FrancophonIA/ELRC3.0 huggingface dataset:
English: • if after previously having Tritanrix HepB or another vaccine against pertussis (whooping cough) disease, your child had any problems, especially: ♦ A high temperature (over 40°C) within 48 hours of vaccination ♦ A collapse or shock-like state within 48 hours of vaccination ♦ Persistent crying lasting 3 hours or more within 48 hours of vaccination ♦ Seizures/fits with or without a high temperature within 3 days of vaccination
Slovenian: • če je po predhodnem prejemu Tritanrix HepB ali drugega cepiva proti oslovskemu kašlju (pertusisu) vaš otrok imel kakršnekoli težave, še posebej: ♦ visoko vročino (nad 40 ºC) v 48 urah po cepljenju, ♦ kolaps ali šoku podobno stanje v 48 urah po cepljenju, ♦ če je v 48 urah po cepljenju vztrajno jokal 3 ure ali dlje, ♦ epileptične napade/krče z zvišano telesno temperaturo ali brez v 3 dneh po cepljenju;
English: Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours.
Slovenian: Kolaps ali šoku podobno stanje (hipotonična-hiporesponzivna epizoda) v 48 urah.
English: PSUR: The Marketing Authorisation Holder will continue to submit Periodic Safety Update Reports on a 2
Slovenian: Periodična poročila o varnosti (PSUR): Imetnik dovoljenja za promet z zdravilom bo periodična poročila o varnosti še naprej predajal vsaki 2 leti.
English: As with other vaccines, a dose of vaccine should be withdrawn under strict aseptic conditions and precautions taken to
Slovenian: Tako kot pri drugih cepivih morate odmerek cepiva odvzeti v striktnih aseptičnih pogojih in paziti, da ne
English: However, you should seek immediate treatment in
Slovenian: V vsakem primeru morate nemudoma poiskati zdravniško pomoč.
English: Non-clinical data reveal no special hazard for humans based on general safety studies.
Slovenian: Predklinični podatki na osnovi splošnih študij varnosti ne kažejo posebnega tveganja za človeka.
English: Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of adverse reactions) and a clinical examination.
Slovenian: Pred cepljenjem je potrebno oceniti anamnezo (še posebno glede na predhodna cepljenja in možen pojav neželenih reakcij) in opraviti klinični pregled.
English: Each injection is given on a separate visit.
Slovenian: Vsak odmerek se da ob drugem obisku.
English: As Tritanrix HepB is not intended for use in adults, information on the safety of the vaccine when used during pregnancy or lactation is not available.
Slovenian: Ker Tritanrix HepB ni predviden za uporabo pri odraslih, podatki o varnosti uporabe cepiva med nosečnostjo ali dojenjem niso na voljo.
English: * in a subgroup of infants not administered hepatitis B vaccine at birth, 89.9% of subjects had anti-HBs titres † cut-off accepted as indicative of protection †† vaccine response: % of subjects considered to have responded to the Bordetella pertussis antigen
Slovenian: * v podskupini dojenčkov, ki niso prejeli cepiva proti hepatitisu B ob rojstvu, jih je 89,9 % imelo titer † mejna vrednost velja kot kazalec zaščite †† odziv na cepivo: % oseb, za katere smatramo, da so se odzvali na Bordetella pertussis antigen
English: In the case of children born of known HBV carrier mothers the immunoprophylactic measures for hepatitis B should not be modified.
Slovenian: Pri novorojenčkih mater, ki so znane nosilke HBV, se ukrepov imunoprofilakse proti hepatitisu B ne sme spreminjati.
English: When Tritanrix HepB is given according to the 6-10-14 weeks schedule, it is recommended to administer a dose of HBV vaccine at birth to improve protection.
Slovenian: Pri dajanju cepiva Tritanrix HepB v skladu s shemo 6-10-14 tednov priporočamo odmerek cepiva HBV ob rojstvu, da bi tako izboljšali zaščito.
English: Pharmaco-therapeutic group: Bacterial and viral vaccines combined, ATC code J07CA05.
