natgillin/translations-raw huggingface dataset:
As with other vaccines, the administration of PRIORIX should be postponed in subjects suffering from acute severe febrile illness. 
Kot pri cepljenju z drugimi cepivi, morate tudi cepljenje s cepivom PRIORIX odložiti pri osebah s hudo akutno vročično boleznijo.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose (0.5 ml) To be completed nationally 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 odmerek (0,5 ml) [izpolni država članica]
PARTICULARS TO APPEAR ON THE OUTER PACKAGING VIAL + PRE-FILLED SYRINGE WITH 1 SEPARATE NEEDLE: PACK OF 20, 40 
PODATKI NA ZUNANJI OVOJNINI VIALA + NAPOLNJENA INJEKCIJSKA BRIZGA Z 1 LOČENO IGLO: PAKIRANJE PO 20, 40
Transmission of measles and mumps virus from vaccinees to susceptible contacts has never been documented. 
Prenos virusa ošpic in mumpsa s cepljenih oseb na dovzetne osebe, ki so bile s cepljenimi v stiku, ni bil nikoli dokumentiran.
• infection of the middle ear 
• vnetje srednjega ušesa;
PARTICULARS TO APPEAR ON THE OUTER PACKAGING VIAL + AMPOULE, PACK OF 1, 10, 20, 25, 40, 100 
PODATKI NA ZUNANJI OVOJNINI VIALA + AMPULA, PAKIRANJE PO 1, 10, 20, 25, 40, 100
Priorix is intended for children from 9 months up, adolescents and adults. 
Cepivo Priorix je namenjeno otrokom, starejšim od 9 mesecev, mladostnikom in odraslim.
Vaccinees with a history of febrile convulsions should be closely followed-up. 
Cepljene osebe z anamnezo vročinskih krčev je treba natančno spremljati.
MMR-associated thrombocytopenia is rare and generally selflimited. 
Trombocitopenija, povezana s cepivom proti MMR, je redka in na splošno mine sama.
Children below 12 months of age 
Otroci, mlajši od 12 mesecev
• measles and mumps like symptoms 
• ošpicam in mumpsu podobni simptomi;
• redness, irritation and watering of the eyes (conjunctivitis) 
• rdečina, razdražljivost in solzenje oči (konjunktivitis);
What Priorix is and what it is used for What you need to know before you or your child receives Priorix How Priorix is given 
Kaj je cepivo Priorix in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli cepivo Priorix Kako uporabljati cepivo Priorix Možni neželeni učinki
Priorix is injected under the skinor into the muscle. 
Cepivo Priorix injiciramo pod kožo, lahko pa tudi v mišico.
• if you or your child has had a side effect after vaccination against measles, mumps or rubella that involved easy bruising or bleeding for longer than usual (see section 4). 
• če ste po cepljenju proti ošpicam, mumpsu ali rdečkam vi ali vaš otrok imeli neželene učinke, med katerimi je bila nagnjenost k nastanku podplutb ali dolgotrajnejše krvavitve kot ponavadi (glejte poglavje 4);
PRIORIX may be used in individuals who have previously been vaccinated with another monovalent or combined measles, mumps and rubella vaccine. 
Cepivo PRIORIX se lahko uporabi pri posameznikih, predhodno cepljenih s kakšnim drugim monovalentnim cepivom ali kombiniranim cepivom proti ošpicam, mumpsu in rdečkam.
Alcohol and other disinfecting agents must be allowed to evaporate from the skin before injection of the vaccine since they can inactivate the attenuated viruses in the vaccine. 
Alkohol in druga razkužila lahko inaktivirajo oslabljene viruse cepiva, zato morajo pred injiciranjem cepiva izpareti s kože.
Due caution should be employed in administration of PRIORIX to individuals with Central Nervous System (CNS) disorder, susceptibility to febrile convulsions or family history of convulsions. 
Ustrezna previdnost je potrebna pri uporabi cepiva PRIORIX pri posameznikih z motnjo osrednjega živčevja, nagnjenostjo k vročinskim krčem ali z družinsko anamnezo konvulzij.
Infants less than 9 months of age 
Dojenčki, mlajši od 9 mesecev
Infants between 9 and 12 months of age 
Dojenčki v starosti od 9 do 12 mesecev
However there is no evidence of transmission of these excreted vaccine viruses to susceptible contacts. 
