FrancophonIA/ELRC3.0 huggingface dataset:
English: 2 body surface area/day administered by intravenous The recommended dose of topotecan is 1.5 mg/m infusion over 30 minutes daily for five consecutive days with a three week interval between the start of each course.
Slovenian: Začetni odmerek Priporočeni odmerek topotekana je 1,5 mg/m2 telesne površine na dan, z intravensko infuzijo, ki traja po 30 minut dnevno, v ciklih po pet zaporednih dni in s tritedenskimi presledki med začetki vsakega cikla zdravljenja.
English: The second study included a dose range of 2.0 mg/m2 to 5.2 mg/m2 in children (n = 8), adolescents (n = 3), and young adults (n = 3) with leukaemia.
Slovenian: V drugi študiji so otroci (n = 8), mladostniki (n = 3) in mlajši odrasli (n = 3) z levkemijo prejemali odmerek od 2,0 mg/m2 do 5,2 mg/m2.
English: 1 ml concentrate in type 1 clear glass vial, together with grey butyl rubber stopper and aluminium seal with blue polypropylene flip-off cap, and with yellow vial ring collar.
Slovenian: 1 ml koncentrata v viali iz prozornega stekla (tip I), ki je opremljena s sivim zamaškom iz butilne gume, aluminijasto zaporko z modrim polipropilenskim pokrovčkom (flip-off) in rumenim obročkom na vratu viale.
English: Not known: severe bleeding (associated with thrombocytopenia) Respiratory, thoracic and mediastinal disorders Rare: interstitial lung disease (some cases have been fatal)
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Redki: intersticijska bolezen pljuč (nekateri primeri s smrtnim izidom).
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Slovenian: • Če kateri koli neželeni učinek postane resen, ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
English: 5 ml concentrate in type 1 clear glass vial, together with grey butyl rubber stopper and aluminium seal with yellow polypropylene flip-off cap, and with yellow vial ring collar.
Slovenian: 5 ml koncentrata v viali iz prozornega stekla (tip I), ki je opremljena s sivim zamaškom iz butilne gume, aluminijasto zaporko z rumenim propilenskim pokrovom (flip-off) in rumenim obročkom.
English: What Topotecan Eagle looks like and contents of the pack - Topotecan Eagle is a clear yellow to orange liquid in a colourless glass vial with a butyl rubber stopper, aluminium seal and blue snap-cap and with yellow vial ring collar.
Slovenian: • Zdravilo Topotekan Eagle je bistra, rumena do oranžna tekočina v viali iz prozornega stekla, ki je opremljena z zamaškom iz butilne gume, aluminijasto zaporko z modrim pokrovom in rumenim
English: Cervical cancer - The usual dose is 0.75 mg of the medicine for each square meter of your body.
Slovenian: • običajni odmerek je 0,75 mg zdravila na kvadratni meter telesne površine;
English: For reduced dose '0.60 mg/m
Slovenian: Za zmanjšani odmerek „0,60 mg/m
English: Patients with prior Cisplatin chemoradiotherapy
Slovenian: Bolnice s predhodno kemoterapijo s cisplatinom topotekan/cisplatin
English: For reduced dose '0.45 mg/m
Slovenian: Za zmanjšani odmerek „0,45 mg/m
English: • Lung inflammation (rare), with signs such as: - difficulty in breathing - cough - fever.
Slovenian: • Vnetje pljuč (redko) z znaki, kot so:
English: - Do not breast-feed while using Topotecan Eagle.
Slovenian: • Med zdravljenjem z zdravilom Topotekan Eagle ne smete dojiti.
English: Rare - severe allergic (anaphylactic) reactions causing swelling of the lips, face or neck leading to severe difficulty in breathing, skin rash or hives, anaphylactic shock (a severe reduction in blood pressure, paleness, agitation, weak pulse, decreased consciousness) - sudden swelling of the skin and mucosa (e.g. throat or tongue) caused by fluid build up (angioedema) - itchy rash (or hives).
Slovenian: • hude alergijske (anafilaktične), ki povzročijo otekanje ustnic, obraza ali vratu, kar vodi v oteženo dihanje, kožni izpuščaj ali koprivnica, anafilaktični šok (hud padec krvnega tlaka, bledost,
English: Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥ 1.5 x 109/l, a platelet count of ≥ 100 x 109/l and a haemoglobin level of ≥ 9 g/dl (after transfusion if necessary).
Slovenian: Pred prvim ciklom zdravljenja s topotekanom morajo imeti bolniki izhodiščno število nevtrofilcev  1,5 x 109/l, število trombocitov  100 x 109/l in koncentracijo hemoglobina  9 g/dl (po transfuziji, če je le-ta potrebna).
English: Mild abdominal pain was also reported amongst 4 % of patients.
Slovenian: 4 % bolnikov je imelo blage bolečine v trebuhu.
English: - unusual bruising or bleeding, sometimes severe.
Slovenian: • neobičajne (lahko hujše) podplutbe ali krvavitve.
English: Topotecan should not be re-administered unless the neutrophil count is more than or equal to 1.5 x 109/l, the platelet count is more than or equal to 100 x 109/l, and the haemoglobin level is more than or equal to 9 g/dl (after transfusion if necessary).
Slovenian: Bolnica topotekana ne sme prejeti, če število nevtrofilcev ni večje ali enako 1,5 x 109/l, število trombocitov večje ali enako 100 x 109/l in vrednost hemoglobina večja ali enaka 9 g/dl (po transfuziji, če je le-ta potrebna).
English: Topotecan Eagle 3 mg/1 ml is for single use only.
Slovenian: Zdravilo Topotekan Eagle 3 mg/1 ml je za enkratno uporabo.
English: ITT population Cisplatin 50mg/m d.1
Slovenian: cisplatin 50 mg/m2 1. dan +
English: Each 1 ml single dose vial contains 3 mg of topotecan.
Slovenian: Ena 1 ml enoodmerna viala vsebuje 3 mg topotekana.
English: Instructions for Preparation for Intravenous Administration for Small Cell Lung Cancer For recommended dose '1.5 mg/m2'
Slovenian: Navodilo za pripravo za intravensko dajanje pri drobnoceličnem pljučnem raku Za priporočeni odmerek „1,5 mg/m
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 1 ml vial
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA 1 ml viala
English: EXP Read the leaflet for the shelf life of the diluted product.
Slovenian: EXP Za rok uporabnosti razredčenega zdravila glejte priloženo navodilo.
English: Difference in response rate (95 % CI) Median time to progression (weeks)
Slovenian: Mediani čas do napredovanja (tedni) (95 % IZ)
English: - fever - sudden decline of your general health - sore throat or burning sensation when passing water - severe stomach pain, fever and possibly diarrhoea (rarely with blood in it) - these can be signs of bowel inflammation (neutropenic colitis).
Slovenian: ‐ resno poslabšanje splošnega zdravstvenega stanja; ‐ vnetje žrela ali pekoč občutek med uriniranjem; ‐ huda bolečina v želodcu, povišana telesna temperatura in lahko tudi driska (redko krvava),
English: For reduced dose '1.25 mg/m2'
Slovenian: Za zmanjšani odmerek „1,25 mg/m
English: Very common: nausea, vomiting and diarrhoea (all of which may be severe), constipation,
Slovenian: Zelo pogosti: navzeja, bruhanje in driska (vse lahko hudo), zaprtje, abdominalna bolečina1*, mukozitis.
English: - One ml of concentrate for solution for infusion contains 3 mg topotecan (as hydrochloride).
Slovenian: • En ml koncentrata za raztopino za infundiranje vsebuje 3 mg topotekana (v obliki klorida).
English: The concentration of topotecan in the 5 ml vial is higher (3 mg/ml) than with other topotecan products.
Slovenian: Koncentracija topotekana v 5 ml viali je večja (3 mg/ml) kot pri drugih zdravilih s topotekanom.
English: The concentration of topotecan is higher (3 mg/ml) than with other topotecan products.
Slovenian: Koncentracija topotekana je večja (3 mg/ml) kot pri drugih zdravilih s topotekanom.
English: Median (95 % C.I) Hazard ratio (95 % C.I.)
Slovenian: Mediana vrednost (95 % interval zaupanja) Razmerje tveganja (95 % interval zaupanja) Log rank p-vrednost
English: Severe (grade 3 or 4) nausea, vomiting, diarrhoea and mucositis incidence was 4, 3, 2 and 1 % respectively.
Slovenian: Hude oblike (3. ali 4. stopnje) motenj so ugotavljali v naslednjih odstotkih: navzea 4 %, bruhanje 3 %, driska 2 %, mukozitis 1 %.
English: Cervical Carcinoma
Slovenian: Karcinom materničnega vratu
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: Common: hypersensitivity reaction including rash Rare: anaphylactic reaction, angioedema, urticaria
Slovenian: Redki: anafilaktična reakcija, angioedem, urtikarija.
English: − already have severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils < 1.5 x 109/l and/or a platelet count of < 100 x 109/l.
Slovenian: - bolnicah, ki dojijo (glejte poglavje 4.6); - bolnikih, ki imajo hudo depresijo kostnega mozga že pred začetkom prvega cikla, kar je razvidno iz izhodiščnega števila nevtrofilcev < 1,5 x 109/l in/ali števila trombocitov
English: Hydrochloric acid (E507) (for pH adjustment) Water for injections
Slovenian: 6.1 Seznam pomožnih snovi klorovodikova kislina (E507) (za uravnavanje pH) voda za injekcije
English: The concentration of topotecan in the 1 ml vial is higher (3 mg/ml) than with other topotecan products.
Slovenian: Koncentracija topotekana v 1 ml viali je večja (3 mg/ml) kot pri drugih zdravilih s topotekanom.
English: Common: malaise
Slovenian: Pogosti: pruritus.
English: To be diluted before use.
Slovenian: Pred uporabo razredčiti.
English: One Phase 2 study (Study 065) and one Phase 3 study (Study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed ≥ 90 days after completion of one prior regimen of chemotherapy (see Table 1).
Slovenian: Za oceno učinkovitosti peroralnega topotekana v primerjavi z intravenskim topotekanom pri bolnikih, ki se jim je pojavil relaps ≥ 90 dni po koncu ene predhodne sheme kemoterapije, sta bili narejeni ena študija 2. faze (študija 065) in ena študija 3. faze (študija 396) (glejte preglednico 1).
English: surface area
Slovenian: Station Approach
English: Cisplatin 50mg/m d.1 + Topotecan 0.75mg/m2 dx3 q21
Slovenian: topotekan 2/dan x 3 0,75 mg/m na 21 dni
English: Hazard ratio (95 % CI) Response rate (%)
Slovenian: Delež odziva (%) (95 % IZ)
English: 2 Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4)
Slovenian: 2 Pri bolnikih, ki so se zdravili s topotekanom, so poročali o smrti zaradi sepse (glejte poglavje
English: Very common: febrile neutropenia, neutropenia (see Gastrointestinal disorders),
Slovenian: Zelo pogosti: nevtropenija s sočasno povišano telesno temperaturo, nevtropenija (glejte Bolezni prebavil), trombocitopenija, anemija, levkopenija.
English: How Topotecan Eagle is given Topotecan Eagle is normally given by a doctor or nurse: - as a drip (infusion) for about 30 minutes - usually into your arm.
Slovenian: Kako se zdravilo Topotekan Eagle daje Zdravilo Topotekan Eagle običajno daje zdravnik ali medicinska sestra:
English: This medicine is not recommended if you have severe liver problems; - if you have lung problems, or if you have had lung problems before from using other medicines or radiation.
Slovenian: • če imate težave s pljuči ali če ste že imeli težave s pljuči zaradi drugih zdravil ali obsevanja.
English: Topotecan should not be re-administered unless the neutrophil count is ≥ 1 x 109/l, the platelet count is ≥ 100 x 109/l, and the haemoglobin level is ≥ 9 g/dl (after transfusion if necessary).
Slovenian: Pred naslednjo uporabo topotekana mora biti število nevtrofilcev  1 x 109/l, število trombocitov  100 x 109/l, vrednost hemoglobina pa  9 g/dl (po transfuziji, če je le-ta potrebna).
English: Oral and intravenous topotecan were associated with similar symptom palliation in patients with relapsed sensitive SCLC in patient selfreports on an unblinded symptom scale assessment in each of these two studies.
Slovenian: Na podlagi neslepljene ocene lestvice simptomov po navedbi bolnikov samih v obeh teh študijah sta peroralni in intravenski topotekan pri bolnikih z relapsom občutljivega drobnoceličnega pljučnega raka dosegla podobno ublažitev simptomov.
English: Topotecan/Cisplatin
Slovenian: Peroralni topotekan
English: A.
Slovenian: Ena
English: Cisplatin is administered as an intravenous infusion on day 1 at a dose of 50 mg/m2/day and following the topotecan dose.
Slovenian: Bolnica ga 1., 2. in 3. dan prejme v obliki 30minutne intravenske infuzije enkrat na dan. 1. dan po prejemu odmerka topotekana bolnica prejme še intravensko infuzijo cisplatina v odmerku 50 mg/m2/dan.
English: - if you are breast-feeding.
Slovenian: • če imate težave z jetri.
English: Insufficient data are available to make a recommendation for patients with a creatinine clearance < 20 ml/min.
Slovenian: Samostojno zdravljenje (drobnocelični pljučni karcinom) Za zdravljenje bolnikov z očistkom kreatinina < 20 ml/min ne moremo priporočiti ustreznih odmerkov, saj imamo premalo izkušenj.
English: Small cell lung cancer - The usual dose is 1.5 mg of the medicine for each square meter of your body.
Slovenian: • običajni odmerek je 1,5 mg zdravila na kvadratni meter telesne površine;
English: NAME OF THE MEDICINAL PRODUCT Topotecan Eagle 3 mg/1 ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA Topotekan Eagle 3 mg/1 ml koncentrat za raztopino za infundiranje
English: − are breast feeding (see section 4.6)
Slovenian: (glejte poglavje 4.5).
English: Median survival (weeks)
Slovenian: Mediano preživetje (tedni) (95 % IZ)
English: Hydrochloric acid (E507) Water for injections
Slovenian: 6.1 Seznam pomožnih snovi klorovodikova kislina (E507) (za uravnanje pH) voda za injekcije
English: NAME OF THE MEDICINAL PRODUCT Topotecan Eagle 15 mg/5 ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA Topotekan Eagle 15 mg/5 ml koncentrat za raztopino za infundiranje
English: For more information about cisplatin, please read its Package Leaflet.
Slovenian: Več informacij o cisplatinu najdete v njegovem navodilu za uporabo.
English: Topotecan Eagle 15 mg/5 ml concentrate for solution for infusion topotecan
Slovenian: Topotekan Eagle 15 mg/5 ml koncentrat za raztopino za infundiranje topotekan
English: Tell your doctor immediately if you notice any of the following serious side effects.
Slovenian: Če opazite katerega od naslednjih resnih neželenih učinkov, nemudoma obvestite zdravnika.
English: For reduced dose '1.0 mg/m2'
Slovenian: Za zmanjšani odmerek „1,0 mg/m
English: Topotecan Eagle 3 mg/1 ml concentrate for solution for infusion Topotecan
Slovenian: Topotekan Eagle 3 mg/1 ml koncentrat za raztopino za infundiranje topotekan
English: In another randomised phase III trial which compared intravenous topotecan to cyclophosphamide, Adriamycin (doxorubicin) and vincristine (CAV) in patients with relapsed, sensitive SCLC, the overall response rate was 24.3 % for topotecan compared to 18.3 % for the CAV group.
Slovenian: V drugi randomizirani raziskavi III. faze so primerjali intravenski topotekan s ciklofosfamidom, Adriamycinom (doksorubicin) in vinkristinom (CAV).
English: Cytotoxic Notice concentration or life-threatening overdose may occur.
Slovenian: Citotoksično zdravilo Upoštevajte koncentracijo, sicer lahko pride do življenjsko nevarnega prevelikega odmerjanja.
English: In patients (n = 39) with recurrence within 180 days after chemoradiotherapy with cisplatin, the median survival in the topotecan plus cisplatin arm was 4.6 months (95 % C.I.
Slovenian: Pri bolnicah (n = 39) s ponovitvijo v 180 dneh po kemoradioterapiji s cisplatinom je bila mediana vrednost preživetja v skupini, ki je prejemala topotekan in cisplatin, 4,6 meseca (95 % interval zaupanja: 2,6; 6,1), v skupini, ki je prejemala cisplatin, pa 4,5 meseca (95 % intervala zaupanja: 2,9; 9,6), razmerje tveganja 1,15 (0,59; 2,23).
English: Topotecan is contraindicated in patients who
Slovenian: Topotekan je kontraindiciran pri: - bolnikih, ki imajo v anamnezi hudo preobčutljivostno reakcijo na zdravilno učinkovino ali
English: Common - mild allergic reactions (including rash) - yellow skin (jaundice) caused by liver problems - itching (pruritus)
Slovenian: • rumeno obarvanje kože (zlatenica) zaradi težav z jetri;
English: It is a type of chemotherapy.
Slovenian: • ponovitve drobnoceličnega pljučnega raka po kemoterapiji.
English: Concentrate for solution for infusion (3 mg/ml)
Slovenian: klorovodikova kislina (E507) voda za injekcije koncentrat za raztopino za infundiranje (3 mg/ml)
English: The recommended dose of topotecan is 0.75 mg/m2/day administered as 30 minute intravenous infusion daily on days 1, 2 and 3.
Slovenian: Priporočeni odmerek topotekana je 0,75 mg/m2/dan.
English: Median (95 % C.I.)
Slovenian: Mediana vrednost (95 % interval zaupanja)
English: : 4.9, 9.5) for the cisplatin arm with an hazard ratio of 0.75 (0.49, 1.16).
Slovenian: Pri bolnicah (n = 102) s ponovitvijo po 180 dneh je bila mediana vrednost preživetja v skupini, ki je prejemala topotekan in cisplatin, 9,9 meseca (95 % interval zaupanja: 7; 12,6) v skupini, ki je prejemala cisplatin, pa 6,3 meseca (95 % interval zaupanja: 4,9; 9,5), razmerje tveganja 0,75 (0,49; 1,16).
English: Read the leaflet for the shelf life of the diluted product.
Slovenian: Za rok uporabnosti razredčenega zdravila glejte priloženo navodilo.
English: Topotecan Eagle 3 mg/1 ml concentrate for solution for infusion topotecan
Slovenian: NAVODILO ZA UPORABO Topotekan Eagle 3 mg/1 ml koncentrat za raztopino za infundiranje topotekan
English: Topotecan Eagle 15 mg/5 ml concentrate for solution for infusion Topotecan
Slovenian: NAVODILO ZA UPORABO Topotekan Eagle 15 mg/5 ml koncentrat za raztopino za infundiranje topotekan
English: This medicine is not recommended if you have severe kidney problems; - if you have liver problems.
Slovenian: Zdravila Topotekan Eagle se ne priporoča v primeru hudih težav z ledvicami;
English: NAME OF THE MEDICINAL PRODUCT Topotecan Eagle 3 mg/1 ml concentrate for solution for infusion topotecan
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Topotekan Eagle 3 mg/1 ml koncentrat za raztopino za infundiranje topotekan i.v.
English: You should stop breast-feeding before starting treatment with
Slovenian: Pred začetkom zdravljenja z zdravilom Topotekan Eagle morate prekiniti z
English: NAME OF THE MEDICINAL PRODUCT Topotecan Eagle 15 mg/5 ml concentrate for solution for infusion topotecan
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Topotekan Eagle 15 mg/5 ml koncentrat za raztopino za infundiranje topotekan i.v.
English: The information provided in the Physician Leaflet should provide information on dose reduction, discontinuation and wash out procedures in the event of raised ALT.
Slovenian: Informacije v navodilu za zdravnika morajo vsebovati podatke o prilagajanju odmerka, prenehanju zdravljenja in postopkih za odstranitev v primeru povišanih vrednosti ALT.
English: • The identified risk of synergistic hepato- or haematotoxicity associated with combination therapy with another Disease-Modifying Antirheumatic Drug (e.g. methotrexate)
Slovenian: • O ugotovljenem tveganju za sinergistično hepato ali hematotoksičnost v povezavi s kombinirano terapijo z drugimi imunomodulirajočimi protirevmatičnimi zdravili (diseasemodifying antirheumatic drug (DMARD) (na primer metotreksat).
English: The Member States shall ensure that the Marketing Authorisation Holder (MAH) provides physicians who are expected to prescribe/use Repso with a physician educational pack containing the following:
Slovenian: Imetnik dovoljenja za promet bo poskrbel, da bodo vsi zdravniki, ki nameravajo predpisovati zdravilo Repso dobili izobraževalno gradivo, ki vsebuje:
English: • That there is a risk of severe liver injury and so regular measurement of ALT (SGPT) levels to monitor liver function is important.
Slovenian: • Da obstaja tveganje za hudo jetrno poškodbo in je zato pomembno redno spremljanje jetrne funkcije z meritvami vrednosti ALT (SGPT).
English: • inactivated polioviruses;
Slovenian: • inaktivirane polioviruse;
English: The choice of booster vaccine depends on official recommendations.
Slovenian: Izbira poživitvenega cepiva je odvisna od uradnih priporočil.
English: The main measure of effectiveness was the production of protective antibodies.
Slovenian: Glavno merilo učinkovitosti je bila tvorba zaščitnih protiteles.
English: • parts of the hepatitis B virus;
Slovenian: • dele virusa hepatitisa B;
English: The full EPAR for Infanrix hexa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Infanrix hexa je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) to defend the body against the infections.
Slovenian: Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo“, kako naj brani telo pred okužbami.
English: This is a summary of the European public assessment report (EPAR) for Infanrix hexa.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Infanrix hexa.
English: The European Medicines Agency therefore decided that Infanrix hexa's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Infanrix hexa večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
English: Infanrix hexa has been studied in nine studies, involving a total of almost 5,000 children aged between 6 weeks and 2 years.
Slovenian: Zdravilo Infanrix hexa so raziskali v devetih študijah, v katere je bilo skupaj vključenih skoraj 5 000 otrok, starih od šest tednov do dveh let.
English: • toxoids (chemically weakened toxins) from diphtheria and tetanus;
Slovenian: • toksoide (kemično oslabljene toksine) davice in tetanusa;
English: The European Commission granted a marketing authorisation valid throughout the EU for Infanrix hexa on 23 October 2000.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Infanrix hexa, veljavno po vsej Evropski uniji, izdala 23. oktobra 2000.
English: What measures are being taken to ensure the safe and effective use of Infanrix hexa?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Infanrix hexa?
English: The vaccination schedule for Infanrix hexa is a course of 2 or 3 doses, given at least 1 month apart, according to official recommendations, usually in the first 6 months of life.
Slovenian: Program cepljenja za zdravilo Infanrix hexa sta 2 ali 3 odmerki, ki se dajo v razmaku vsaj enega meseca, v skladu z uradnimi priporočili, običajno v prvih šestih mesecih življenja.
English: When a child is given the vaccine, the immune system recognises the parts of the bacteria and viruses in the vaccine as ‘foreign' and makes antibodies against them.
Slovenian: Ko otrok prejme cepivo, imunski sistem prepozna dele bakterij in virusov v cepivu kot „tujke“ in proti njim razvije protitelesa.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Infanrix hexa have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Infanrix hexa upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Other information about Infanrix hexa:
Slovenian: Druge informacije o zdravilu Infanrix hexa:
English: Infanrix hexa must not be used in infants who have had encephalopathy (brain disease) of unknown cause within 7 days of receiving a pertussis vaccine.
Slovenian: Cepivo Infanrix hexa se ne sme uporabljati pri dojenčkih, ki so v preteklosti preboleli encefalopatijo (obolenje možganov) neznanega vzroka v sedmih dneh po prejemu cepiva proti oslovskemu kašlju.
English: • parts of Bordetella pertussis (B. pertussis, a bacterium that causes whooping cough);
Slovenian: • dele bakterije Bordetella pertussis (B. pertussis, bakterije, ki povzroča oslovski kašelj);