FrancophonIA/ELRC3.0 huggingface dataset:
English: - are hypersensitive (allergic) to nimesulide or any of the other ingredients of TRADEMARK; - have had allergic reactions (e.g. wheezing, runny or blocked nose, hives or nettle rash) after aspirin or other non-steroidal anti-inflammatory drugs; - had a reaction to nimesulide affecting the liver in the past; - are taking other medicines that are known to affect the liver, e.g. paracetamol or any other pain killers or NSAID treatment - are taking drugs of addiction, or have developed a habit that makes you dependent on drugs or other substances - are a regular heavy drinker (alcohol), - if you have liver disease or increased liver enzymes - have a peptic ulcer (stomach or duodenal ulcer) now or had one in the past; - have had bleeding from the stomach or bowel; - have had bleeding into the brain (a stroke); - have any other problem with bleeding or any problems due to your blood not clotting; - have heart failure or a kidney disorder (poor kidney function) or any liver disorder; - are suffering from fever or flu (feeling generally achy, unwell, chills or shivering or have a temperature); - are in the last 3 months of pregnancy; - are breastfeeding.
Slovenian: koprivnico) po jemanju aspirina ali drugega nesteroidnega protivnetnega zdravila; - če ste v preteklosti imeli reakcijo na nimesulid, ki je vplivala na delovanje vaših jeter; - če jemljete druga zdravila, za katera je znano, da škodljivo vplivajo na jetra, npr. paracetamol ali kakšna druga zdravila proti bolečinam ali druga nesteroidna protivnetna zdravila (NSAID); - če ste zasvojeni z mamili ali če ste zaradi zasvojenosti odvisni od nedovoljenih ali drugih snovi; - če redno uživate velike količine alkohola, - če imate bolezen jeter ali povečane vrednosti jetrnih encimov; - če imate ali ste kdaj v preteklosti imeli peptični ulkus (razjedo želodca ali dvanajstnika); - če ste kdaj krvaveli iz želodca ali črevesa; - če ste kdaj imeli možgansko krvavitev (možgansko kap); - če imate kakršnekoli druge težave v zvezi s krvavitvami ali težave zaradi motenj v strjevanju krvi; - če imate srčno popuščanje ali bolezen ledvic (zmanjšano delovanje ledvic) ali kakršnokoli bolezen jeter; - če imate zvišano telesno temperaturo (vročino) ali gripo (splošno slabo počutje, bolečine v mišicah, mrzlico z drgetanjem ali zvišano telesno temperaturo); - če ste v zadnjih 3 mesecih nosečnosti; - če dojite.
English: If you have ever suffered from peptic ulcers, bleeding from the stomach or bowel, ulcerative colitis or Crohn's disease, you should tell your doctor before taking TRADEMARK.
Slovenian: Če ste kdaj imeli peptični ulkus, krvavitev iz želodca ali črevesa, ulcerativni kolitis ali Crohnovo bolezen, obvestite zdravnika, preden začnete z jemanjem zdravila TRADEMARK.
English: Patients with fever and/or flu-like symptoms.
Slovenian: Bolniki z zvišano telesno temperaturo in/ali gripi podobnimi simptomi.
English: - If you are planning a pregnancy, you should inform your doctor since TRADEMARK may decrease fertility.
Slovenian: - Če nameravate zanositi, o tem obvestite svojega zdravnika, ker lahko zdravilo TRADEMARK zmanjša plodnost.
English: Known hypersensitivity to nimesulide or to any of the excipients of the products.
Slovenian: Znana preobčutljivost za nimesulid ali katerokoli pomožno snov tega zdravila.
English: - If you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
Slovenian: - Če ne prenašate nekaterih sladkorjev, se pred jemanjem tega zdravila posvetujte s svojim zdravnikom.
English: It is used for treatment of acute pain, for the treatment of symptoms of painful osteoarthritis, and for the treatment of period pains.
Slovenian: Uporablja se za zdravljenje akutnih bolečin, za lajšanje simptomov osteoartritisa z bolečinami in za lajšanje bolečin zaradi menstruacije.
English: History of hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria) in response to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
Slovenian: Preobčutljivostne reakcije v anamnezi (npr. bronhospazem, rinitis, koprivnica) po uporabi acetilsalicilne kisline ali drugih nesteroidnih antirevmatikov.
English: History of hepatotoxic reactions to nimesulide
Slovenian: Hepatotoksične reakcije na nimesulid v anamnezi.
English: As nimesulide can interfere with platelet function, it should be used with caution in patients with bleeding diathesis (see also section 4.3).
Slovenian: Nimesulid lahko moti delovanje trombocitov, zato ga je treba uporabljati previdno pri bolnikih, ki so nagnjeni h krvavitvam (glejte tudi poglavje 4.3).
English: Liver damage, in most cases reversible, has been reported following short exposure to the drug.
Slovenian: Znani so primeri jetrnih poškodb po krajši izpostavljenosti zdravilu, ki pa so v večini primerov reverzibilni.
English: Impaired renal function: on the basis of pharmacokinetics, no dosage adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance of 30-80 ml/min), while Nimesulide 100mg Tablets/granules is contraindicated in case of severe renal impairment (creatinine clearance < 30ml/min) (see sections 4.3 and 5.2).
Slovenian: Ledvična okvara: Glede na nimesulidove farmakokinetične lastnosti prilagoditev odmerka pri bolnikih z blago do zmerno ledvično okvaro (očistek kreatinina 30 do 80 ml/min) ni potrebna, pri bolnikih, ki imajo hudo ledvično okvaro (očistek kreatinina < 30 ml/min), pa je uporaba zdravil, ki vsebujejo nimesulid, kontraindicirana (glejte poglavji 4.3 in 5.2).
English: However, Nimesulide 100mg Tablets/granules is not a substitute for acetylsalicylic acid for cardiovascular prophylaxis.
Slovenian: Vendar pa zdravila, ki vsebujejo nimesulid, niso nadomestek za acetilsalicilno kislino pri preprečevanju bolezni srca in ožilja.
English: During therapy with Nimesulide 100mg Tablets/granules, patients should be advised to refrain from other analgesics.
Slovenian: Med zdravljenjem z zdravili, ki vsebujejo nimesulid, je treba bolnikom svetovati, naj ne jemljejo drugih analgetikov.
English: BEFORE YOU TAKE TRADEMARK Do not use TRADEMARK if you:
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO TRADEMARK Ne jemljite zdravila TRADEMARK:
English: Elderly: In elderly patients there is no need to reduce the daily dosage (see section 5.2).
Slovenian: Starostniki: Starostnikom dnevnega odmerka ni treba zmanjšati (glejte poglavje 5.2).
English: - If you suffer from heart or kidney disease, you should tell your doctor before taking TRADEMARK; kidney function may become worse on TRADEMARK.
Slovenian: - Če imate bolezen srca ali ledvic, obvestite zdravnika preden vzamete zdravilo TRADEMARK; ob jemanju zdravila TRADEMARK se lahko delovanje ledvic poslabša.
English: Symptomatic treatment of painful osteoarthritis (see section 4.2).
Slovenian: simptomatsko zdravljenje bolečin pri osteoartritisu (glejte poglavje 4.2).
English: If gastrointestinal bleeding or ulceration occurs, nimesulide should be discontinued.
Slovenian: Če se pojavi krvavitev iz prebavil ali nastane razjeda, je treba prenehati z jemanjem nimesulida.
English: Nimesulide should be used with caution in patients with gastrointestinal disorders, including history of peptic ulceration, history of gastrointestinal haemorrhage, ulcerative colitis or Crohn's disease.
Slovenian: Nimesulid je treba uporabljati previdno pri bolnikih z motnjami pri delovanju prebavil, tudi s peptičnimi razjedami, krvavitvami iz prebavil, ulceroznim kolitisom ali Crohnovo boleznijo v anamnezi.
English: NSAIDs may mask the fever related to an underlying bacterial infection.
Slovenian: Nesteroidni antirevmatiki lahko prikrijejo zvišano telesno temperaturo, ki nastane zaradi bakterijske okužbe.
English: Patients receiving nimesulide who develop fever and/or flu-like symptoms should discontinue treatment
Slovenian: Bolniki, ki jemljejo nimesulid in pri katerih se pojavi zvišana telesna temperatura in/ali gripi podobni simptomi, morajo zdravljenje prekiniti.
English: 100mg bid after meal.
Slovenian: Odrasli: 100 mg nimesulida dvakrat na dan po obroku.
English: In patients with renal or cardiac impairment, caution is required since the use of Nimesulide 100mg Tablets/granules may result in deterioration of renal function.
Slovenian: Pri bolnikih z ledvično ali srčno okvaro je potrebna previdnost, ker se lahko zaradi uporabe zdravil, ki vsebujejo nimesulid, poslabša delovanje ledvic.
English: The risk of undesirable effects may be reduced by using Nimesulide 100mg Tablets/granules for the shortest possible duration (see section 4.2)
Slovenian: Pri uporabi zdravil, ki vsebujejo nimesulid, se lahko nevarnost pojava neželenih učinkov zmanjša tako, da se jih uporablja najkrajši možni čas (glejte poglavje 4.2).
English: Nimesulide 100mg Tablets/granules should be used for the shortest possible duration, as required by the clinical situation.
Slovenian: Zdravila, ki vsebujejo nimesulid, je treba uporabljati kar najkrajši čas glede na bolnikovo klinično stanje.
English: Symptoms suggesting a liver condition include loss of appetite, nausea, vomiting, abdominal pain, persistent tiredness or dark urine.
Slovenian: Simptomi, ki kažejo na bolezen jeter, so izguba apetita, navzeja (občutek siljenja na bruhanje), bruhanje, bolečine v trebuhu, nenehna utrujenost ali temen urin.
English: Concomitant administration with known hepatotoxic drugs, and alcohol abuse must be avoided during treatment with Nimesulide 100mg tablets/granules treatment, since either may increase the risk of hepatic reactions.
Slovenian: Med zdravljenjem z zdravili, ki vsebujejo nimesulid, se morate izogibati sočasni uporabi tega zdravila in znanih hepatotoksičnih zdravil ter zlorabi alkohola, saj se lahko zveča nevarnost pojava jetrnih reakcij.
English: Children (< 12 years): Nimesulide 100mg Tablets/granules is contraindicated in these patients (see also section 4.3).
Slovenian: Otroci (< 12 let): Uporaba zdravil, ki vsebujejo nimesulid, je pri otrocih kontraindicirana (glejte tudi poglavje 4.3).
English: Rarely Nimesulide 100mg Tablets/granules has been reported to be associated with serious hepatic reactions, including very rare fatal cases (see also section 4.8).
Slovenian: Poročila o povezanosti zdravil, ki vsebujejo nimesulid, z resnimi jetrnimi reakcijami, tudi zelo redkimi smrtnimi primeri (glejte tudi poglavje 4.8), so redka.
English: - If you are taking any of the following as they may interact with TRADEMARK: - medicine to thin the blood (anti-coagulants, aspirin or other salicylates) - water tablets (diuretics) used for heart failure or blood pressure - lithium which is used to treat depression and similar conditions - methotrexate - cyclosporin make sure that your doctor or pharmacist knows that you are taking these medicines before taking TRADEMARK.
Slovenian: - Če jemljete katero od spodaj naštetih zdravil, ki lahko medsebojno delujejo z zdravilom TRADEMARK: - zdravila za preprečevanje strjevanja krvi (antikoagulanti, aspirin ali drugi salicilati), - tablete za odvajanje vode (diuretiki), ki se uporabljajo za zdravljenje srčnega popuščanja in visokega krvnega tlaka, - litij, ki se uporablja za zdravljenje depresije in podobnih bolezni, - metotreksat, - ciklosporin.
English: In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Nimesulide 100mg Tablets/granules should be considered (see section 4.6).
Slovenian: Pri ženskah, ki imajo težave z zanositvijo ali pri katerih potekajo preiskave neplodnosti, je treba - če je to potrebno - zdravljenje z zdravili, ki vsebujejo nimesulid, prekiniti (glejte poglavje 4.6).
English: - If during treatment with TRADEMARK, you develop fever and/or flu-like symptoms (feeling generally achy, unwell and chills or shivering) you should stop taking the product and inform your doctor.
Slovenian: - Če se med zdravljenjem z zdravilom TRADEMARK pojavi zvišana telesna temperatura in/ali gripi podobni simptomi (splošno slabo počutje, bolečine v mišicah, mrzlica z drgetanjem ali zvišana telesna temperatura), prenehajte z jemanjem zdravila in obvestite zdravnika.
English: Hepatic impairment: the use of Nimesulide 100mg Tablets/granules is contraindicated in patients with hepatic impairment (see section 5.2).
