kg, 4 to 50 mg/kg and 4 to placebo for 24 weeks. 
Edini primerjalni podatki izhajajo iz študije 201 (n = 12), pri kateri so bili 24 tednov štirje bolniki randomizirani na 30 mg/kg, štirje na 50 mg/kg in štirje na placebo.
A trend favouring eteplirsen treated patients was observed in loss of ambulation (2/12 in eteplirsen treated patients vs. 10/13 in external controls at Year 4), North Star Ambulatory Assessment and ability to rise from supine. 
Gibanje v korist bolnikov, zdravljenih z eteplirsenom, je bilo vidno pri krajši prehojeni razdalji (v četrtem letu pri 2 bolnikih od 12, zdravljenih z eteplirsenom, in pri 10 bolnikih od 13 iz zunanjih kontrolnih skupin), oceni gibanja po lestvici North Star in sposobnosti bolnika za dvig iz ležečega položaja.
For the long-term safety assessment, safety data are available only for a small set of patients (6 on eteplirsen 30 mg/kg and 6 on 50 mg/kg). 
Varnostni podatki za oceno dolgoročne varnosti so na voljo samo za majhno podskupino bolnikov (šest bolnikov, zdravljenih s 30 mg/kg eteplirsena, in šest bolnikov, zdravljenih s 50 mg/kg eteplirsena).
There are data available from the extension study 202 in which only 6 patients were treated with eteplirsen, 30 mg/kg and 6 with eteplirsen 50 mg/kg for approximately 3 additional years. 
Na voljo so podatki iz podaljšane študije 202, v kateri so približno tri dodatna leta samo šest bolnikov zdravili s 30 mg/kg eteplirsena in šest bolnikov s 50 mg/kg eteplirsena.
A comparison versus a different external and non-concurrent cohort was provided (DMD patients on placebo from the pivotal trial of another medicinal product) for both the whole population and that restricted to those DMD patients walking between 300 and 450 m., and similar shortcomings regarding the comparison groups were identified there. 
Za celotno populacijo in populacijo bolnikov z DMD, ki lahko prehodijo od 300 do 450 m, je bila predložena primerjava z različno zunanjo in nesočasno kohorto (bolniki z DMD, zdravljeni s placebom, iz ključnega preskušanja drugega zdravila), tam pa so bile ugotovljene podobne pomanjkljivosti glede primerjalnih skupin.
There was no difference in 6MWD between eteplirsen and placebo during this 24 week treatment period. 
Pri šestminutnem preizkusu hoje v 24-tedenskem obdobju zdravljenja ni bilo razlike med eteplirsenom in placebom;
One myocardytis event with an atypical presentation was identified in one patient on eteplirsen 30 mg/kg. 
Pri enem bolniku, zdravljenem s 30 mg/kg eteplirsena, je bila prepoznana ena epizoda miokarditisa z atipično klinično sliko.
Interim analysis became available for one of them, the PROMOVI (study 301) an open-label, multicentre study performed in DMD patients with genetically confirmed DMD with exon deletions amenable to exon 51 skipping. 
Pri eni izmed njih - odprti, multicentrični študiji PROMOVI (študija 301), ki je bila izvedena z bolniki z genetsko potrjeno DMD z delecijami eksonov, dovzetnimi za preskok eksona 51 -, je bila predložena vmesna analiza.
The lack of a placebo controlled arm prevent from drawing any conclusions. 
Ker kontrolnega kraka s placebom zdravljenih bolnikov ni bilo, ni mogoče oblikovati nobenega sklepa.
All patients (100%) included in the pivotal trial and around 50% of all patients treated with any dose of eteplirsen reported AEs, mainly hypokaliemia, dermatitis contact, oropharyngeal pain, procedural pain, vomiting, balance disorder and cough. 
O neželenih učinkih, predvsem hipokaliemiji, kontaktnem dermatitisu, orofaringealni bolečini, bolečini pri posegu, bruhanju, motnjah ravnotežja in kašlju, so poročali vsi (100 %) bolniki, vključeni v ključno preskušanje, in približno 50 % vseh bolnikov, zdravljenih s katerim koli odmerkom eteplirsena.
A more pronounced deterioration was observed in the external control groups (both the amenable to exon 51 skipping control group and the one including amenable to any exon skipping patients) than in eteplirsen treated patients. 