Slovenian: Farmakoterapevtska skupina: Kombinacije bakterijskih in virusnih cepiv, oznaka ATC: J07CA05
English: Novartis Vaccines and Diagnostics GmbH & Co. KG
Slovenian: Novartis Vaccines and Diagnostics GmbH & Co.
English: The primary vaccination schedule consists of three doses within the first six months of life.
Slovenian: Shema osnovnega cepljenja je sestavljena iz treh odmerkov, ki jih dajemo v prvih šestih mesecih starosti.
English: • fever (more than 38°C)
Slovenian: • zvišana telesna temperatura (višja od 38 °C)
English: The administration of a booster dose with trivalent DTP vaccine is recommended before the end of the second year of life.
Slovenian: Cepljenje z obnovitvenim odmerkom trivalentnega DTP cepiva je priporočljivo opraviti pred dopolnjenim drugim letom starosti.
English: For this reason, the vaccinee should remain under medical supervision for 30 minutes after vaccination.
Slovenian: Zaradi tega razloga je po cepljenju potreben še 30-minutni zdravniški nadzor.
English: This HBsAg expressed in yeast cells is purified by several physico-chemical steps.
Slovenian: Ta v kvasovkah izražen HBsAg je prečiščen z različnimi fizikalno-kemičnimi postopki.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 July 1996.
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 19. julij 1996
English: Percentage of subjects with antibody titres ≥ assay cut-off one month after primary vaccination with
Slovenian: Odstotek oseb s titrom protiteles ≥ mejnih vrednosti testa en mesec po osnovnem cepljenju s
English: Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Slovenian: Občasni (≥ 1/1.000 do < 1/100) Redki ((≥ 1/10.000 do < 1/1.000) Zelo redki (< 1/10.000)
English: • allergic reactions, including anaphylactic and anaphylactoid reactions.
Slovenian: • alergijske reakcije, vključno z anafilaksijskimi in anafilaktoidnimi reakcijami.
English: Convulsions with or without fever, occurring within 3 days.
Slovenian: Konvulzije z zvišano telesno temperaturo ali brez, ki so se pojavile v 3 dneh.
English: The vaccine should never be given into a vein.
Slovenian: Cepivo se ne sme dajati v žilo.
English: This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.3)
Slovenian: To cepivo vsebuje tiomersal (organska živosrebrova spojina) kot konzervans, zato je možen pojav preobčutljivostnih reakcij (glejte poglavje 4.3).
English: The Pw component is obtained by heat inactivation of phase I culture of Bordetella pertussis bacteria.
Slovenian: Komponenta Pw je pridobljena z inaktivacijo faze I kultur bakterije Bordetella pertussis z vročino.
English: Where HBV vaccine is not given at birth, the combined vaccine can be administered beginning as early as 8 weeks of age.
Slovenian: Če cepivo proti HBV ni bilo dano ob rojstvu, se lahko kombinirano cepivo prične dajati pri 8 tednih starosti.
English: In these circumstances the vaccination course should be continued with DT and HBV vaccines.
Slovenian: V takšnih primerih je potrebno cepljenje nadaljevati z DT in HBV cepivi.
English: • Hepatitis B: Hepatitis B is caused by the hepatitis B virus.
Slovenian: • Hepatitis B: Povzročitelj hepatitisa B je virus hepatitisa B, ki povzroči vnetje in oteklino jeter.
English: • in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination
Slovenian: • pri zelo prezgodaj rojenih dojenčkih (tj. rojenih 28. teden gestacije ali prej) se lahko od 2 do 3 dni po cepljenju pojavljajo daljši presledki med dihi, kot je normalno.
English: For each component of the vaccine, the following immune responses have been documented one month after completion of the primary vaccination schedule.
Slovenian: Za vsako komponento cepiva so bili en mesec po zaključku osnovne sheme cepljenja dokazani
English: • if your child has previously had any allergic reaction to Tritanrix HepB, or any ingredient contained in this vaccine.
Slovenian: • če je predhodno imel kakršnokoli alergijsko reakcijo na cepivo Tritanrix HepB ali na katerokoli sestavino v tem cepivu.
