FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will advise you whether your child should have Hexyon.
Croatian: Liječnik će Vas posavjetovati treba li se Vaše dijete cijepiti cjepivom
English: After a 3-dose WHO EPI schedule with Hexyon (6, 10, 14 weeks) and in the absence of hepatitis B vaccination at birth, a hepatitis B vaccine booster must be given.
Croatian: Nakon primarnog cijepljenja s 3 doze cjepiva Hexyon prema programu SZO EPI (6, 10, 14 tjedana) kada nije provedeno cijepljenje protiv hepatitisa B po rođenju, mora se provesti docjepljivanje protiv hepatitisa B.
English: Poliovirus (Inactivated)4 Type 1 (Mahoney)
Croatian: Inaktivirani virus poliomijelitisa4 Tip 1 (Mahoney)
English: Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, to trace residuals (glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B), to any pertussis vaccine, or after previous administration of Hexyon or a vaccine containing the same components or constituents.
Croatian: Preosjetljivost na djelatne tvari, na bilo koju od pomoćnih tvari navedenih u dijelu 6.1, na tvari zaostale u tragovima (glutaraldehid, formaldehid, nemicin, streptomicin i polimiksin B), na bilo koje cjepivo protiv hripavca, ili nakon prethodnog cijepljenja cjepivom Hexyon ili drugim cjepivom istog sastava.
English: 10 pre-filled syringes (0.5ml) without needle.
Croatian: 10 napunjenih štrcaljki (0,5 ml) bez igle.
English: Hexyon does not protect against infectious diseases caused by other types of Haemophilus influenzae or against meningitis of other origins.
Croatian: Hexyon ne štiti od zaraznih bolesti koje su prouzročene drugim tipovima bakterije Haemophilus influenzae ili drugim uzročnicima meningitisa.
English: Hexyon is provided as a suspension for injection in vial (0.5 ml).
Croatian: Hexyon je suspenzija za injekciju u bočici (0,5 ml).
English: Hexyon is provided as a suspension for injection in pre-filled syringe (0.5 ml).
Croatian: Hexyon je suspenzija za injekciju u napunjenoj štrcaljki (0,5 ml).
English: Sanofi Pasteur Europe, 14 Espace Henry Vallée, 69007 Lyon, France
Croatian: Sanofi Pasteur Europe, 14 Espace Henry Vallée, 69007 Lyon, Francuska
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Hexyon - Carton for vial.
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Hexyon - kutija s bočicama.
English: Table 2: Seroprotection/Seroconversion rates* one month after booster vaccination with Hexyon Antibody Thresholds
Croatian: Tablica 2: Stope serozaštite/serokonverzije* mjesec dana nakon docjepljivanja s cjepivom Hexyon
English: Other side effects not listed above have been reported occasionally with other diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines and not directly with Hexyon:
Croatian: Ostale nuspojave koje nisu gore navedene, a prijavljene su povremeno za druga cjepiva protiv difterije, tetanusa, hripavca, poliomijelitisa, hepatitisa B i Hemofilusa influence tip b, a ne direktno za cjepivo Hexyon:
English: These reactions start within 24-72 hours after vaccination, may be associated with redness, warmth, tenderness or pain at the injection site, and get better within 3-5 days without the need for treatment.
Croatian: Navedene reakcije započinju unutar 24-72 sata nakon cijepljenja, mogu biti udružene s crvenilom, toplinom, osjetljivošću na dodir ili boli na mjestu uboda i povlače se bez liječenja unutar 3-5 dana
English: When a dose of hepatitis B vaccine is given at birth, the sequential infant primary vaccination hexavalent/pentavalent/hexavalent schedule with Hexyon and a pentavalent DTaP-IPV/Hib vaccine can be used in accordance with official recommendations.
Croatian: Kada je po rođenju dobivena doza cjepiva protiv hepatitisa B u seriji primarnog cijepljenja dojenčadi prema programu „šesterovalentno/peterovalentno/šesterovalentno”, može se primijeniti cjepivo Hexyon i peterovalentno DTaP-IPV/Hib cjepivo u skladu sa službenim preporukama.
English: Otherwise, post-booster antibody concentration should be ≥ pre immunisation level (pre-dose 1)
Croatian: U suprotnom, koncentracija protutijela nakon docjepljivanja treba biti jednaka ili veća (≥) razini prije cijepljenja (prije 1. doze).
