natgillin/translations-raw huggingface dataset:
Gentamicin, at most .......................................................................................................................... 34 µg Solvent:
Gentamicin, največ ........................................................................................................................... 34 µg Vehikel:
As the company had supplied additional information requested, the ‘exceptional circumstances' ended on 6 May 2013.
Ker je podjetje predložilo zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati 6. maja 2013.
Further information on BTVPUR can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Nadaljnje informacije o zdravilu BTVPUR so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Other information about BTVPUR:
Druge informacije o zdravilu BTVPUR:
BTVPUR received a marketing authorisation valid throughout the EU on 12 April 2016.
Zdravilo BTVPUR je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 12. aprila 2016.
The second injection is given three to four weeks later.
Drugi odmerek se živalim injicira od tri do štiri tedne pozneje.
BTVPUR is a vaccine.
Zdravilo BTVPUR je cepivo.
The European Medicines Agency decided that BTVPUR's benefits are greater that its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je odločila, da so koristi zdravila BTVPUR večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What is BTVPUR and what is it used for?
Kaj je zdravilo BTVPUR in za kaj se uporablja?
Vaccination may be followed by a small local swelling at the injection site, which normally resolves within five weeks.
Po cepljenju se lahko pojavi majhna oteklina na mestu injiciranja, ki običajno izzveni v petih tednih.
BTVPUR is developed using data from the vaccine BTVPUR AlSap 1-8 originally authorised under ‘exceptional circumstances' on 17 December 2010 because limited information was available at the time of approval.
Zdravilo BTVPUR je bilo razvito z uporabo podatkov iz cepiva BTVPUR AlSap 1-8, ki je prvotno 17. decembra 2010 pridobilo dovoljenje za promet „v izjemnih okoliščinah“, saj so bile ob odobritvi na voljo le omejene informacije.
The withdrawal period for meat and milk from sheep and cattle treated with BTVPUR is ‘zero' days, which means that there is no mandatory waiting time.
Karenca za meso in mleko ovac in goveda, zdravljenih z zdravilom BTVPUR, je „nič“ dni, kar pomeni, da ni obvezne čakalne dobe.
The vaccine is used to prevent viraemia (the presence of viruses in the blood) and reduce the signs of the disease.
Uporablja se za preprečevanje viremije (prisotnosti virusa v krvi) in zmanjšanje znakov bolezni.
For more information about using BTVPUR see the package leaflet or contact your veterinarian or pharmacist.
Za več informacij glede uporabe zdravila BTVPUR glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) that enhance the response of the immune system.
Cepivo vsebuje tudi „adjuvansa“ (aluminijev hidroksid in saponin) za povečanje imunskega odziva.
Why is BTVPUR authorised in the EU?
Zakaj je zdravilo BTVPUR odobreno v EU?
There can also be a slight rise in body temperature, usually of no more than 1 °C, in the 24 hours following vaccination.
V 24 urah po cepljenju se lahko pojavi tudi rahlo povišanje telesne temperature, običajno za največ za 1 °C.
Previously known as BTVPUR AlSap 1-8 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Predhodno znano kot BTVPUR AlSap 1-8 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom imunski sistem prepozna viruse kot tujke in proti njim razvije protitelesa.
An overview of BTVPUR and why it is authorised in the EU
Pregled zdravila BTVPUR in zakaj je odobreno v EU
The vaccine is given to young animals as two injections under the skin.
Cepivo se mladičem injicira pod kožo v dveh odmerkih.
What benefits of BTVPUR have been shown in studies?
Kakšne koristi je zdravilo BTVPUR izkazalo v študijah?
In 2016 the CVMP considered that data submitted allowed BTVPUR AlSap 1-8 to convert to a BTVPUR vaccine based on three possible serotypes with one or two serotypes selected depending on the need.
Leta 2016 je odbor CVMP menil, da je na podlagi predloženih podatkov mogoče zdravilo BTVPUR AlSap 1-8 spremeniti v cepivo BTVPUR na podlagi treh možnih serotipov z enim ali dvema serotipoma, izbranima glede na potrebe.
What are the risks associated with BTVPUR?
Kakšna tveganja so povezana z zdravilom BTVPUR?
For a vaccine containing only bluetongue virus serotype 2 or 4 (or both together) in sheep, one injection is sufficient.
Pri cepivu za ovce, ki vsebuje samo serotip 2 ali 4 virusa modrikastega jezika (oziroma oba skupaj), zadostuje le ena injekcija.
