natgillin/translations-raw huggingface dataset:
Lower back spine fusion surgery If you have a lot of pain from a damaged disc in your lower back and other treatments have not proved effective, you may be considered for lower back spine fusion surgery.
Operacija za fuzijo ledvenega dela hrbtenice Če imate zaradi okvarjene medvretenčne ploščice v spodnjem delu hrbtenice hude bolečine in se drugi načini zdravljenja niso izkazali za učinkovite, morda pride v poštev operacija za fuzijo ledvenega dela hrbtenice.
When used in lower back fusion surgery InductOs is used in combination with a metal cage which corrects the position of your spine.
Kadar se zdravilo InductOs uporablja za fuzijo ledvenega dela hrbtenice, se uporabi v kombinaciji s kovinskim vstavkom, ki popravi položaj hrbtenice.
If you have any question about the cage, please ask your doctor.
Če imate kakšna vprašanja o vstavku, se posvetujte z zdravnikom.
Fractures of the shin bone If you have broken your shin bone, InductOs is used to increase the chance that your broken bone will heal, to help your fracture heal faster, and to reduce the need for additional surgeries to help your fracture heal.
Zlomi golenice Če ste si zlomili golenico, zdravilo InductOs uporabimo zato, da zvečamo možnost, da se vaša zlomljena golenica zaceli, da pospešimo celjenje zloma in da zmanjšamo potrebo po dodatnih kirurških posegih, ki bi pripomogli k celjenju zloma.
InductOs is used in addition to standard treatment and care of shin bone fractures.
Zdravilo InductOs se uporablja kot dodatek k standardni terapiji in oskrbi zlomov golenice.
BEFORE YOU RECEIVE INDUCTOS
KAJ MORATE VEDETI, PREDEN BOSTE PREJELI ZDRAVILO INDUCTOS
You should not receive InductOs • if you are allergic (hypersensitive) to dibotermin alfa or bovine collagen or any of the other ingredients of InductOs. • if you are still growing (skeletally immature). • if you have an active infection at the surgery site. • if the doctor treating you decides that you have inadequate blood supply at the fracture site. • for treating a fracture that is disease-related (eg. fractures due to Paget’s disease or cancer). • if you have been diagnosed with or are being treated for cancer.
Zdravila InductOs ne smete dobiti v naslednjih primerih: • če ste alergični na (preobčutljivi za) dibotermin alfa ali goveji kolagen ali katerokoli sestavino zdravila InductOs; • če še rastete (če vaše okostje še ni zrelo); • če imate akutno okužbo na operativnem mestu; • če zdravnik, ki vas zdravi, ugotovi, da je mesto vašega zloma nezadostno prekrvavljeno; • za zdravljenje bolezenskih zlomov (npr. zlomi kot posledica Pagetove bolezni ali raka); • če so vam postavili diagnozo raka ali se zdravite zaradi te bolezni.
You should inform your doctor if you have an autoimmune disease such as rheumatoid arthritis, sytemic lupus erythematosus, scleroderma, Sjögren's syndrome or dermatomyositis/ polymyositis.
28 V nadaljevanju so navedeni previdnostni ukrepi za uporabo zdravila InductOs, o katerih se pogovorite s svojim zdravnikom: • Svojega zdravnika morate obvestiti, če imate avtoimunsko bolezen, npr. revmatoidni artritis, sistemski eritematozni lupus, sklerodermijo, Sjögrenov sindrom ali dermatomiozitis / polimiozitis. • Zdravnika obvestite, če imate kakšno bolezen kosti. • Zdravilo ne sme biti v neposrednem stiku z določenimi kostmi.
Use of InductOs may cause bone formation (heterotopic ossification) in the surrounding tissues, which can result in complications.
Vaš kirurg bo vedel, za katere kosti gre. • Uporaba zdravila InductOs lahko povzroči nastajanje kostnega tkiva (heterotrofna ostifikacija) v okolnih tkivih, kar lahko privede do zapletov. • Pri nekaterih bolnikih se lahko razvijejo protitelesa (ki jih vaše telo izdela za borbo proti tuji beljakovini) proti zdravilu InductOs.