Vendar pa ni dokazov o prenosu izločenega vakcinalnega virusa na dovzetne osebe, ki so v stiku s cepljenimi.
These patients should be vaccinated with caution and preferably using subcutaneous route. 
Takšne bolnike je treba cepiti previdno in po možnosti s subkutanim injiciranjem cepiva.
PRIORIX can be given simultaneously (but at separate injection sites) with any of the following monovalent or combination vaccines [including hexavalent vaccines (DTPa-HBV-IPV/Hib)]: diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus influenzae type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), hepatitis A vaccine (HAV), Meningococcal serotype C conjugated vaccine (MenC), varicella zoster vaccine (VZV), oral polio vaccine (OPV) and 10-valent pneumococcal conjugate vaccine in accordance with local recommendations. 
Cepivo PRIORIX se lahko da sočasno (vendar na ločenih mestih injiciranja) s katerimkoli od naslednjih monovalentnih ali kombiniranih cepiv [vključno s heksavalentnimi cepivi (DTPa-HBVIPV/Hib)]: cepivom proti davici, tetanusu in oslovskemu kašlju -acelularno (DTPa), cepivom proti Haemophilus influenzae tipa b (Hib), inaktiviranim cepivom proti otroški ohromelosti (IPV), cepivom proti hepatitisu B (HBV), cepivom proti hepatitisu A (HAV), konjugiranim cepivom proti meningokokom serotipa C (MenC), cepivom proti zostru (VZV), peroralnim cepivom proti otroški ohromelosti (OPV) in 10-valentnim konjugiranim cepivom proti pnevmokokom v skladu z lokalnimi priporočili.
Although women should be asked about the possibility of early pregnancy prior to vaccination, screening tests to exclude pregnancy are not required. 
Ženske je pred cepljenjem sicer treba vprašati, ali so v zgodnjem obdobju nosečnosti, niso pa potrebni presejalni testi nosečnosti.
• inflammation of the meninges, brain, spinal cord and peripheral nerves, Guillain-Barré syndrome (ascending paralysis up to respiratory paralysis) 
• vnetje ovojnic osrednjega živčevja, možganov, hrbtnega mozga in perifernih živcev; GuillainBarréjev sindrom (od ascendentne do respiratorne paralize);
• punctual or small spotted bleeding or bruising more easily than normal due to a drop in platelets 
• pikčaste ali lisaste krvavitve ali hitrejši pojav modric od običajnega zaradi zmanjšanja števila trombocitov;
Infections and infestations: Meningitis, orchitis, epididymitis, atypical mild or attenuated measles, mumps-like syndrome 
Infekcijske in parazitske bolezni: Meningitis, orhitis, epididimitis, netipične ali oslabljene ošpice, mumpsu podoben sindrom
Contacts with disinfectants should be avoided (see section 4.4). 
Preprečite stik z razkužili (glejte poglavje 4.4).
In subjects who have received human gammaglobulins or a blood transfusion, vaccination should be delayed for three months or longer (up to 11 months) depending on the dose of human globulins administered because of the likelihood of vaccine failure due to passively acquired measles, mumps and rubella antibodies. 
Pri osebah, ki so prejele humane gamaglobuline ali transfuzijo krvi, je treba cepljenje odložiti za tri mesece ali dlje (do 11 mesecev) glede na uporabljeni odmerek humanih globulinov.
The use of PRIORIX should be based on official recommendations. 
Za uporabo cepiva PRIORIX je treba upoštevati uradna priporočila.
Post-marketing data 
Podatki iz obdobja trženja
To be completed nationally 
[izpolni država članica]
Therefore, this SmPC, labelling and package leaflet may not necessarily represent the current text. 
Zato ta povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo mogoče potem ne bodo več predstavljali veljavnega besedila.
The following side effects may happen with this medicine: 
Pri tem cepivu se lahko pojavijo naslednji neželeni učinki:
Common (1/100 to <1/10) 
(≥ 1/100 do < 1/10)
Women of Childbearing Potential 
Ženske v rodni dobi
For instructions on reconstitution of the medicinal product before administration see section 6.6. 
