natgillin/translations-raw huggingface dataset:
Experience with tocofersolan therapy in patients with renal impairment or underlying liver impairment has demonstrated no need to adapt the dose regimen of Vedrop (see section 4.4). 
Izkušnje s terapijo tokofersolana pri bolnikih z ledvično okvaro ali že obstoječo okvaro jeter so pokazale, da ni potrebno prilagoditi odmerka zdravila Vedrop (glejte poglavje 4.4).
Caution should be exercised when prescribing to pregnant women. 
Bodite pazljivi, ko zdravilo predpišete nosečnicam.
Swallow the solution with or without water. 
Raztopino pogoltnite z ali brez vode.
The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary. 
Evropska agencija za zdravila bo vsako leto ponovno pregledala vse nove podatke o tem zdravilu, ki bodo na voljo, in posodobila navodilo za uporabo, če bo potrebno.
Located principally on cell membranes, within mitochondria and microsomes, vitamin E is ubiquitously distributed (red blood cells, brain, muscle, liver, platelets) and fat tissues are its major reservoir. 
E vitamin, ki se v večini nahaja v celičnih membranah, znotraj mitohondrijev in mikrosomov, se razširi povsod (rdeče krvne celice, možgani, mišice, jetra, krvne ploščice) in se pretežno shranjuje v maščobnih tkivih.
As data on patients with renal impairment are limited, Vedrop should be administered with caution and under close monitoring of the renal function in patients with renal impairment e.g. dehydrated patients (see section 4.2). 
Ker so podatki pri bolnikih z okvaro ledvic omejeni, zdravilo Vedrop uporabljajte pazljivo in z nadzorom renalne funkcije pri bolnikih z okvaro ledvic, npr. dehidriranih bolnikih (glejte poglavje 4.2).
Oral solution volume (ml) 
Volumen peroralne raztopine (ml)
Fat-soluble vitamins (such as vitamin A, D, E or K) or highly fat-soluble medicines (such as corticoids, ciclosporin, tacrolimus, antihistamine). 
vitamine, ki se topijo v maščobah (kot so vitamin A, D, E ali K) ali zdravila, ki se hitro topijo v maščobah (kot so kortikoidi, ciklosporin, takrolimus, antihistamin).
10 ml 20 ml 60 ml 
peroralna raztopina 10 ml 20 ml 60 ml
The MAH shall provide yearly updates on any new information concerning efficacy and safety of the product in patients with congenital chronic cholestasis or hereditary cholestasis. 
Imetnik dovoljenja za promet z zdravilom bo predložil letna posodobljena poročila o novih informacijah glede učinkovitosti in varnosti zdravila pri bolnikih s prirojeno kronično holestazo ali dedno holestazo.
If you stop taking Vedrop 
Če prenehate jemati zdravilo Vedrop
Vedrop contains vitamin E (in the form of tocofersolan). 
Zdravilo Vedrop vsebuje E vitamin (v obliki tokofersolana).
The relative bioavailability of tocofersolan tended to be higher (Frel of 1.01 ± 1.74) with AUC0-t of 0.383 ± 0.203µM.h/mg, Cmax of 0.013 ± 0.006, tmax of 6.0 h (6.0 - 24.0), and t1/2 of 29.7 h (16.0 - 59.5). 
Študija na 12 zdravih prostovoljcih je primerjala tokofersolan z referenčnim E vitaminom, ki ga je mogoče mešati z vodo, po enojnem peroralnem odmerku 1200 i.e. Relativna biološka uporabnost tokofersolana je bila višja (Frel 1,01 ± 1,74) z AUC0-t 0,383 ± 0,203µM.h/mg, Cmax 0,013 ± 0,006, tmax 6,0 h (6,0 - 24,0) in t1/2 29,7 h (16,0 - 59,5).
There is no data on whether or not this medicine is present in the breast milk. 
Ni podatkov o vsebnosti zdravila v materinem mleku.
The following table gives the volume of oral solution in function of patients' weights. 
Naslednja tabela prikazuje volumen peroralne raztopine v odvisnosti od telesne mase bolnika.