English: Pharmaco-therapeutic group: Vaccines, Bacterial and viral vaccines combined, ATC code: J07CA09 The immunogenicity of Hexyon in children over 24 months of age has not been studied in clinical trials.
Croatian: Farmakoterapijska skupina: cjepiva, bakterijska i virusna cjepiva u kombinaciji, ATK oznaka: J07CA09
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Hexyon - Carton for pre-filled syringe without needle.
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Hexyon - kutija s napunjenim štrcaljkama bez igle.
English: Anti-diphtheria (≥ 0.01 IU/ml) Anti-tetanus (≥ 0.01 IU/ml) Anti PT (Seroconversion‡‡) (Vaccine response§) Anti FHA (Seroconversion‡‡) (Vaccine response§)
Croatian: Anti-difterija (≥ 0,01 IU/ml) Anti-tetanus (≥ 0,01 IU/ml) Anti-PT (Serokonverzija ‡‡) (Serološki odgovor §) Anti-FHA (Serokonverzija ‡‡) (Serološki odgovor §)
English: After a 3-dose primary vaccination with Hexyon, a booster dose should be given.
Croatian: Nakon završetka primarnog cijepljenja s 3 doze Hexyon, trebalo bi provesti docjepljivanje.
English: 0.5 ml suspension in vial (type I glass) with a stopper (halobutyl).
Croatian: 0,5 ml suspenzije u bočici (staklo tip I) s čepom (halobutil).
English: Hexyon - Carton for pre-filled syringe with two separate needles.
Croatian: Hexyon - kutija s napunjenom štrcaljkom s dvije zasebne igle.
English: Hexyon - Carton for pre-filled syringe with one separate needle.
Croatian: Hexyon - kutija s napunjenom štrcaljkom s jednom zasebnom iglom.
English: • Inflammation of several nerves causing sensory disorders or weakness of limbs
Croatian: • Upala nekoliko živaca koja uzrokuje poremećaj osjeta ili slabost udova (poliradikuloneuritis),
English: Hexyon is available in multipack comprising 5 cartons, each containing 10 pre-filled syringes without attached needle.
Croatian: Hexyon je dostupan u višestrukom pakiranju koje sadrži 5 pakiranja s 10 napunjenih štrcaljki bez pričvršćene igle.
English: Contents of the pack and other information What Hexyon contains The active substances are per dose (0.5 ml)1: Diphtheria Toxoid not less than 20 IU2
Croatian: Jedna doza1 (0,5 ml) sadrži: Toksoid difterije ne manje od 20 IU2
English: • has had respiratory disorder or swelling of the face (anaphylactic reaction) after administration of Hexyon
Croatian: • je imalo poremećaj u disanju ili oteklinu lica (anafilaktična reakcija) nakon primjene cjepiva
English: Hexyon is available in pack containing 1,10 or 50 pre-filled syringes without attached needle.
Croatian: Hexyon je dostupan u pakiranju koje sadrži 1,10 ili 50 napunjenih štrcaljki bez pričvršćene igle.
English: Hexyon in vials
Croatian: Hexyon u bočicama
English: After a 2-dose primary vaccination with Hexyon, a booster dose must be given.
Croatian: Nakon završetka primarnog cijepljenja s 2 doze Hexyon mora se provesti docjepljivanje.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One dose1 (0.5 ml) contains:
Croatian: Jedna doza (0,5 ml) 1 sadrži sljedeće djelatne tvari:
English: Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination.
Croatian: S obzirom na dugu inkubaciju hepatitisa B, postoji mogućnost da je u trenutku cijepljenja prisutna neprepoznata zaraza hepatitisom B. U takvim slučajevima cjepivo možda neće spriječiti infekciju hepatitisom B.
English: Pack size of 1 or 10 pre-filled syringes with or without needle.
Croatian: Veličina pakiranja od 1 ili 10 napunjenih štrcaljki, s ili bez igle Veličina pakiranja od 50 napunjenih štrcaljki bez igle.
English: Hexyon helps to protect against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and serious diseases caused by Haemophilus influenzae type b. Hexyon is given to children from six weeks of age.
