natgillin/translations-raw huggingface dataset:
Nimenrix powder and solvent for solution for injection in ampoule Meningococcal group A, C, W-135 and Y conjugate vaccine 
Nimenrix prašek in vehikel za raztopino za injiciranje v ampuli cepivo proti meningokokom skupin A, C, W-135 in Y, konjugirano
Study MenACWY-TT-040(2) 
Študija MenACWY-TT-040
Mening ococcal Group 
Mening okokna skupina
Vaccine group rSBA* 
Skupina, ki je prejemala cepivo rSBA*
Instructions for reconstitution of the vaccine with the solvent presented in pre-filled syringe: 
Navodilo za rekonstitucijo cepiva, pri katerem je vehikel v napolnjeni injekcijski brizgi:
Table 5: Bactericidal antibody responses (hSBA*) in toddlers aged 12-23 months Meningococcal 
Preglednica 5: Odziv baktericidnih protiteles (hSBA*) pri malčkih, starih od 12 do 23 mesecev Meningokokna skupina
Very common Irritability Uncommon 
Psihiatrične motnje zelo pogosti razdražljivost občasni nespečnost jok
The analysis of immunogenicity was conducted on the primary according-to-protocol (ATP) cohort for immunogenicity. 
Analizo imunogenosti so opravili na kohortah ATP (ATP - According-to-Protocol) za imunogenost.
Musculoskeletal and connective tissue disorders 
Bolezni mišično-skeletnega sistema in vezivnega tkiva občasni mialgija bolečina v okončinah
Toddlers aged 12-14 months had similar rSBA responses to groups A, C, W-135 and Y at one month after one dose of Nimenrix or at one month after two doses of Nimenrix given two months apart. 
Imunski odzivi pri malčkih, starih od 12 do 14 mesecev Malčki, stari od 12 do 14 mesecev, so imeli en mesec po enem odmerku cepiva Nimenrix ali en mesec po dveh odmerkih cepiva Nimenrix, danih v presledku 2 mesecev, podobne odzive rSBA proti skupinam A, C, W-135 in Y.
EU/1/12/767/006 - pack of 10 
EU/1/12/767/006 - pakiranje po 10
Instructions for reconstitution of the vaccine with the solvent presented in pre-filled syringe 
Navodila za rekonstitucijo cepiva z vehiklom, priloženim v napolnjeni injekcijski brizgi
100 vials: powder 100 ampoules: solvent 100 x 1 dose (0.5 ml) 
100 vial: prašek 100 ampul: vehikel 100 x 1 odmerek (0,5 ml)
1 vial: powder 1 pre-filled syringe: solvent 2 needles 
1 napolnjena injekcijska brizga: vehikel 2 igli
How Nimenrix works 
Kako deluje cepivo Nimenrix
Previously vaccinated individuals 12 months of age and older: Please tell your doctor if you have received a previous injection with another meningococcal vaccine than Nimenrix. 
Obvestite zdravnika, če ste bili predhodno cepljeni z drugim meningokoknim cepivom kot je cepivo Nimenrix.
The analysis of immunogenicity was conducted on ATP cohort for persistence. 
Analizo imunogenosti so opravili na kohorti ATP za trajanje.
Table 7: Bactericidal antibody responses (hSBA)* in toddlers aged 12-14 months Meningococcal 
Preglednica 7: Odziv baktericidnih protiteles (hSBA*) pri malčkih, starih od 12 do 14 mesecev Meningokokna skupina
The analysis of immunogenicity was conducted on the according-to-protocol (ATP) cohort for immunogenicity (1) blood sampling performed 21-48 days post vaccination * tested at Public Health England laboratories 
odvzem krvi so opravili od 21 do 48 dni po cepljenju * testirano v laboratorijih PHE (Public Health England)
The analysis of immunogenicity was conducted on ATP cohort for immunogenicity. 
Analizo imunogenosti so opravili na kohorti ATP za imunogenost.