BATCH NUMBER EU/1/09/533/001 10 ml bottle EU/1/09/533/00 2 20 ml bottle EU/1/09/533/003 60 ml bottle 
EU/1/09/533/001 10 ml steklenica EU/1/09/533/002 20 ml steklenica EU/1/09/533/003 60 ml steklenica
Driving and using machines Vedrop is not likely to affect your ability to drive and use machines. 
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Vedrop vplivalo na sposobnost vožnje in upravljanja s stroji.
As large doses of vitamin E have been reported to increase bleeding tendency in vitamin-K deficient patients or those taking oral anti-vitamins K treatment, it is therefore recommended to monitor the prothrombin time and international normalised ratio (INR). 
Ker lahko velike količine vitamine E povečajo možnost krvavitev pri bolnikih s pomanjkanjem vitamina K ali pri bolnikih, ki peroralno jemljejo zdravila proti vitaminu K, je priporočljivo nadzorovati protrombinski čas in mednarodno normalizirano razmerje (INR).
Doses for administration should be extracted from the bottle using the oral syringes which are provided in the pack. 
Odmerke je iz steklenice treba odvzemati z brizgami, ki so priložene paketu.
The excretion of tocofersolan in milk has not been studied in animals. 
Študij na živalih, ki bi preučevale izločanje tokofersolana v mleko ni bilo izvedenih.
• Abnormal level of sodium in the blood 
• nenormalna raven natrija v krvi
Vedrop is indicated in vitamin E deficiency due to digestive malabsorption in paediatric patients with congenital chronic cholestasis or hereditary chronic cholestasis, from birth (full term newborns) up to 18 years of age. 
Zdravilo Vedrop se uporablja pri pomanjkanju vitamina E zaradi digestivne malabsorbcije pri pediatričnih bolnikih s kongenitalno kronično holestazo ali dedno kronično holestazo, od rojstva (novorojenčki) do 18 leta starosti.
Dose of Vedrop (in ml) = dose of d-alpha-tocopherol (in mg) 
Odmerek zdravila Vedrop (v ml) = odmerek d-alfa-tokoferola (v mg)
Yearly, simultaneously with submission of Periodic Safety Update reports 
Letno, sočasno s predložitvijo rednega posodobljenega poročila o varnosti zdravila (PSUR)
If you forget to take Vedrop 
Če ste pozabili vzeti zdravilo Vedrop
Vedrop should be used with caution and liver functions closely monitored. 
Pri uporabi zdravila Vedrop je potrebna previdnost in natančno spremljanje delovanja jeter.
Each ml contains 6 mg sodium methyl parahydroxybenzoate (E219), 4 mg sodium ethyl parahydroxybenzoate (E215) and 0.18 mmoles (4.1 mg) of sodium. 
En ml vsebuje 6 mg natrijevega metilparahidroksibenzoata (E219), 4 mg natrijevega etilparahidroksibenzoata (E215) in 0,18 mmolov (4,1 mg) natrija.
What Vedrop looks like and contents of the pack 
Izgled zdravila Vedrop in vsebina pakiranja
The dose will be adjusted by your doctor according to your vitamin E blood level. 
Zdravnik bo prilagodil odmerek glede na nivo vitamina E v krvi.
- The other ingredients are: potassium sorbate, sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215) (see end of section 2 for further information on these 2 ingredients), glycerol, disodium phosphate dodecahydrate, concentrated hydrochloric acid, purified water. 
- Pomožne snovi so: kalijev sorbat, natrijev metilparahidroksibenzoat (E219) in natrijev etilparahidroksibenzoat (E215) (glejte na koncu poglavja 2 za dodatne informacije o teh 2 sestavinah), glicerol, natrijev hidrogenfosfat dodekahidrat, koncentrirana klorovodikova kislina, prečiščena voda.
- Vedrop must not be used in newborn premature babies. 
- Zdravila Vedrop ne smete uporabljati pri nedonošenih novorojenčkih.
Uncommon: serum sodium abnormal, serum potassium abnormal, transaminases increase 
Občasno: nenormalna raven natrija v serumu, nenormalna raven kalija v serumu, povečanje transaminaz
The dose should be prescribed in mg of d-alpha-tocopherol in the form of tocofersolan. 
Odmerek mora biti predpisan v mg d-alfa-tokoferola v obliki tokofersolana.