Croatian: Hexyon pomaže u zaštiti od difterije, tetanusa, hripavca, hepatitisa B, poliomijelitisa i teških oboljenja prouzročenih bakterijom Haemophilus influenzae tip b.
English: 1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al3+) 2 As lower confidence limit (p= 0.95)
Croatian: 1 Adsorbirana na aluminijev hidroksid, hidratizirani (0,6 mg Al3+) 2 Kao donja granica pouzdanosti (p= 0,95) 3 Ili ekvivalentna aktivnost utvrđena određivanjem imunogenosti 4 Umnožen na Vero stanicama
English: Hexyon is available in pack containing 1 or 10 pre-filled syringes with 2 separate needles.
Croatian: Hexyon je dostupan u pakiranju koje sadrži 1 ili 10 napunjenih štrcaljki s 2 zasebne igle.
English: Marketing Authorisation Holder: Sanofi Pasteur Europe, 14 Espace Henry Vallée, 69007 Lyon, France
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet: Sanofi Pasteur Europe, 14 Espace Henry Vallée, 69007 Lyon, Francuska
English: In addition, immunity against the hepatitis B component of the vaccine has been shown to persist up to 9 years of age after a primary series consisting of one dose of Hepatitis B vaccine given at birth followed by a 3-dose infant series at 2, 4, and 6 months of age without a toddler booster where 49.3%
Croatian: Dodatno, pokazalo se da imunost protiv hepatitis B komponente cjepiva traje do dobi od 9 godina, nakon primarne serije cijepljenja koja se sastoji od jedne doze cjepiva protiv hepatitisa B dobivene po rođenju koju slijedi serija od 3 doze za dojenčad u dobi od 2, 4 i 6 mjeseci bez docjepljivanja te nakon toga u dobi malog djeteta gdje je 49,3% cijepljenih imalo protutijela ≥ 10 mIU/ml s geometrijskom srednjom vrijednosti koncentracija od 13,3 (95% CI: 8,82 - 20,0) mIU/ml.
English: Multipack: 50 (5 packs of 10) pre-filled syringes (0.5ml) without needle.
Croatian: Suspenzija za injekciju u napunjenoj štrcaljki Višestruko pakiranje: 50 (5 pakiranja s 10) napunjenih štrcaljki (0.5ml) bez igle.
English: DTaP-IPV-HB-Hib
Croatian: Hexyon suspenzija za injekciju DTaP-IPV-HB-Hib i.m.
English: • Inflammation of several nerves causing sensory disorders or weakness of limbs (polyradiculoneuritis), facial paralysis, visual disturbances, sudden dimming or loss of vision
Croatian: • Upala nekoliko živaca koja uzrokuje poremećaj osjeta ili slabost udova (poliradikuloneuritis), pareza facijalisa, smetnje vida, iznenadno zamračenje ili gubitak vida (optički neuritis), upala mozga i leđne moždine (demijelinizacija središnjeg živčanog sustava, multipla skleroza)
English: The vaccine effectiveness against Hib invasive disease of DTaP and Hib combination vaccines (pentavalent and hexavalent including vaccines containing the Hib antigen from Hexyon) has been demonstrated in Germany via an extensive (over five years follow-up period) post-marketing surveillance study.
Croatian: Učinkovitost kombiniranih cjepiva DTaP i Hib (pentavalentno i heksavalentno, uključujući cjepiva koja sadrže antigen Hib-a iz cjepiva Hexyon) protiv invazivne bolesti
English: Data on concomitant administration of Hexyon with a pneumococcal polysaccharide conjugate vaccine have shown no clinically relevant interference in the antibody response to each of the antigens.
Croatian: Podaci o istovremenoj primjeni cjepiva Hexyon s polisaharidnim konjugiranim cjepivom protiv pneumokoka nisu pokazali klinički značajnu interferenciju u odgovoru protutijela na svaki od antigena.
English: (polyradiculoneuritis), facial paralysis, visual disturbances, sudden dimming or loss of vision (optic neuritis), inflammatory disease of brain and spinal cord (central nervous system demyelination, multiple sclerosis) have been reported after administration of a hepatitis B antigen containing vaccine.
Croatian: pareza facijalisa, smetnje vida, iznenadno zamračenje ili gubitak vida (optički neuritis), upala mozga i leđne moždine (demijelinizacija središnjeg živčanog sustava, multipla skleroza)
English: N=249** N=123 to
Croatian: N=249**
English: Hexyon is available in pack containing 1 or 10 pre-filled syringes with 1 separate needle.
