FrancophonIA/ELRC3.0 huggingface dataset:
English: Data on outcomes of a limited number of pregnancies in vaccinated women do not indicate any adverse effects of Twinrix Paediatric on pregnancy or on the health of the fetus/newborn child.
Slovenian: Podatki o izidih nosečnosti, pridobljeni pri manjšem številu cepljenih nosečnic, ne kažejo na možnost škodljivih vplivov cepiva Twinrix za otroke na nosečnost ali zdravje plodu/novorojenca.
English: • Degenerative disease of the brain (encephalopathy)
Slovenian: • degenerativna bolezen možganov (encefalopatija);
English: The standard primary course of vaccination with Twinrix Paediatric consists of three doses, the first administered at the elected date, the second one month later and the third six months after the first dose.
Slovenian: Standardno osnovno cepljenje s cepivom Twinrix za otroke sestoji iz treh odmerkov: prvi odmerek apliciramo na izbrani dan cepljenja, drugi odmerek sledi 1 mesec po prvem cepljenju in tretji odmerek 6 mesecev po prvem cepljenju.
English: Read all of this leaflet carefully before you start/ your child starts receiving this vaccine because it contains important information for you.
Slovenian: Preden boste prejeli/bo vaš otrok prejel cepivo natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: What Twinrix Paediatric is and what it is used for
Slovenian: Kaj je cepivo Twinrix za otroke in za kaj ga uporabljamo
English: The need for a booster dose of hepatitis B vaccine in healthy individuals who have received a full primary vaccination course has not been established; however some official vaccination programmes currently include a recommendation for a booster dose of hepatitis B vaccine and these should be respected.
Slovenian: Pri zdravih osebah, ki so prejele celotno osnovno shemo cepljenja, ni potrebno obnovitveno cepljenje s cepivom proti hepatitisu B. Kljub temu nekateri uradni programi cepljenja vsebujejo priporočilo za obnovitveno cepljenje s cepivom proti hepatitisu B in ta priporočila je potrebno upoštevati.
English: 0.5 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (rubber butyl).
Slovenian: 0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z batnim zamaškom (butilna guma).
English: It is not yet fully established whether immunocompetent individuals who have responded to hepatitis A vaccination will require booster doses as protection in the absence of detectable antibodies may be ensured by immunological memory.
Slovenian: Še vedno ni popolnoma dognano, če imunsko kompetentne osebe, ki so se odzvale na cepljenje s cepivom proti hepatitisu A, potrebujejo obnovitveni odmerek, saj kljub temu, da se protiteles ne zazna, zaščito lahko zagotavlja imunološki spomin.
English: In situations where a booster dose of hepatitis A and/or hepatitis B is desired, a monovalent or combined vaccine can be given.
Slovenian: V okoliščinah, ko je zaželen obnovitveni odmerek proti hepatitisu A in/ali hepatitisu B, je mogoče uporabiti monovalentno ali kombinirano cepivo.
English: EU/1/97/029/001 - pack of 1 without needle EU/1/97/029/002 - pack of 10 without needle EU/1/97/029/008 - pack of 50 without needle EU/1/97/029/006 - pack of 1 with 1 needle EU/1/97/029/007 - pack of 10 with 10 needles
Slovenian: EU/1/97/029/001 - pakiranje po 1 brez igle EU/1/97/029/002 - pakiranje po 10 brez igle EU/1/97/029/008 - pakiranje po 50 brez igle EU/1/97/029/006 - pakiranje po 1 z 1 iglo EU/1/97/029/007 - pakiranje po 10 z 10 iglami EU/1/97/029/009 - pakiranje po 1 z 2 iglama EU/1/97/029/010 - pakiranje po 10 z 20 iglami
English: The safety and immunogenicity of Twinrix Paediatric administered as a booster dose following a three dose primary course have not been evaluated.
Slovenian: Varnost in imunogenost cepiva Twinrix za otroke, uporabljenega kot obnovitveni odmerek po treh odmerkih primarnega cepljenja, nista raziskani.