In 2018 a fourth possible serotype was added still with one or two serotypes selected depending on the need.
Leta 2018 je bil dodan četrti možni serotip, še vedno pa velja, da se uporabi sam ali v kombinaciji z drugim izbranim serotipom glede na potrebe.
The company also presented results from a series of studies conducted with vaccines of similar composition but including different serotypes from the ones in BTVPUR to provide supportive information that could be used to calculate the effectiveness of the vaccine.
Podjetje je predstavilo tudi rezultate niza študij, izvedenih s cepivi s podobno sestavo, ki pa so vključevali serotipe, drugačne od serotipov v zdravilu BTVPUR, da bi pridobili nadaljnje zaključke o učinkovitosti cepiva.
BTVPUR contains bluetongue viruses that have been inactivated so that they cannot cause the disease.
Zdravilo BTVPUR vsebuje viruse modrikastega jezika, ki so inaktivirani in ne morejo povzročiti bolezni.
The variety (serotype) of the virus in the vaccine is selected depending on which serotypes are circulating and causing disease at the time of manufacture, so it may contain serotype 1, 2, 4 or 8 or a combination of any two of these.
Vrsta (serotip) virusa v cepivu je izbrana glede na to, kateri serotipi krožijo in povzročajo obolenje v času proizvodnje cepiva, zato lahko vsebuje serotip 1, 2, 4 ali 8 oziroma katero koli kombinacijo dveh serotipov.
BTVPUR is a vaccine used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Zdravilo BTVPUR je cepivo, ki se uporablja pri ovcah in govedu za zaščito pred boleznijo modrikastega jezika, tj. okužbo, ki jo prenašajo trzače, povzroča pa jo virus modrikastega jezika.
The studies showed that the vaccine is safe for sheep and cattle and that it reduces the signs of the disease and prevents viraemia in animals from one month of age that are infected with bluetongue virus serotypes 1, 4 and 8.
Študije so pokazale, da je cepivo varno za uporabo pri ovcah in govedu ter da zmanjšuje znake bolezni in preprečuje viremijo pri živalih, starejših od enega meseca, ki so okužene s serotipi 1, 4 in 8 virusa modrikastega jezika.
The studies also showed that the vaccine can be used in pregnant and lactating sheep and cattle.
Pokazale so tudi, da se cepivo lahko uporabi pri brejih ovcah in govedu ter tistih v laktaciji.
The first injection is given from one month of age in animals that have never been exposed to the disease, and from two-and-a-half months if the animal's mother is already immune to the disease and has bluetongue virus antibodies.
Živali, ki še nikoli niso bile izpostavljene bolezni, prejmejo prvo injekcijo od enega meseca starosti dalje, mladiči mater, ki so že imune proti bolezni in imajo protitelesa proti virusu modrikastega jezika, pa od starosti dveh mesecev in pol dalje.
Further laboratory studies were conducted in calves using a vaccine containing bluetongue serotype 2 and in sheep and calves using a vaccine containing bluetongue serotype 4.
Nadaljnje laboratorijske študije so izvedli pri teletih, kjer so uporabili cepivo s serotipom 2 virusa modrikastega jezika, ter pri ovcah in teletih z uporabo cepiva, ki vsebuje serotip 4 virusa modrikastega jezika.
BTVPUR contains bluetongue virus of one or two types selected from serotypes 1, 2, 4 and 8.
Zdravilo BTVPUR vsebuje eno ali dve vrsti izbranih serotipov 1, 2, 4 in 8 virusa modrikastega jezika.
How is BTVPUR used?
Kako se zdravilo BTVPUR uporablja?
The studies also showed that the vaccine reduces the signs of the disease in sheep and prevents viraemia in sheep and cattle from one month of age that are infected with bluetongue virus serotype 2.
Poleg tega so študije pokazale, da cepivo zmanjšuje znake bolezni pri ovcah ter preprečuje viremijo pri ovcah in govedu, starejših od enega meseca, ki so okuženi s serotipom 2 virusa modrikastega jezika.
The effectiveness of the vaccine was studied in laboratory studies using vaccines containing bluetongue serotype 1, bluetongue serotype 8, or both, in sheep and cattle of young age.
Učinkovitost cepiva so proučevali v laboratorijskih študijah, v katerih so pri mladih ovcah in govedu uporabljali cepiva, ki vsebujejo serotip 1, serotip 8 ali oba serotipa virusa modrikastega jezika.
(Bluetongue virus inactivated vaccine containing either serotype 1, 2, 4 or 8 or a combination of any two)
BTVPUR1 (inaktivirano cepivo proti virusu modrikastega jezika, ki vsebuje serotip 1, 2, 4 ali 8 oziroma katero koli kombinacijo dveh serotipov)
How does BTVPUR work?
Kako zdravilo BTVPUR deluje?
Date of latest renewal: 28 November 2017
Datum zadnjega podaljšanja: 28. november 2017
The signs of pandemic flu are similar to those of ordinary flu but may be more serious.
Znaki pandemske gripe so podobni znakom običajne gripe, vendar pa so lahko resnejši.
Special population:
Posebne populacije:
• Serious stabbing or throbbing pain along one or more nerves
• resna zbadajoča ali kljuvajoča bolečina vzdolž enega ali več živcev;
In the first few weeks after vaccination with Prepandrix the results of these tests may not be correct.
V prvih nekaj tednih po cepljenju s cepivom Prepandrix so lahko rezultati teh preiskav napačni.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 May 2008
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odovritve: 16. maj 2008
It is best to see how Prepandrix affects you before you try these activities.
Najbolje je, da ugotovite, kako cepivo Prepandrix vpliva na vas, preden opravljate te dejavnosti.
The use of Prepandrix may be considered during pregnancy if this is thought to be necessary taking into account official recommendations.
Cepivo Prepandrix se lahko uporabi med nosečnostjo, če se oceni, da je potrebno in ob upoštevanju uradnih priporočil.
See sections 4.4, 4.8 and 5.1.
Glejte poglavja 4.4, 4.8 in 5.1.
Prepandrix should be used in accordance with official guidance.
Cepivo Prepandrix je treba uporabljati v skladu z uradnimi smernicami.
Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Preden dobite to cepivo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
The safety and efficacy of Prepandrix in children aged less than 3 years and in children and adolescents aged 10 to 17 years have not been established.
Pediatrična populacija Varnost in učinkovitost cepiva Prepandrix pri otrocih, mlajših od treh let, in pri otrocih in mladostnikih v starosti od 10 do 17 let, nista ugotovljeni.
See sections 4.4, 4.8 and 6.1.
Glejte poglavja 4.4, 4.8 in 6.1.
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines or have recently received any other vaccine.
Obvestite svojega zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali, boste morda začeli jemati katerokoli zdravilo, ali pa ste pred kratkim dobili kakršnokoli drugo cepivo..
MARKETING AUTHORISATION NUMBER(S) EU/1/08/453/002
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/453/002
For any information about this vaccine, please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem cepivu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Pandemic flu is a type of influenza that happens at intervals that vary from less than 10 years to many decades.
Pandemska gripa je vrsta gripe, ki se pojavi v presledkih, ki trajajo od manj kot 10 let do več desetletij, in se hitro širi po vsem svetu.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you receive this vaccine
Če ste noseči ali dojite, menite, da ste noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden dobite to cepivo.
Immunisation should be postponed in subjects with a severe febrile illness or acute infection.
Cepljenje je treba odložiti pri osebah s hudo vročinsko boleznijo ali akutno okužbo.
What you need to know before you receive Prepandrix
Kaj morate vedeti, preden boste dobili cepivo Prepandrix
There is currently no evidence to indicate that Prepandrix may be associated with a risk of narcolepsy.
Trenutno ni dokazov, da bi bilo cepivo Prepandrix morda povezano s tveganjem za narkolepsijo.
If a double dose is given, the injections should be given into opposite limbs.
Če je uporabljen dvojni odmerek, je treba injekciji dati v nasprotni okončini.
• Generalised skin reactions including urticaria (hives)
• generalizirane kožne reakcije, vključno z urtikarijo (koprivnico).
As with all vaccines, Prepandrix may not fully protect all persons who are vaccinated.
Kot druga cepiva tudi cepivo Prepandrix morda ne bo popolnoma zaščitilo vseh cepljenih oseb.
Prepandrix is not intended to be given at the same time as some other vaccines.
Cepivo Prepandrix ni namenjeno za dajanje ob istem času z nekaterimi drugimi cepivi.
Prepandrix can still be given but your response to the vaccine may be poor.
Cepivo Prepandrix lahko dobite kljub temu, a vaš odziv nanj je lahko šibek.
Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB02
Farmakoterapevtska skupina: Cepiva proti gripi, oznaka ATC: J07BB02
• They will give Prepandrix as an injection into a muscle.