V zunanjih kontrolnih skupinah (pri kontrolni skupini, dovzetni za preskok eksona 51, in tudi pri skupini z bolniki, dovzetnimi za kakršen koli preskok eksona) je bilo opaženo izrazitejše poslabšanje kot pri bolnikih, zdravljenih z eteplirsenom.
There were no significant differences in the clinical endpoints between eteplirsen treated and untreated patients. 
Med bolniki, zdravljenimi z eteplirsenom, in nezdravljenimi bolniki ni bilo razlike v kliničnih opazovanih dogodkih.
Both groups (eteplirsen treated patients and untreated external controls) experienced a decline in ambulation. 
Prehojena razdalja se je skrajšala pri obeh skupinah (bolnikih, zdravljenih z eteplirsenom, in nezdravljenih zunanjih kontrolnih skupinah).
The vaccine efficacy was found to be 84%. 
Učinkovitost cepiva je bila 84-%.
Frequencies per dose are defined as follows: 
Pogostnost na odmerek je definirana kot:
4.7 Effects on ability to drive and use machines Not relevant. 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Podatek ni potreben.
• your child has an undiagnosed or progressive disease of the brain or epilepsy which is not controlled. 
• ima vaš otrok nediagnosticirano ali napredujočo bolezen možganov ali epilepsijo, ki ni nadzorovana.
≥ 30 IU ≥ 40 IU 
≥ 30 i.e. ≥ 40 i.e.
Date of latest renewal: 23 October 2005 
Datum zadnjega podaljšanja dovoljenja za promet: 23. oktober 2005
Upon removal from the refrigerator, the vaccine is stable for 8 hours at 21°C. 
Ko vzamemo cepivo iz hladilnika, je stabilno 8 ur pri temperaturi 21 ºC.
† cut-off accepted as indicative of protection 
† mejna vrednost je sprejeta kot kazalnik zaščite
Please tell your doctor if your child has had an allergic reaction to these ingredients. 
Obvestite svojega zdravnika, če je vaš otrok imel alergično reakcijo na ti sestavini.
These measures will help to protect the not less than 30 IU not less than 40 IU 
Takšni ukrepi pomagajo varovati ne manj kot 30 i.e. ne manj kot 40 i.e.
• your child has a severe infection with a high temperature (over 38°C). 
• ima hudo okužbo z zvišano telesno temperaturo (nad 38 ºC).
The MAH must ensure that the system of pharmacovigilance, as described in version 3.06 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market. 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 3,06 in predložen v modulu 1.8.1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in ves čas trženja zdravila.
not less than 30 IU not less than 40 IU 
ne manj kot 30 i.e. ne manj kot 40 i.e.
• This vaccine has been prescribed for your child. Do not pass it on to others. 
• Cepivo je bilo predpisano vašemu otroku in ga ne smete dajati drugim.
As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or 
Ker je korist cepljenja v tej skupini otrok velika, cepljenja ne bi smeli odložiti ali ga izpustiti.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 October 2000 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 23. oktober 2000
• temporarily stopping breathing (apnoea) 
• začasna prekinitev dihanja (apneja),
EU/1/00/153/001 - 1 pre-filled syringe without needle EU/1/00/153/002 - 10 pre-filled syringes without needles EU/1/00/153/003 - 20 pre-filled syringes without needles EU/1/00/153/004 - 50 pre-filled syringes without needles EU/1/00/153/005 - 1 pre-filled syringe with 1 needle EU/1/00/153/006 - 10 pre-filled syringes with 10 needles EU/1/00/153/007 - 20 pre-filled syringes with 20 needles EU/1/00/153/008 - 50 pre-filled syringes with 50 needles EU/1/00/153/009 - 1 pre-filled syringe with 2 needles EU/1/00/153/010 - 10 pre-filled syringes with 20 needles 
EU/1/00/153/001 - 1 napolnjena injekcijska brizga brez igle EU/1/00/153/002 - 10 napolnjenih injekcijskih brizg brez igel EU/1/00/153/003 - 20 napolnjenih injekcijskih brizg brez igel EU/1/00/153/004 - 50 napolnjenih injekcijskih brizg brez igel EU/1/00/153/005 - 1 napolnjena injekcijska brizga z 1 iglo EU/1/00/153/006 - 10 napolnjenih injekcijskih brizg z 10 iglami EU/1/00/153/007 - 20 napolnjenih injekcijskih brizg z 20 iglami EU/1/00/153/008 - 50 napolnjenih injekcijskih brizg s 50 iglami EU/1/00/153/009 - 1 napolnjena injekcijska brizga z 2 iglama EU/1/00/153/010 - 10 napolnjenih injekcijskih brizg z 2 iglama
Please tell your doctor if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently had any other vaccine. 