To calculate the dose of Vedrop to be administered, divide the prescribed dose of d-alpha-tocopherol (in mg) by 50. 
Za izračun potrebnega odmerka zdravila Vedrop, delite predpisani odmerek d-alfa-tokoferola (v mg) s 50.
Each box contains one bottle and one oral syringe (a 1 ml syringe with a 10 ml or 20 ml bottle, a 2 ml syringe with a 60 ml bottle). 
Vsaka škatla vsebuje eno steklenico in eno peroralno brizgo (1 ml brizga pri 10 ml ali 20 ml steklenici, 2 ml brizga pri 60 ml steklenici).
For the full list of excipients, see section 6.1. 
Glejte poglavje 6.1 za celotni seznam pomožnih snovi.
The hydrolysis of tocofersolan occurs in the gut lumen. 
Do hidrolize tokofersolana pride v črevesnem lumnu.
Vedrop must not be used in preterm newborn infants. 
Zdravila Vedrop ne uporabljajte pri nedonošenih novorojenčkih.
Certain medicines to thin the blood (oral anticoagulants such as warfarin). 
Obvestite svojega zdravnika ali farmacevta, če jemljete: določena zdravila, ki redčijo kri (peroralni antikoagulansi kot je varfarin).
If you take large doses of Vitamin E, you may experience temporary diarrhoea and stomach ache. 
Če ste vzeli večji odmerek zdravila Vedrop, kot bi smeli V primeru, da ste vzeli večje odmerke vitamina E, lahko pride do začasne driske in bolečin v trebuhu.
Type III brown glass bottle with a child-resistant screw cap of HDPE and LDPE seal. 
Rjava steklenička tipa III z za otroke varnim navojnim pokrovčkom iz HDPE in tesnilom iz LDPE.Brizge za peroralno uporabo imajo ohišje iz LDPE in bat iz polistirola.
• Loss of hair 
• izpadanje las in dlak
How to take Vedrop 
Kako jemati zdravilo Vedrop
Inform your doctor if you want to breast-feed. 
Obvestite svojega zdravnika, če dojite.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). 
Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Vedrop should be administered with caution in patients with underlying liver impairment and under close monitoring of the hepatic functions in such patients (see section 4.2). 
Zdravilo Vedrop je treba pri teh bolnikih z že obstoječo okvaro jeter uporabljati pazljivo in s strogim nadzorom delovanja jeter (glejte poglavje 4.2).
What Vedrop contains - The active substance is tocofersolan. 
Kaj vsebuje zdravilo Vedrop - Zdravilna učinkovina je tokofersolan.
Vedrop 50 mg/ml oral solution Tocofersolan 
Vedrop 50 mg/ml peroralna raztopina tokofersolan
Use only with the oral syringe provided in the box. 
Uporabljajte samo s priloženo brizgo za peroralno uporabo.
What Vedrop is and what it is used for What you need to know before you take Vedrop How to take Vedrop 
Kaj je zdravilo Vedrop in za kaj se uporablja Kaj morate vedeti, preden boste vzeli zdravilo Vedrop Kako jemati zdravilo Vedrop Možni neželeni učinki
Vedrop contains sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215) which may cause allergic reactions (possibly delayed). 
Zdravilo Vedrop vsebuje natrijev metilparahidroksibenzoat (E219) in natrijev etilparahidroksibenzoat (E215), ki lahko povzročita alergijske reakcije (lahko zapoznele).
It is recommended to monitor the coagulation function when administered with anti-vitamins K treatment (see section 4.4). 
Študij medsebojnega delovanja niso izvedli Priporočeno je nadzorovati koagulacijsko funkcijo, če se jemljejo zdravila proti vitaminu K (glejte poglavje
Uncommon: asthenia, headache 
Občasno: astenija, glavobol
Talk to your doctor before taking Vedrop if you have: 
Posvetujte se z zdravnikom preden vzamete zdravilo Vedrop, če imate: Težave z ledvicami ali dehidracijo.
Not known: abdominal pain 
Pogosto: diareja Ni znano: bolečine v trebuhu
Excipients: sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215). 
Pomožne snovi: Natrijev metilparahidroksibenzoat (E219), natrijev etilparahidroksibenzoat (E215).