English: • Reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
Slovenian: • znižanje števila krvnih ploščic (trombocitov), ki zviša tveganje za krvavitev ali pojav modric
English: What Twinrix Paediatric is and what it is used for What you need to know before you receive Twinrix Paediatric How Twinrix Paediatric is given Possible side effects
Slovenian: Kaj je cepivo Twinrix za otroke in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli cepivo Twinrix za otroke Kako uporabljati cepivo Twinrix za otroke Možni neželeni učinki
English: • you are allergic to: - the active substances, or any of the ingredients of this medicine (listed in section 6).
Slovenian: - zdravilne učinkovine ali katero koli sestavino tega cepiva (navedeno v poglavju 6).
English: • Purple or red brown spots visible through the skin (thrombocytopenic purpura)
Slovenian: • rdeče ali rdečerjave lise, ki se vidijo skozi kožo (trombocitopenična purpura);
English: Influenza like illness*, chills*
Slovenian: redki gripi podobna bolezen*, mrzlica*
English: • you have a bleeding problem or bruise/ bruises easily.
Slovenian: • imate težave s krvavitvami ali hitrim nastankom modric.
English: The doctor will give Twinrix Paediatric as an injection into your upper arm muscle or into the thigh muscle of your child.
Slovenian: Zdravnik vam bo dal cepivo Twinrix za otroke v obliki injekcije v mišico nadlakti, vašemu otroku pa v stegensko mišico.
English: • Generally feeling unwell, tiredness
Slovenian: • splošno slabo počutje, utrujenost,
English: • Upper respiratory tract infection
Slovenian: • okužba zgornjih dihalnih poti.
English: Twinrix Paediatric is indicated for use in non immune infants, children and adolescents from 1 year up to and including 15 years who are at risk of both hepatitis A and hepatitis B infection.
Slovenian: Cepivo Twinrix za otroke je indicirano za uporabo pri neimunih dojenčkih, otrocih in mladostnikih, starih od enega leta do vključno 15 let, pri katerih obstaja tveganje za okužbo z virusom hepatitisa A in virusom hepatitisa B.
English: It is not known if Twinrix Paediatric passes into breast milk, however the vaccine is not expected to cause problems in breast-fed babies.
Slovenian: Ni znano, če cepivo Twinrix za otroke prehaja v materino mleko, vendar pa težav pri dojenih otrocih ne pričakujemo.
English: • Inflammation of nerves (neuritis)
Slovenian: • vnetje živcev (nevritis);
English: Twinrix Paediatric is for intramuscular injection, preferably in the deltoid region in adolescents and children or in the anterolateral thigh in infants.
Slovenian: Twinrix za otroke se injicira intramuskularno, najbolje v deltoidni predel pri mladostnikih in otrocih ali v anterolateralni del stegna pri dojenčkih.
English: Twinrix Paediatric has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Twinrix za otroke nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: In haemodialysis patients, patients receiving immunosuppressive treatment or patients with an impaired immune system, the anticipated immune response may not be achieved after the primary immunisation course.
Slovenian: Pri bolnikih na hemodializi, bolnikih, ki prejemajo imunosupresivno terapijo in osebah z okvarjenim imunskim sistemom po osnovnem cepljenju morda ne bo dosežen ustrezen titer protiteles.
English: However, exceptionally Twinrix Paediatric can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects (see section 4.2).
Slovenian: Izjemoma se Twinrix za otroke lahko daje subkutano in sicer bolnikom s trombocitopenijo in bolnikom z motnjami strjevanja krvi, ker lahko pri njih po intramuskularnem injiciranju nastopi krvavitev (glejte poglavje 4.2).
English: Your doctor will advise on the possible need for extra doses, and future booster dosing.
Slovenian: Vaš zdravnik vam bo svetoval v primeru, da bi potrebovali/bi vaš otrok potreboval dodatne odmerke cepiva in kasnejše obnovitvene odmerke.
English: The effect of Twinrix Paediatrict on embryo-fetal, peri-natal and post-natal survival and development has been assessed in rats.
Slovenian: Vpliv cepiva Twinrix za otroke na embriofetalno, perinatalno in postnatalno preživetje ter razvoj so ovrednotili pri podganah.
English: - This vaccine has been prescribed for you/ your child only.