Localised swelling, in some cases resulting in breathing difficulties, has been reported in patients when InductOs has been used in surgery of the upper (neck) region of the spine.
Pri tem niso opazili nikakršnih neželenih učinkov, vendar njihovi dolgoročni učinki niso znani. • Zdravnika obvestite, če imate kakšno bolezen jeter ali ledvic. • Pri nekaterih bolnikih se lahko pojavi bolečina živca zaradi krajevno omejenega kopičenja tekočine, ki jo je treba odstraniti z drenažo ali kirurškim postopkom. • Pri bolnikih, pri katerih so zdravilo InductOs uporabili pri operacijah na zgornjem (vratnem) delu hrbtenice, so poročali o lokaliziranem otekanju, ki je v nekaterih primerih povzročilo oteženo dihanje.
The safety and effectiveness of InductOs in cervical spine surgery have not been established and InductOs should not be used in this situation.
Varnost in učinkovitost uporabe zdravila InductOs pri operacijah vratne hrbtenice nista ugotovljeni, zato naj se zdravilo InductOs v takih primerih ne uporablja.
Using InductOs with other medicines Some shin bone clinical trials have shown that if you are treated with InductOs and take pain medication such as aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), like ibuprofen, for a longer period of time (e.g. for more than 14 days) more fluid may discharge from your wound.
Uporaba zdravila InductOs z drugimi zdravili Nekatera klinična preskušanja pri bolnikih z zlomi golenice so pokazala, da se lahko iz vaše rane izloča več tekočine, če vas zdravijo z zdravilom InductOs in dalj časa (npr. več kot 14 dni) jemljete zdravila proti bolečinam, npr. aspirin, ali nesteroidna protivnetna zdravila (NSAID), npr. ibuprofen.
This additional fluid discharge has not been associated with problems in fracture or wound healing.
To dodatno izločanje tekočine ni povezano s težavami glede celjenja zloma ali rane.
Please inform your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Pregnancy and breast-feeding The effects of InductOs on pregnancy are not known.
Nosečnost in dojenje Vpliv zdravila InductOs na nosečnost ni znan.
Ask your doctor for advice if you become pregnant or intend to become pregnant.
Če zanosite ali nameravate zanositi, se posvetujte s svojim zdravnikom.
Your doctor should advise you about using contraception for one year after having been treated with InductOs.
Zdravnik vam bo svetoval, da še eno leto po koncu zdravljenja z zdravilom InductOs uporabljate kontracepcijo.
Treatment with InductOs is not recommended in mothers who are breastfeeding an infant.
Zdravljenja z zdravilom InductOs ne priporočajo materam, ki dojijo otroka.
Ask your doctor for advice before breast-feeding your baby.
Posvetujte se z zdravnikom, preden začnete dojiti svojega otroka.
Driving and using machines InductOs will not affect your ability to drive or operate machinery.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo InductOs ne bo vplivalo na vašo sposobnost vožnje in upravljanja s stroji.
Important information about some of the ingredients of InductOs Some patients may develop antibodies (made by your body to fight a foreign protein) against dibotermin alfa or against the collagen in the sponge.
Pomembne informacije o nekaterih sestavinah zdravila InductOs Nekateri bolniki lahko razvijejo protitelesa (snovi, ki jih izdeluje vaše telo za borbo proti tujim beljakovinam) proti diboterminu alfa ali proti kolagenu v gobi.
In clinical studies, the presence of antibodies was not associated with side effects, e.g. allergies, nor was it shown to decrease the effectiveness of InductOs.
V kliničnih raziskavah prisotnost protiteles ni bila povezana s pojavom neželenih učinkov, npr. alergij, niti ni bilo ugotovljeno, da bi protitelesa zmanjševala učinkovitost zdravila InductOs.
HOW INDUCTOS IS GIVEN
KAKO SE ZDRAVILO INDUCTOS DAJE
The doctor treating you will administer InductOs during surgery.