Potassium sorbate 
peroralna raztopina
How to store Vedrop 
Shranjevanje zdravila Vedrop
Boxes containing: one 10 ml bottle and one 1 ml oral syringe one 20 ml bottle and one 1 ml oral syringe one 60 ml and one 2 ml oral syringe 
eno 10 ml steklenico in eno 1 ml brizgo za peroralno uporabo eno 20 ml steklenico in eno 1 ml brizgo za peroralno uporabo eno 60 ml steklenico in eno 2 ml brizgo za peroralno uporabo
2- Put the oral syringe included in the pack in the bottle. 
2- Vstavite brizgo v steklenico.
Bottle of 60 ml and 2 ml oral syringe. 
60 ml steklenica in 2 ml brizga za peroralno uporabo.
Each ml contains 50 mg of d-alpha-tocopherol in the form of tocofersolan, corresponding to 74.5 IU of tocopherol. 
En ml vsebuje 50 mg d-alfa-tokoferola v obliki tokofersolana, kar ustreza 74,5 i.e. tokoferola.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Bottle label - 10 ml, 20 ml and 60 ml bottles 
Nalepka na steklenici - 10 ml, 20 ml in 60 ml steklenica
The bottles contain 10 ml, 20 ml or 60 ml of oral solution. 
Steklenica vsebuje 10 ml, 20 ml ali 60 ml peroralne raztopine.
Each ml of solution contains 50 mg of d-alpha-tocopherol in the form of tocofersolan, corresponding to 74.5 IU of tocopherol. 
En ml vsebuje 50 mg d-alfa-tokoferola v obliki tokofersolana, ki ustreza 74,5 i.e. tokoferola.
Each bottle contains 10 ml, 20 ml or 60 ml of oral solution. 
Ena steklenica vsebuje 10 ml, 20 ml ali 60 ml peroralne raztopine.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton box - 10 ml, 20 ml and 60 ml bottle 
Kartonska škatla - 10 ml, 20 ml in 60 ml steklenica
Bottle of 20 ml and 1 ml oral syringe. 
20 ml steklenica in 1 ml brizga za peroralno uporabo.
Bottle of 10 ml and 1 ml oral syringe. 
10 ml steklenica in 1 ml brizga za peroralno uporabo.
Taken up by cells, the alpha-tocopherol moiety appears in chylomicrons in the lymph in a manner identical to vitamin E absorbed from the diet. Cellular uptake does not require receptors, binding proteins or metabolic processes and does not occur by pinocytosis. 
Celični prevzem ne potrebuje receptorjev, veznih proteinov ali presnovnih procesov in se ne zgodi z pinocitozo.
Skin and subcutaneous tissue disorders Uncommon: alopecia, pruritus, rash General disorders and administration site conditions 
Občasno: alopecija, pruritus, osip
Sodium methyl parahydroxybenzoate (E219) Sodium ethyl parahydroxybenzoate (E215) Glycerol 
6.1 Seznam pomožnih snovi kalijev sorbat natrijev metilparahidroksibenzoat (E219) natrijev etilparahidroksibenzoat (E215) glicerol natrijev hidrogenfosfat dodekahidrat koncentrirana klorovodikova kislina prečiščena voda
The following side effects were reported: 
Škatle vsebujejo:
Marketing Authorisation Holder Recordati Rare Diseases Immeuble “Le Wilson” 70 avenue du General de Gaulle 92800 Puteaux 
Imetnik dovoljenja za promet z zdravilom Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux
Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux France or 
Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux Francija
One graduation of the 1 ml oral syringe corresponds to 2.5 mg of d-alpha-tocopherol in the form of tocofersolan. 
2 ml brizga ima označbe od 0,1 do 2 ml v korakih po 0,1 ml. Ena označba na 2 ml brizgi za peroralno uporabo ustreza 5 mg d-alfa-tokoferola v obliki tokofersolana.
Vedrop contains 0.18 mmoles (4.1 mg) sodium per ml. 
Zdravilo Vedrop vsebuje 0,18 mmolov (4,1 mg) natrija na ml. Posvetujte se z zdravnikom, če ste na dieti z nadzorovanim vnosom natrija.
Slightly viscous, pale yellow solution. 
peroralna raztopina Rahlo gosta, svetlorumena raztopina.
