natgillin/translations-raw huggingface dataset:
• Solvent: 4.5 ml of solvent in a 15 ml clear glass vial (type I) closed with a grey chlorobutyl rubber closure sealed by a gold colour aluminium cap covered with a colourless plastic flip-off cap. Each vial contains 4.5 ml nominal volume (fill volume: 5.67 ml). 
• Vehikel: 4,5 ml vehikla v 15-ml viali iz bistrega stekla (tipa I), zaprti s sivim zamaškom iz klorobutilne gume, zapečatenim z aluminijsko zaporko zlate barve, pokrito z brezbarvno plastično snemno zaporko.
• Concentrate: 1.5 ml of concentrate in a 15 ml clear glass vial (type I) closed with a grey chlorobutyl rubber closure sealed by an aluminium cap covered with a light green plastic flip-off cap. Each vial contains 60 mg cabazitaxel per 1.5 ml nominal volume (fill volume: 73.2 mg of cabazitaxel/1.83 ml). 
• Koncentrat: 1,5 ml koncentrata v 15-ml viali iz bistrega stekla (tipa I), zaprti s sivim zamaškom iz klorobutilne gume, zapečatenim z aluminijsko zaporko, pokrito s svetlozeleno plastično snemno zaporko.
Aseptically withdraw the required amount of concentrate-solvent mixture (10 mg/ml of cabazitaxel), with a graduated syringe fitted with a needle. 
Z graduirano brizgo, ki ima nameščeno iglo, aseptično izvlecite potrebno količino mešanice koncentrata in vehikla (10 mg/ml kabazitaksela).
This is common (may affect up to 1 in 10 people). 
Ta je pogosta (pojavi se lahko pri največ 1 od 10 ljudi).
Upper respiratory tract infection Herpes zoster Candidiasis 
Infekcijske in parazitske bolezni septični šok sepsa flegmona okužbe sečil gripa cistitis okužba zgornjih dihal herpes zoster kandidoza
JEVTANA is contraindicated in patients with severe hepatic impairment (see section 4.3). 
Pri bolnikih s hudo okvaro jeter je zdravilo JEVTANA kontraindicirano (glejte poglavje 4.3).
• haemorrhoids 
• spremenjeno okušanje
Neuropathy peripheral Peripheral sensory neuropathy Dizziness Headache Paraesthesia Lethargy 
Pogosti periferna senzorična nevropatija omotica glavobol parestezije letargija hipestezija išias
Clinical neutropenia Urinary tract infection Peripheral sensory neuropathy 
Bolezni živčevja dizgvezija periferna nevropatija
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL for CONCENTRATE 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
• muscle discomfort, aches or pain 
• nelagodje, občutljivost ali bolečnost mišic
Reproductive system and breast disorders 
Motnje reprodukcije in dojk bolečine v predelu medenice
Concentrate‐solvent mixture 10 mg/ml 
10 mg/ml mešanica koncentrata in vehikla
Cabazitaxel is extensively metabolised by the liver. 
Kabazitaksel se izdatno presnovi v jetrih.
One ml of concentrate contains 40 mg cabazitaxel. 
En mililiter koncentrata vsebuje 40 mg kabazitaksela.
Talk to your doctor before getting vaccinations while you are receiving JEVTANA. 
Med zdravljenjem z zdravilom JEVTANA se pred kakršnimkoli cepljenjem posvetujte s svojim zdravnikom.
Common (may affect up to 1 in 10 people): 
Pogosti (pojavijo se lahko pri največ 1 od 10 ljudi):
Each vial of concentrate contains 60 mg cabazitaxel. 
Ena viala koncentrata vsebuje 60 mg kabazitaksela.
The expiry date refers to the last day of that month. 
Navodilo je bilo revidirano dne.
Cabazitaxel crossed the placenta barrier in rats. 
Kabazitaksel pri podganah prehaja skozi placentno pregrado.
This overfill ensures that after dilution with the ENTIRE contents of the accompanying solvent, there is solution containing 10 mg/ml cabazitaxel. 
Po redčenju s CELOTNO količino spremljajočega vehikla ta prepolnitev zagotavlja, da raztopina vsebuje 10 mg/ml kabazitaksela.
The concentrate solution and the solvent should be clear. 
Raztopina v viali s koncentratom in vehikel morata biti bistra.