1 vial: powder 1 ampoule: solvent 1 dose (0.5 ml) 
1 viala: prašek 1 ampula: vehikel 1 odmerek (0,5 ml)
Neisseria meningitidis group Y polysaccharide1 
Polisaharid Neisseria meningitidis skupine Y
Check with your doctor or nurse before you receive this vaccine if: 
Preden prejmete to cepivo, se posvetujte z zdravnikom ali medicinsko sestro:
10 vials: powder 10 ampoules: solvent 10 x 1 dose (0.5 ml) 
10 vial: prašek 10 ampul: vehikel 10 x 1 odmerek (0,5 ml)
How to store Nimenrix 
Kako se daje cepivo Nimenrix
Persistence of the immune response was evaluated in children initially vaccinated in MenACWY-TT081 (Table10). 
Trajanje imunskega odziva so ocenili z rSBA in hSBA pri otrocih, ki so prejeli začetno cepljenje v študiji MenACWY-TT-081 (preglednica 10).
The clinical relevance of the findings is unknown. 
Klinični pomen teh ugotovitev ni znan.
MenC-CRM 
cepivo MenC-CRM 121
Table 4: Bactericidal antibody responses (rSBA*) in toddlers aged 12-23 months Menin gococc al 
Preglednica 4: Odziv baktericidnih protiteles (rSBA*) pri malčkih, starih od 12 do 23 mesecev Meningokokna skupina
Intramuscular use. 
NAPOLNJENA INJEKCIJSKA BRIZGA Z VEHIKLOM
The clinical relevance of this finding is unknown. 
Klinični pomen tega izsledka ni znan.
Syringe cap 
Pokrovček brizge
VR: vaccine response * tested at GSK laboratories Persistence of the immune response was evaluated up to 5 years after vaccination in adolescents primed in study MenACWY-TT-036 (Table 13). 
Trajanje imunskega odziva so ocenili do 5 let po cepljenju pri mladostnikih, ki so prejeli osnovno cepljenje v študiji MenACWY-TT-036 (preglednica 13).
Nimenrix is a vaccine which helps protect against infections caused by bacteria (germs) called “Neisseria meningitidis" types A, C, W-135 and Y. “Neisseria meningitidis" types A, C, W-135 and Y bacteria can cause serious illnesses such as: 
Bakterije “Neisseria meningitidis" tipov A, C, W-135 in Y lahko povzročijo resne bolezni, na primer:
N ≥8 (95% CI) 
Časovna točka n  8 (95 % IZ)
W-135 Nimenrix 354 100% Y Nimenrix 354 100% 
W-135 Nimenrix 1 odmerek po 1. odmerku
Timepoint 
Časovni okvir
Adverse reactions 
Obnovitveni odmerki
The analysis of immunogenicity was conducted on the according-to-protocol (ATP) cohort for immunogenicity (1) blood sampling performed 21-48 days post vaccination *tested at GSK laboratories 
odvzem krvi so opravili od 21 do 48 dni po cepljenju * testirano v laboratorijih družbe GSK
Nimenrix MenCCRM vaccine W-135 Nimenrix 
Shranjevanje cepiva Nimenrix
Table 6: Bactericidal antibody responses (rSBA)* in toddlers aged 12-14 months Meningococcal 
Preglednica 6: Odziv baktericidnih protiteles (rSBA*) pri malčkih, starih od 12 do 14 mesecev
1 year CSR Q1 2017 3 year CSR Q1 2019 5 year CSR Q1 2021 
Poročilo o klinični študiji za 3. leto - 1. četrtletje 2019
1 vial: powder 1 pre-filled syringe: solvent 1 dose (0.5 ml) 
1 napolnjena injekcijska brizga: vehikel 1 odmerek (0,5 ml)
• itching 
• jok
Nimenrix 2 doses 
Nimenrix 2 odmerka po 1. odmerku po 2. odmerku
10 vials: powder 10 pre-filled syringes: solvent 10 x 1 dose (0.5 ml) 
10 napolnjenih injekcijskih brizg: vehikel 10 x 1 odmerek (0,5 ml)
Very common Drowsiness Headache 
Bolezni živčevja zelo pogosti zaspanost glavobol občasni hipestezija omotica
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE WITH SOLVENT 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL WITH MEN ACWY CONJUGATE POWDER 
VIALA S PRAŠKOM KONJUGATA MEN ACWY
Y 657 93.8% 
leto 1 356 97,8 % (95,6; 99,0)
• Keep this medicine out of the sight and reach of children. 
