natgillin/translations-raw huggingface dataset:
For all age groups: - Immunogenicity results observed with the seroneutralisation (SN) method reflect those observed 
Za vse starostne skupine: - Rezultati imunogenosti določeni po metodi seronevtralizacije (SI) odgovarjajo rezultatom
All children aged from 6 to 35 months were seronegative prior to vaccination. 
Vsi otroci, stari od 6 do 35 mesecev, so bili pred cepljenjem seronegativni.
In adolescents from 9 to 17 years of age, the most frequent reactions were injection site pain and headache. 
Pri mladostnikih, starih od 9 do 17 let, sta bili najpogostejši reakciji bolečina na mestu injiciranja in glavobol.
Pharmacovigilance The MAH will submit the results of a prospective cohort safety study in at least 9,000 patients in different age groups, including immunocompromised subjects, in accordance with the protocol submitted with the Risk 
Farmakovigilanca Imetnik dovoljenja za promet z zdravilom bo rezultate prospektivne kohortne študije varnosti na najmanj 9000 bolnikih iz različnih starostnih skupin, vključno z imunokomprimiranimi osebami, posredoval v skladu s protokolom, predloženim skupaj z načrtom o
These reactions were usually resolved spontaneously within 1 to 3 days after onset. 
Te reakcije so spontano izzvenele v 1 do 3 dneh od pojava.
• Including swelling most apparent in the head and neck, including the face, lips, tongue, throat or any other part of the body (angioedema) in very rare cases. 
• v zelo redkih primerih so se pojavile otekline, ki so bile najbolj očitne na glavi in vratu, vključno z obrazom, ustnicami, jezikom, grlom ali drugimi deli telesa (angioedem).
In particular rates of fever (axillary temperature ≥38°C) may increase considerably after the second dose. 
Še zlasti se lahko po drugem odmerku občutno poveča pojavnost zvišane telesne temperature (aksilarna temperatura ≥ 38°C).
However, if co-administration with another vaccine is considered, immunisation should be carried out on separate limbs. 
Toda če se razmišlja o sočasni uporabi z drugim cepivom, je treba imunizacijo opraviti na drugi okončini.
The adjuvant, AF03, was not mutagenic or clastogenic and induced transient inflammatory changes in repeat dose toxicity studies (in rats and rabbits). 
Adjuvans, AF03, ni mutagen ali klastogen in je povzročil prehodne vnetne spremembe v študijah toksičnosti cepljenja pri ponavljajočih se odmerkih (pri podganah in kuncih).
- Side effects related to the central nervous system: 
- Z osrednjim živčnim sistemom povezani neželeni učinki:
Overall, systemic reactions were more frequently reported in children from 6 to 11 months compared to children from 12 to 23 months. 
V splošnem so o sistemskih reakcijah pogosteje poročali pri otrocih, starih od 6 do 11 mesecev, v primerjavi z otroci, starimi od 12 do 23 mesecev.
Neuralgia, paraesthesia, febrile convulsions, neurological disorders, such as encephalomyelitis, neuritis and Guillain-Barré syndrome 
Nevralgija, parestezija, febrilne konvulzije, nevrološke motnje, kot so encefalomielitis, nevritis in Guillain-Barréjev sindrom
Elderly 81 years of age and over 
Starejše osebe, stare 81 let in več
HUMENZA should under no circumstances be administered intravascularly. 
Cepiva HUMENZA se ne sme v nobenem primeru aplicirati intravaskularno.
• The MAH shall agree with Member Sates on the provision of a targeted communication to healthcare professionals which should address the following: 
• Imetnik dovoljenja za promet se bo z državami članicami dogovoril o zagotavljanju ciljanega obveščanja za zdravnike, ki mora obravnavati naslednje:
Moreover, a higher frequency of fever and headache was reported after the second dose than after the first dose. 
Pogostnost zvišane telesne temperature in glavobola je bila večja po drugem odmerku kot po prvem.
The most frequent reaction was injection site pain. 
Najpogostejša reakcija je bila bolečina na mestu injiciranja.
