natgillin/translations-raw huggingface dataset:
This can cause muscle stiffness, painful muscle spasms, fits and even death. 
Bakterije sproščajo strup, ki lahko povzroči otrplost mišic, boleče krče mišic, krče in celo smrt.
Infanrix hexa should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. 
Otrokom s trombocitopenijo ali motnjami strjevanja krvi cepivo Infanrix hexa dajemo previdno, ker se pri njih po intramuskularni aplikaciji lahko pojavi krvavitev.
This can cause death by suffocation. 
Lahko povzroči tudi oteklost grla, kar lahko povzroči smrt z zadušitvijo.
N = number of subjects * in a subgroup of infants not administered hepatitis B vaccine at birth, 77.7% of subjects had anti-HBs titres ≥ 10 mIU/ml ** Post booster, 98.4% of subjects had anti-PRP concentration ≥ 1 µg/ml indicative of long-term protection † cut-off accepted as indicative of protection 
N = število preiskovancev * V podskupini otrok, ki ob rojstvu niso dobili cepiva proti hepatitisu B, jih je 77,7 % imelo titre anti-HBs ≥ 10 mi.e./ml.
• Infanrix hexa is available in packs of 1 and 10 with or without needles, and a multipack of 5 packs, 
• Cepivo Infanrix hexa je na voljo v pakiranjih po 1 in 10 napolnjenih injekcijskih brizg s priloženimi injekcijskimi iglami ali brez njih in pakiranje, ki vsebuje 5 posameznih pakiranj z 10 vialami in 10 napolnjenimi injekcijskimi brizgami brez igel.
Poliovirus (inactivated) type 1 (Mahoney strain)4 
10 mikrogramov poliovirus (inaktivirani) tip 1 (sev Mahoney) 4
1 dose (0.5 ml) 
(0,5 ml).
Store in the original package, in order to protect from light. 
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
Pack sizes of 1 and 10 with or without needles and a multipack of 5 packs, each containing 10 vials and 10 pre-filled syringes, without needles. 
Pakiranja po 1 in 10 napolnjenih injekcijskih brizg s priloženimi injekcijskimi iglami ali brez njih in pakiranje, ki vsebuje 5 posameznih pakiranj z 10 vialami in 10 napolnjenimi injekcijskimi brizgami brez igel.
In these circumstances pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria-tetanus, hepatitis B, polio and Hib vaccines. 
V takšnih primerih moramo cepljenje proti oslovskemu kašlju opustiti, cepljenje pa nadaljevati s cepivi proti davici, tetanusu, hepatitisu B, otroški ohromelosti in Hib.
Uncommon (these may occur with up to 1 in 100 doses of the vaccine): upper respiratory tract infection, feeling sleepy, cough, large swelling at the injected limb. 
Občasni (pojavijo se lahko pri največ 1 od 100 odmerkov cepiva): okužbe zgornjih dihalnih poti, občutek zaspanosti, kašelj, močna oteklost uda, v katerega je bilo injicirano cepivo.
Store in a refrigerator (2°C - 8°C). 
6.4 Posebna navodila za shranjevanje Shranjujte v hladilniku (2 ºC - 8 ºC).
QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (0.5 ml) contains: Diphtheria toxoid1 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Po rekonstituciji en odmerek cepiva (0,5 ml) vsebuje:
This can cause nerve damage, heart problems, and even death. 
Bakterije sproščajo tudi strup, ki lahko poškoduje živce, povzroči težave s srcem in celo smrt.
2produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 3adsorbed on aluminium phosphate (AlPO4) 
2pridobljen s tehnologijo rekombinantne DNA na celični kulturi Saccharomyces cerevisiae
• There should be an interval of at least 1 month between primary doses. 
• Med posameznimi odmerki v primarnem cepljenju mora miniti vsaj 1 mesec.
However the stability has been demonstrated for 8 hours at 21°C after reconstitution. 
Po rekonstituciji: priporoča se takojšnja uporaba, čeprav so na voljo podatki o stabilnosti cepiva 8 ur pri 21 °C po rekonstituciji.
Bordetella pertussis antigens Pertussis toxoid1 
antigeni Bordetella pertussis toksoid Bordetellae pertussis1
The expected immunological response may not be obtained after vaccination of immunosuppressed patients. 