English: Three vaccine doses must be administered at intervals of at least 4 weeks.
Slovenian: Dati moramo tri odmerke cepiva, presledek med odmerki mora biti vsaj 4 tedne.
English: The D and T toxoids are prepared from the toxins of cultures of Corynebacterium diphtheriae and Clostridium tetani by formalin inactivation using established technology.
Slovenian: D toksoid in T toksoid sta pripravljena z inaktivacijo toksinov kultur Corynebacterium diphtheriae in Clostridium tetani s formalinom ob uporabi uveljavljene tehnologije.
English: Hypersensitivity to the active substances or to any of the excipients.
Slovenian: Preobčutljivost za zdravilne učinkovine ali katerokoli pomožno snov.
English: In these studies the immune response to the oral polio vaccine has not been investigated, however, previous experience with simultaneous administration of DTP, OPV and HBV vaccines has not shown any interference.
Slovenian: Imunskega odziva na peroralno polio cepivo v teh študijah niso raziskovali, vendar pa predhodne izkušnje s sočasnim dajanjem DTP, OPV in HBV cepiv ne kažejo medsebojnega vpliva.
English: This may require separate vaccination with HBV and DTPw vaccines and also include the administration of HBIg at birth.
Slovenian: Ti lahko zahtevajo ločeno cepljenje s cepivi HBV in DTPw ter lahko vključujejo tudi dajanje HBIg ob rojstvu.
English: Wounds that are especially prone to infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure/dung or wood splinters.
Slovenian: K okužbi so še posebej nagnjene rane, kot so opekline, zlomi, globoke rane ali rane, onesnažene z zemljo, s prahom, konjskim gnojilom/iztrebki ali z lesenimi ivermi.
English: • Diphtheria: Diphtheria mainly affects the airways and sometimes the skin.
Slovenian: • Davica: Davica v glavnem prizadene dihalne poti in občasno kožo.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains:
Slovenian: - Zdravilne učinkovine v 1 odmerku (0,5 ml) so:
English: Димитър Манов бл.10 София 1408
Slovenian: Димитър Манов бл.10
English: In these circumstances, vaccination with the combined vaccine should start at 6 weeks of age.
Slovenian: S cepljenjem s kombiniranim cepivom je v takšnih primerih potrebno pričeti pri starosti 6 tednov.
English: The HBsAg assembles spontaneously, in the absence of chemical treatment, into spherical particles of 20 nm in average diameter containing non-glycosylated HBsAg polypeptide and a lipid matrix consisting mainly of phospholipids.
Slovenian: HBsAg, zbran spontano brez kemične obdelave v obliki sferičnih delcev s povprečnim premerom 20 nm, vsebuje neglikoliziran polipeptid HBsAg in lipidni matriks, ki sestoji predvsem iz fosfolipidov.
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Slovenian: Znaki alergijske reakcije lahko vključujejo srbeč kožni izpuščaj, zasoplost in oteklino obraza ali jezika.
English: • Tetanus (Lockjaw): Tetanus bacteria enter the body through cuts, scratches or wounds in the skin.
Slovenian: • Tetanus (mrtvični krč): Bakterije, povzročiteljice tetanusa, vstopajo v telo preko vreznin, opraskanin ali ran na koži.
English: You will be informed by the doctor or nurse when you should
Slovenian: Zdravnik ali sestra vam bosta naročila, kdaj morate priti po naslednje odmerke.
English: • if your child has experienced any health problems after previous administration of a vaccine.
Slovenian: • če je vaš otrok po predhodnem cepljenju imel kakršnekoli zdravstvene težave.
English: The doctor will give Tritanrix HepB as an injection into the thigh muscle.
Slovenian: Zdravnik bo dal Tritanrix HepB v obliki injekcije v stegensko mišico.
English: The surface antigen of the HBV (HBsAg) is produced by culture of genetically-engineered yeast cells (Saccharomyces cerevisiae) which carry the gene coding for the major surface antigen of the HBV.