Overall, reactions were more frequent in adults than in elderly and less frequent after the second dose in both age groups. 
V splošnem so bile reakcije pogostejše pri odraslih kot pri starejših bolnikih in manj pogoste po drugem odmerku v obeh skupinah.
- Temporary reduction in the number of certain types of particles in the blood called platelets; a low number of these can result in excessive bruising or bleeding (transient thrombocytopenia), temporary swelling of the glands in the neck, armpit or groin (transient lymphadenopathy). 
- Prehodno zmanjšanje števila nekaterih vrst delcev v krvi, ki se imenujejo trombociti; nizko število trombocitov lahko povzroči prekomerno nastajanje modric ali krvavitev (prehodna trombocitopenija), prehodno oteklost bezgavk v vratu, pod pazduho ali v dimljah (prehodna
What HUMENZA looks like and contents of the pack 
Izgled cepiva HUMENZA in vsebina pakiranja
Pharmacovigilance The MAH commits to present a plan for the definition of the sources to collect safety data on immunocompromised patient within the prospective cohort safety study. 
Farmakovigilanca Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo predstavil načrt za določanje virov zbiranja podatkov o varnosti pri imunokomprimitiranih bolnikih s prospektivno kohortno študijo varnosti.
Campus Mérieux 1541, avenue Marcel Mérieux 69280 Marcy l'Etoile France 
Campus Mérieux 1541, avenue Marcel Mérieux 69280 Marcy l'Etoile Francija
When HUMENZA is given for the first dose, it is recommended that HUMENZA (and not another vaccine against H1N1) be given for the complete vaccination course. 
Če je za prvi odmerek uporabljeno cepivo HUMENZA, je priporočljivo, da se cepljenje tudi dokonča s cepivom HUMENZA (in ne drugim cepivom proti H1N1).
The MAH must ensure that the system of pharmacovigilance, as described in version 10.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use. 
Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 10.0, predstavljeni v modulu 1.8.1 vloge za pridobitev dovoljenja za promet, vzpostavljen in da deluje preden začne tržiti zdravilo in ves čas uporabe cepiva.
If any of these side effects occur, please tell your doctor or nurse immediately. 
Če opazite kateregakoli od teh neželenih učinkov, takoj obvestite svojega zdravnika ali medicinsko sestro.
Immune system disorders: Allergic reactions, in rare cases leading to shock, angioedema 
Bolezni imunskega sistema: Alergijske reakcije, ki so v redkih primerih povzročile šok, angioedem
If deviations from this description and/or any foreign particulate matter are observed (including rubber particles from the stopper), the vaccine should be discarded. 
Če videz odstopa od tega opisa in/ali opazite tujke (vključno z delci gume od zamaška), morate cepivo zavreči.
In this leaflet: What HUMENZA is and what it is used for 
KAJ JE CEPIVO HUMENZA IN ZA KAJ GA UPORABLJAMO
Immunogenicity data obtained in a limited number of children aged 6-35 months show that there is a further immune response to a second half-dose of 0.25 ml administered after an interval of three weeks. 
Podatki o imunogenosti, pridobljeni pri majhnem številu otrok, starih od 6 do 35 mesecev, kažejo dodaten imunski odziv na drugi odmerek 0,25 ml, uporabljen po presledku treh tednov.
per 0.5 ml dose 
na 0,5 ml odmerek
This section describes the clinical experience with HUMENZA following administration of one or two vaccine doses (0.5 ml or 0.25 ml) at a 3-week interval. 
To poglavje opisuje klinične izkušnje pri cepljenju z enim ali dvema odmerkoma cepiva (0,5ml ali 0,25 ml) z 3 tedenskim intervalom med cepljenji.
A mean body weight loss of 20% was recorded in control group 4 days after infection. 
V kontrolni skupini so 4 dni po okužbi v povprečju zabeležili 20-odstotno izgubo telesne mase.
In children from 3 to 8 years of age, the most frequent reactions were injection site pain and injection site erythema. 
Pri otrocih, starih od 3 do 8 let, so bile najpogostejše reakcije bolečina na mestu injiciranja in eritem na mestu injiciranja.