Lahko se zgodi, da pri bolnikih, ki prejemajo imunosupresivno terapijo, po cepljenju ne dosežete ustreznega imunskega odziva.
However, data indicate that protection against pertussis may be waning at 7-8 years of age with this 3-5-12 month's schedule. 
Vendar pa podatki kažejo tudi, da pri cepljenju po shemi (3-5-12 mesec) zaščita proti oslovskemu kašlju v starosti od 7 do 8 let lahko oslabi,
As for any vaccination, the risk-benefit of immunising with Infanrix hexa or deferring this vaccination should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe neurological disorder. 
Pri dojenčku ali otroku, pri katerem se je pojavilo novo hujše nevrološko obolenje ali pa je prišlo do njegovega poslabšanja, je, tako kot pri vsakem cepljenju, treba skrbno presoditi o koristih in tveganjih, povezanih s cepljenjem ali z odložitvijo cepljenja s cepivom Infanrix hexa.
This suggests that a second booster dose of pertussis vaccine is warranted in children aged 5-7 years who have previously been vaccinated following this particular schedule. 
kar kaže, da je pri otrocih, ki so bili cepljeni po tej shemi, v starosti od 5 do 7 let upravičeno cepljenje še z drugim obnovitvenim odmerkom cepiva.
Ask your pharmacist how to throw away medicines your child no longer uses. 
O načinu odstranjevanja cepiva, ki ga ne potrebujete več, se posvetujte s farmacevtom.
Post-dose 3 
Po 3. odmerku
Multipack comprising 5 packs, each containing 10 vials and 10 pre-filled syringes without needles 50 x 1 dose (0.5 ml) 
V pakiranju je 5 posameznih pakiranj z 10 vialami in 10 napolnjenimi injekcijskimi brizgami brez igel 50 x 1 odmerek (0,5 ml)
How to store Infanrix hexa 
Kako uporabljati cepivo Infanrix hexa
2-dose 
2 odmerka
Antibody (cut-off) 
Protitelo (mejna vrednost)
Hepatitis B surface antigen2,3 
8 mikrogramov površinski antigen virusa hepatitisa B2,3
(polyribosylribitol phosphate) 2 conjugated to tetanus toxoid as carrier protein approximately 25 micrograms 
(poliribozilribitol-fosfat)2 vezan na tetanusni toksoid kot nosilni protein približno 25 mikrogramov
Clinical data indicate that Infanrix hexa can be given to preterm infants, however, as expected in this population, a lower immune response has been observed for some antigens (see section 4.8 and section 
Vendar je bil pri tej populaciji, v skladu s pričakovanji, opažen manjši imunski odziv za nekatere antigene (glejte poglavji 4.8 in 5.1).
• rashes that may be itchy or blistering 
• izpuščaj, ki lahko srbi ali ga spremlja pojav mehurjev,
(polyribosylribitol phosphate)3 conjugated to tetanus toxoid as carrier protein approximately 25 micrograms 
(poliribozilribitol-fosfat)3 vezan na tetanusni toksoid kot nosilni protein približno 25 mikrogramov
Percentage of subjects with antibody titres indicative of seroprotection / seropositivity one month after 2-dose primary and booster vaccination with Infanrix hexa 
Odstotek preiskovancev, pri katerih so titri protiteles kazali na serološko zaščito/seropozitivnost en mesec po primarnem cepljenju z 2 odmerkoma in obnovitvenem odmerku cepiva Infanrix hexa
(polyribosylribitol phosphate, PRP) 3 conjugated to tetanus toxoid as carrier protein approximately 25 micrograms 
(poliribozilribitol-fosfat, PRP)3 vezan na tetanusni toksoid kot nosilni protein približno 25 mikrogramov
If your child gets any side effects, talk to your doctor or pharmacist. 
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
Uncommon Upper respiratory tract infection 
Infekcijske in parazitske bolezni Občasni okužbe zgornjih dihalnih poti
Efficacy study (NIH sponsored) 
(sponzorirana s strani NIH)
Diarrhoea, vomiting 
Pogosti driska, bruhanje
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DTPa HBV IPV for Infanrix hexa 
IME ZDRAVILA IN POT(I) UPORABE DTPa HBV IPV za Infanrix hexa suspenzija za suspenzijo za injiciranje i.m.
In a follow-up study conducted in 74 children, approximately 2.5 to 3 years after the booster dose, 85.3% of the children were still seroprotected against hepatitis B and at least 95.7% were seroprotected against the three poliovirus types and PRP. 
otrok še vedno serološko zaščitenih proti hepatitisu B in vsaj 95,7 % serološko zaščitenih proti trem vrstam poliovirusa in PRP.
Syringe 
Brizga
Very common Appetite lost 
Presnovne in prehranske motnje Zelo pogosti izguba apetita
10 vials and 10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml) 
10 vial in 10 napolnjenih injekcijskih brizg + 20 igel 10 x 1 odmerek (0,5 ml)
ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
• If your child misses an injection which is due, it is important that you make another appointment. 
Če vaš otrok izpusti odmerek • Če vaš otrok zamudi predvideni odmerek, je pomembno, da ga prenaročite.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OF 50 (5 X 10) (OUTER WRAPPER LABEL TO BE APPLIED ON TRANSPARENT FOIL, INCLUDING BLUE BOX) 
PAKIRANJE, KI VSEBUJE 5 POSAMEZNIH PAKIRANJ (5 X 10) (NALEPKA Z MODRIM OKENCEM NA ZUNANJI PROZORNI FOLIJI)
Post-dose 2 
Po 2. odmerku
After a complete vaccination according to a 2-dose primary and booster schedule with Infanrix hexa, at least 97.9% of the subjects had developed seroprotective or seropositive antibody levels against each of the vaccine antigens. 
Po celotnem cepljenju s shemo 2 primarnih in enega obnovitvenega odmerka cepiva Infanrix hexa se je serološka zaščitna ali seropozitivna koncentracija protiteles proti vsakemu od antigenov v cepivu pojavila pri vsaj 97,9 % preiskovancev.
Fever ≥39.5°C was observed in 2.6% and 1.5% of infants receiving Infanrix hexa with or without Prevenar, respectively (see sections 4.4 and 4.5). 
Zvišano telesno temperaturo ≥ 39,5 °C so zabeležili pri 2,6 % otrok, ki so dobili cepivo Infanrix hexa in cepivo Prevenar, ter pri 1,5 % otrok, ki so dobili samo cepivo Infanrix hexa (glejte poglavji 4.4 in 4.5).
A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Infanrix hexa. 
Anamneze vročinskih krčev, družinske obremenjenosti s krči ali sindroma nenadne smrti dojenčka
1 vial and 1 pre-filled syringe 1 dose (0.5 ml) 
1 viala in 1 napolnjena injekcijska brizga 1 odmerek (0,5 ml)
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very preterm infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. 
Pri aplikaciji odmerkov primarne imunizacije veliko prezgodaj rojenim nedonošenčkom (rojenim pred ali v 28. tednu nosečnosti), še posebno tistim z respiratorno nezrelostjo v anamnezi, je treba upoštevati možnost pojava apneje in potrebo po 48 do 72 urnem spremljanju pljučnega delovanja.
Haemophilus influenzae type b polysaccharide 
32 D-antigenskih enot polisaharid hemofilusa influence tipa b
In clinical studies in which some of the vaccinees received Infanrix hexa concomitantly with Prevenar (PCV7) as a booster (4th) dose of both vaccines, fever ≥ 38.0°C was reported in 43.4% of infants receiving Prevenar and Infanrix hexa at the same time as compared to 30.5% of infants receiving the hexavalent vaccine alone. 
odmerek obeh cepiv, so poročali o zvišani telesni temperaturi ≥ 38,0 °C pri 43,4 % otrok, ki so obenem dobili cepivo Prevenar in cepivo Infanrix hexa, v primerjavi s 30,5 % otrok, ki so dobili samo heksavalentno cepivo.
• If additional injections (boosters) are necessary, the doctor will tell you. 
• Zdravnik vam bo povedal, če so potrebni še dodatni ali "obnovitveni" odmerki.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE WITH DTPA HBV IPV SUSPENSION 
NAPOLNJENA INJEKCIJSKA BRIZGA S SUSPENZIJO (DTPA HBV IPV)
• If your child gets any side effects, talk to your doctor or pharmacist. 
• Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 10 VIALS AND 10 PRE-FILLED SYRINGES WITHOUT NEEDLES FOR MULTIPACK OF 50 (5 X 10) (WITHOUT BLUE BOX) 
PAKIRANJE, KI VSEBUJE 5 POSAMEZNIH PAKIRANJ Z 10 VIALAMI IN 10 NAPOLNJENIMI INJEKCIJSKIMI BRIZGAMI BREZ IGEL (5 X 10) (BREZ MODREGA OKENCA)
10 vials and 10 pre-filled syringes 10 x 1 dose (0.5 ml) 
10 vial in 10 napolnjenih injekcijskih brizg 10 x 1 odmerek (0,5 ml)
Data from clinical studies indicate that, when Infanrix hexa is co-administered with pneumococcal conjugate vaccines, the rate of febrile reactions is higher compared to that occurring following the administration of Infanrix hexa alone. 
Podatki kliničnih študij kažejo, da je delež febrilnih reakcij večji, če je cepivo Infanrix hexa uporabljeno skupaj s konjugiranimi pnevmokoknimi cepivi, kot če je cepivo Infanrix hexa uporabljeno samo.
With regards to hepatitis B, seroprotective antibody concentrations (≥10 mIU/ml) following a 3-dose primary and booster schedule with Infanrix hexa have been shown to persist in ≥ 85% of subjects 4-5 years of age, in ≥72% of subjects 7-8 years of age, in ≥60% of subjects 12-13 years of age and in 53.7% of subjects 14-15 years of age. 
preiskovancev v starosti od 4 do 5 let, pri ≥ 72 % preiskovancev v starosti od 7 do 8 let, pri ≥ 60 % preiskovancev v starosti od 12 do 13 let in pri 53,7 % preiskovancev v starosti od 14 do 15 let.
40, 8, 32 DU 
Italija 2, 4, 6 mesecev
Infanrix hexa, Powder and suspension for suspension for injection in a pre-filled syringe Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed) 
Infanrix hexa - prašek in suspenzija za suspenzijo za injiciranje v napolnjeni injekcijski brizgi Adsorbirano cepivo proti davici (D), tetanusu (T), oslovskemu kašlju (brezcelično, pripravljeno iz antigenskih sestavin) (Pa), hepatitisu B (rekombinantno) (HBV), otroški ohromelosti (inaktivirano) (IPV) in hemofilusu influence tipa b (konjugirano) (Hib)
Uncommon Somnolence Rare 
Občasni zaspanost
Component of a multipack comprising 5 packs, each containing 10 vials and 10 pre-filled syringes without needles 
V pakiranju je 5 posameznih pakiranj z 10 vialami in 10 napolnjenimi injekcijskimi brizgami brez igel
Percentage of subjects with antibody titres indicative of seroprotection / seropositivity one month after 3-dose primary and booster vaccination with Infanrix hexa 
Odstotek preiskovancev, pri katerih so titri protiteles kazali na serološko zaščito/seropozitivnost en mesec po primarnem cepljenju s 3 odmerki in obnovitvenem odmerku cepiva Infanrix hexa Protitelo (mejna vrednost)
Immunogenicity in preterm infants 
Imunogenost pri nedonošenčkih
After booster vaccination (post-dose 4), at least 98.4% of children had developed seroprotective or seropositive antibody levels against each of the vaccine antigens. 
Po obnovitvenem cepljenju (po 4. odmerku) se je serološka zaščitna ali seropozitivna koncentracija protiteles proti vsakemu od antigenov v cepivu pojavila pri vsaj 98,4 % otrok.
Syringe cap 
Občasni kašelj
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL WITH HIB POWDER 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, polio or Hib vaccines. 
Preobčutljivost po predhodnem cepljenju s cepivi proti davici, tetanusu, oslovskemu kašlju, hepatitisu B, otroški ohromelosti ali boleznim, ki jih povzroča Hib.
Percentage of subjects with antibody titres indicative of seroprotection / seropositivity after primary and booster vaccination with Infanrix hexa 
Odstotek preiskovancev, pri katerih so titri protiteles kazali na serološko zaščito/seropozitivnost po primarnem cepljenju in obnovitvenem odmerku cepiva Infanrix hexa Protitelo (mejna vrednost)
• fits - this may be when they have a fever These side effects have happened very rarely with Infanrix hexa as with other vaccines against whooping cough. 