Slovenian: - Cepivo je bilo predpisano vam /vašemu otroku osebno in ga ne smete dajati drugim.
English: 12-15 years, all subjects followed up retained ≥15 mIU/ml anti-HAV antibody and 85% had anti-HBs antibody ≥10 mIU/ml.
Slovenian: 1., 6. mesec so se protitelesa anti-HAV vsem spremljanim preiskovancem ohranila na ≥ 15 mi.e./ml in 85 % jih je imelo protitelesa anti-HBs ≥ 10 mi.e./ml.
English: 1 month later
Slovenian: • drugi odmerek: 1 mesec pozneje
English: • Purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema multiforme)
Slovenian: • škrlatne ali rdeče-škrlatne izbokline na koži (lichen planus), močan kožni izpuščaj (multiformni eritem), koprivnica;
English: How to store Twinrix Paediatric Contents of the pack and other information
Slovenian: Shranjevanje cepiva Twinrix za otroke Vsebina pakiranja in dodatne informacije
English: • Drooping eyelid and sagging muscles on one side of the face (facial palsy)
Slovenian: • povešena veka in mlahave mišice na eni strani obraza (paraliza obraza);
English: Twinrix Paediatric should under no circumstances be administered intravascularly.
Slovenian: Cepiva Twinrix za otroke se v nobenem primeru ne sme dajati v žilo.
English: What Twinrix Paediatric looks like and contents of the pack Suspension for injection in pre-filled syringe.
Slovenian: Izgled cepiva Twinrix za otroke in vsebina pakiranja Suspenzija za injiciranje v napolnjeni injekcijski brizgi.
English: Twinrix Paediatric is not recommended for postexposure prophylaxis (e.g. needle stick injury).
Slovenian: Twinrix za otroke ni priporočljiv za zaščito po predhodni izpostavljenosti (npr. po vbodu z iglo).
English: The excretion of Twinrix Paediatric in milk has not been studied in animals.
Slovenian: Študije izločanja cepiva Twinrix za otroke v mleko pri živalih niso bile izvedene.
English: Swelling at the injection site, injection site reaction (such as bruising), fatigue, malaise, fever (≥ 37.5°C)
Slovenian: utrujenost, občutek slabosti, zvišana telesna temperatura (≥ 37.5°C)
English: However, when the monovalent hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins, no influence on seroconversion was observed although it may result in lower antibody titres.
Slovenian: ali hepatitisu B aplicirani sočasno s specifičnimi imunoglobulini, ni bilo opaziti vpliva na serokonverzijo, čeprav so titri protiteles lahko nižji.
English: The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people.
Slovenian: Virus hepatitisa B je prisoten v telesnih tekočinah, kot so kri, sperma, vaginalni izločki ali slina (izpljunek)
English: Twinrix Paediatric is a combined vaccine formulated by pooling bulk preparations of the purified, inactivated hepatitis A (HA) virus and purified hepatitis B surface antigen (HBsAg), separately adsorbed onto aluminium hydroxide and aluminium phosphate.
Slovenian: Twinrix za otroke je kombinirano cepivo, pripravljeno iz posameznih pripravkov prečiščenega, inaktiviranega virusa hepatitisa A (HA) in prečiščenega površinskega antigena virusa hepatitisa B (HBsAg), ki sta ločeno adsorbirana na aluminijev hidroksid in aluminijev fosfat.
English: • Diarrhoea, vomiting, stomach pain
Slovenian: • driska, bruhanje, bolečine v trebuhu,
English: It is unknown whether Twinrix Paediatric is excreted in human breast milk.
Slovenian: Ni znano, če se cepivo Twinrix za otroke izloča v materino mleko.
English: Twinrix Paediatric confers immunity against HAV and HBV infection by inducing specific anti-HA and anti-HBs antibodies.
Slovenian: Twinrix za otroke omogoča imunost proti virusu hepatitisa A in hepatitisa B z indukcijo specifičnih anti-HAV in anti-HBs protiteles.
English: • Swelling or infection of the brain (encephalitis)
Slovenian: • oteklost ali okužba možganov (encefalitis);
English: Administration of Twinrix Paediatric at the same time as Cervarix (HPV vaccine) has shown no clinically relevant interference in the antibody response to the HPV and hepatitis A antigens.