There are no safety, immunogenicity or efficacy data to support interchangeability of HUMENZA with other H1N1 pandemic vaccines. 
Ni podatkov o varnosti, imunogenosti ali učinkovitosti, ki bi potrjevali zamenljivost zdravila HUMENZA z drugimi pandemskimi cepivi proti H1N1.
A challenge ferret study showed vaccine similar protection after one or two human doses based on lung macroscopic examination, body weight loss (as indicator of disease after challenge) and viral loads in lungs and in the upper respiratory tract. 
Pri provokacijskem testu z belim dihurjem je pokazalo cepivo podobno zaščito po enem ali dveh človeških odmerkih na podlagi makroskopske pljučne preiskave, izgube telesne mase (kot kazalnik bolezni po provokaciji) in količine virusa v pljučih in zgornjih dihalnih poteh.
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.4). 
Cepivo vsebuje tiomersal (organska živosrebrova spojina) kot konzervans, ki lahko povzroči preobčutljivostne reakcije (glejte poglavje 4.4).
Very limited data in children aged 6 to 35 months (N=96) who received two doses of 0.25 ml (half of the adult dose) with an interval of 3 weeks between doses indicate an increase in the rates of injection site reactions and general symptoms (see section 4.8.). 
Zelo omejeni podatki pri otrocih, starih od 6 do 35 mesecev (n = 96), ki so dobili dva odmerka 0,25 ml (polovični odmerek za odrasle) v presledku 3 tednov med odmerkoma, kažejo večji delež reakcij na mestu injiciranja in splošnih simptomov (glejte poglavje 4.8.).
Like all medicines, HUMENZA can cause side effects, although not everybody gets them. 
Kot vsa zdravila ima lahko tudi cepivo HUMENZA neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
After mixing, store in a refrigerator and use within 24 hours. 
Po premešanju shranjujte v hladilniku in uporabite v 24 urah.
What HUMENZA contains 
Kaj vsebuje zdravilo HUMENZA
However, if this cannot be avoided, the vaccines should be injected into separate limbs. 
Toda, če tega ni mogoče preprečiti, je treba drugo cepivo dati v drugo okončino.
Groups of 7 ferrets were immunized intramuscularly (IM) with one human dose of HUMENZA (3.8 µg of HA and full dose AF03) (at D21) or 2-dose administration of one human dose at 3-week intervals (at D0 and D21) and compared to a control group (AF03 adjuvant diluted in PBS). 
so imunizirali skupine po 7 dihurjev z enim človeškim odmerkom cepiva HUMENZA (3,8 µg HA) in polnim odmerkom AF03 (pri D21) ali 2-odmerkoma, ki odgovarjata enemu humanemu odmerku v 3-tedenskih intervalih (pri D0 in D21) in jih primerjali s kontrolno skupino (adjuvans AF03 razredčen v PBS).
Pharmacovigilance The MAH will submit the results of the GBS surveillance 
Farmakovigilanca Imetnik dovoljenja za promet z zdravilom bo predložil rezultate študije spremljanja GBS.
Overall, local and systemic reactions were less frequently observed in children from 6 to 35 months of age than in children from 3 to 8 years, except fever which was more frequently observed in children from 6 to 23 months. 
V splošnem so bile lokalne in sistemske reakcije manj pogoste pri otrocih od 6 do 35 mesecev starosti, kot pri otrocih, starih od 3 do 8 let, razen zvišane telesne temperature, ki je bila pogostejša pri otrocih, starih od 6 do 23 mesecev.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 7.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP. 
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 7.0 načrta za obvladovanje tveganja (RMP), predloženem v modulu 1.8.2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
Blood and lymphatic system disorders: Transient thrombocytopenia, transient lymphadenopathy 
Bolezni krvi in limfatičnega sistema: Prehodna trombocitopenija, prehodna limfadenopatija
Tell the doctor requesting these tests that you have recently been given HUMENZA. 
Zdravnika, ki želi opraviti takšne preiskave opozorite, da ste bili pred kratkim cepljeni s cepivom HUMENZA.