Zdravnik, ki vas zdravi, vam bo zdravilo InductOs vstavil med operacijo.
The metal cages
29 Če dobivate zdravilo InductOs za fuzijo ledvenega dela hrbtenice, bo kirurg odstranil okvarjeno medvretenčno ploščico, ki povzroča bolečine, in jo nadomestil z dvema kovinskima vstavkoma, napolnjenima z zdravilom InductOs.
29 correct the position of your spine, and InductOs encourages the bone to grow between the two vertebrae to join them permanently in the correct position.
Kovinska vstavka popravita položaj hrbtenice, zdravilo InductOs pa spodbudi rast kosti med vretencema, da se trajno združita v pravilnem položaju.
If you are receiving InductOs for a broken shin bone, your doctor will then place InductOs around your broken bone when your fracture is treated.
Če ste dobili zdravilo InductOs za zlomljeno golenico, bo zdravnik med kirurškim posegom namestil zdravilo InductOs okrog vaše zlomljene kosti.
The doctor will determine how many kits of InductOs you will receive, depending on the size and number of fractures.
Zdravnik bo določil, koliko kompletov zdravila InductOs boste prejeli glede na velikost in število zlomov.
Generally, one kit is used.
Običajno se uporabi vsebina enega kompleta.
However, a maximum of 2 kits may be used.
Uporabiti se smeta največ 2 kompleta.
Side effects specific to shin bone fracture surgery Like all medicines, InductOs can cause side effects, although not everybody gets them.
Neželeni učinki, specifični za operacije zlomov golenice Kot vsa zdravila ima lahko tudi zdravilo InductOs neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The most frequent (likely to occur in more than 1 in 10 patients) events reported in clinical studies were similar to those due to the traumatic injuries sustained by the patients or to the surgery itself.
Najpogostejši neželeni učinki (ki se bodo verjetno pojavili pri več kot 1 od 10 bolnikov), o katerih poročajo v kliničnih študijah, so bili podobni tistim, ki nastanejo zaradi travmatskih poškodb, ki so jih imeli bolniki, ali zaradi same operacije.
These effects were pain, swelling, wound infection, and fever.
Ti učinki so bili bolečina, otekanje, okužba rane in zvišana telesna temperatura.
Common side effects were (likely to occur in fewer than 1 out of 10 patients), headache, signs indicating malfunction of the pancreas (amylasemia), decreased levels of magnesium in the blood, and a transient increase in heart rate.
Pogosti neželeni učinki (ki se bodo verjetno pojavili pri manj kot 1 od 10 bolnikov), so bili glavobol, znaki motenega delovanja trebušne slinavke (amilazemija), znižane vrednosti magnezija v krvi in prehodna pospešitev srčnega utripa.
These were observed slightly more frequently in patients treated with InductOs for shin bone studies than in patients who did not receive the product.
Te neželene učinke so opazili nekoliko pogosteje pri bolnikih, zdravljenih z zdravilom InductOs, kot pri bolnikih, ki tega zdravila niso dobili.
Side effects specific to lower back fusion surgery The most common (more that 1 in 10 patients) side effects observed in spinal fusion studies were: accidental injury, nerve pain, back pain and disorders of the bone such as delayed healing.
Neželeni učinki, specifični za operacije fuzije ledvenega dela hrbtenice Najpogostejši neželeni učinki (pri več kot 1 od 10 bolnikov) v študijah fuzije hrbtenice so bili naključna poškodba, bolečina živca, bolečina v hrbtu in bolezni kosti, npr. upočasnjeno celjenje.
There have been reports of nerve pain due to localised fluid collection which would require drainage or a surgical procedure to remove the fluid.
Poročali so o bolečini živca zaradi krajevno omejenega kopičenja tekočine, ki jo je treba odstraniti z drenažo ali kirurškim postopkom.