• Cepivo Prepandrix vam bodo injicirali v mišico.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v RMP, predloženem v modulu 1.8.2 vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah RMP
5 years
5 let.
• From 80 years onwards: you may receive two double injections of Prepandrix.
• Odrasli, starejši od 80 let: morda boste prejeli dve dvojni injekciji cepiva Prepandrix.
Prepandrix contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose.
Cepivo Prepandrix vsebuje manj kot 1 mmol natrija (23 mg) in manj kot 1 mmol kalija (39 mg) na odmerek.
Other medicines and Prepandrix
Druga zdravila in cepivo Prepandrix
Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Imunizacijo je treba opraviti z intramuskularno injekcijo, po možnosti v deltoidno mišico ali anterolateralni del stegna (odvisno od mišične mase).
What Prepandrix is and what it is used for
Kaj je cepivo Prepandrix in za kaj ga uporabljamo
Control groups included ferrets immunized with adjuvant alone, non-adjuvanted vaccine (15 micrograms HA) or phosphate buffered saline solution.
Kontrolne skupine so vključevale dihurje, ki so prejeli samo adjuvans, cepivo brez adjuvansa (15 mikrogramov HA) ali fiziološko raztopino fosfatnega pufra.
Epidemiological studies relating to another AS03-adjuvanted vaccine (Pandemrix H1N1, also manufactured in the same facility as Prepandrix), in several European countries have indicated an increased risk of narcolepsy with or without cataplexy in vaccinated as compared with unvaccinated individuals.
Epidemiološke študije, povezane z drugim cepivom z adjuvansom AS03 (Pandemrix H1N1, ki ga prav tako izdeluje isti obrat kot cepivo Prepandrix), so v več evropskih državah nakazale večje tveganje za narkolepsijo (s katapleksijo ali brez nje) pri cepljenih osebah v primerjavi z necepljenimi.
2.5 ml per vial
2,5 ml na vialo
50 vials: emulsion (adjuvant)
50 vial: emulzija (adjuvans)
There are currently no data available on the use of Prepandrix in pregnancy.
Trenutno ni podatkov o uporabi cepiva Prepandrix med nosečnostjo.
Tell the doctor requesting these tests that you have recently received Prepandrix.
Zdravnika, ki želi opraviti takšne preiskave opozorite, da ste bili pred kratkim cepljeni s cepivom Prepandrix.
Animal studies with Prepandrix containing A/Vietnam/1194/2004 do not indicate reproductive toxicity (see section 5.3).
Študije na živalih, opravljene s cepivom Prepandrix, ki vsebuje sev A/Vietnam/1194/2004, ne kažejo na vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
In adults 18 to 60 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (76.6%), muscle aches (46.8%), fatigue (43.6%), headache (25.3%) and joint pain
Pri odraslih v starosti od 18 do 60 let so bili najpogosteje zabeleženi neželeni učinki po cepljenju: bolečina na mestu injiciranja (76,6 %), boleče mišice (46,8 %), utrujenost (43,6 %), glavobol (25,3 %) in bolečine v sklepih (13,5 %).
• Increased sweating, shivering, flu-like symptoms
• močnejše znojenje, drgetanje, gripi podobni simptomi,
*propagated in eggs **expressed in microgram haemagglutinin
* namnožen v jajcih ** izražen v mikrogramih hemaglutinina
Prepandrix is a vaccine for use in adults from 18 years old.
Kaj je cepivo Prepandrix in za kaj ga uporabljamo Cepivo Prepandrix uporabljamo pri odraslih, starejših od 18 let.
• From 18 years onwards: you will receive two doses of Prepandrix.
• Odrasli, starejši od 18 let: prejeli boste dva odmerka cepiva Prepandrix.
Based on very limited data, adults aged >80 years may require a double dose of Prepandrix on an elected date and again after an interval of at least three weeks in order to achieve an immune response (see section 5.1).
Na podlagi zelo omejenih podatkov kaže, da lahko odrasli, starejši od 80 let, potrebujejo za doseganje imunskega odziva dvojni odmerek cepiva Prepandrix na izbrani datum in znova po presledku vsaj treh tednov (glejte poglavje 5.1).
If any of the side effects below occur, please tell your doctor or nurse immediately:
Če se pojavi kateri od spodaj navedenih neželenih učinkov, nemudoma obvestite zdravnika ali medicinsko sestro:
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja cepiva je le na recept.