Nervous system disorders - Very common: headache 
Bolezni živčevja - Zelo pogosti: glavobol
* propagated in eggs ** expressed in microgram haemagglutinin 
* namnožen v jajcih ** izražen v mikrogramih hemaglutinina
Prior to each administration, the multidose vial should be gently shaken by at least 5 rotating movements. 
Pred vsakim apliciranjem morate večodmerno vialo nežno stresti z vsaj 5 krožnimi gibi.
In order to keep the traceability of the product received by each vaccinee the name of the vaccine and the lot number should be recorded by using the stickers provided in the pack containing both the antigen and adjuvant vials. 
Zaradi zagotovitve sledljivosti prejetega cepiva ob vsakem cepljenju je treba zabeležiti ime cepiva in serijsko številko na oznako, ki je priložena v pakiranju, ki vsebuje viali z adjuvansom in antigenom.
The volume of HUMENZA after mixing is at least 6 ml and allows the withdrawal of several doses (multidose vial). 
Količina cepiva HUMENZA po mešanju je vsaj 6 ml in zadošča za izvlek več odmerkov (večodmerna viala).
2nd dose 
2. odmerek
The immunogenicity 21 days after each half-dose (0.25 ml) of HUMENZA in term of the seroprotection rate, the seroconversion rate and the seroconversion factor, using HI method, were as follows: 
Imunogenost 21 dni po vsakem polovičnem odmerku (0,25 ml) cepiva HUMENZA v smislu deleža serozaščite, deleža serokonverzije in faktorja serokonverzije po metodi HI so bili sledeči:
Independently of the cohort safety study (9,000 subjects), the MAH commits to implement a post-licensure prospective clinical safety study (N=3,000 subjects from 6 months of age). 
Neodvisno od študij varnosti kohorte se je imetnik dovoljenja za promet obvezal, da bo izvedel predvideno klinično študijo o varnosti zdravila po prihodu na trg (N = 3.000 udeleženih v starosti 6 mesecev).
In the different age groups, there are limited data (adults aged 18 to 60 years), very limited data (adults aged 61 years and over, children aged 6 months to 17 years) or no data (children aged less than 6 months) with HUMENZA as detailed in sections 4.4, 4.8 and 5.1. 
Za nekatere starostne skupine je o cepljenju s cepivom Humenza malo podatkov (odrasli, stari od 18 do 60 let), zelo malo podatkov (odrasli, starejši od 61 let in otroci od 6 mesecev do 17 let) ali jih sploh ni (otroci, mlajši od 6 mesecev), kot je podrobno opisano v poglavjih 4.4, 4.8 in 5.1
The severity of the local and systemic reactions was mainly from grade 1 (mild) to grade 2 (moderate). 
Resnost lokalnih in sistemskih reakcij je bila večinoma 1. stopnje (blage) do 2. stopnje (zmerne).
Instructions for mixing the vaccine: 
Navodila za mešanje cepiva:
Each vaccine dose of 0.5 ml or 0.25 ml (half-dose) is withdrawn with a new sterile syringe for injection and administered intramuscularly. 
Vsak odmerek cepiva (0,5 ml ali 0,25 ml (polovični odmerek)) posrkajte z novo sterilno injekcijsko brizgo in ga aplicirajte intramuskularno.
These side effects may occur with HUMENZA. 
Ti neželeni učinki se lahko pojavijo s cepivom HUMENZA.
There are no data on administration of AF03-adjuvanted vaccines before or following other types of influenza vaccines intended for pre-pandemic or pandemic use. 
Ni podatkov o cepljenju s cepivi z adjuvansom AF0-3, pred ali po cepljenju z drugimi vrstami cepiv proti gripi, ki so namenjena za prepandemsko ali pandemsko uporabo.
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON 
• POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM
Very rare: - Skin reactions that may spread throughout the body including itchiness of the skin (pruritus, urticaria), rash. 