Croatian: Hexyon je dostupan u pakiranju koje sadrži 1 ili 10 napunjenih štrcaljki s 1 zasebnom iglom.
English: Pack size of 10.
Croatian: Veličina pakiranja od 10.
English: Months
Croatian: mjeseci).
English: What Hexyon is and what it is used for What you need to know before Hexyon is given to your child How to use Hexyon
Croatian: Što morate znati prije nego što Vaše dijete primi cjepivo Hexyon Kako primjenjivati cjepivo Hexyon
English: • has had an allergic reaction - to the active substances, - to any of the excipients listed in section 6, - to glutaraldehyde, formaldehyde, neomycin, streptomycin or polymyxin B, as these substances are used during the manufacturing process - after previous administration of Hexyon or any other diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines.
Croatian: - na glutaraldehid, formaldehid, neomicin, streptomicin ili polimiksin B jer se ove tvari koriste u postupku proizvodnje - na prethodno cijepljenje cjepivom Hexyon ili nekim drugim cjepivom protiv difterije, tetanusa, hripavca, poliomijelitisa, hepatitisa B i Hemofilusa influence tip b.
English: • Temporary inflammation of nerves causing pain, paralysis and sensitivity disorders (GuillainBarré syndrome) and severe pain and decreased mobility of arm and shoulder (brachial neuritis) have been reported after administration of a tetanus containing vaccine.
Croatian: • Privremena upala živaca koja uzrokuje bol, paralizu i poremećaj osjeta (Guillain-Barréov sindrom) i jaka bol i smanjena mogućnosti pokretanja nadlaktice i ramena (brahijalni neuritis)
English: The immune responses to PRP, PT and FHA antigens one month after 2 doses given at 2 and 4 months of age were similar to those observed one month after a 2-dose priming given at 3 and 5 months of age: anti-PRP
Croatian: Imunološki odgovor na PRP, PT i FHA antigene mjesec dana nakon davanja 2 doze u dobi od 2 i 4 mjeseca starosti bio je sličan onome koji je zapažen mjesec dana nakon primarnog cijepljenja s 2 doze u dobi od 3 i 5 mjeseci: titar anti-PRP protutijela ≥ 0,15µg/ml zapažen je u 73,0% ispitanika, anti-PT serološki odgovor u 97,9% ispitanika, a anti-FHA serološki odgovor u 98,6% ispitanika.
English: Data on concomitant administration of a booster dose of Hexyon with measles-mumps-rubella vaccines have shown no clinically relevant interference in the antibody response to each of the antigens.
Croatian: Podaci o istovremenoj primjeni docjepljivanja cjepivom Hexyon s cjepivom protiv ospica-zaušnjakarubeole nisu pokazali klinički značajnu interferenciju u odgovoru protutijela na svaki od antigena.
English: Anti-PRP (≥ 1.0 µg/ml) * Generally accepted surrogates (PT, FHA) or correlates of protection (other components) N = Number of individuals analysed (per protocol set) ** 3, 5 months without hepatitis B vaccination at birth (Finland, Sweden) † 6, 10, 14 weeks with and without hepatitis B vaccination at birth (Republic of South Africa) †† 2, 3, 4 months without hepatitis B vaccination at birth (Finland) ‡ 2, 4, 6 months without hepatitis B vaccination at birth (Mexico) and with hepatitis B vaccination at birth (Costa Rica and Colombia) ‡‡ Seroconversion: minimum 4-fold increase compared to pre-vaccination level (pre-dose 1) § Vaccine response: If pre-vaccination antibody concentration (pre-dose 1) <8 EU/ml, then the post-booster antibody concentration should be ≥8 EU/ml.
Croatian: †† 2, 3, 4 mjeseci bez cijepljenja protiv hepatitisa B pri rođenju (Finska) ‡ 2, 4, 6 mjeseci bez cijepljenja protiv hepatitisa B pri rođenju (Meksiko) i s cijepljenjem protiv hepatitisa B po rođenju (Costa Rica i Kolumbija) ‡‡ Serokonverzija: minimalno četverostruko povećanje u usporedbi s razinom prije cijepljenja (prije 1. doze)
English: NA
Croatian: DRUGO
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hexyon suspension for injection
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA
English: Hexyon will not protect against hepatitis infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E or by other liver pathogens.