Slovenian: Površinski antigen HBV (HBsAg) je pridobljen z genetskim inženiringom na kulturi celic kvasovk (Saccharomyces cerevisiae), ki so nosilec gena, ki kodira glavni površinski antigen HBV.
English: Any unused product of waste material should be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno cepivo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: • Clinical trials: In clinical studies, the most commonly reported adverse events were reactions at the injection site, including redness, swelling and pain.
Slovenian: • Klinična preskušanja: Najpogostejši neželeni učinki, o katerih so poročali v kliničnih študijah, so bile reakcije na mestu injiciranja, vključujoč rdečino, oteklino in bolečino.
English: Where there is a high endemicity of HBV, the practice to administer HBV vaccine at birth should be continued.
Slovenian: V primeru visoke endemičnosti HBV je potrebno nadaljevati s prakso dajanja cepiva proti HBV ob rojstvu.
English: General disorders and administration site conditions: very common: fever, swelling, pain and redness very rare: allergic reactions including anaphylactic and anaphylactoid reactions and serum sickness very common: unusual crying, irritability
Slovenian: Splošne težave in spremembe na mestu aplikacije: zelo pogosti: zvišana telesna temperatura, oteklina, bolečina in rdečina zelo redki: alergijske reakcije, vključno z anafilaksijskimi in anafilaktoidnimi reakcijami in zelo pogosti: neobičajen jok, razdražljivost
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/014/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/96/014/001
English: • if your child experienced problems of the nervous system within 7 days after previous vaccination with a vaccine against pertussis (whooping cough) disease.
Slovenian: • če je imel težave z živčevjem v 7 dneh po predhodnem cepljenju s cepivom proti oslovskemu
English: Generally the airways become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation.
Slovenian: Navadno pride do vnetja (otekline) dihalnih poti, kar močno oteži dihanje in občasno povzroča dušenje.
English: These may be local or widespread rashes that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness.
Slovenian: Alergijske reakcije so lahko kažejo z omejenimi ali razširjenimi kožnimi izpuščaji, ki so lahko srbeči ali mehurčasti, oteklino oči ali obraza, težavami pri dihanju ali požiranju, nenadnim znižanjem krvnega tlaka in izgubo zavesti.
English: • serum sickness like disease (a hypersensitivity reaction to the administration of a foreign serum with symptoms like fever, swelling, skin rash, enlargement of the lymph nodes)
Slovenian: • serumski bolezni podobno stanje (preobčutljivostna reakcija po dajanju tujega seruma s simptomi, kot so zvišana telesna temperatura, otekline, kožni izpuščaj, povečanje bezgavk).
English: Do not use Tritanrix HepB after the expiry date which is stated on the carton.
Slovenian: Cepiva Tritanrix HepB ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
English: In patients receiving immunosuppressive therapy or patients with immunodeficiency, an adequate
Slovenian: Pri bolnikih z imunosupresivnim zdravljenjem ali bolnikih z imunsko pomanjkljivostjo lahko zadosten
English: The bacteria also release a toxin (poison), which can cause nerve damage, heart problems, and even death.
Slovenian: Bakterije tudi sproščajo toksin (strup), ki lahko poškoduje živce, povzroči težave s srcem in celo smrt.
English: 6.6 Special precautions for disposal and other handling Tritanrix HepB can be mixed with the lyophilised Hib vaccine (Hiberix).
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Tritanrix HepB se lahko meša z liofiliziranim Hib cepivom (Hiberix).
English: The vaccine should be well shaken in order to obtain a homogeneous turbid white suspension and be inspected visually for any foreign particulate matter and/or variation of physical aspect.
Slovenian: Cepivo morate dobro pretresti, da nastane homogena motna bela suspenzija, in ga vizualno preveriti glede morebitne prisotnosti tujih delcev in/ali spremenjenega fizičnega izgleda.
English: 1 adsorbed on aluminium hydroxide, hydrated
Slovenian: 1 Adsorbiran na hidratirani aluminijev hidroksid
English: 1 Adsorbed on aluminium hydroxide, hydrated
Slovenian: 1 adsorbiran na hidratirani aluminijev hidroksid
English: The active substances and other ingredients in Tritanrix HepB are listed at the end of the leaflet.