What Prepandrix is and what it is used for What you need to know before you receive Prepandrix How Prepandrix is given
Kaj je cepivo Prepandrix in za kaj ga uporabljamo Kaj morate vedeti, preden boste cepljeni s cepivom Prepandrix Kako uporabljati cepivo Prepandrix
For instructions on mixing of the medicinal product before administration, see section 6.6.
Za navodila o mešanju cepiva pred uporabo glejte poglavje 6.6.
However, following two administrations of a double dose of vaccine, the seroprotection rate at day 42 was 75%.
Po dvakratni uporabi dvojnega odmerka cepiva pa je bil delež serološke zaščite 42. dan 75 %.
One pack of Prepandrix consists of:
Eno pakiranje cepiva Prepandrix vsebuje:
The reproductive toxicity studies have been conducted using Prepandrix containing A/Vietnam/1194/2004.
Študije toksičnih učinkov na sposobnost razmnoževanja so bile opravljene s cepivom Prepandrix, ki je vseboval A/Vietnam/1194/2004.
A minor infection such as a cold should not be a problem, but your doctor will advise whether you could still be vaccinated with Prepandrix.
Blažja okužba, npr. prehlad, ne predstavlja težave, vendar se pred cepljenjem s cepivom Prepandrix o tem vseeno posvetujte s svojim zdravnikom.
• Problems with your brain and nerves such as inflammation of the central nervous system (encephalomyelitis), inflammation of nerves (neuritis) or a type of paralysis known as ‘GuillainBarré Syndrome'.
• težave z vašimi možgani in živci, kot je vnetje osrednjega živčevja (encefalomielitis), vnetje živcev (nevritis) ali vrsta ohromitve, imenovana Guillain-Barréjev sindrom; • vnetje žil (vaskulitis).
Half dose
Polovični odmerek
• if you have a bleeding problem or you bruise easily.
• če imate kakšno motnjo strjevanja krvi ali ste nagnjeni k podplutbam.
In subjects > 60 years of age, the most frequently reported adverse reaction after vaccination was injection site pain (32.6%).
Pri preiskovancih, starejših od 60 let, je bil najpogosteje zabeleženi neželeni učinek po cepljenju bolečina na mestu injiciranja (32,6 %).
This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared with H5N1 subtype strains (see section 5.1).
Indikacija temelji na podatkih o imunogenosti pri zdravih prostovoljcih, starejših od 18 let, po cepljenju z dvema odmerkoma cepiva, pripravljenega iz podtipov sevov H5N1(glejte poglavje 5.1).
• Tingling or numbness of the hands or feet
• mravljinčenje ali odrevenelost v rokah ali nogah,
Suspension and emulsion for emulsion for injection.
Suspenzija in emulzija za emulzijo za injiciranje.
Do not have Prepandrix if any of the above apply to you.
Ne cepite se s cepivom Prepandrix, če karkoli od naštetega velja za vas.
The European Medicines Agency has deferred the obligation to submit the results of studies with Prepandrix in one or more subsets of the paediatric population in influenza infection caused by an influenza strain contained in the vaccine or related to a strain contained in the vaccine.
Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij s cepivom Prepandrix pri eni ali več podskupinah pediatrične populacije za okužbo z gripo, povzročeno s sevom v cepivu, ali s sevom, sorodnim sevu v cepivu(za informacije o pediatrični uporabi glejte poglavje
Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.
Zato mora zdravnik oceniti koristi in možna tveganja uporabe cepiva pri posameznikih s trombocitopenijo ali kakršnokoli motnjo strjevanja krvi,
• Periodic Safety Update Reports
• Periodična poročila o varnosti (PSUR)
If this applies to you then your vaccination will be postponed until you are feeling better.
V tem primeru, bo zdravnik cepljenje običajno odložil, dokler ne boste ozdraveli.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
If the mixed vaccine is stored in a refrigerator, it should be allowed to reach room temperature (for a minimum of 15 minutes) before each withdrawal.
Če pripravljeno cepivo shranjujete v hladilniku, ga je treba pred odvzemom posameznega odmerka vsaj 15 minut pustiti, da doseže sobno temperaturo.
In other clinical studies where children 6 months to 17 years received Prepandrix, increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose in children aged less than 6 years.
V drugih kliničnih študijah, v katerih so otroci v starosti od 6 mesecev do 17 let dobili cepivo Prepandrix, so pri otrocih, mlajših od 6 let, po drugem odmerku opažali večjo pogostnost nekaterih neželenih učinkov (vključno z bolečino na mestu injiciranja, pordelostjo in zvišano telesno temperaturo).