Croatian: Hexyon neće zaštititi od infekcije hepatitisom prouzročene drugim patogenima poput virusa hepatitisa
English: Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed).
Croatian: Clostridium tetani, Bordetella pertussis, virus hepatitisa B, poliovirus ili Haemophilus influenzae tip b.
English: When a hepatitis B vaccine is given at birth, after a 3-dose primary vaccination, Hexyon or a pentavalent DTaP-IPV/Hib vaccine can be administered for the booster.
Croatian: za docjepljivanje se može primijeniti cjepivo Hexyon ili peterovalentno DTaP-IPV/Hib cjepivo.
English: Anti-PRP (≥ 0.15 µg/ml) * Generally accepted surrogates (PT, FHA) or correlates of protection (other components) N = Number of individuals analysed (per protocol set) ** 3, 5 months without hepatitis B vaccination at birth (Finland, Sweden) † 6, 10, 14 weeks with and without hepatitis B vaccination at birth (Republic of South Africa) †† 2, 3, 4 months without hepatitis B vaccination at birth (Finland) ‡ 2, 4, 6 months without hepatitis B vaccination at birth (Argentina, Mexico, Peru) and with hepatitis B vaccination at birth (Costa Rica and Colombia) ‡‡ Seroconversion: minimum 4-fold increase compared to pre-vaccination level (pre-dose 1) § Vaccine response: If pre-vaccination antibody concentration <8 EU/ml, then the post-vaccination antibody concentration should be ≥ 8 EU/ml.
Croatian: †† 2, 3, 4 mjeseci bez cijepljenja protiv hepatitisa B pri rođenju (Finska) ‡ 2, 4, 6 mjeseci bez cijepljenja protiv hepatitisa B pri rođenju (Argentina, Meksiko, Peru) i s cijepljenjem protiv hepatitisa B po rođenju (Costa Rica i Kolumbija)
English: Otherwise, post-vaccination antibody concentration should be ≥ pre immunisation level.
Croatian: Odnosno, koncentracija protutijela nakon cijepljenja treba biti jednaka ili veća (≥) razini prije cijepljenja
English: Package leaflet: Information for the user Hexyon suspension for injection Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Croatian: Cjepivo protiv difterije, tetanusa, hripavca (nestanično, komponentno), hepatitisa B (rDNK),
English: EU/1/19/1382/001 Azacitidine Celgene 25 mg/ml
Croatian: EU/1/19/1382/001 Azacitidin Celgene 25 mg/mL prašak za suspenziju za injekciju supkutana primjena bočica (staklo)
English: (Invented) name Strength Pharmaceutical form
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Jačina Farmaceutski oblik
English: Subcutaneous use vial (glass) 100 mg
Croatian: 100 mg
English: 24 July 2013
Croatian: 24. srpnja 2013.
English: 01 October 2013
Croatian: 01. listopada 2013.
English: Implementation of the agreement by the Member States (submission of the variation by the Marketing Authorisation Holder):
Croatian: Provedba sporazuma u zemljama članicama (predaja izmjene nositelja odobrenja za stavljanje lijeka u promet):
English: June 2013 CMDh meeting
Croatian: Sastanak CMDh-a u lipnju 2013.
English: Transmission to National Competent Authorities of the translations of the annexes to the agreement:
Croatian: Prosljeđivanje prijevoda priloga sporazumu nadležnim državnim tijelima:
English: Annex IV
Croatian: Prilog IV Raspored provedbe sporazuma
English: Route of Administration
Croatian: Za potkožnu primjenu
English: Oral use blister (OPA/aluminium/PVC/ aluminium)
Croatian: Kroz usta blister (OPA/aluminij/PVC/alu minij)
English: Strength Pharmaceutical Form
Croatian: Farmaceutski oblik Način primjene
English: MA (EU) number (Invented) name
Croatian: Broj odobrenja u EU
English: Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.
Croatian: Ελλάδα Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.
English: Your doctor will discuss this with you.
Croatian: Liječnik će o tome raspraviti s Vama.
English: Adult and children (1 to 17 years):
Croatian: Odrasli i djeca (u dobi od 1 do 17 godina):
English: Before you begin
Croatian: Prije nego što počnete
English: Both studies were similarly designed.
Croatian: Oba ispitivanja imala su sličan dizajn.
English: • Do check your dose before starting this step.
Croatian: • Provjerite svoju dozu prije nego što počnete s ovim korakom.
English: Reassessment of body weight is recommended every 12 weeks.
Croatian: Ponovna provjera tjelesne težine preporučuje se svakih 12 tjedana.
English: Perform step 3a before step 3b.
Croatian: Provedite korak 3a prije koraka 3b.
English: • Wash your hands with soap and warm water.
Croatian: • Operite ruke sapunom i toplom vodom.
English: Overall survival was similar to placebo.
Croatian: Ukupno preživljenje bilo je slično placebu.
English: Do the following:
Croatian: Učinite sljedeće:
English: • Select a well lit, flat work surface, such as a table.
Croatian: • Odaberite dobro osvijetljenu, ravnu radnu površinu, kao što je stol.
English: One Amgen Center Drive Thousand Oaks, CA 91320 USA
Croatian: One Amgen Center Drive Thousand Oaks, CA 91320 SAD
English: A risk to the newborns/infants cannot be excluded.
Croatian: Rizik za novorođenče/dojenče ne može biti isključen.
English: The overall safety profile was similar to that seen in adults.
Croatian: Ukupan sigurnosni profil bio je sličan onome u odraslih bolesnika.
English: Your doctor will tell you how much you must take.
Croatian: Liječnik će Vam reći koliko morate dobiti.
English: The injection volume may be very small.
Croatian: Injekcijski volumen otopine može biti vrlo malen.
English: Do not use if frozen.
Croatian: Nemojte ga uporabiti ako je zamrznut.
English: The European Medicines Agency has waived the obligation to submit data for children < 1 year.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja podataka koji se odnose na djecu u dobi od < 1 godine.
English: Rhinitis***
Croatian: Rinitis***
English: Always use Nplate exactly as your doctor has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako Vam je rekao Vaš liječnik.
English: IMMEDIATELY continue to step 7.
Croatian: ODMAH nastavite s korakom 7.
English: • allergic reaction;
Croatian: • alergijska reakcija;
English: No overall differences in safety or efficacy have been observed in patients < 65 and ≥ 65 years of age (see section 5.1).
Croatian: Nisu primijećene razlike u sigurnosti i djelotvornosti u bolesnika < 65 i ≥ 65 godina (vidjeti dio 5.1).
English: • if you are allergic to romiplostim or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na romiplostim ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Effects of romiplostim on red and white blood cells
Croatian: Učinci romiplostima na crvene i bijele krvne stanice
English: • Do not touch this area again before giving the injection.
Croatian: • Nemojte više dodirivati to područje prije davanja injekcije.
English: Nplate should be reconstituted in accordance with good aseptic practice.
Croatian: Nplate je potrebno rekonstituirati u skladu s principima dobre aseptičke prakse.
English: Children (1 to 17 years old): in addition to adjusting your dose based on platelet counts, your doctor will also regularly reassess your body weight in order to adjust your dose.
Croatian: Djeca (u dobi od 1 do 17 godina): osim što će prilagoditi Vašu dozu na temelju broja trombocita, Vaš liječnik će također redovito mjeriti Vašu tjelesnu masu kako bi prilagodio Vašu dozu.
English: Date of first authorisation: 4 February 2009 Date of latest renewal: 20 December 2013
Croatian: Datum posljednje obnove: 20. prosinca 2013.
English: Other medicines and Nplate
Croatian: Drugi lijekovi i Nplate
English: What Nplate is and what it is used for
Croatian: Što je Nplate i za što se koristi
English: Administer subcutaneous injection following local protocols and good aseptic technique.
Croatian: Primijenite potkožnu injekciju prema lokalnom protokolu i dobroj aseptičkoj tehnici.
English: Progression of existing Myelodysplastic Syndromes (MDS)
Croatian: Progresija postojećeg mijelodisplastičnog sindroma (MDS)
English: ITP is a disease in which your body's immune system destroys its own platelets.
Croatian: ITP je bolest u kojoj Vaš imunološki sustav uništava vlastite trombocite.