Respiratory disorders 
• mišični spazem
• low blood potassium 
• nizek kalij v krvi
Package leaflet: Information for the patient JEVTANA 60 mg concentrate and solvent for solution for infusion cabazitaxel 
Navodilo za uporabo JEVTANA 60 mg koncentrat in vehikel za raztopino za infundiranje kabazitaksel
This overfill ensures that after initial dilution with the ENTIRE content of the solvent vial, the concentration of cabazitaxel is 10 mg/ml. 
Po prvotnem redčenju s CELOTNO količino priloženega vehikla ta prepolnitev zagotavlja, da raztopina vsebuje 10 mg/ml kabazitaksela.
Cardiac disorders and arrhythmias 
Srčne bolezni in motnje srčnega ritma
NAME OF THE MEDICINAL PRODUCT JEVTANA 60 mg concentrate and solvent for solution for infusion cabazitaxel 
JEVTANA 60 mg koncentrat in vehikel za raztopino za infundiranje kabazitaksel
JEVTANA requires TWO dilutions prior to administration. 
Zdravilo JEVTANA morate pred uporabo redčiti DVAKRAT.
Blood and lymphatic system disorders 
Bolezni krvi in limfatičnega sistema nevtropenijaa* anemija a levkopenijaa trombocitopenijaa febrilna nevtropenija
Abdominal pain 43 (11.6) Dyspepsia 
s 6,3 %), febrilna nevtropenija (11,2 % v prim.
Cabazitaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells. 
Deluje tako, da poruši celično mikrotubularno mrežje.
Risk of nausea, vomiting, diarrhoea and dehydration If patients experience diarrhoea following administration of cabazitaxel they may be treated with commonly used anti-diarrhoeal medicinal products. 
Če se bolnikom po uporabi kabazitaksela pojavi driska, jo je mogoče zdraviti z običajnimi antidiaroiki.
Respiratory, thoracic and mediastinal disorders 
Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja kašelj orofaringealna bolečina pljučnica
Concentratesolvent mixture 10 mg/ml 
10 mg/ml mešanica koncentrata in vehikla vehikla.
Malaise 
Slabost
Febrile neutropenia or neutropenic infection 
Periferna senzorična nevropatija
Do not use PVC infusion containers or polyurethane infusion sets for the preparation and administration of JEVTANA. 
Za pripravo in dajanje zdravila JEVTANA ne uporabljate infuzijskih vsebnikov iz PVC ali kompletov za infundiranje iz poliuretana.
Strength Pharmaceutical Form 
Številka EU Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
What you need to know before you use <product name>, and 3. 
Kaj morate vedeti, preden boste uporabili zdravilo <ime zdravila> in 3.
Adopted at the 27-30 November 2017 PRAC 
Sprejeto na seji odbora PRAC, 27.-30. novembra 2017
Insulin (pre-filled pens and cartridges): insulin aspart; insulin bovine; insulin degludec; insulin degludec, insulin aspart; insulin degludec, liraglutide; insulin detemir; insulin glargine; insulin glulisine; insulin human (rDNA); insulin human, insulin isophane; insulin lispro; insulin porcinePotential increased risk of medication error associated with withdrawing insulin from pre-filled pens and cartridges, leading to dysglycaemia (EPITT no 18893) 
Insulin (napolnjeni injekcijski peresniki in vložki): insulin aspart; goveji insulin; insulin degludek; insulin degludek, insulin aspart; insulin degludek, liraglutid; insulin detemir; insulin glargin; insulin glulizin; humani insulin (rDNA); humani insulin, insulin izofan; insulin lispro; svinjski insulinmorebitno povečano tveganje za napake pri uporabi zdravil, povezano z odvzemom insulina iz napolnjenih injekcijskih peresnikov in vložkov, ki lahko privede do disglikemije (št. EPITT 18893)
Posology and method of administration, and/or 4.4. 
Odmerjanje in način uporabe in/ali 4.4.
Tofacitinib - Angioedema (EPITT no 18904) 
Tofacitinib - angioedem (št. EPITT 18904)
Allergic reactions included angioedema and urticaria; serious reactions have occurred. 
Alergijske reakcije so vključevale angioedem in urtikarijo; pojavile so se resne reakcije.
Other side effects which have been observed with XELJANZ are listed below. 
Drugi neželeni učinki , ki so jih opazili pri jemanju zdravila XELJANZ, so navedeni spodaj.
If any serious allergic or anaphylactic reaction occurs, tofacitinib should be discontinued immediately. 
Če se pojavi resna alergijska ali anafilaktična reakcija, je treba zdravljenje s tofacitinibom nemudoma prekiniti.
Frequency ‘not known': hypersensitivity; angioedema; urticaria 
Neznana pogostnost: preobčutljivost, angioedem, urtikarija
Standard (100 units/mL) and lower (< 100 units/mL) strength insulin products The text to be adapted to individual products is in bold. 
Zdravila z insulinom standardne (100 enot/ml) in nižje (< 100 enot/ml) jakosti Besedilo, ki ga je treba spremeniti pri posameznih zdravilih, je označeno krepko.
In post-marketing experience, cases of hypersensitivity associated with tofacitinib administration have been reported. 
V obdobju trženja so poročali o primerih preobčutljivosti, povezanih z uporabo tofacitiniba.
Special precautions for disposal and other handling The following text and any related package leaflet text should be removed: ‘If the <pen / infusion pump> malfunctions (see instructions for using the pen / infusion pump), the solution may be drawn from the cartridge into a syringe (suitable for an insulin with 100 units/mL) and injected.' 
Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Naslednje besedilo in povezano besedilo v navodilu za uporabo je treba izbrisati: „Če se <injekcijski peresnik/infuzijska črpalka> pokvari (glejte navodila za uporabo injekcijskega peresnika/črpalke), je mogoče raztopino potegniti iz vložka z brizgo (primerno za insulin s 100 enotami/ml) in injicirati.“
< If administration by syringe, <intravenous injection> or <infusion pump> is necessary, a vial should be used.>> 
<Če je potrebno dajanje z injekcijsko brizgo, <intravensko injekcijo> ali <infuzijsko črpalko>, je treba uporabiti vialo.>>
Not known (frequency cannot be estimated from the available data): hives (itchy, bumpy rash) 
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): koprivnica (srbeč izpuščaj z izboklinicami)
Special warnings and precautions for use <<Product name in cartridges> is only suitable for subcutaneous injections from a reusable pen. 
Posebna opozorila in previdnostni ukrepi <Zdravilo <ime zdravila v vložkih> je primerno samo za podkožno injiciranje z injekcijskim peresnikom za večkratno uporabo.
<<Product name in pre-filled pen> is only suitable for subcutaneous injections. 
<Zdravilo <ime zdravila v napolnjenem injekcijskem peresniku> je primerno samo za podkožno injiciranje.
<Product name in pre-filled pen> is only suitable for injecting just under the skin. 
Zdravilo <ime zdravila v napolnjenem injekcijskem peresniku> je primerno samo za injiciranje tik pod kožo.
How to use <product name> <Product name in cartridges> is only suitable for injecting just under the skin using a reusable pen. 
Zdravilo <ime zdravila v vložkih> je primerno samo za injiciranje tik pod kožo z injekcijskim peresnikom za večkratno uporabo.
Rabbits need to be revaccinated every year. 
Kunce je treba vsako leto ponovno cepiti.
Protection starts at three weeks and lasts for one year. 
Zaščita se vzpostavi po treh tednih in traja eno leto.
The virus causes swelling and discharge from the eyes, nose and bottom with most rabbits dying within 10 - 14 days. 
Virus povzroča otekanje in izcedek iz oči, nosu in zadka, večina kuncev pa umre v 10 do 14 dneh.
The swelling resolves completely by 3 weeks after vaccination. 
Oteklina popolnoma izgine v treh tednih po cepljenju.
Antibody levels increased for up to six weeks following vaccination and stayed at this level for 12 months. 
Raven protiteles je naraščala največ šest tednov po cepljenju in je na tej stopnji ostala 12 mesecev.
It is given to rabbits from five weeks of age as a single injection under the skin. 
Cepivo se daje kuncem od petega tedna starosti dalje z enkratnim injiciranjem pod kožo.
RHD, caused by classical RHD virus (RHDV1) and RHD type 2 virus (RHDV2), leads to blood clots in major organs such as the heart, lungs and kidneys leading to heart and respiratory failure when the heart and lungs do not work properly. 
Hemoragična bolezen kuncev, ki jo povzročata klasični virus RHD (RHDV1) in virus RHD tipa 2 (RHDV2), povzroča krvne strdke v glavnih organih, kot so srce, pljuča, ledvice, kar vodi do odpovedi srca in dihal, kadar srce in pljuča ne delujejo pravilno.
Further information on Nobivac Myxo-RHD Plus can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/nobivac-myxo-rhd-plus. 
Nadaljnje informacije o zdravilu Nobivac Myxo-RHD Plus so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/nobivac-myxo-rhd-plus.
The most common side effects with Nobivac Myxo-RHD Plus (which may affect up to 1 in 10 animals) are a short-lived temperature increase of 1 to 2 °C and a small, non-painful swelling (maximum 2 cm diameter) at the injection site within the first two weeks after vaccination. 
Najpogostejša neželena učinka cepiva Nobivac Myxo-RHD Plus (ki lahko prizadeneta največ 1 žival od 10) sta prehodno povišanje temperature za 1-2 °C in majhna, neboleča oteklina (največ 2 cm premera) na mestu injiciranja v prvih dveh tednih po cepljenju.
For myxoma virus, rabbits were tested for antibodies only. 
Pri virusu miksoma so kunce testirali samo na protitelesa.
These studies showed that rabbits that were vaccinated with Nobivac Myxo-RHD had fewer signs of myxomatosis, more antibodies against RHDV1 virus in their blood and a lower death rate than unvaccinated rabbits. 
Te študije so pokazale, da so kunci, ki so bili cepljeni s cepivom Nobivac Myxo-RHD, imeli manj znakov miksomatoze, več protiteles proti virusu RHDV1 v krvi in nižjo stopnjo smrtnosti kot necepljeni kunci.
Four laboratory studies were conducted in young rabbits that showed protection began three weeks after vaccination and lasted 12 months against RHDV1 and RHDV2. 
Pri mladih kuncih so bile opravljene štiri laboratorijske študije, ki so pokazale, da se je zaščita pred virusoma RHD1 in RHDV2 začela tri tedne po cepljenju in je trajala 12 mesecev.
The European Medicines Agency decided that Nobivac Myxo-RHD Plus's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je odločila, da so koristi zdravila Nobivac Myxo-RHD Plus večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
These viruses have been modified so that they also produce proteins from the outer coat of either RHDV1 (strain 009) or RHDV2 (strain MK1899). 
Ti virusi so bili spremenjeni tako, da proizvajajo tudi beljakovine iz zunanje ovojnice virusov RHDV1 (sev 009) ali RHD2 (sev MK1899).
In addition, the company also presented field studies with the already authorised vaccine Nobivac Myxo-RHD which contains live myxoma vectored RHD virus strain 009 only. 
Poleg tega je podjetje predstavilo terenske študije z že odobrenim cepivom Nobivac Myxo-RHD, ki vsebuje le sev 009 živega vektorskega RHD virusa miksoma.
The withdrawal period for meat from rabbits treated with Nobivac Myxo-RHD Plus is ‘zero' days, which means that there is no mandatory waiting time. 
Karenca za meso kuncev, zdravljenih s cepivom Nobivac Myxo-RHD Plus, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
Nobivac Myxo-RHD Plus is a vaccine. 
Zdravilo Nobivac Myxo-RHD Plus je cepivo.
For more information about using Nobivac Myxo-RHD Plus, see the package leaflet or contact your veterinarian or pharmacist. 
Za več informacij glede uporabe zdravila Nobivac Myxo-RHD Plus glejte navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
When a rabbit is given the vaccine, the immune system recognises the weakened viruses in the vaccine as ‘foreign' and makes antibodies against both the myxoma virus and the RHD virus proteins. 
Ko kunca cepimo, imunski sistem prepozna oslabljene viruse kot tujek in začne tvoriti protitelesa proti virusu miksoma in beljakovinam virusa RHD.
Myxomatosis is caused by the myxoma virus and is spread between rabbits by close contact and biting insects such as fleas and mosquitoes. 
Miksomatozo povzroča virus miksoma, širi pa se ob tesnem stiku kuncev in z ugrizi žuželk, kot so bolhe in komarji.
Nobivac Myxo-RHD Plus contains small amounts of weakened forms of the myxoma virus that causes myxomatosis. 
Cepivo Nobivac MyxoRHD Plus vsebuje majhne količine oslabljenih oblik virusa miksoma, ki povzroča miksomatozo.
Nobivac Myxo-RHD Plus is a vaccine used in rabbits to reduce death and clinical signs due to myxomatosis and rabbit haemorrhagic disease (RHD). 