Recordati Rare Diseases Immeuble “le Wilson” 70 avenue du Général de Gaulle 92800 Puteaux 
Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux
The 1 ml oral syringe is graduated from 0.05 to 1 ml in steps of 0.05 ml. 
1 ml brizga ima označbe od 0,05 do 1 ml v korakih po 0,05 ml. Ena označba na 1 ml brizgi za peroralno uporabo ustreza 2,5 mg d-alfa-tokoferola v obliki tokofersolana.
ANNEX III LABELLING AND PACKAGE LEAFLET 
OZNAČEVANJE IN NAVODILA ZA UPORABO
This summary was last updated in 07-2010. 
Povzetek je bil nazadnje posodobljen 07-2010.
It contains the following 
Vsebuje naslednje zdravilne
The choice of which vaccine to use depends on official recommendations. 
Izbira, katero cepivo uporabiti, je odvisna od uradnih priporočil.
This helps to protect against the diseases that these bacteria and viruses cause. 
To pomaga pri zaščiti pred boleznimi, ki jih te bakterije in virusi
• polioviruses (types 1, 2 and 3) that have been inactivated (killed) so that they do not cause any 
• poliovirusov (tipov 1, 2 in 3), ki so bili inaktivirani (uničeni), tako da ne povzročijo bolezni.
This means that the active substances are fixed onto aluminium compounds, to stimulate a better response. 
To pomeni, da so zdravilne učinkovine vezane na aluminijeve spojine, kar spodbudi boljši odziv.
The site of injection should be alternated for subsequent injections. 
Mesto injiciranja je treba pri naslednjih injekcijah zamenjati.
The European Commission granted a marketing authorisation valid throughout the EU for Infanrix Penta to GlaxoSmithKline Biologicals s.a. on 23 October 2000. 
Evropska komisija je dovoljenje za promet s cepivom Infanrix Penta, veljavno po vsej Evropski uniji, odobrila družbi GlaxoSmithKline Biologicals s.a. dne 23. oktobra 2000.
Their breathing should be monitored for up to three 
Njihovo dihanje je treba
For more information about treatment with Infanrix Penta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Infanrix Penta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
After one month, between 86 and 100% of the infants had developed protective levels of antibodies against all of the active substances in Infanrix Penta. 
Po enem mesecu je od 86 % do 100 % otrok razvilo zaščitne ravni protiteles proti vsem učinkovinam v cepivu Infantrix Penta.
This document is a summary of the European public assessment report (EPAR) for Infanrix Penta. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Infanrix Penta.
The studies showed that a first course of vaccination with Infanrix Penta led to the development of protective levels of antibodies. 
Študije so pokazale, da je prvo cepljenje s cepivom Infantrix Penta pripeljalo do razvoja zaščitnih ravni protiteles.
The main measure of effectiveness was the production of antibodies against the active substances after vaccination. 
Glavno merilo učinkovitosti je bila tvorba protiteles proti zdravilnim učinkovinam po cepljenju.
The surface antigens of the hepatitis B virus are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins. 
Površinski antigeni virusa hepatitisa B se izdelujejo z metodo, imenovano „tehnologija rekombinantne DNK“: proizvajajo jih kvasovke, ki so prejele gen (DNK), s katerim lahko
When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses as ‘foreign' and makes antibodies against them. 
Ko otrok prejme cepivo, imunski sistem prepozna dele bakterij in virusov kot „tujke“ in proti njim razvije protitelesa.
The recommended vaccination schedule for Infanrix Penta is two or three doses, given at least one month apart, usually within the first six months of life. 
Priporočena shema cepljenja s cepivom Infanrix Penta sta dva ali trije odmerki, ki se dajo v presledku vsaj enega meseca, običajno v prvih šestih mesecih življenja.
The marketing authorisation is valid for 
Dovoljenje za promet z
The studies involved over 10,000 infants, about three quarters of whom received Infanrix Penta, given according to various time schedules. 
V študije je bilo vključenih več kot 10 000 otrok, od katerih so približno tri četrtine prejele cepivo Infanrix Penta, dano v različnih časovnih razporedih.