• Cepivo shranjujte nedosegljivo otrokom!
• crying 
• utrujenost
Post dose Post dose 
po 2. odmerku po obnovitven
Imatinib Actavis is available as capsules (50, 100 and 400 mg) and tablets (100 and 400 mg). 
Zdravilo Imatinib Actavis je na voljo v obliki kapsul (50, 100 in 400 mg) in tablet (100 in 400 mg).
It is also used in children in the ‘chronic phase' of the disease if it is not responding to interferon alfa (another medicine used to treat cancer), and in more advanced phases of the disease (‘accelerated phase' and ‘blast crisis'). 
Uporablja se tudi pri otrocih v kronični fazi bolezni, če se ta ne odziva na interferon alfa (drugo zdravilo za zdravljenje raka), ter v napredovalih fazah bolezni (pospešeni fazi in blastni krizi).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imatinib Actavis have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Imatinib Actavis, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Further information can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/imatinib-actavis. 
Nadaljnje informacije o zdravilu Imatinib Actavis so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/imatinib-actavis Informacije o referenčnem zdravilu so prav tako na voljo na spletni strani agencije.
What measures are being taken to ensure the safe and effective use of Imatinib Actavis? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Imatinib Actavis?
Because Imatinib Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Imatinib Actavis generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Glivec, and do not need to be repeated for Imatinib Actavis. 
Študije o koristih in tveganjih učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Glivec, zato jih ni treba ponoviti za zdravilo Imatinib Actavis.
The European Medicines Agency concluded that, in accordance with EU requirements, Imatinib Actavis has been shown to have comparable quality and to be bioequivalent to Glivec. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Imatinib Actavis primerljivo raven kakovosti in je bioekvivalentno z zdravilom Glivec.
The medicine can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of patients with cancers of the blood. 
Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem krvnega raka.
These enzymes can be found in some receptors on cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably. 
Ti encimi se nahajajo v določenih receptorjih v rakavih celicah, vključno z receptorji, ki spodbujajo celice, da se nenadzorovano delijo.
As for every medicine, the company provided studies on the quality of Imatinib Actavis. 
Kot to velja za vsako zdravilo, je podjetje zagotovilo študije o kakovosti zdravila Imatinib Actavis.
An overview of Imatinib Actavis and why it is authorised in the EU 
Pregled zdravila Imatinib Actavis in zakaj je odobreno v EU
Side effects reported with Imatinib Actavis are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Imatinib Actavis, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
As for all medicines, data on the use of Imatinib Actavis are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Imatinib Actavis stalno spremljajo.
What are the benefits and risks of Imatinib Actavis? 
Kakšne so koristi in tveganja, povezani z zdravilom Imatinib Actavis?
This means that it blocks enzymes known as tyrosine kinases. 
To pomeni, da zavira delovanje določenih encimov, imenovanih tirozin kinaze.
It is also used alone to treat adults with Ph+ ALL that has returned following previous treatment, or if other medicines are not working. 
Uporablja se tudi samostojno pri odraslih za zdravljenje Ph+ ALL, ki se je po predhodnih zdravljenjih ponovno pojavila ali se ne odziva na druga zdravljenja;
Imatinib Actavis is used to treat adults with DFSP that cannot be removed with surgery, and in adults who cannot have surgery when the cancer has returned after treatment or has spread to other parts of the body. 
Zdravilo Imatinib Actavis se uporablja za zdravljenje odraslih s to boleznijo, pri kateri sarkoma ni mogoče odstraniti s kirurškim posegom, ter odraslih, ki niso primerni za kirurški poseg po ponovnem pojavu raka po zaključenem zdravljenju ali pri razširitvi na druge dele telesa.
This means that Imatinib Actavis contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Glivec. 
To pomeni, da vsebuje enako učinkovino in ima enak način delovanja kot referenčno zdravilo Glivec, ki je že odobreno v Evropski uniji (EU).
Why is Imatinib Actavis authorised in the EU? 
Zakaj je bilo zdravilo Imatinib Actavis odobreno v EU?
Imatinib Actavis is given by mouth with a meal and a large glass of water to reduce the risk of irritation of the stomach and gut. 
Zdravilo Imatinib Actavis se zaužije peroralno s hrano in velikim kozarcem vode, da se zmanjša tveganje za draženje želodca in črevesja.
What is Imatinib Actavis and what is it used for? 
Kaj je zdravilo Imatinib Actavis in za kaj se uporablja?
Imatinib Actavis received a marketing authorisation valid throughout the EU for Imatinib Actavis on 17 April 2013. 
Zdravilo Imatinib Actavis je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 17. aprila 2013.
The medicine is used in children who have been newly diagnosed with Ph+ CML and who cannot have a bone marrow transplant. 
Zdravilo se uporablja pri otrocih, pri katerih je bila Ph+ KML na novo diagnosticirana in niso primerni za presaditev kostnega mozga.
Other information about Imatinib Actavis 
Druge informacije o zdravilu Imatinib Actavis
Imatinib Actavis is a ‘generic medicine'. 
Zdravilo Imatinib Actavis je „generično zdravilo“.
• myelodysplastic or myeloproliferative diseases (MD/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells. 
• mielodisplastičnih ali mieloproliferativnih bolezni (MDS/MPD), tj. skupine bolezni, pri katerih telo proizvaja velike količine nenormalnih krvnih celic.
• dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably. 
• protuberantnega dermatofibrosarkoma (DFSP), tj. vrste raka (sarkoma), pri kateri se celice pod kožo nenadzorovano delijo.
Imatinib Actavis is used to treat adults with MD/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR); 
Zdravilo Imatinib Actavis se uporablja za zdravljenje odraslih z MDS/MPD v povezavi s preureditvijo genov za receptor za rastni faktor iz trombocitov (PDGFR);
• Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly. 
• Ph+ akutne limfoblastne levkemije (ALL), tj. vrste raka, pri kateri se limfociti (druga vrsta belih krvnih celic) prehitro množijo.
Imatinib Actavis is used with other cancer medicines in adults and children who have been newly diagnosed with Ph+ ALL. 
Zdravilo Imatinib Actavis se uporablja v kombinaciji z drugimi zdravili za zdravljenje raka pri odraslih in otrocih z na novo diagnosticirano Ph+ ALL.
The active substance in Imatinib Actavis, imatinib, is a protein-tyrosine-kinase inhibitor. 
Učinkovina v zdravilu Imatinib Actavis, imatinib, je zaviralec beljakovine tirozin kinaze.
Imatinib Actavis is a cancer medicine that contains the active substance imatinib. 
Imatinib Actavis je zdravilo za zdravljenje raka, ki vsebuje učinkovino imatinib.
The dose depends on the age and condition of the patient, and the response to treatment, but it should not exceed 800 mg a day. 
Odmerek je odvisen od starosti bolnika, njegovega bolezenskega stanja in odziva na zdravljenje, vendar ne sme presegati 800 mg na dan. Za več informacij o uporabi zdravila Imatinib Actavis glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Imatinib Actavis is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα; 
Zdravilo Imatinib Actavis se uporablja za zdravljenje odraslih z napredovalim hipereozinofilnim sindromom ali kronično eozinofilno levkemijo, ki imajo posebno preureditev dveh genov, imenovanih FIP1L1 in PDGFRα;
• advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL), diseases in which eosinophils (another type of white blood cell) start growing out of control. 
• napredovalega hipereozinofilnega sindroma (HES) ali kronične eozinofilne levkemije (CEL), tj. bolezni, pri katerih eozinofilci (druga vrsta belih krvnih celic) začnejo nenadzorovano rasti.
Imatinib Actavis is also used in adults with Ph+ CML in blast crisis. 
Zdravilo Imatinib Actavis se uporablja tudi pri odraslih s Ph+ KML v blastni krizi;
By blocking these receptors, Imatinib Actavis helps to control and slow down cell division. 
Zdravilo Imatinib Actavis z zaviranjem teh receptorjev pomaga pri nadzoru deljenja celic.
Therefore, the Agency's view was that, as for Glivec, the benefit of Imatinib Actavis outweighs the identified risk and it can be authorised for use in the EU. 
Zato je menila, da koristi zdravila Imatinib Actavis enako kot pri zdravilu Glivec odtehtajo znana tveganja in se zdravilo lahko odobri v EU.
Imatinib Actavis is used when the patients are ‘Philadelphia-chromosome positive' (Ph+). 
Zdravilo Imatinib Actavis se uporablja pri bolnikih s prisotnim kromosomom Philadelphia (Ph+).
• chronic myeloid leukaemia (CML), a cancer of the white blood cells in which granulocytes (a type of white blood cell) start growing out of control. 
• kronične mieloidne levkemije (KML), tj. raka belih krvnih celic, pri katerem začnejo granulociti (vrsta belih krvnih celic) nenormalno rasti.
How has Imatinib Actavis been studied? 
Kako je bilo zdravilo Imatinib Actavis raziskano?
How is Imatinib Actavis used? 
Kako se zdravilo Imatinib Actavis uporablja?
How does Imatinib Actavis work? 
Kako zdravilo Imatinib Actavis deluje?
No data are available in older children (see sections 4.8 and 5.1) 
Podatkov ni na voljo za starejše otroke (glejte poglavje 4.8 in 5.1)
However children with long standing problems with their immune system such as HIV infection (AIDS) may still be given Hexyon but the protection may not be as good as in children whose immune system is healthy. 
Vendar pa se otroke z dolgotrajnimi težavami s svojim imunskim sistemom kot so okužbo s HIV (AIDS) lahko cepi s Hexyon, vendar morda zaščita ne bo tako dobra, kot pri otrocih, katerih imunski sistem je zdrav.
If you forget one dose of Hexyon 
Če pozabite en odmerek cepiva Hexyon
• As with any vaccine, Hexyon may not protect 100% of children who receive the vaccine. 
• Kot velja za vsa cepiva, tudi cepivo Hexyon ne more 100% zaščititi otroka, ki je prejel to cepivo.
Pack of 1, 10 or 50. 
Pakiranje po 1, 10 ali 50.
Other medicines or vaccines and Hexyon 
Druga zdravila ali cepiva in cepivo Hexyon
Your doctor will advise you whether your child should have Hexyon. 
Zdravnik vam bo svetoval, ali naj vaš otrok prejme cepivo Hexyon.
Vaccination with Hexyon may need to be delayed until your child is better. 
Cepljenje s cepivom Hexyon bo morda treba preložiti, dokler se stanje vašega otroka ne izboljša.
Hexyon (DTaP-IPV-HB-Hib) is a vaccine used to protect against infectious diseases. 
Hexyon (DTaP-IPV-HB-Hib) je cepivo, ki se uporabljajo za zaščito pred nalezljivimi boleznimi.
Other paediatric population: 
Ostala pediatrična populacija
At the end of this period, Hexyon should be used or discarded. 
Ob koncu tega obdobja morate cepivo Hexyon uporabiti ali zavreči.
What Hexyon is and what it is used for 
Kaj je cepivo Hexyon in za kaj ga uporabljamo
† See section c c- Description of selected adverse reactions 
† Poglejte poglavje c c- Opis označenega neželenega učinka
Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) 
Zelo pogosti (≥1/10) Pogosti (≥1/100 do <1/10) Občasni (≥1/1.000 do <1/100) Redki (≥1/10.000 do <1/1.000) Zelo redki (<1/10.000)
• Hexyon will only help to prevent these diseases if they are caused by the bacteria or viruses targeted by the vaccine. 
• Cepivo Hexyon ščiti pred temi boleznimi samo, če jih povzročajo bakterije ali virusi, proti katerim je cepivo usmerjeno.
What Hexyon is and what it is used for What you need to know before Hexyon is given to your child How to use Hexyon 
Kaj je cepivo Hexyon in za kaj ga uporabljamo Kaj morate vedeti, preden bo vaš otrok prejel cepivo Hexyon Kako uporabljati cepivo Hexyon
Possible side effects Like all medicines, this vaccine can cause side effects, although not everybody gets them. 
Možni neželeni učinki Kot vsa zdravila ima lahko tudi to cepivo neželene učinke, ki pa se ne pojavijo pri vseh cepljenih osebah.
d- Potential adverse events (i.e. adverse events which have been reported with other vaccines containing one or more of the components or constituents of Hexyon and not directly with Hexyon) 
d- Možni neželeni učinki (Tj. neželeni učinki, o katerih poročajo pri drugih cepivih, ki vsebujejo eno ali več komponent ali sestavin cepiva Hexyon, in ne neposredno pri cepivu Hexyon.)
The safety of Hexyon in children over 24 months of age has not been studied in clinical trials. 
Varnost cepiva Hexyon pri otrocih starejših od 24 mesecev ni bila raziskana v kliničnih preskušanjih.
The coughing often has a “whooping” sound. 
Kašelj ima pogosto »oslovski«
• sudden and serious malaise with drop in blood pressure causing dizziness and loss of consciousness, accelerated heart rate associated with respiratory disorders 
• nenadno in resno slabo počutje s padcem krvnega tlaka, ki povzroča omotico in izgubo zavesti, pospešen srčni utrip, povezan z boleznimi dihal.
In clinical studies in individuals who received Hexyon, the most frequently reported reactions include injection-site pain, irritability, crying, and injection-site erythema. 
V kliničnih študijah pri posameznikih, ki so prejeli cepivo Hexyon, so bili najpogosteje poročani neželeni učinki: bolečina na mestu injiciranja, razdražljivost, jok in pordelost na mestu injiciranja.
These reactions start within 24-72 hours after vaccination, may be associated with redness, warmth, tenderness or pain at the injection site, and get better within 3-5 days without the need for treatment. 
Te reakcije se pojavijo v 24-72 urah po cepljenju, lahko so povezane s pordelostjo, toploto, občutljivostjo ali bolečino na mestu injiciranja in se izboljšajo v 3-5 dneh brez potrebe po zdravljenju
The safety and efficacy of Hexyon in infants less than 6 weeks of age have not been established. 
Varnost in učinkovitost cepiva Hexyon pri dojenčkih, mlajših od 6 tednov, nista bili dokazani.
Hexyon must not be mixed with any other vaccines or other parenterally administered medicinal products. 
Cepiva Hexyon ne smemo mešati z drugimi cepivi ali drugimi parenteralno apliciranimi zdravili.
• Inflammation of several nerves causing sensory disorders or weakness of limbs 
• vnetje več živcev, ki povzroči senzorične motnje ali mišično oslabelost okončin
Hexyon suspension for injection 
Hexyon suspenzija za injiciranje
• has a moderate or high temperature or an acute illness (e.g. fever, sore throat, cough, cold or flu). 
• ima zmerno do zelo povišano telesno temperaturo ali akutno bolezen (npr. vročino, vnetje grla, kašelj, prehlad ali gripo).
Pack of 10 for multipack (without blue box) 
Pakiranje po 10 v združenem pakiranju (brez modrega okna)
Hexyon is given as an injection into a muscle (intramuscular route IM) in the upper part of your child's leg or upper arm. 
Cepivo Hexyon se daje kot injekcija v mišico (intramuskularna pot uporabe - i. m.) v zgornji del otrokove noge ali nadlahti.
• Hexyon should not be mixed with other medicinal products. 
• Cepiva Hexyon ne smete mešati z drugimi zdravili.
titers ≥ 0.15 µg/ml were observed in 73.0% of individuals, anti-PT vaccine response in 97.9% of individuals and anti-FHA vaccine response in 98.6% of individuals. 
proti-PRP titer ≥ 0,15µg/ml je imelo 73,0% posameznikov, proti-PT odziv je imelo 97,9% posameznikov in proti-FHA odziv je imelo 98,6% posameznikov.
Component of a multipack, cannot be sold separately. 
Komponente združenega pakiranja se ne izdajajo posebej.
Hexyon is available in pack containing 10 vials. 
Cepivo Hexyon je na voljo v pakiranju, ki vsebuje 10 vial.