Slovenian: Med uporabo cepiva Twinrix za otroke hkrati s cepivom Cervarix (cepivo proti HPV) ni bilo klinično pomembnih medsebojnih vplivov na odziv protiteles proti antigenoma HPV in hepatitisa A.
English: Twinrix Paediatric can be given with a Human Papillomavirus (HPV) vaccine at a separate injection site (another part of your body, e.g. the other arm) during the same visit.
Slovenian: Cepivo Twinrix za otroke je mogoče dati na istem pregledu kot cepivo proti humanemu papilomavirusu (HPV), vendar mesto injiciranja mora biti drugo (drug del telesa, npr. druga roka).
English: PHARMACEUTICAL FORM AND CONTENTS Suspension for injection in pre-filled syringe 1 pre-filled syringe
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Suspenzija za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga 1 odmerek (0,5 ml)
English: Other medicines and Twinrix Paediatric
Slovenian: Druga zdravila in cepivo Twinrix za otroke
English: Alternatively, subjects primed with Twinrix Paediatric may be administered a booster dose of either of the monovalent vaccines.
Slovenian: Osebe, cepljene s cepivom Twinrix za otroke, lahko prejmejo obnovitveni odmerek posameznega monovalentnega cepiva.
English: Abnormal liver function tests * refers to adverse reactions observed in clinical trials performed with the adult formulation
Slovenian: *se nanaša na splošne reakcije, ki se lahko pojavijo v kliničnih preskusih z cepivom za odrasle
English: Twinrix Paediatric can be given concomitantly with Human Papillomavirus (HPV) vaccine.
Slovenian: Cepivo Twinrix za otroke je mogoče uporabiti sočasno s cepivom proti humanemu papilomavirusu
English: Twinrix Paediatric contains neomycin Please tell your doctor if you have had an allergic reaction to neomycin (antibiotic).
Slovenian: Obvestite zdravnika, če ste kdaj imeli alergijsko reakcijo na neomicin (antibiotik).
English: Only the concomitant administration of Twinrix Paediatric with Cervarix has been specifically studied.
Slovenian: Posebej je bila raziskana samo sočasna uporaba cepiva Twinrix za otroke s cepivom Cervarix.
English: • Abnormal laboratory liver test results
Slovenian: • nenormalne vrednosti preiskav jetrne funkcije;
English: • Aching muscles
Slovenian: • boleče mišice,
English: It is advised that vaccines other than Cervarix should not be administered at the same time as Twinrix Paediatric.
Slovenian: Drugih cepiv ni priporočljivo uporabljati sočasno s cepivom Twinrix za otroke.
English: • Numbness or weakness of the arms and legs (neuropathy), paralysis
Slovenian: • otrplost ali šibkost rok in nog (nevropatija), paraliza;
English: Symptoms of hepatitis A begin 3 to 6 weeks after coming into contact with the virus.
Slovenian: 6 tednov po stiku z virusom.
English: • Joint swelling, muscular weakness
Slovenian: • oteklost sklepov, mišična oslabelost;
English: Talk to you doctor or pharmacist before you receive Twinrix Paediatric if:
Slovenian: Preden prejmete cepivo Twinrix za otroke se posvetujte z zdravnikom ali farmacevtom, če:
English: Specific humoral antibodies against hepatitis B were observed in approximately 67% of the subjects after the first dose and 100% after the third dose.
Slovenian: Specifična humoralna protitelesa proti hepatitisu B so bila opažena pri 67 %
English: • Multiple sclerosis, swelling of the spinal cord (myelitis)
Slovenian: • multipla skleroza, oteklost hrbtenjače (mielitis);
English: Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders.
Slovenian: Twinrix za otroke se lahko izjemoma aplicira podkožno pri osebah s trombocitopenijo ali motnjami strjevanja krvi.
English: • Fits or seizures
Slovenian: • krči ali napadi krčev;
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, težave z dihanjem (zasoplost)
English: In situations where a booster dose of both hepatitis A and hepatitis B are desired, Twinrix Paediatric can be given.