• toxoids and other proteins purified from B. pertussis; 
• toksoidov in drugih beljakovin, prečiščenih iz B. pertussis,
• surface antigen (proteins from the surface) of the hepatitis B virus; 
• površinskega antigena (beljakovin s površine) virusa hepatitisa B,
A booster dose of Infanrix Penta or a similar vaccine must be given at least six months after the last dose of the initial course. 
Obnovitveni odmerek cepiva Infanrix Penta ali podobnega cepiva je treba dati najmanj šest mesecev po zadnjem odmerku začetnega cepljenja.
Infanrix Penta has been studied in 16 studies looking at the first course of vaccination. 
Cepivo Infanrix Penta so raziskovali v 16 študijah, v katerih so proučevali prvi cikel cepljenja.
The most common side effects with Infanrix Penta (seen in more than 1 in 10 doses of the vaccine) are loss of appetite, fever of 38ºC or more, local swelling, pain and redness at the injection site, fatigue (tiredness), abnormal crying, irritability and restlessness. 
Najpogostejši neželeni učinki cepiva Infanrix Penta (opaženi pri več kot 1 odmerku cepiva od 10) so izguba teka, povišana telesna temperatura na 38ºC ali več, lokalna oteklina, bolečina in rdečina na mestu injiciranja, utrujenost, neobičajen jok, razdražljivost in nemir.
Other information about Infanrix Penta: 
Druge informacije o zdravilu Infanrix Penta:
• toxoids from the bacteria that cause diphtheria and tetanus; 
• toksoidov iz bakterij, ki povzročajo davico in tetanus,
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Infanrix Penta. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Infanrix Penta, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Infanrix Penta is a vaccine. 
Infanrix Penta je cepivo.
Infanrix Penta is a vaccine, which is available as a suspension for injection. 
Infanrix Penta je cepivo, ki je na voljo kot suspenzija za injiciranje.
• toxoids (chemically weakened toxins) from diphtheria and tetanus; • parts of Bordetella pertussis (B. pertussis, a bacterium that causes whooping cough); 
• toksoide (kemično oslabljene toksine) iz bakterij, ki povzročajo davico in tetanus; • dele bakterije Bordetella pertussis (B. pertussis, bakterije, ki povzroča oslovski kašelj);
Infanrix Penta is a combination of components that have been available in the European Union (EU) in other vaccines: diphtheria, tetanus, pertussis and hepatitis B were available in Infanrix HepB from 1997 until 2005, and diphtheria, tetanus, pertussis and polioviruses are available in other vaccines. 
Cepivo Infanrix Penta je kombinacija sestavin, ki so v Evropski uniji (EU) na voljo v drugih cepivih: komponente davice, tetanusa, oslovskega kašlja in hepatitisa B so bili na voljo v cepivu Infanrix HepB od leta 1997 do 2005, komponente davice, tetanusa, oslovskega kašlja in poliovirusi pa so na voljo v
Infanrix Penta has also been studied in nine studies of booster vaccination involving over 4,000 infants, 714 of whom received Infanrix Penta as a booster. 
Cepivo Infanrix Penta so proučevali tudi v devetih študijah obnovitvenega cepljenja, v katere je bilo vključenih okoli 4 000 dojenčkov, od katerih jih je 714 cepivo Infanrix Penta prejelo kot obnovitveno cepljenje.
The CHMP decided that Infanrix Penta's benefits are greater than its risks and recommended that it be 
CHMP je zaključil, da so koristi zdravila Infanrix Penta večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
After booster vaccination, there was an increase in the number of infants with protective levels of antibodies against the active substances. 
Po obnovitvenem cepljenju se je povečalo število otrok z zaščitnimi ravnmi protiteles proti zdravilnim učinkovinam.
What benefit has Infanrix Penta shown during the studies? 
Kakšne koristi je zdravilo Infanrix Penta izkazalo med študijami?
Infanrix Penta can be given to infants who received a hepatitis B vaccine at birth. 
Cepivo Infanrix Penta se lahko da dojenčkom, ki so bili ob rojstvu cepljeni proti hepatitisu B.
For the full list of all side effects reported with Infanrix Penta, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi cepiva Infanrix Penta, glejte navodilo za uporabo.
Infanrix Penta is given by deep injection into a muscle. 
Cepivo Infanrix Penta se daje z globoko injekcijo v mišico.