Za navodila glede rekonstitucije cepiva pred uporabo, glejte poglavje 6.6.
Priorix is a vaccine for use in children from 9 months up, adolescents and adults to protect them against illnesses caused by measles, mumps and rubella viruses. 
Cepivo Priorix uporabljamo pri otrocih, starejših od 9 mesecev, mladostnikih in odraslih za zaščito pred boleznimi, ki jih povzročajo virusi ošpic, mumpsa in rdečk.
Skin and subcutaneous tissue disorders: Erythema multiforme 
Bolezni kože in podkožja: Multiformni eritem
After the addition of the solvent to the powder, the mixture should be well shaken until the powder is completely dissolved in the solvent. 
Po dodajanju vehikla prašku morate mešanico dobro pretresti, da se prašek v vehiklu popolnoma raztopi.
In patients with existing thrombocytopenia or a history of thrombocytopenia after measles, mumps or rubella vaccination the risk-benefit of administering PRIORIX should be carefully evaluated. 
Pri bolnikih z obstoječo trombocitopenijo ali z anamnezo trombocitopenije po cepljenju proti ošpicam, mumpsu ali rdečkam je treba natančno oceniti razmerje tveganja in koristi cepljenja s cepivom PRIORIX.
When a person is vaccinated with Priorix, the immune system (the body's natural defence system) will make antibodies to protect the person from being infected by measles, mumps and rubella viruses. 
Po cepljenju s cepivom Priorix imunski sistem (naravni obrambni sistem telesa) tvori protitelesa, ki ščitijo pred ošpicami, mumpsom in rdečkami.
Like all medicines, this vaccine can cause side effects, although not everybody gets them. 
Kot vsa zdravila, ima lahko tudi to cepivo neželene učinke, ki pa se ne pojavijo pri vseh cepljenih osebah.
As this anergy may last up to a maximum of 6 weeks, tuberculin testing should not be performed within that period after vaccination to avoid false negative results. 
Da bi se izognili lažno negativnim rezultatom, se tuberkulinskega testa v tem obdobju po cepljenju ne sme izvajati.
Two years after primary vaccination seroconversion rates were 93.4% for measles, 94.4% for mumps and 100% for rubella. 
Dve leti po primarnem cepljenju so bili deleži serokonverzije 93,4 % za ošpice, 94,4 % za mumps in 100 % za rdečke.
The most common adverse reactions following PRIORIX administration were injection site redness and fever 38°C (rectal) or 37.5°C (axillary/oral). 
Najpogostejša neželena učinka po uporabi cepiva PRIORIX sta bila rdečina na mestu injiciranja in zvišana telesna temperatura  38 °C (rektalno) ali  37,5 °C (aksilarno/oralno).
PHARMACEUTICAL FORM To be completed nationally 
FARMACEVTSKA OBLIKA [izpolni država članica]
The safety and immunogenicity of PRIORIX in adolescents and adults has not been specifically studied in clinical trials. 
V kliničnih preskušanjih niso posebej raziskali varnosti in imunogenosti cepiva PRIORIX pri mladostnikih in odraslih.
Cases of overdose (up to 2 times the recommended dose) have been reported during post-marketing surveillance. 
Med spremljanjem cepiva v obdobju trženja so poročali o primerih prevelikega odmerjanja (do 2kratni priporočeni odmerek).
• pain and swelling at the injection site 
• bolečina in oteklina na mestu injiciranja;
The seroconversion rates reported following the second dose given 3 months after the first dose were 100% for measles and 99.2% for mumps. 
Delež serokonverzije, zabeležen po drugem odmerku, uporabljenem 3 mesece po prvem, je bil za ošpice 100 % in za mumps 99,2 %.
SPECIAL STORAGE CONDITIONS To be completed nationally 
POSEBNA NAVODILA ZA SHRANJEVANJE [izpolni država članica]
In the event of either being observed, discard the solvent or reconstituted vaccine. 
Če opazite karkoli od navedenega, vehikel ali rekonstituirano cepivo zavrzite.
• transient, painful swelling of the testicles 
• prehodna, boleča oteklina mod.
If you or your child is vaccinated within 72 hours after contact with someone with measles, Priorix will to some extent protect you against the disease. 