Slovenian: V okoliščinah, ko je zaželen obnovitveni odmerek proti hepatitisu A in tudi proti hepatitisu B, se lahko uporabi cepivo Twinrix za otroke.
English: • Fever equal to or greater than 37.5°C
Slovenian: • zvišana telesna temperatura do 37.5°C ali višja, • razdražljivost.
English: At 10 years following the initiation of a 0, 1, 6 month schedule of Twinrix Paediatric in children aged
Slovenian: Deset let po začetku cepljenja otrok, starih od 12 do 15 let, s cepivom Twinrix za otroke po shemi 0.,
English: PHARMACEUTICAL FORM Suspension for injection.
Slovenian: FARMACEVTSKA OBLIKA Suspenzija za injiciranje Motna bela suspenzija
English: • Drowsiness, headache
Slovenian: • zaspanost, glavobol,
English: Uncommon Upper respiratory tract infection*
Slovenian: Infekcijske in parazitske bolezni občasni okužba zgornjih dihalnih poti *
English: Twinrix Paediatric is a white, slightly milky liquid presented in a glass pre-filled syringe (0.5 ml).
Slovenian: Cepivo Twinrix za otroke je bela, rahlo mlečna tekočina v stekleni napolnjeni injekcijski brizgi
English: (meningitis)
Slovenian: (zlatenica).
English: România GlaxoSmithKline (GSK) SRL
Slovenian: GlaxoSmithKline (Cyprus) Ltd
English: Urticaria, pruritus*
Slovenian: • koprivnica, srbečica,
English: Side effects occured during clinical studies or routine use of the vaccine or with individual hepatitis A and hepatitis B vaccines or with the adult formulation of Twinrix.
Slovenian: Twinrix za otroke ali posameznim cepivom proti hepatitisu A in hepatitisu B ali s cepivom Twinrix za odrasle.
English: The effect of Twinrix Paediatric on embryo-fetal, peri-natal and post-natal survival and development has not been prospectively evaluated in clinical trials.
Slovenian: V kliničnih preskušanjih vpliva cepiva Twinrix za otroke na embriofetalno, perinatalno in postnatalno preživetje ter razvoj prospektivno niso ovrednotili.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Twinrix Paediatric, suspension for injection
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Twinrix za otroke, suspenzija za injiciranje HAB cepivo i.m.
English: Hypotension*
Slovenian: redki artralgija*
English: Side effects that may occur are the following:
Slovenian: - Zdravilni učinkovini sta:
English: Vasculitis
Slovenian: Hrvatska
English: Very rare (these may occur with up to 1 in 10,000 doses of the vaccine)
Slovenian: Zelo redki (ki se lahko pojavijo pri največ 1 od 10.000 odmerkov cepiva):
English: How to store Twinrix Paediatric
Slovenian: Kako uporabljati cepivo Twinrix za otroke
English: Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection.
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Po vsakem cepljenju ali celo pred njim se lahko pojavi sinkopa (omedlevica), zlasti pri mladostnikih,
English: What you need to know before you receive Twinrix Paediatric
Slovenian: Kaj morate vedeti, preden boste prejeli cepivo Twinrix za otroke Cepiva Twinrix za otroke ne smete prejeti, če:
English: Uncommon Myalgia* Rare
Slovenian: Žilne bolezni redki hipotenzija*
English: Irritability
Slovenian: Pogostnost
English: Very common Pain and redness at the injection site Common
Slovenian: Splošne težave in spremembe na mestu aplikacije takojšnja bolečina na mestu vboda
English: 10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml)
Slovenian: 10 napolnjenih injekcijskih brizg + 20 igel 10 x 1 odmerek (0,5 ml)
English: At 5 years following initiation of a 0, 1, 6 month schedule of Twinrix Paediatric in children aged 1-11
Slovenian: Pet let po začetku cepljenja otrok, starih od 1 do 11 let, s cepivom Twinrix za otroke po shemi 0., 1., 6. mesec so se protitelesa anti-HAV vsem spremljanim preiskovancem ohranila na ≥ 15 mIE/ml in 97 %
English: No data on concomitant administration of Twinrix Paediatric with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated.
Slovenian: Ni zbranih podatkov o sočasni aplikaciji cepiva Twinrix za otroke in specifičnih imunoglobulinov proti hepatitisu A ali hepatitisu B. Vsekakor pa, kadar sta bili monovalentni cepivi proti hepatitisu A
English: Frequency Adverse reactions
Slovenian: - Obnovitveni odmerek
English: 1 pre-filled syringe + 1 needle 1 dose (0.5 ml)
Slovenian: 1 napolnjena injekcijska brizga + 1 igla 1 odmerek (0,5 ml)
English: Twinrix Paediatric, Suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Slovenian: Twinrix za otroke - suspenzija za injiciranje v napolnjeni injekcijski brizgi Cepivo proti hepatitisu A, inaktivirano, in hepatitisu B, rekombinantno (HAB), adsorbirano
English: Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
Slovenian: Redki (ki se lahko pojavijo pri največ 1 od 1000 odmerkov cepiva):
English: 50 x 1 dose (0.5 ml)
Slovenian: 50 napolnjenih injekcijskih brizg 50 x 1 odmerek (0,5 ml)
English: 1 pre-filled syringe + 2 needles 1 dose (0.5 ml)
Slovenian: 1 napolnjena injekcijska brizga + 2 igli 1 odmerek (0,5 ml)
English: Contents of the pack and other information What Twinrix Paediatric contains - The active substances are: Hepatitis A virus (inactivated)1,2
Slovenian: 1 odmerek (0,5 ml) vsebuje: Virus hepatitisa A (inaktivirani)1,2
English: The dose of 0.5 ml (360 ELISA Units HA/10 µg HBsAg) is recommended for infants, children and adolescents from 1 year up to and including 15 years of age.
Slovenian: Za dojenčke, otroke in mladostnike stare od 1 leta do vključno 15 let je priporočljiv odmerek 0,5 ml
English: Cases of overdose have been reported during post-marketing surveillance.
Slovenian: 4.9 Preveliko odmerjanje Med spremljanjem cepiva po pridobitvi dovoljenja za promet so poročali o primerih prevelikega odmerjanja.
English: It is not known whether Twinrix Paediatric will prevent HA and HB in such cases.
Slovenian: Obstaja možnost, da so osebe v času cepljenja v inkubacijski dobi za hepatitis A ali hepatitis B. Ni znano, če Twinrix za otroke v teh primerih prepreči bolezni.
English: 10 pre-filled syringes + 10 needles 10 x 1 dose (0.5 ml)
Slovenian: 10 napolnjenih injekcijskih brizg + 10 igel 10 x 1 odmerek (0,5 ml)
English: Hypoaesthesia*, paraesthesia*, dizziness
Slovenian: Bolezni živčevja pogosti zaspanost, glavobol redki hipestezija*, parestezija*, omotica
English: • Dizziness
Slovenian: • izpuščaj,
English: NAME OF THE MEDICINAL PRODUCT Twinrix Paediatric - Suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Slovenian: Navodilo za uporabo Twinrix za otroke, suspenzija za injiciranje v napolnjeni injekcijski brizgi Cepivo proti hepatitisu A, inaktivirano, in hepatitisu B, rekombinantno (HAB), adsorbirano
English: Uncommon (these may occur with up to 1 in 100 doses of the vaccine)
Slovenian: Občasni (ki se lahko pojavijo pri največ 1 od 100 odmerkov cepiva):
English: Gastrointestinal symptoms, nausea Uncommon Diarrhoea, vomiting, abdominal pain
Slovenian: Bolezni prebavil pogosti gastrointestinalni simptomi, navzea.
English: Common (these may occur with up to 1 in 10 doses of the vaccine)
Slovenian: Pogosti (ki se lahko pojavijo pri največ 1 od 10 odmerkov cepiva):
English: - If you get / your child gets any side effects, talk to your doctor or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: 10 x 1 dose (0.5 ml)
Slovenian: 10 napolnjenih injekcijskih brizg 10 x 1 odmerek (0,5 ml)
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFATURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Uncommon Rash Rare
Slovenian: Pshiatrične motnje pogosti razdražljivost
English: GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
Slovenian: GlaxoSmithKline (GSK) SRL Tel: +40 (0)21 3028 208