Obvestite svojega zdravnika, če vaš otrok jemlje ali je pred kratkim jemal katerokoli zdravilo, tudi če ste ga dobili brez recepta ali če je vaš otrok pred kratkim bil cepljen s katerim koli drugim cepivom.
- Tabulated summary of adverse reactions (clinical trials): 
- Povzetek neželenih učinkov v preglednici (klinična preskušanja):
• Do not freeze. 
Ne zamrzujte.
• Temperature of ≥ 40.0 C within 48 hours, not due to another identifiable cause; 
• Zvišana telesna temperatura ≥ 40,0 ºC v 48 urah, ki ji ni možno pripisati drugega vzroka.
- a prospective blinded household contact study performed in Germany (3, 4, 5 months schedule). 
- prospektivni slepi kontaktni študiji v gospodinjstvih, ki je bila izvedena v Nemčiji (cepljenje pri 3, 4 in 5 mesecih).
• Tetanus - tetanus bacteria enter the body through cuts, scratches or wounds in the skin. 
• Tetanus - bakterije tetanusa pridejo v telo skozi vreznine, praske ali rane na koži.
If your child misses a dose 
Če vaš otrok izpusti odmerek
The causal relationship to the vaccine has not been established. 
Vzročna povezava s cepivom ni bila ugotovljena.
months N= 1146) 
mesecev n = 1146)
• Hepatitis B - is caused by the hepatitis B virus. 
• Hepatitis B - povzroča ga virus hepatitisa B, ki povzroči oteklino jeter.
• Diphtheria - a serious bacterial infection that mainly affects the airways and sometimes the skin. 
• Davica - resna bakterijska okužba, ki v glavnem prizadene dihalne poti in občasno kožo.
Booster doses should be given in accordance with the official recommendations. 
Cepljenje z obnovitvenim odmerkom je treba opraviti v skladu z uradnimi priporočili.
However, it can be expected that hepatitis D will be prevented by immunisation as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. 
Vendar je mogoče pričakovati, da bo cepljenje preprečilo hepatitis D, kajti hepatitis D (ki ga povzroča agens delta) se ne pojavi, če ni okužbe s hepatitisom B.
- a NIH sponsored efficacy study performed in Italy (2, 4, 6 months schedule). 
- študiji učinkovitosti, sponzorirani s strani NIH, ki je bila izvedena v Italiji (cepljenje pri 2, 4 in 6 mesecih).
• Infanrix Penta helps your child's body make its own protection (antibodies). 
• Cepivo Infanrix Penta pomaga telesu vašega otroka ustvariti lastno zaščito (protitelesa).
Very common: crying abnormal, irritability, restlessness Uncommon: nervousness 
Zelo pogosti:nenormalen jok, razdražljivost, nemirnost Občasni: živčnost
Medium 199 containing principally amino acids, mineral salts, vitamins 
medij 199, ki vsebuje predvsem aminokisline, mineralne soli, vitamine
• Your child will have a total of two or three injections with at least 1 month between each injection. 
• Vaš otrok bo prejel skupaj dva ali tri odmerke cepiva z vsaj enomesečnim presledkom med odmerki.
Locally established immunoprophylactic measures against hepatitis B should be maintained. 
Treba je upoštevati predpisane lokalne imunoprofilaktične ukrepe proti hepatitisu B.
• Medicines should not be disposed of via wastewater or household waste. 
• Cepiva ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
• As with all vaccines, Infanrix Penta may not fully protect all children who are vaccinated. 
• Tako kot velja za vsa cepiva, cepivo Infanrix Penta morda ne bo popolnoma zaščitilo vseh cepljenih otrok.
Allergic reactions, including anaphylactic and anaphylactoid reactions 
Alergijske reakcije, vključno z anafilaktičnimi in anafilaktoidnimi reakcijami