V primeru stika z osebo, ki ima ošpice, vas bo cepivo Priorix do neke mere zaščitilo proti bolezni, če boste vi ali vaš otrok cepljeni v 72 urah po stiku.
Rare (1/10,000 to <1/1,000) 
(≥ 1/10.000 do < 1/1.000)
Although Priorix contains live viruses, they are too weak to cause measles, mumps or rubella in healthy people. 
Cepivo Priorix sicer vsebuje žive viruse, ki pa so toliko oslabljeni, da pri zdravih osebah ne morejo povzročiti ošpic, mumpsa in rdečk.
• nervousness 
• živčnost;
As with any vaccine, a protective immune response may not be elicited in all vaccinees. 
Kot druga cepiva tudi to cepivo morda ne bo sprožilo zaščitnega imunskega odziva pri vseh cepljenih osebah.
Do not use this vaccine after the expiry date which is stated on the carton after EXP. After reconstitution, the vaccine should be administered promptly. 
Tega cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP.
• upper respiratory tract infection 
• okužba zgornjih dihal.
- This vaccine has been prescribed for you only. 
- Cepivo je bilo predpisano vam osebno in ga ne smete dajati drugim.
What Priorix looks like and contents of the pack To be completed nationally 
Izgled cepiva Priorix in vsebina pakiranja [izpolni država članica]
Immune system disorders: Anaphylactic reactions 
Bolezni imunskega sistema: Anafilaktične reakcije
Adverse reactions which might occur following the use of a combined mumps, measles, rubella vaccine correspond to those observed after administration of the monovalent vaccines alone or in combination. 
Neželeni učinki, ki se lahko pojavijo po aplikaciji kombiniranega cepiva proti ošpicam, mumpsu in rdečkam, ustrezajo neželenim učinkom po dajanju enega samega monovalentnega cepiva ali kombinacije monovalentnih cepiv.
Nervous system disorders: Transverse myelitis, Guillain Barré syndrome, peripheral neuritis, encephalitis* 
Bolezni živčevja: Transverzni mielitis, Guillain-Barréjev sindrom, periferni nevritis, encefalitis*,
• erythema multiforme (symptoms are red, often itchy spots, similar to the rash of measles, 
• multiformni eritem (simptomi so rdeči madeži, ki pogosto srbijo, so podobni izpuščaju pri ošpicah in se pojavijo na okončinah, včasih tudi obrazu in ostalih predelih telesa);
Priorix may be given at the same time you or your child receives other recommended vaccinations such as diphtheria, tetanus, pertussis, Haemophilus influenzae type b, oral or inactivated polio, hepatitis A and B, meningococcal serogroup C conjugate vaccines, varicella as well as 10-valent pneumococcal conjugate vaccine. 
Cepljenje s cepivom Priorix se lahko opravi sočasno z drugimi priporočenimi cepljenji, kot je proti davici, tetanusu, oslovskemu kašlju, hemofilusu tipa b, peroralnim ali inaktiviranim cepivom proti otroški ohromelosti, cepivom proti hepatitisu A in B, konjugiranim cepivom proti meningokokom serotipa C, noricam in 10-valentnim konjugiranim cepivom proti pnevmokokom.
PRIORIX is indicated for the active immunisation of children from the age of 9 months or older, adolescents and adults against measles, mumps and rubella. 
Cepivo PRIORIX je indicirano za aktivno imunizacijo otrok, starih 9 mesecev ali več, mladostnikov in odraslih proti ošpicam, mumpsu in rdečkam.
There is limited experience with PRIORIX during breast-feeding. 
Izkušenj s cepivom PRIORIX med obdobjem dojenja je malo.
The solvent and reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspects prior to administration. 
Pred uporabo vehikel in rekonstituirano cepivo vizualno preverite glede morebitne prisotnosti kakršnihkoli tujih delcev in/ali odstopanj od normalnega fizikalnega videza.
• swollen parotid glands (glands in the cheek) 
• oteklina obušesnih slinavk (žleze v licih);
MARKETING AUTHORISATION NUMBER(S) <To be completed nationally> 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET [izpolni država članica]
A limited number of subjects received PRIORIX intramuscularly in clinical trials. 
Majhno število preiskovancev v kliničnih preskušanjih je dobilo cepivo PRIORIX intramuskularno.
The vaccine should preferably be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder (see section 4.4). 
Bolnikom s trombocitopenijo ali kakšno koagulacijsko motnjo je treba cepivo po možnosti dati subkutano (glejte poglavje 4.4).
To be completed nationally For storage conditions after reconstitution of the medicinal product, see section 6.3. 
Za pogoje shranjevanja po rekonstituciji glejte poglavje 6.3.
Pharyngeal excretion of the rubella and measles virus is known to occur about 7 to 28 days after vaccination with peak excretion around the 11th day. 
Znano je, da se izločanje virusa rdečk v žrelu običajno pojavi od 7 do 28 dni po cepljenju.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose To be completed nationally 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 odmerek [izpolni država članica]
• Priorix must not be administered to pregnant women. 
• S cepivom Priorix se ne sme cepiti nosečnic.
If not given at the same time, an interval of at least one month is recommended between administration of Priorix and other live attenuated vaccines. 
Če se cepljenja ne opravi sočasno je priporočljivo, da med cepljenjem s cepivom PRIORIX in drugimi živimi oslabljenimi cepivi mine vsaj en mesec.
6.5 Nature and contents of container 
6.5 Vrsta ovojnine in vsebina [izpolni država članica]
Intramuscular route of administration 
Intramuskularna pot uporabe
• reduced measles 
• oslabljene ošpice;
• swollen lymph glands (glands in the neck, armpit or groin) 
• oteklina bezgavk (žleze v vratu, podpazduhi ali dimljah);
• redness at the injection site 
• rdečina na mestu injiciranja,
What Priorix contains To be completed nationally 
Kaj vsebuje cepivo Priorix [izpolni država članica]
Blood and lymphatic system disorders: Thrombocytopenia, thrombocytopenic purpura 
Bolezni krvi in limfatičnega sistema: Trombocitopenija, trombocitopenična purpura
Respiratory, thoracic and mediastinal disorders: Uncommon: bronchitis, cough 
Bolezni dihal, prsnega koša in mediastinalnega prostora: Občasni: bronhitis, kašelj
PHARMACEUTICAL FORM AND CONTENTS To be completed nationally 
FARMACEVTSKA OBLIKA IN VSEBINA [izpolni država članica]
Blood and lymphatic system disorders: Uncommon: lymphadenopathy 
Bolezni krvi in limfatičnega sistema: Občasni: limfadenopatija
Priorix must not be administered to pregnant women. 
Cepiva Priorix se nosečnicam ne sme dati.
In case of inadvertent vaccination of pregnant woman with Priorix, this should not be a reason for termination of pregnancy. 
Če ženska, ki ne ve, da je noseča, nevede prejme cepivo Priorix, to ni razlog za prekinitev nosečnosti.
Transmission 
Prenašanje
Seroconversion rates for measles, mumps and rubella were 92.6%, 91.5% and 100%, respectively. 
Delež serokonverzije za ošpice je bil 92,6 %, za mumps 91,5 % in 100 % za rdečke.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. 
Pri cepljenju je, tako kot pri vseh cepivih, ki se jih injicira, treba zagotoviti ustrezno obliko zdravljenja in nadzora, ki bo v takšnem primeru nemudoma na voljo.
How to store Priorix 
Kako uporabljati cepivo Priorix
Your doctor may delay vaccination for at least 3 months if you or your child has received a blood transfusion or human antibodies (immunoglobulins). 
Če ste vi ali vaš otrok prejeli transfuzijo krvi ali humana protitelesa (imunoglobuline), bo zdravnik lahko cepljenje s cepivom Priorix odložil vsaj za 3 mesece.
Side effects that occurred during clinical trials with Priorix were as follows: 
Med kliničnimi preskušanji cepiva Priorix so se pojavili naslednji neželeni učinki:
Transmission of the rubella vaccine virus to infants via breast milk as well as transplacental transmission has been documented without any evidence of clinical disease. 
Dokumentirano je prenašanje virusa iz cepiva proti rdečkam na dojenčke z materinim mlekom; prav tako je dokumentirano transplacentalno prenašanje.
Rare: allergic reactions 
Bolezni imunskega sistema: Redki: alergijske reakcije
Uncommon: conjunctivitis 
Očesne bolezni: Občasni: konjunktivitis
How Priorix works 
Kako cepivo Priorix deluje
Very common: redness at the injection site, fever 38°C (rectal) or 37.5°C (axillary/oral) Common: pain and swelling at the injection site, fever >39.5°C (rectal) or >39°C (axillary/oral) 
Pogosti: bolečina in oteklina na mestu injiciranja, zvišana telesna temperatura > 39,5 °C (rektalno) ali  39,0 °C (aksilarno/oralno)
Immunocompromised patients who have no contraindication for this vaccination (see section 4.3) may not respond as well as immunocompetent patients, therefore some of these patients may acquire measles, mumps or rubella in case of contact, despite appropriate vaccine administration. 
Imunsko oslabeli bolniki, ki nimajo kontraindikacij za to cepljenje (glejte poglavje 4.3), se lahko odzovejo slabše kot imunokompetentni bolniki.
This leaflet was last revised in {MM/YYYY} To be completed nationally 
Navodilo je bilo odobreno {MM/YYYY}: [izpolni država članica]
No adverse reactions have been associated to the overdose. 
Preveliko odmerjanje ni bilo povezano s pojavom neželenih učinkov.
In these cases, the vaccination will be postponed until recovery. 
V tem primeru se bo cepljenje odložilo, dokler vi ali vaš otrok ne boste ozdraveli.
 Very common (these may occur with more than 1 in 10 doses of the vaccine): 
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 odmerkov cepiva):
• if you or your child has disorders of the central nervous system, a history of convulsion accompanying high fever or family history of convulsions. 
• če imate vi ali vaš otrok bolezen osrednjega živčevja, ste vi/je vaš otrok kdaj imel vročinske krče ali pa so se krči pojavljali v družini.
STATEMENT OF ACTIVE SUBSTANCE(S) To be completed nationally 
SEZNAM POMOŽNIH SNOVI [izpolni država članica]
METHOD OF ADMINISTRATION 
Način uporabe
INFORMATION IN BRAILLE To be completed nationally 
PODATKI V BRAILLOVI PISAVI [izpolni država članica]
Rare: febrile convulsions 
Bolezni živčevja: Redki: vročinski krči
• rash (spots) 
• izpuščaj (pikice);
What you need to know before you or your child receive(s) Priorix 
Kaj morate vedeti, preden boste prejeli cepivo Priorix
6.4 Special precautions for storage 
6.4 Posebna navodila za shranjevanje [izpolni država članica]
1%, against mumps in 94.4% and against rubella in 100% of previously seronegative vaccinees. 
Cepljenje z enim samim odmerkom cepiva PRIORIX je sprožilo nastanek protiteles proti ošpicam pri 98,1 %, proti mumpsu pri 94,4 % in proti rdečkam pri 100 % pred tem seronegativnih cepljenih otrok.
Uncommon: anorexia 
Presnovne in prehranske motnje: Občasni: anoreksija
 Rare (these may occur with up to 1 in 1,000 doses of the vaccine): 
Redki (pojavijo se lahko pri največ 1 od 1.000 odmerkov cepiva):
Skin and subcutaneous tissue disorders: Common: rash 
Bolezni kože in podkožja: Pogosti: izpuščaj
Individuals who have experienced anaphylaxis after egg ingestion should be vaccinated with extreme caution, with adequate treatment for anaphylaxis on hand should such a reaction occur. 
Treba je zagotoviti takojšnje ustrezno zdravljenje anafilaksije, če se takšna reakcija pojavi.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SC or IM See Annex I - To be completed nationally 
IME ZDRAVILA IN POT(I) UPORABE s.c. ali i.m.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION See Annex I - To be completed nationally 
IME ZDRAVILA IN POT(I) UPORABE [glejte Prilogo I - izpolni država članica]
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL WITH POWDER 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Talk to the doctor or pharmacist before you or your child receives Priorix : 
Pred cepljenjem s cepivom Priorix se posvetujte s svojim zdravnikom ali farmacevtom:
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER <See Annex I - To be completed nationally> 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [glejte Prilogo I - izpolni država članica]
The vaccine should never be given into a vein. 
Cepiva Priorix se v nobenem primeru ne sme injicirati v žilo.