Localised swelling, in some cases resulting in breathing difficulties, has been reported in patients when InductOs has been used in surgery of the upper (neck) region of the spine.If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
HOW TO STORE INDUCTOS
SHRANJEVANJE ZDRAVILA INDUCTOS
Keep out of the reach and sight of children You will not be required to store this product.
Tega zdravila ne bo treba shranjevati vam.
What InductOs contains The active substance in InductOs is dibotermin alfa (recombinant human Bone Morphogenetic Protein-2), 12 mg.
Kaj vsebuje zdravilo InductOs Zdravilna učinkovina v zdravilu InductOs je dibotermin alfa (rekombinantni humani protein za morfogenezo kosti- 2) v odmerku 12 mg.
The kit contains 12 mg of dibotermin alfa powder, a solvent (water) and a sponge, which is made from a protein called collagen obtained from cattle (otherwise known as bovine Type I collagen).
Komplet vsebuje 12 mg dibotermina alfa v obliki praška, vehikel (vodo) in gobo, ki je izdelana iz beljakovine, ki se imenuje kolagen in ki jo pridobivajo iz goveda (znana je tudi pod imenom goveji kolagen tipa I).
Dibotermin alfa is supplied in the kit as a white powder.
Dibotermin alfa je v kompletu v obliki belega praška.
30 For use during surgery, it must be dissolved in the water provided to form a solution, which is used to soak the sponge.
30 Za uporabo pri operaciji ga je treba raztopiti v priloženi vodi, da nastane raztopina, s katero se navlaži goba.
The soaked sponge may then be placed where bone growth is desired.
Navlaženo gobo kirurg nato namesti tja, kjer je zaželena rast kosti.
The sponge and dibotermin alfa solution will gradually disappear as bone is formed.
Goba in raztopina dibotermina alfa med nastajanjem kosti postopoma izgineta.
Marketing Authorisation Holder Wyeth Europa Ltd.
Imetnik dovoljenja za promet z zdravilom Wyeth Europa Ltd.
Manufacturer Wyeth Pharmaceuticals New Lane Havant Hants, PO9 2NG United Kingdom
Izdelovalec Wyeth Pharmaceuticals New Lane Havant Hants, PO9 2NG Velika Britanija
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu.
What is Infanrix Hexa?
Kaj je zdravilo Infanrix Hexa?
Infanrix Hexa is a vaccine, which is available as a powder and suspension to be made up into a suspension for injection.
Infanrix Hexa je cepivo, ki je na voljo kot prašek in suspenzija za pripravo suspenzije za injiciranje.
It contains the following active substances: toxoids (chemically weakened toxins) from diphtheria and tetanus, parts of Bordetella pertussis (a bacterium that causes whooping cough), parts of the hepatitis B virus, inactivated (killed) polioviruses and polysaccharides (sugars) from the bacterium Haemophilus influenzae type b (‘ Hib’, a bacterium that causes meningitis).
Vsebuje naslednje zdravilne učinkovine: toksoide (kemično oslabljene toksine) davice in tetanusa, dele Bordetella pertussis (bakterije, ki povzroča oslovski kašelj), dele virusa hepatitisa B, inaktivirane (mrtve) polioviruse in polisaharide (sladkorje) iz bakterije Haemophilus influenzae tipa b („ Hib “, bakterije, ki povzroča meningitis).
What is Infanrix Hexa used for?
Za kaj se zdravilo Infanrix Hexa uporablja?
Infanrix Hexa is used to vaccinate infants under three years of age against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and diseases caused by Hib (such as bacterial meningitis).
Zdravilo Infanrix Hexa se uporablja za cepljenje otrok, mlajših od treh let, proti davici, tetanusu, oslovskemu kašlju, hepatitisu B, otroški ohromelosti (polio) in boleznim, ki jih povzroča Hib (kot je bakterijski meningitis).
It is also used as a booster vaccination.
Uporablja se tudi kot obnovitveno cepivo.
How is Infanrix Hexa used?
Kako se zdravilo Infanrix Hexa uporablja?
The recommended vaccination schedule for Infanrix Hexa is two or three doses, given at least one month apart, usually within the first six months of life.