Zelo redki: - Kožne reakcije, ki se lahko razširijo po vsem telesu in vključujejo srbenje kože (pruritus,
In ferrets administered with one or two doses of HUMENZA, a significant reduction of lung damages (4 % or 1 % of affected lung, respectively) and of lung viral loads (more than 4 log10 reduction) was achieved resulting in 86% (6 out of 7 ferrets) or 100% of ferrets with no detectable virus in lungs, respectively. 
Pri dihurjih, ki so dobili en ali dva odmerka cepiva HUMENZA, so opazili značilno nižjo poškodbo pljuč (4 % oz. 1 % prizadetih pljuč) in količine virusa v pljučih (zmanjšanje za več kot 4 log10), kar pomeni 86 % (6 od 7 dihurjev) oz. 100 % dihurjev brez zaznavnega virusa v pljučih.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Sanofi Pasteur SA 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sanofi Pasteur SA
The reproductive and developmental toxicity studies conducted in rats and rabbits with AF03 did not show any effects on female fertility, pregnancy, embryofetal development or early postnatal development. 
Študije vpliva na sposobnost razmnoževanja in razvoja z AF03 pri podganah in kuncih ne kažejo vpliva na plodnost pri samicah, brejost, razvoj embria-zarodka in zgodnji postnatalni razvoj.
Pharmacovigilance The MAH commits to update the observational study protocol to screen for auto-antibodies those patients presenting visual or ocular events during the study followup. 
Farmakovigilanca Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo posodabljal protokol opazovalnih študij za presejalne raziskave za oceno avtoprotiteles pri tistih bolnikih, ki so v fazi sledenja po študiji imeli težave z vidom ali očmi.
Percentages of subjects who reported the following adverse reactions after each dose are provided by age group in the table below: 
Odstotki oseb, ki so poročali o naslednjih neželenih učinkih po vsakem odmerku, so razvrščeni po starostnih skupinah v naslednji tabeli:
Children below 6 months of age: Vaccination is currently not recommended in this age group. 
Otroci, mlajši od 6 mesecev: Cepljenje v tej starostni skupini trenutno ni priporočeno.
- Vessel inflammation (vasculitis) which may result in skin rashes and in very rare cases in temporary kidney problems. 
- Vnetje žil (vaskulitis), ki lahko povzroči kožni osip in v zelo redkih primerih prehodne težave z
C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING 
C. POSEBNE ZAHTEVE, KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA
Rabbits dosed with vaccine, or with AF03 adjuvant alone, showed a slight increase of apoptosis / necrosis in the lachrymal tissues at doses higher than the human dose. 
Pri kuncih je injiciranje cepiva ali samo adjuvansa AF03 povzročilo nekoliko zvišano apoptozo/nekrozo lakrimalnega tkiva pri odmerkih, ki so bili višji od odmerkov pri človeku.
Elderly 71 to 80 years of age 
Starejše osebe, stare od 71 do 80 let
Vascular disorders: Vasculitis associated in very rare cases with transient renal involvement 
Žilne bolezni: Vaskulitis, v zelo redkih primerih povezan s prehodno prizadetostjo ledvic
Musculoskeletal and connective tissue disorders - Very common: myalgia 
Bolezni mišično-skeletnega sistema - Zelo pogosti: mialgija
The rate of grade 3 (severe) reactions was overall low (from 6.5 to 8.3% in children from 6 to 11 months of age and from 8.3 to 12.5% in children from 12 to 35 months of age). 
Pojav reakcij 3. stopnje (hude) reakcije je bil v splošnem majhen (od 6,5 do 8,3 % pri otrocih od 6 do 11 mesecev starosti in od 8,3 do 12,5 % pri otrocih od 12 do 35 mesecev starosti..
For storage conditions after opening, see section 6.3. 
Za pogoje shranjevanja odprtega cepiva glejte poglavje 6.3.
4.6 Pregnancy and lactation 
4.6 Plodnost, nosečnost in dojenje
Skin and subcutaneous tissue disorders: Generalised skin reactions including pruritus, urticaria or non-specific rash 
Bolezni kože in podkožja: Generalizirane reakcije kože, vključno s pruritisom, urtikarijo ali nespecifičnim izpuščajem
Available non clinical data obtained with the vaccine HUMENZA or with the same vaccine but with another strain (A/H5N1) revealed no special hazard for humans based on conventional repeat dose toxicity studies, reproductive and developmental toxicity studies and an investigative pneumopathology study. 