Ti neželeni učinki so se pojavili zelo redko pri cepljenju s cepivom Infanrix hexa, kot tudi pri drugih cepivih proti oslovskemu kašlju.
The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV-IPV) component is a turbid white suspension. 
Komponenta cepiva (DTPa-HBV-IPV) proti davici, tetanusu, oslovskemu kašlju (acelularno), hepatitisu B, otroški ohromelosti (inaktivirano) je motna bela suspenzija.
N = number of subjects † cut-off accepted as indicative of protection * Post booster, 94.4% of subjects in the 2-4-12 months schedule and 97.0% of subjects in the 3-5-11 months schedule had anti-PRP concentration ≥ 1 µg/ml indicative of long-term protection. 
94,4 % preiskovancev, cepljenih po shemi 2-4-12 mesecev, in 97,0 % preiskovancev, cepljenih po shemi 3-5-11 mesecev.
Syringe plunger 
Valj brizge
Lactose anhydrous 
anafilaktoidne reakcije
After a 2-dose primary vaccination schedule, at least 84.3% of infants had developed seroprotective or seropositive antibody levels against each of the vaccine antigens. 
Po shemi osnovnega cepljenja z 2 odmerkoma se je serološka zaščitna ali seropozitivna koncentracija protiteles proti vsakemu od antigenov v cepivu pojavila pri vsaj 84,3 % dojenčkov.
After a 3-dose primary vaccination schedule, at least 95.7% of infants had developed seroprotective or seropositive antibody levels against each of the vaccine antigens. 
Po shemi osnovnega cepljenja s 3 odmerki se je serološka zaščitna ali seropozitivna koncentracija protiteles proti vsakemu od antigenov v cepivu pojavila pri vsaj 95,7 % dojenčkov.
redness 
Opombe
What Infanrix hexa looks like and contents of the pack 
5 Shranjevanje cepiva Infanrix hexa Vsebina pakiranja in dodatne informacije
What Infanrix hexa contains 
Kaj vsebuje cepivo Infanrix hexa
Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed). 
Adsorbirano cepivo proti davici (D), tetanusu (T), oslovskemu kašlju (brezcelično, pripravljeno iz antigenskih sestavin) (Pa), hepatitisu B (rekombinantno) (HBV), otroški ohromelosti (inaktivirano) (IPV) in hemofilusu influence tipa b (konjugirano) (Hib).
Infanrix hexa will confer an anti-PRP immune response (cut-off ≥ 0.15µg/ml) in at least 84% of the infants. 
≥ 0,15 µg/ml) pri vsaj 84 % dojenčkov.
• Keep this vaccine out of the sight and reach of children. 
• Cepivo shranjujte nedosegljivo otrokom!
Uncommon Diffuse swelling of the injected limb, sometimes involving the adjacent joint1 
Občasni difuzna oteklina okončine, v katero je bilo cepivo injicirano,
Swelling of the entire injected limb1, 2, extensive swelling reactions2, injection site mass2, injection site vesicles2 1 Children primed with acellular pertussis vaccines are more likely to experience swelling reactions after booster administration in comparison with children primed with whole cell vaccines. 
1 Pri otrocih, ki so bili osnovno cepljeni z acelularnim cepivom proti oslovskemu kašlju, je verjetneje, da se bo po obnovitvenem cepljenju pojavila reakcija v obliki otekline kot pa pri otrocih, ki so bili osnovno cepljeni s cepivom proti oslovskemu kašlju, ki je vsebovalo celotno celico.
25 micrograms 
25 mikrogramov pertaktin1
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hib for Infanrix hexa 
IME ZDRAVILA IN POT(I) UPORABE Hib za Infanrix hexa prašek za suspenzijo za injiciranje i.m.
Increased reporting rates of convulsions (with or without fever) and hypotonic hyporesponsive episode (HHE) were observed with concomitant administration of Infanrix hexa and Prevenar 13 (see section 
Pri sočasni uporabi cepiva Infanrix hexa in cepiva Prevenar 13 so opazili povečano pogostnost poročanja o konvulzijah (z ali brez vročine) in hipotonično-hiporesponzivni epizodi (glejte poglavje 4.8).