Nobivac Myxo-RHD Plus je cepivo, ki se uporablja pri kuncih za zmanjšanje smrtnosti in kliničnih znakov miksomatoze in hemoragične bolezni kuncev (RHD).
For the full list of side effects and restrictions for Nobivac Myxo-RHD Plus, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Nobivac Myxo-RHD Plus glejte navodilo za uporabo.
Nobivac Myxo-RHD Plus contains live myxoma vectored RHD virus strains 009 and MK1899. 
Cepivo Nobivac Myxo-RHD Plus vsebuje živa vektorska seva RHD virusa miksoma 009 in MK1899.
An overview of Nobivac Myxo-RHD Plus and why it is authorised in the EU 
Pregled zdravila Nobivac Myxo-RHD Plus in zakaj je odobreno v EU
Other information about Nobivac Myxo-RHD Plus 
Druge informacije o zdravilu Nobivac Myxo-RHD Plus
Nobivac Myxo-RHD Plus is available as a freeze dried powder (lyophilisate) and solvent for suspension for injection and can only be obtained with a prescription. 
Zdravilo Nobivac Myxo-RHD Plus je na voljo v obliki praška, posušenega z zamrzovanjem, (liofilizata) in vehikla za pripravo suspenzije za injiciranje.
Why is Nobivac Myxo-RHD Plus authorised in the EU? 
Zakaj je bilo zdravilo Nobivac Myxo-RHD Plus odobreno v EU?
What is Nobivac Myxo-RHD Plus and what is it used for? 
Kaj je zdravilo Nobivac Myxo-RHD Plus in za kaj se uporablja?
Nobivac Myxo-RHD Plus received a marketing authorisation valid throughout the EU on 19 November 
Zdravilo Nobivac Myxo-RHD Plus je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji,
What benefits of Nobivac Myxo-RHD Plus have been shown in studies? 
Kakšne koristi je zdravilo Nobivac Myxo-RHD Plus izkazalo v študijah?
What are the risks associated with Nobivac Myxo-RHD Plus? 
Kakšna tveganja so povezana z zdravilom Nobivac Myxo-RHD Plus?
together with other components of the immune system, will be able to kill the viruses and help protect against the diseases. 
Ko je kunec izpostavljen tem ali podobnim virusom, ta protitelesa skupaj z drugimi mehanizmi imunskega sistema uničijo virus in pripomorejo k zaščiti pred boleznijo.
How is Nobivac Myxo-RHD Plus used? 
Kako se zdravilo Nobivac Myxo-RHD Plus uporablja?
How does Nobivac Myxo-RHD Plus work? 
Kako zdravilo Nobivac Myxo-RHD Plus deluje?
Date of first authorisation: 15 February 2016 
Datum prve odobritve: 15. februar 2016
The recommended dose is as follows: 
Priporočeni odmerek je naslednji:
If not, your child may not be fully protected against the diseases. 
V nasprotnem primeru vaš otrok morda ne bo popolnoma zaščiten pred boleznimi.
Not relevant. 
Ni relevantno.
4.8 Undesirable effects a- Summary of the safety profile 
4.8 Neželeni učinki a- Povzetek varnostnega profila
(See section 4.8). 
(Glejte poglavje 4.8).
Important information about the protection provided 
Pomembne informacije o zagotovljeni zaščiti
Stability data indicate that the vaccine is stable at temperatures up to 25°C for 150 hours. 
Podatki o stabilnosti kažejo, da je cepivo stabilno 150 ur pri temperaturi do 25 °C.
Pack of 1 or 10. 
Pakiranje po 1 ali 10.
No data are available in older children (see sections 4.8 and 5.1) 
Podatki za starejše otroke niso na voljo (glejte poglavji 4.8 in 5.1)
The cough may last for one to two months or longer. 
Kašelj lahko traja od enega do dveh mesecev ali dlje.
No pharmacokinetic studies have been performed. 
Farmakokinetičnih študij niso izvedli.
• Temperature of 40.5°C within 48 hours, not attributable to another identifiable cause 
• temperatura  40,5 °C v 48 urah, ki ji ni možno pripisati drugega prepoznavnega vzroka;
Component of a multipack. 
Komponenta skupnega pakiranja.
No cases of overdose have been reported. 
O primerih prevelikega odmerjanja niso poročali.
N=89 subjects from a separate study 
bN=89 oseb iz ločenega preskušanja.
The coughing often has a “whooping” sound. 
Kašelj ima pogosto »oslovski« zvok.
These data are intended to guide healthcare professionals in case of a temporary temperature excursion only. 
Ti podatki so namenjeni kot smernica zdravstvenim delavcem le v primeru začasne spremembe temperature.
40/8/32 DU 
40/8/32 D.e.
• difficulty in breathing 
• težave z dihanjem;
As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed. 
Ker je korist cepljenja v tej skupini dojenčkov velika, cepljenja ne bi smeli izpustiti ali odložiti.
There may be some circumstances, such as high incidence of pertussis, when the potential benefits outweigh possible risks. 
Obstajajo okoliščine, kot je visoka incidenca oslovskega kašlja, ko potencialna korist prevlada nad možnim tveganjem.
When these signs or symptoms occur they usually develop quickly after the injection is given and while the child is still in the clinic or doctor's surgery. 
Če se pojavijo ti znaki ali simptomi, se običajno razvijejo hitro po prejeti injekciji, ko je otrok še vedno v zdravstvenem domu ali v zdravnikovi ambulanti.
It can lead to paralysis or muscle weakness most commonly of the legs. 
Pride lahko do paralize ali mišične oslabelosti, najpogosteje v nogah.
For instructions on handling of the medicinal product before administration, see section 6.6. 
Za navodila glede ravnanja z zdravilom pred aplikacijo glejte poglavje 6.6.
At the end of this period Vaxelis should be used or discarded. 
Ob koncu tega obdobja je treba cepivo Vaxelis uporabiti ali zavreči.
Other tests should be performed in order to confirm Hib infection during this period. 
V tem obdobju je treba za potrditev okužbe s Hib opraviti druge preiskave.
EXP: {MM/YYYY} 
EXP: {MM/LLLL}
Type 2 (MEF-1) 
tipa 2 (sev MEF-1)
• The vaccine does not contain any live bacteria or viruses and it cannot cause any of the infectious diseases against which it protects. 
• Cepivo ne vsebuje živih bakterij ali virusov in ne more povzročiti nalezljivih bolezni, proti katerim ščiti.
• As with any vaccine, Vaxelis may not protect 100% of children who receive the vaccine. 
• Kot velja za vsa cepiva, Vaxelis morda ne bo zaščitil 100 % otrok, ki ga prejmejo.
However, a lower immune response may be observed and the level of clinical protection is unknown. 
Opazili pa so, da je imunski odziv lahko slabši, raven klinične zaščite pa je neznana.
Component of a multipack, cannot be sold separately 
Komponenta skupnega pakiranja, ni za ločeno prodajo.
If any of these symptoms occur after leaving the place where your child received his/her injection, you must consult a doctor IMMEDIATELY: 
Če se kateri od teh simptomov pojavi, ko zapustite kraj, kjer je vaš otrok prejel injekcijo, se morate TAKOJ posvetovati z zdravnikom:
Serious allergic reactions 
Hude alergijske reakcije
Do not use this vaccine after the expiry date which is stated on the carton and the label after EXP. 
Tega cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki poleg oznake „EXP“.
• was born very prematurely (at or before 28 weeks of gestation). 
• se je rodil veliko prezgodaj (v ali pred 28. tednom nosečnosti).
In some people, the virus can stay in the body for a long time, and can eventually lead to serious liver problems, including liver cancer. 
Pri nekaterih ljudeh lahko virus ostane v telesu zelo dolgo časa in lahko privede do resnih težav z jetri, vključno z rakom na jetrih.
Vaccination with Vaxelis may need to be delayed until your child is better. 
Cepljenje s cepivom Vaxelis bo morda treba preložiti, dokler se stanje vašega otroka ne izboljša.
Do not use Vaxelis if your child: 
Cepiva Vaxelis ne uporabljajte, če je vaš otrok:
Immunosuppressive therapy may interfere with the development of expected immune response (see section 4.4) 
Imunosupresivna terapija lahko vpliva na razvoj pričakovanega imunskega odziva (glejte poglavje 4.4).
Other medicines or vaccines and Vaxelis 
Druga zdravila ali cepiva in cepivo Vaxelis
• blueness of the tongue or lips 
• pomodrel jezik ali ustnice;
Results obtained for each component of the vaccine are summarised in Table 2 and Table 3. 
Rezultati za posamezno komponento cepiva so povzeti v preglednici 2 in preglednici 3.