Predklinični podatki, pridobljeni s cepivom HUMENZA ali z enakim cepivom, a drugim sevom (A/H5N1) na osnovi običajnih študij toksičnosti pri ponavljajočih se odmerkih, vpliva na sposobnost razmnoževanja in razvoja ter raziskovalnih pnevmopatoloških študij ne kažejo posebnega tveganja za človeka.
One half-dose of 0.25 ml at an elected date. 
En polovični 0,25-ml odmerek na izbrani datum.
The vaccine will be injected into a muscle, preferably in the upper arm or the front of the thigh (depending on the muscle mass). 
Cepivo se injicira v mišico, priporočeno v zgornji del roke ali v prvi del stegna (odvisno od mišične mase).
Immunisation should be carried out by intramuscular injection (IM) preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass). 
Cepljenje je treba opraviti z intramuskularnim injiciranjem, po možnosti v deltoidno mišico ali anterolateralni del stegna (odvisno od mišične mase).
The vaccine is mixed by withdrawing with a sterile syringe and needle the entire content of the antigen vial and adding it into the adjuvant vial. 
Cepivo zmešate tako, da s sterilno injekcijsko brizgo in iglo izvlečete celotno vsebino viale z antigenom in jo dodate v vialo z adjuvansom.
A single administration of a human dose of HUMENZA elicited HI titers ≥ 80 and MN (Microneutralization) titers ≥ 160 specific to the vaccinal strain in 100% of vaccinated animals and a two-dose administration regimen markedly increased (at least a 5-fold increase) HI and MN antibody titers. 
Enkratna aplikacija človeškega odmerka cepiva HUMENZA je izzvala titre HI ≥ 80 in titre MN (mikronevtralizacije) ≥ 160, specifične za sev cepiva pri 100 % cepljenih živali, shema apliciranja dveh odmerkov pa je znatno (vsaj 5-kratno povečanje) zvišala titre protiteles HI in MN.
Therefore, monitoring of temperature and measures to lower fever (such as antipyretic medication as seems clinically necessary) are recommended in young children (e.g. up to approximately 8 years of age) after each vaccination. 
Zato je mlajšim otrokom (npr. do približno 8. leta starosti) po vsakem cepljenju priporočljivo spremljati telesno temperaturo in uporabiti ukrepe za znižanje zvišane telesne temperature (npr. antipiretična zdravila, če se zdi klinično potrebno).
The RMP will be updated accordingly to reflect this study within 15 calendar days of the receipt of the opinion. 
Načrt za obvladovanje tveganja bo posodobljen potemtakem v 15 koledarskih dneh po prejemu presoje o izvedeni študiji.
Elderly above 60 years of age: 
Starejši od 60 let:
Sanofi pasteur - Parc Industriel d'Incarville - F-27100 Val-de-Reuil - France Sanofi pasteur - Campus Mérieux - 1541, avenue Marcel Mérieux - F-69280 Marcy l'Etoile - France 
Sanofi pasteur - Parc Industriel d'Incarville - F-27100 Val-de-Reuil - Francija Sanofi pasteur - Campus Mérieux - 1541, avenue Marcel Mérieux - F-69280 Marcy l'EtoileFrancija
For the most up-to-date information please consult the website of the European Medicines Agency : http://www.ema.europa.eu/. 
Za najnovejše informacije glejte spletno stran Evropske agencije za zdravila (EMA): http://www.ema.europa.eu/.
• Neurological disorders that may result in stiff neck, confusion, numbness, pain and weakness of the limbs, loss of balance, loss of reflexes, paralysis of part or all the body (encephalomyelitis, neuritis, Guillain-Barré Syndrome). 
• nevrološke motnje lahko povzročijo otrdelost vratu, zmedenost, odrevenelost, bolečino in oslabelost okončin, izgubo ravnotežja, izgubo refleksov, paralizo dela ali vsega telesa
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE 
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