Bordetella pertussis antigens (Pertussis toxoid1, Filamentous haemagglutinin1, Pertactin1) 
antigeni Bordetella pertussis (toksoid Bordetella pertussis1, filamentozni hemaglutinin1, pertaktin1) 25, 25, 8 mikrogramov površinski antigen virusa hepatitisa B2,
25, 25, 8 micrograms 
Nemčija 3, 4, 5 mesecev
• Experience in co-administration: 
• Izkušnje s sočasno uporabo dveh cepiv:
STATEMENT OF ACTIVE SUBSTANCE(S) After reconstitution, 1 dose (0.5 ml): Diphtheria toxoid1 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 odmerek (0,5 ml) po rekonstituciji:
Anti-Polio type 2 (1/8 dilution) 
Antipolio tip 2
3-5-11 months of age N=530 (4 studies) 
N = 530 (4 študije)
• if your child is allergic to: - Infanrix hexa or any of the ingredients of this vaccine (listed in section 6). 
- cepivo Infanrix hexa ali katero koli sestavino tega cepiva (navedeno v poglavju 6); - formaldehid; - neomicin ali polimiksin (antibiotika).
Anti-Polio type 3 (1/8 dilution) 
Antipolio tip 3
IPV) component is a white, slightly milky liquid presented in a pre-filled syringe (0.5 ml). 
poliomielitis (inaktivirani) je bela, rahlo mlečna tekočina v napolnjeni injekcijski brizgi
2-4-12 months of age N=223 (1 study) 
N = 223 (1 študija)
Lymphadenopathy2, thrombocytopenia2 
Redki limfadenopatija2, trombocitopenija2
Infanrix hexa should not be given if any of the above apply to your child. 
Če karkoli od navedenega velja za vašega otroka, ne sme prejeti cepiva Infanrix hexa.
1 vial and 1 pre-filled syringe + 2 needles 
1 viala in 1 napolnjena injekcijska brizga + 2 igli 1 odmerek (0,5 ml)
Film-Coated Tablet Oral Use 
Eurefin filmsko obložena tableta
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for fenspiride containing medicinal products 
Priloga I Seznam zdravil in oblik
Oral Drops, Solution Oral Use 
Litva peroralne kapljice, raztopina
These changes usually resolve over time. 
Spremembe običajno izzvenijo s časom.
The study protocol should be submitted within 3 months of the EC decision. 
Protokol študije je treba predložiti v roku treh mesecev od odločbe EK.
Each course lasts one month. 
Vsak cikel traja en mesec.
The clinical study report should be submitted by 
Poročilo o klinični študiji je treba predložiti do
The terminal halflife was estimated at 10 (+ 6) days. 
Razpolovni čas je bil ocenjen na 10 (+6) dni.
However, the presence of HACA appears to increase the clearance of dinutuximab by approximately 60%. 
Vendar se zdi, da prisotnost HACA poveča izločanje dinutuksimaba za približno 60 %.
Dilution must be carried out under aseptic conditions. 
Redčenje je treba izvesti v aseptičnih pogojih.
Grade 3 (sensory changes for more than 2 weeks, objective motor weakness) or Grade 4 
Stopnja 3 (senzorične spremembe za več kot 2 tedna, objektivna motorična oslabelost) ali stopnja 4
As with all therapeutic proteins, there is potential for immunogenicity. 
Kot za vse terapevtske proteine obstaja možnost imunogenosti.
United Therapeutics Corporation 1040 Spring Street Silver Spring, Maryland 20910 USA 
United Therapeutics Corporation 1040 Spring Street Silver Spring, Maryland 20910 ZDA
You will not be given all of the medicines in every course. 
V posameznih ciklih ne boste prejemali vseh zdravil.
Classical biotransformation studies have not been performed. 
Klasične študije o biotransformaciji niso bile izvedene.
Non-clinical data reveal no special hazard for humans based on conventional studies conducted to date. 
Neklinični podatki ne kažejo nobenih posebnih nevarnosti za ljudi na podlagi konvencionalnih študij,
You will be given an anti-histamine medicine which helps to prevent allergic reactions. 
Prejeli boste antihistaminsko zdravilo, ki pomaga pri preprečevanju alergijskih reakcij.
The safety and efficacy of Unituxin in children aged less than 12 months have not yet been established. 
Varnost in učinkovitost zdravila Unituxin pri otrocih, mlajših od 12 mesecev, še nista dokazani.