Slovenian: Jetrna okvara: Uporaba zdravil, ki vsebujejo nimesulid, je kontraindicirana pri bolnikih z jetrno okvaro (glejte poglavje 5.2).
English: - If you are elderly, your doctor may want to see you at intervals to make sure that TRADEMARK is not causing stomach, kidney, heart or liver problems.
Slovenian: Tako se bo prepričal, da vam zdravilo TRADEMARK ne povzroča težav z želodcem, ledvicami, srcem ali jetri.
English: Treatment of acute pain (see section 4.2).
Slovenian: 4.1 Terapevtske indikacije zdravljenje akutnih bolečin (glejte poglavje 4.2).
English: Patients who experience symptoms compatible with hepatic injury during treatment with Nimesulide 100mg Tablets/granules (e.g. anorexia, nausea, vomiting, abdominal pain, fatigue, dark urine) or patients who develop abnormal liver function tests should have treatment discontinued.
Slovenian: Pri bolnikih, ki imajo simptome, ki bi lahko kazali na jetrno poškodbo med zdravljenjem z zdravili, ki vsebujejo nimesulid (npr. neješčnost, slabost, bruhanje, trebušne bolečine, utrujenost, temen seč), ali pri tistih, pri katerih se pojavijo nenormalni izvidi preiskav delovanja jeter, je treba zdravljenje prekiniti; nimesulida se jim ne sme več dajati.
English: TRADEMARK is a non-steroidal anti-inflammatory drug (“NSAID”), with pain-killing and feverlowering properties.
Slovenian: TM je nesteroidno protivnetno zdravilo (“NSAID”), ki blaži bolečine in znižuje telesno temperaturo.
English: Always take TRADEMARK exactly as your doctor has instructed you.
Slovenian: Pri jemanju zdravila TRADEMARK natančno upoštevajte zdravnikova navodila.
English: Elderly patients are particularly susceptible to the adverse effects of NSAIDs, including gastrointestinal haemorrhage and perforation, impaired renal, cardiac and hepatic function.
Slovenian: Starostniki so za neželene učinke nesteroidnih antirevmatikov, tudi krvavitve iz prebavil in perforacijo ter ledvično, srčno in jetrno okvaro še posebej občutljivi, zato jih je priporočljivo ustrezno klinično spremljati.
English: Active gastric or duodenal ulcer, a history of recurrent ulceration or gastrointestinal bleeding, cerebrovascular bleeding or other active bleeding or bleeding disorders.
Slovenian: Cerebrovaskularne krvavitve ali druge aktivne krvavitve ali hemoragijske motnje.
English: Severe coagulation disorders.
Slovenian: Hude motnje strjevanja krvi.
English: Severe heart failure
Slovenian: Hudo srčno popuščanje.
English: Hepatic impairment.
Slovenian: Jetrna okvara.
English: - Do not take other medicines that are known to affect the liver, e.g. paracetamol or any other pain killers or NSAID treatment - Avoid excess alcohol during treatment with TRADEMARK - If during nimesulide treatment you develop symptoms that suggest a liver condition, you should stop taking nimesulide and inform your doctor immediately.
Slovenian: - Če med zdravljenjem z nimesulidom opazite simptome, ki kažejo na bolezen jeter, prenehajte z jemanjem nimesulida in o tem nemudoma obvestite zdravnika.
English: Most people recover completely but the illness is usually severe enough to keep people off work for about a month.
Slovenian: Večina ljudi popolnoma okreva, toda bolezen je običajno tako težka, da so bolniki odsotni z dela približno mesec dni.
English: Vaccination is the best way to protect against these diseases.
Slovenian: Cepljenje je najboljši način zaščite pred tema boleznima.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 February 1997
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 10. februar 1997
English: 6 months after the first dose
Slovenian: 6 mesecev po prvem odmerku
English: The safety profile presented below is based on data from approximately 800 subjects.
Slovenian: Povzetek varnostnega profila Prikazan varnostni profil je osnovan na pridobljenih podatkih približno 800 oseb.
English: • you have a poor immune system due to illness or drug treatment.
Slovenian: • imate oslabljen imunski sistem zaradi bolezni ali zdravljenja z zdravili,
English: Very rare: System Organ Class
Slovenian: Zelo redki: Organski sistem
English: Guidelines for boosting are based on the assumption that antibodies are required for protection.
Slovenian: Smernice za obnovitveno cepljenje temeljijo na predpostavki, da so za zaščito nujno potrebna protitelesa.
English: Inspect the vaccine again: a. If the vaccine appears as a uniform hazy white suspension, it is ready to use - the appearance should not be clear.
Slovenian: Ponovno preglejte cepivo: a. če je cepivo enotna, motno bela suspenzija, je pripravljeno za uporabo - videz ne sme biti bister;
English: Signs of serious allergic reactions may be 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: Znako hude alergijske reakcije so lahko izpuščaji, ki so lahko srbeči ali mehurjasti, oteklina okrog oči in obraza, težave pri dihanju in požiranju, nenaden padec krvnega tlaka in izguba zavesti.
English: However, if you get any of these symptoms you should contact a doctor urgently.
Slovenian: Če se vam pojavi kateri koli od teh simptomov, morate nujno poklicati zdravnika;
English: • A temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities and often progressing to the chest and face (Guillain-Barré syndrome)
Slovenian: • začasno vnetje živcev, ki povzročajo bolečino, šibkost in paralizo v okončinah in često napredujejo proti prsnemu košu in obrazu (Guillain-Barré-jev sindrom);
English: 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 PRE-FILLED SYRINGES WITHOUT NEEDLE 50 PRE-FILLED SYRINGES WITHOUT NEEDLE 1 PRE-FILLED SYRINGE WITH 1 NEEDLE 10 PRE-FILLED SYRINGES WITH 10 NEEDLES 1 PRE-FILLED SYRINGE WITH 2 NEEDLES 10 PRE-FILLED SYRINGES WITH 20 NEEDLES
Slovenian: 1 NAPOLNJENA INJEKCIJSKA BRIZGA BREZ IGLE 10 NAPOLNJENIH INJEKCIJSKIH BRIZG BREZ IGEL 50 NAPOLNJENIH INJEKCIJSKIH BRIZG BREZ IGEL 1 NAPOLNJENA INJEKCIJSKA BRIZGA Z 1 IGLO 10 NAPOLNJENIH INJEKCIJSKIH BRIZG Z 10 IGLAMI 1 NAPOLNJENA INJEKCIJSKA BRIZGA Z 2 IGLAMA 10 NAPOLNJENIH INJEKCIJSKIH BRIZG Z 20 IGLAMI
English: Such patients may require additional doses of vaccine; nevertheless immunocompromised patients may fail to demonstrate an adequate response.
Slovenian: Ti bolniki bodo morda potrebovali dodatne odmerke cepiva; vendar pa pri imunokompromitiranih bolnikih odziv kljub temu morda ne bo zadosten.
English: The proportion of subjects reaching anti-HBs ≥ 10 mIU/ml was 98.3% for concomitant vaccination and 100% for Twinrix alone.
Slovenian: Delež oseb, ki so dosegle anti-HBs ≥ 10 mi.e./ml, je bil 98,3 % v primeru sočasnega cepljenja in 100 % v primeru cepljenja s cepivom Twinrix samim.
English: General guidelines for booster vaccination can therefore be drawn from experience with the monovalent vaccines, as follows.
Slovenian: Splošne napotke za obnovitvena cepljenja se zato lahko povzame iz izkušenj z monovalentnimi cepivi, kot sledi.
English: Pack sizes of 1, 10 and 50 with or without needles.
Slovenian: Velikosti pakiranja: 1, 10 ali 50 z injekcijskimi iglami ali brez njih.
English: 0.025 milligrams Al3+
Slovenian: 0,025 miligrama Al3+
English: The most commonly reported adverse reactions following Twinrix Paediatric administration are pain and redness occurring in a per dose frequency of 28.5% and 11.5% respectively.
Slovenian: Najbolj pogosto poročani neželeni reakciji po cepljenju s cepivom Twinrix za otroke sta bili bolečina in rdečina s pogostnostjo 28,5 % in 11,5 % na odmerek.
English: • you have experienced any health problems after previous administration of a vaccine.
Slovenian: • ste po predhodnem cepljenju imeli kakršne koli zdravstvene težave,
English: In two long term clinical trials, persistence of anti-HAV and anti-HBs antibodies has been demonstrated up to 10 years in children aged 12-15 years and up to 5 years in children aged 1-11
Slovenian: V dveh dolgotrajnih kliničnih preskušanjih so dokazali prisotnost anti-HAV in anti-HBs protiteles še do 10 let pri otrocih, starih od 12 do 15 let, in do 5 let pri otrocih, starih od 1 do 11 let.
English: 0.2 milligrams Al3+
Slovenian: 0,2 miligrama Al3+
English: • Swelling of the face, mouth or throat (angioneurotic oedema)
Slovenian: • oteklina obraza, ust ali grla (angionevrotični edem);
English: After a few days the whites of eyes and skin may become yellowish (jaundice).
Slovenian: Po nekaj dneh lahko koža in/ali beločnice postanejo rumenkaste barve
English: The hepatitis A virus can be passed from person to person in food and drink, or by swimming in water contaminated by sewage.
Slovenian: To bolezen povzroča virus hepatitisa A. Virus hepatitisa A se z osebe na osebo lahko prenaša s hrano in pijačo ali s plavanjem v vodi, onesnaženi s fekalijami.
English: For some categories of subjects or patients exposed to HBV (e.g. haemodialysis or immunocompromised patients) a precautionary attitude should be considered to ensure a protective antibody level ≥ 10IU/l.
Slovenian: Pri nekaterih kategorijah oseb ali bolnikov, izpostavljenih HBV (npr. bolniki na hemodializi ali imunsko pomanjkljive osebe), je zaradi zagotovitve zaščitnega nivoja protiteles ≥ 10 i.e./l potrebna posebna previdnost.
English: • Infection around the brain which may give severe headache with stiff neck and sensitivity to light
Slovenian: • okužba okrog možganov, ki lahko povzroči hud glavobol z otrdelim vratom in občutljivostjo na svetlobo (meningitis);
English: Twinrix Paediatric is a vaccine used in infants, children and adolescents from 1 year up to and including 15 years to prevent two diseases: hepatitis A and hepatitis B. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.
Slovenian: Twinrix za otroke je cepivo, ki se uporablja pri dojenčkih, otrocih in mladostnikih, starih od enega leta do vključno 15 let, za preprečevanje dveh bolezni: hepatitisa A in hepatitisa B. Cepivo deluje tako, da spodbudi telo k proizvajanju lastne zaščite (protiteles) proti tema boleznima.
English: In the clinical studies, specific humoral antibodies against hepatitis A were observed in approximately 89% of the subjects one month after the first dose and in 100% one month after the third dose (i.e. month 7).
Slovenian: V kliničnih študijah so specifična humoralna protitelesa proti hepatitisu A ugotovili pri približno 89 % cepljenih oseb en mesec po aplikaciji prvega odmerka cepiva in pri 100 % cepljenih oseb en mesec po aplikaciji tretjega odmerka (to je mesec 7).
English: Twinrix Paediatric is available in packs of 1, 10 and 50 with or without needles.
Slovenian: Cepivo Twinrix za otroke je na voljo v pakiranjih po 1, 10 in 50 z injekcijskimi iglami ali brez njih.
English: 0.2 milligrams Al3+ - The other ingredients in Twinrix Paediatric are: sodium chloride, water for injections.
Slovenian: 0,2 miligrama Al3+ - Pomožne snovi cepiva Twinrix za otroke so: natrijev klorid in voda za injekcije.
English: AntiHBs geometric mean antibody concentrations were lower on co-administration, but the clinical significance of this observation is not known since the seroprotection rates remain unaffected.
Slovenian: Geometrična sredina koncentracije protiteles anti-HBs je bila med sočasno uporabo manjša, toda klinični pomen tega izsledka ni znan, ker so deleži serološke zaščite ostali neokrnjeni.
English: • Inflammation of some blood vessels (vasculitis)
Slovenian: • okužba nekaterih krvnih žil (vaskulitis);
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Twinrix Paediatric should be made taking into account the benefit of breast-feeding to the child and the benefit of Twinrix Paediatric therapy to the woman.
Slovenian: Pri odločanju o nadaljevanju/prekinitvi dojenja ali nadaljevanju/prekinitvi cepljenja s cepivom Twinrix za otroke je treba upoštevati tako korist dojenja za otroka kot korist cepljenja s cepivom Twinrix za otroke za mater.