Slovenian: Učinkovine in druge sestavine v cepivu Tritanrix HepB so navedene na koncu navodila.
English: It is recommended that in patients with thrombocytopenia or bleeding disorders the vaccine be administered
Slovenian: Priporočljivo je, da se pri bolnikih s trombocitopenijo ali z motnjami hemostaze cepivo aplicira
English: DTPw-HBV (combined)
Slovenian: Skupina 2 DTPw-HBV DTPw HBV (kombinirano)
English: MARKETING AUTHORISATION NUMBER EU/1/96/014/002
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/96/014/002
English: ♦ Very rare (side effects which may occur in less than 10,000 doses of vaccine):
Slovenian: ♦ Zelo redki (neželeni učinki, ki se lahko pojavijo pri manj kot 1 od 10.000 odmerkov cepiva):
English: Tritanrix HepB is available in pack of 1.
Slovenian: Cepivo Tritanrix HepB je na voljo v pakiranju po 1.
English: For long-term protection against HBV, a booster dose of HBV vaccine could also be administered after the first year of life.
Slovenian: Za dosego dolgotrajne zaščite proti HBV se po dopolnjenem prvem letu starosti lahko cepi tudi z obnovitvenim odmerkom HBV cepiva.
English: • if your child has a bleeding problem or bruises easily
Slovenian: • če ima vaš otrok težave s krvavitvami ali hitrim pojavom modric;
English: Pertussis can also cause ear infections, bronchitis which may last a long time, pneumonia, fits, brain damage and even death.
Slovenian: Oslovski kašelj je tudi lahko vzrok vnetja ušes, bronhitisa, ki je lahko dolgotrajen, pljučnice, krčev, poškodbe možganov in celo smrti.
English: Important information about some of the ingredients of Tritanrix HepB This medicinal product contains thiomersal as a preservative and it is possible that your child may experience an allergic reaction.
Slovenian: Pomembne informacije o nekaterih sestavinah cepiva Tritanrix HepB Cepivo vsebuje tiomersal kot konzervans, ki lahko pri otroku povzroči alergijsko reakcijo.
English: Tritanrix HepB can be mixed with the lyophilised Hib vaccine (Hiberix).
Slovenian: Tritanrix HepB se lahko meša z liofiliziranim Hib cepivom (Hiberix).
English: What Tritanrix HepB is and what it is used for Before your child receives Tritanrix HepB
Slovenian: Kaj je cepivo Tritanrix HepB in za kaj ga uporabljamo Kaj morate vedeti preden bo vaš otrok prejel cepivo Tritanrix HepB Kako se cepivo Tritanrix HepB uporablja
English: ≥ 30 IU ≥ 60 IU ≥ 4 IU 10 µg
Slovenian: ≥ 30 i.e. ≥ 60 i.e.
English: After control of the disease the vaccine should be administered
Slovenian: Cepivo je treba uporabiti po ureditvi bolezni.
English: • collapse or periods of unconsciousness or lack of awareness have been reported within 2 to 3 days
Slovenian: • v 2 do 3 dneh po cepljenju so poročali o pojavu kolapsa ali obdobij nezavesti ali motenj
English: As with all injectable vaccines, appropriate medical treatment should always be readily available in case of anaphylactic reactions following the administration of the vaccine.
Slovenian: Tako kot pri vseh cepivih za injiciranje, je zaradi možne anafilaksijske reakcije po aplikaciji cepiva potrebno vedno razpolagati s takojšnjim ustreznim zdravljenjem.
English: The coughing is often accompanied by a “whooping” sound, hence the common name “whooping cough”.
Slovenian: Kašelj pogosto spremlja zvok, podoben riganju, zato se bolezen tudi imenuje oslovski kašelj.
English: Your child will remain under medical supervision for 30 minutes after each injection.
Slovenian: Po prejemu vsakega odmerka bo otrok še 30 minut pod zdravniškim nadzorom.
English: In clinical studies, Tritanrix HepB has been administered simultaneously with oral polio vaccine (OPV) and Haemophilus influenzae type b (Hib) vaccine.