Priporočena shema cepljenja za cepivo Infanrix Hexa sta dva ali trije odmerki, ki se dajo v presledku vsaj enega meseca, običajno v prvih šestih mesecih življenja.
Infanrix Hexa is given by deep injection into a muscle.
Cepivo Infanrix Hexa se injicira globoko v mišico.
The site of injection should be alternated for subsequent injections.
Mesto injiciranja je treba pri naslednjih injekcijah menjati.
A booster dose of Infanrix Hexa or a similar vaccine must be given at least six months after the last dose of the initial course.
Obnovitveni odmerek cepiva Infanrix Hexa ali podobnega cepiva je treba dati najmanj šest mesecev po zadnjem odmerku začetnega cepljenja.
Infanrix Hexa can be given to infants who received a hepatitis B vaccine at birth.
Cepivo Infanrix Hexa se lahko da dojenčkom, ki so bili ob rojstvu cepljeni proti hepatitisu B.
How does Infanrix Hexa work?
Kako zdravilo Infanrix Hexa deluje?
Infanrix Hexa is a vaccine.
Infanrix Hexa je cepivo.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against diseases.
Cepiva delujejo tako, da imunski sistem (naravno obrambo telesa) „ naučijo “, kako naj se brani pred boleznimi.
Infanrix Hexa contains small amounts of: • toxoids from the bacteria that cause diphtheria and tetanus; • toxoids and other proteins purified from B. pertussis; • surface antigen (proteins from the surface) of the hepatitis B virus; • inactivated polioviruses (types 1, 2 and 3); • polysaccharides extracted from the ‘ capsules’ that surround the Hib bacteria.
Cepivo Infanrix Hexa vsebuje majhne količine: • toksoidov iz bakterij, ki povzročajo davico in tetanus, • toksoidov in drugih beljakovin, prečiščenih iz B. pertussis, • površinskega antigena (beljakovin s površine) virusa hepatitisa B, • inaktiviranih poliovirusev (tipov 1, 2 in 3), • polisaharidov, pridobljenih iz „ kapsul “, ki obdajajo bakterije Hib.
The polysaccharides are chemically attached (conjugated) to tetanus toxoid as a carrier protein because this improves the response to the vaccine.
Polisaharidi so na tetanusov toksoid kemično vezani (konjugirani) kot nosilna beljakovina, kar izboljša odziv na cepivo.
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 dojenčka cepimo, imunski sistem prepozna dele bakterij kot „ tuje “ in proti njim razvije protitelesa.
The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the bacteria or viruses.
Ko bo oseba naslednjič izpostavljena bakterijam ali virusom, bo lahko imunski sistem hitreje izdelal protitelesa.
This helps to protect against the diseases that these bacteria and viruses cause.
To pripomore k zaščiti pred boleznimi, ki jih te bakterije in virusi povzročajo.
The vaccine is ‘ adsorbed’.
Cepivo je adsorbirano.
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.
Površinske antigene virusa hepatitisa B proizvajajo z metodo, znano kot „ tehnologija rekombinantne DNK “, pri kateri kvasovka prejme gen (DNK), s katerim lahko tvori beljakovine.
Infanrix Hexa 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, polioviruses and the Hib component are available in other vaccines.
Cepivo Infanrix Hexa je kombinacija sestavin, ki so v Evropski uniji (EU) na voljo v drugih cepivih: davica, tetanus, oslovski kašelj in hepatitis B so bili na voljo v cepivu Infanrix HepB od leta 1997 do 2005, davica, tetanus, oslovski kašelj, poliovirusi in sestavina Hib pa so na voljo v drugih cepivih.
How has Infanrix Hexa been studied?
Kako je bilo zdravilo Infanrix Hexa raziskano?
Infanrix Hexa has been studied in nine studies, involving a total of almost 5,000 infants who were at least six weeks of age.
Cepivo Infanrix Hexa je bilo raziskano v devetih študijah, v katere je bilo skupaj vključenih skoraj 5 000 dojenčkov, starih najmanj šest mesecev.
Over 3,000 of the infants received the first course of vaccination with Infanrix Hexa.
Več kot 3 000 dojenčkov je prejelo prvo cepljenje s cepivom Infanrix Hexa.
The effects of Infanrix Hexa were compared with those of separate vaccines containing the same active substances.
Učinke cepiva Infanrix Hexa so primerjali z učinki ločenih cepiv, ki so vsebovala iste učinkovine.
The main measure of effectiveness was the production of protective antibodies in the infants.
Glavno merilo učinkovitosti je bila tvorba zaščitnih protiteles pri dojenčkih.
An additional five studies looked at the effects of a booster vaccination with Infanrix Hexa.
V dodatnih petih študijah so proučevali učinke obnovitvenega cepljenja s cepivom Infanrix Hexa.
What benefit has Infanrix Hexa shown during the studies?
Kakšne koristi je zdravilo Infanrix Hexa izkazalo med študijami?
The nine studies showed that the first course of injections with Infanrix Hexa was as effective at producing protective levels of antibodies as separate vaccines containing the same active substances.
V devetih študijah je bilo dokazano, da je bilo prvo cepljenje s cepivom Infanrix Hexa enako učinkovito pri tvorbi zaščitnih ravni protiteles kot ločena cepiva, ki so vsebovala enake učinkovine.
Overall, between 95 and 100% of infants had antibodies to diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses, and Hib, one month after the first vaccination course.
En mesec po prvem cepljenju je namreč med 95 in 100% dojenčkov razvilo protitelesa proti davici, tetanusu, oslovskemu kašlju, virusu hepatitisa B, poliovirusom in Hib.
The additional studies showed that booster vaccinations with Infanrix Hexa were as effective as separate vaccines containing the same active substances one month after the booster vaccination.
Dodatne študije so pokazale, da so bila obnovitvena cepljenja s cepivom Infanrix Hexa en mesec po obnovitvenem cepljenju enako učinkovita kot ločena cepiva, ki so vsebovala enake učinkovine.
What is the risk associated with Infanrix Hexa?
Kakšna tveganja so povezana z zdravilom Infanrix Hexa?
The most common side effects with Infanrix Hexa (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 Hexa (opaženi pri več kot 1 odmerku cepiva od 10) so izguba teka, telesna temperatura 38º C ali več, lokalna oteklina, bolečina in rdečina na mestu injiciranja, utrujenost, neobičajno jokanje, razdražljivost in nemirnost.
For the full list of all side effects reported with Infanrix Hexa, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi cepiva Infanrix Hexa, glejte navodilo za uporabo.
Infanrix Hexa should not be used in infants who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients of the vaccine, or to neomycin and polymyxin (antibiotics), or if the infant has had an allergic reaction after a previous vaccine containing diphtheria, tetanus, pertussis, hepatitis B, polio or Hib.
Cepivo Infanrix Hexa se ne sme uporabljati pri dojenčkih, ki utegnejo biti preobčutljivi za (alergični na) katero koli zdravilno učinkovino, katero koli drugo sestavino cepiva ali na neomicin in polimiksin (antibiotika), oziroma če je dojenček imel alergično reakcijo po predhodnem cepivu, ki je vsebovalo davico, tetanus, oslovski kašelj, hepatitis B, otroško ohromelost (polio) ali Hib.
Infanrix Hexa should not be given if the infant has had encephalopathy (brain disease) of unknown cause within seven days of a previous vaccination with a vaccine containing pertussis components.
Cepivo Infanrix Hexa se ne sme uporabiti, če je dojenček prebolel encefalopatijo (možganska bolezen) neznanega vzroka, ki se je pojavila v sedmih dneh po predhodnem cepljenju s cepivom, ki je vsebovalo sestavine oslovskega kašlja.
Infanrix Hexa should be postponed in infants with a severe sudden fever.
Pri dojenčkih, ki imajo nenadno visoko telesno temperaturo, je treba cepljenje s cepivom Infanrix Hexa odložiti.