Slovenian: V kliničnih študijah so Tritanrix HepB dajali sočasno s peroralnim polio cepivom (OPV) in cepivom proti okužbi z bakterijo Haemophilus influenzae tipa b (Hib).
English: The bacteria release a toxin (poison), which can cause muscle stiffness, painful muscle spasms, fits and even death.
Slovenian: Bakterije sproščajo toksin (strup), ki lahko povzroči otrplost mišic, boleče krče mišic, konvulzije in celo smrt.
English: Tritanrix HepB is for deep intramuscular injection, preferably in the anterolateral thigh.
Slovenian: Tritanrix HepB se injicira globoko intramuskularno, najboljše v anterolateralni predel stegna.
English: See section 6.5 for the number of doses per vial.
Slovenian: Glede števila odmerkov v eni viali glejte poglavje 6.5.
English: Four different schedules have been studied (6-10-14 weeks, 2-4-6 months; 3-4-5 months and 3-4½-6 months) according to routine vaccination practices in different countries with three doses administered within the first
Slovenian: Glede na rutinsko prakso cepljenja v različnih državah so bile raziskane štiri različne sheme z dajanjem treh odmerkov v prvih šestih mesecih starosti (6-10-14 tednov, 2-4-6 mesecev; 3-4
English: TRITANRIX HepB SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED
Slovenian: TRITANRIX HepB SE V NOBENEM PRIMERU NE SME DAJATI V ŽILO.
English: It is current practice in paediatric vaccination to co-administer different vaccines during the same session with injectable vaccines being administered at separate injection sites.
Slovenian: Običajna praksa pri cepljenju otrok je, da se ob enkratnem obisku sočasno dajejo različna cepiva, pri čemer se cepiva za injiciranje dajejo na različna mesta.
English: • if your child has a tendency to seizures/fits due to a fever, or if there is a history in the family of this
Slovenian: • če je vaš otrok nagnjen k epileptičnim napadom/krčem zaradi vročine ali pa se je to pojavljalo v
English: If any of the following events occur in temporal relation to receipt of Tritanrix HepB, the decision to give subsequent doses of vaccine containing the pertussis component should be carefully considered.
Slovenian: Če je znano, da se je v določenem času po prejemu cepiva Tritanrix HepB pojavil kateri od naslednjih neželenih učinkov, je potrebno odločitev o dajanju nadaljnjih odmerkov cepiva z vsebnostjo komponente proti oslovskemu kašlju temeljito pretehtati.
English: A history of febrile convulsions, a family history of convulsions, a family history of SIDS (Sudden Infant Death Syndrome) and a family history of an adverse reaction following Tritanrix HepB vaccination do not constitute contra-indications.
Slovenian: Febrilne konvulzije v anamnezi ter konvulzije, SIDS (sindrom nenadne smrti dojenčka) in neželena reakcija po cepljenju s Tritanrix HepB v družinski anamnezi ne predstavljajo kontraindikacije.
English: Tritanrix HepB is contraindicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine.
Slovenian: Tritanrix HepB je kontraindiciran, če se je pri otroku v 7 dneh po predhodnem cepljenju s cepivom, ki je vsebovalo tudi komponento proti oslovskemu kašlju, pojavila encefalopatija neznane etiologije.
English: Booster vaccination:
Slovenian: Obnovitveno cepljenje
English: BEFORE YOUR CHILD RECEIVES TRITANRIX HepB Tritanrix HepB should not be given:
Slovenian: Vaš otrok cepiva Tritanrix HepB ne sme prejeti:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Tritanrix HepB - Suspension for injection
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Tritanrix HepB - suspenzija za injiciranje DTPw-HBV cepivo
English: Tritanrix HepB is available in the following pack sizes:
Slovenian: Cepivo Tritanrix HepB je na voljo v naslednjih pakiranjih:
English: After the marketing of Tritanrix HepB, the following additional side effects have been reported on a few
Slovenian: Po prihodu cepiva Tritanrix HepB na trg so bili v nekaj primerih opisani naslednji neželeni učinki: