FrancophonIA/ELRC3.0 huggingface dataset:
English: Pumarix suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Croatian: Pumarix suspenzija i emulzija za emulziju za injekciju cjepivo protiv pandemijske influence (H5N1) (fragmentirani virion, inaktivirano, adjuvantirano)
English: • Reactions where the injection was given such as bruising, a hard lump, itching, warmth
Croatian: • reakcije na mjestu primjene injekcije poput modrica, otvrdnuća, svrbeža, topline • otečene žlijezde na vratu
English: The seroprotection rate against A/Indonesia 21 days after booster vaccination was 92% and 69.2% at day 180.
Croatian: Stopa seroprotekcije protiv A/Indonesia 21 dan nakon docjepljivanja bila je 92%, a
English: Animal studies with Pumarix do not indicate reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama provedena s cjepivom Pumarix ne ukazuju na reproduktivnu toksičnost
English: Ten days after the booster dose, the seroprotection rate against A/Turkey/Turkey/1/2005 and A/Indonesia/5/2005 was 99.2%.
Croatian: A/Turkey/Turkey/1/2005 i A/Indonesia/5/2005 bila je 99,2%.
English: Uncommon: abdominal pain, vomiting, dyspepsia, stomach discomfort
Croatian: Manje često: bol u trbuhu, povraćanje, dispepsija, nelagoda u želucu
English: Uncommon: back pain, musculoskeletal stiffness, neck pain, muscle spasms, pain in extremity
Croatian: Manje često: bol u leđima, ukočenost mišićno-koštanog sustava, bol u vratu, grčevi mišića, bol u
English: This can cause bleeding or bruising.
Croatian: • smanjenje broja trombocita u krvi što može uzrokovati krvarenje ili stvaranje modrica.
English: EXP:
Croatian: RMP-a.
English: • if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in this vaccine (listed in section 6) or to thiomersal, to egg and chicken protein, ovalbumin, formaldehyde or to sodium deoxycholate.
Croatian: • jeste li imali bilo kakvu alergijsku reakciju, osim iznenadne životno ugrožavajuće alergijske reakcije, na bilo koji sastojak ovog cjepiva (naveden u dijelu 6) ili na tiomersal, jaja i pileće proteine, ovalbumin, formaldehid ili natrijev deoksikolat.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK CONTAINING 1 PACK OF 50 VIALS OF SUSPENSION AND 2 PACKS OF 25 VIALS OF EMULSION
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU PAKOVANJE KOJE SADRŽI 1 PAKOVANJE OD 50 BOČICA SA SUSPENZIJOM I 2
English: OTHER SPECIAL WARNING(S), IF NECESSARY Suspension to be exclusively mixed with adjuvant emulsion before administration
Croatian: Suspenziju prije primjene treba pomiješati isključivo s emulzijom adjuvansa.
English: The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of vaccine (5 ml).
Croatian: Volumen dobiven miješanjem 1 bočice suspenzije (2,5 ml) i 1 bočice emulzije (2,5 ml) odgovara 10
English: Immune response to A/Indonesia/5/2005
Croatian: Imunološki odgovor na A/Indonesia/5/2005 >60 godina
English: If any of the side effects below occur, please tell your doctor or nurse immediately:
Croatian: Ako dođe do neke od niže navedenih nuspojava, molimo da odmah o tome
English: Excipients: Sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections
Croatian: Pomoćne tvari: natrijev klorid, natrijev hidrogenfosfat, kalijev dihidrogenfosfat, kalijev klorid, voda za
English: If you have previously received one or two doses of a similar H5N1 AS03-containing vaccine
Croatian: Ako ste ranije primili jednu ili dvije doze sličnog H5N1 cjepiva s adjuvansom AS03 • Odrasli stariji od 18 godina: primit ćete jednu dozu cjepiva Pumarix.
English: In another clinical study (Q-Pan-H5N1-001), anti-HA responses against A/Vietnam/1194/2004 following administration of AS03-adjuvanted vaccine containing 3.75 µg derived from A/Indonesia/5/2005 were as follows:
Croatian: U drugom kliničkom ispitivanju (Q-Pan-H5N1-001), zabilježeni su sljedeći anti-HA odgovori protiv soja A/Vietnam/1194/2004 nakon primjene cjepiva s adjuvansom AS03 koje sadrži 3,75 µg dobivenog
English: In a clinical study (D-Pan-H5N1-012), subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from either A/Vietnam/1194/2004 or Indonesia/5/2005 six months after they had received one or two priming doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 on day 0 or on days 0 and 21 respectively.
Croatian: U kliničkom ispitivanju (D-Pan-H5N1-012) osobe od 18 do 60 godina primile su dozu cjepiva s adjuvansom AS03 koje sadrži 3,75 µg HA dobivenog ili od soja A/Vietnam/1194/2004 ili Indonesia/5/2005, šest mjeseci nakon što su primili jednu ili dvije inicijalne doze cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Vietnam/1194/2004, i to samo na 0. dan ili na 0. i 21. dan.
English: After the vaccine is mixed: After mixing, use the vaccine within 24 hours and do not store above 30°C.
Croatian: Nakon miješanja, primijenite cjepivo unutar 24 sata, te nemojte čuvati iznad 30°C.
English: There are no data with Pumarix using the subcutaneous route.
Croatian: Nema podataka o supkutanoj primjeni cjepiva Pumarix.
English: During the pandemic, the applicant will conduct a prospective cohort study as identified in the
Croatian: Za vrijeme pandemije, plan vođenja registra bit će prijavljen kao dio
English: 3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre
Croatian: 3faktor serokonverzije: omjer geometrijske sredine titra (GMT) nakon i prije cijepljenja.
English: One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 manufactured using a different process administered after one or two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 manufactured using a different
Croatian: Jedna doza cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Indonesia/05/2005, proizvedenog različitim postupkom proizvodnje, primijenjena nakon jedne ili dvije doze cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Vietnam/1194/2004 proizvedenog različitim
English: Half dose N=44
Croatian: Pola doze N=44
English: Full dose N=41
Croatian: Puna doza N=41
English: One pack containing: - one pack of 50 vials (type I glass) of 2.5 ml suspension with a stopper (butyl rubber).
Croatian: - jedno pakovanje s 50 bočica (staklo tip I) od 2,5 ml suspenzije s čepom (butil guma).
English: There was no increase after the second dose whether the children received half of the adult or the adult dose, except for some side effects which were higher after the second dose, particularly for rates of fever in < 6 years old
Croatian: Neovisno o tome jesu li djeca primila pola doze ili cijelu dozu za odrasle, nije zabilježeno povećanje učestalosti nakon druge doze, osim kod nekih nuspojava koje su se javljale češće nakon druge doze, što se osobito odnosi na učestalost vrućice u djece mlađe od
English: In another clinical study, 39 subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 fourteen months after they had received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 administered on day 0 and day 21.
Croatian: U drugom kliničkom ispitivanju, 39 ispitanika od 18 do 60 godina je primilo dozu cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Indonesia/5/2005 četrnaest mjeseci nakon što su primili dvije doze cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Vietnam/1194/2004 i to na 0. i 21. dan.
English: NAME OF THE MEDICINAL PRODUCT Pumarix suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Croatian: Uputa o lijeku: informacija za korisnika Pumarix suspenzija i emulzija za emulziju za injekciju cjepivo protiv pandemijske influence (H5N1) (fragmentirani virion, inaktivirano, adjuvantirano)
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde and sodium deoxycholate) of this vaccine.
Croatian: Anamneza anafilaktičke (tj. životno ugrožavajuće) reakcije na bilo koji sastojak ovog cjepiva ili na tvari koje se u cjepivu nalaze u tragovima (jaja i pileći proteini, ovalbumin, formaldehid i natrijev deoksikolat).
English: In a clinical study (Q-Pan-H5N1-010), a booster dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Turkey/Turkey/1/2005 was given 15 months after primary vaccination.
Croatian: U kliničkom ispitivanju (Q-Pan-H5N1-010) 15 mjeseci nakon primovakcinacije provedeno je docjepljivanje dozom cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Turkey/Turkey/1/2005.
English: A clinical study (D-H5N1-009), evaluated the reactogenicity in children 3 to 5 and 6 to 9 years of age who received either two adult (i.e. 0.5 ml) doses or two half adult (i.e. 0.25 ml) doses (21 days apart) of another Pandemic influenza vaccine (H5N1 A/Vietnam/1194/2004 manufactured in Dresden, Germany).
Croatian: U kliničkom ispitivanju (D-H5N1-009) procjenjivana je reaktogenost u djece od 3 do 5 godina, i od 6 do 9 godina, koja su u razmaku od 21 dan primila dvije doze za odrasle (tj. 0,5 ml) ili dvije polovice doze za odrasle (tj. 0,25 ml) drugog Cjepiva protiv pandemijske influence (H5N1
English: In a consistency study (Q-Pan-H5N1-002), the anti-haemagglutinin (anti-HA) antibody responses twenty-one days and six months after the second dose were as follows:
Croatian: U ispitivanju konzistencije (Q-Pan-H5N1-002), odgovori anti-hemaglutinin (anti-HA) protutijela 21
English: Excipients: Thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections
Croatian: Pomoćne tvari: tiomersal, natrijev klorid, natrijev hidrogenfosfat, kalijev dihidrogenfosfat, kalijev
English: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and
Croatian: Adjuvans AS03 sadrži skvalen (10,69 miligrama), DL-α-tokoferol (11,86 miligrama) i polisorbat 80
English: Therefore, monitoring of temperature and measures to lower the fever (such as antipyretic medication as seems clinically necessary) are recommended in young children (e.g. up to approximately 6 years of age) post
Croatian: Stoga se u male djece (u dobi do približno 6 godina) nakon cijepljenja preporučuje kontrola tjelesne temperature i primjena mjera za snižavanje
English: One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Turkey/Turkey/1/2005 administered after two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from Indonesia/5/2005
Croatian: Jedna doza cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Turkey/Turkey/1/2005 primijenjena nakon dvije doze cjepiva s adjuvansom AS03 koje sadrži 3,75 µg HA dobivenog iz soja
English: • one pack containing 50 vials of 2.5 ml suspension (antigen)
Croatian: • jednog pakovanja koje sadrži 50 bočica s 2,5 ml suspenzije (antigen) • dva pakovanja koja sadrže po 25 bočica s 2,5 ml emulzije (adjuvans)
English: Common: redness at the injection site, swelling at the injection site, fever, shivering Uncommon: injection site reactions (such as bruising, induration, pruritus, warmth), asthenia, chest
Croatian: Manje često: reakcije na mjestu injiciranja (poput stvaranja modrica, otvrdnuća, pruritusa, osjećaja
English: The mixed vaccine is a whitish emulsion.
Croatian: Pripremljeno cjepivo je bjelkasta emulzija.
English: • Shortness of breath
Croatian: • osjećaj omaglice
English: Full dose N=42
Croatian: Puna doza N=42
English: Skin and subcutaneous tissue disorders Common: sweating Uncommon: pruritus, rash
Croatian: Poremećaji kože i potkožnog tkiva Često: znojenje
English: The ability to induce protection against homologous and heterologous vaccine strains was assessed non-clinically with A/Indonesia/05/05 (H5N1) using ferret challenge models.
Croatian: U nekliničkom ispitivanju sa sojem A/Indonesia/05/05 (H5N1) procjenjivala se sposobnost poticanja zaštite protiv homolognih i heterolognih sojeva u cjepivu primjenom modela s izlaganjem tvorova.
English: Full dose N=43
Croatian: Puna doza N=43
English: In another clinical study (Q-Pan-H5N1-001), the anti-haemagglutinin (anti-HA) antibody responses in subjects aged 18-64 years were as follows:
Croatian: U drugom kliničkom ispitivanju (Q-Pan-H5N1-001), odgovori anti-hemaglutinin protutijela (anti-HA)
English: Split influenza virus, inactivated, containing antigen* equivalent to: *Antigen: A/Indonesia/5/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Croatian: fragmentirani virus influence, inaktivirani, koji sadrži antigen* koji odgovara: *Antigen: A/Indonesia/05/2005 (H5N1) poput kojeg je korišten soj (PR8-IBCDC-RG2)
English: There was no evidence of an increased risk of adverse outcomes in over 100 pregnancies that were followed in a prospective clinical study.
Croatian: U prospektivnom kliničkom ispitivanju nije bilo dokaza o povećanom riziku od nuspojava u
English: In a clinical study (D-Pan-H5N1-009, -023), children aged 3 to 5 and 6 to 9 years old received two doses of either a full (0.5 ml) or a half dose (0.25 ml) of an AS03-adjuvanted vaccine containing 3.75
Croatian: U kliničkom ispitivanju (D-Pan-H5N1-009, -023) djeca od 3 do 5, te od 6 do 9 godina primila su u dva navrata punu dozu (0,5 ml) ili polovinu doze (0,25 ml) cjepiva s adjuvansom AS03 koje sadrži 3,75 µg HA dobivenog iz soja A/Vietnam/1194/2004 (H5N1) na 0. i 21. dan.
English: Saint-Foy, Quebec,
Croatian: IB Biomedical Corporation of Quebec koja djeluje kao
English: 3.75 micrograms* AS03 adjuvant composed of squalene, DL-α-tocopherol and polysorbate 80
Croatian: Adjuvans AS03 sadrži skvalen, DL-α tokoferol i polisorbat 80
English: Split influenza virus, inactivated, containing antigen* equivalent to: A/H5N1/Indonesia/5/2005 like strain used (PR8-IBCDC-RG2)3.75 micrograms** per 0.5 ml
Croatian: fragmentirani virus influence,inaktiviran, koji sadrži antigen* koji odgovara soju: A/Indonesia/05/2005 (H5N1) poput kojeg je korišten soj (PR8-IBCDC-RG2) 3,75 mikrograma**
English: Nervous system disorders Very common: headache Uncommon: dizziness, paraesthesia
Croatian: Manje često: vrtoglavica Poremećaji dišnog sustava, prsišta i sredoprsja: Manje često: dispneja
English: Immune response to A/Vietnam/1194/2004 3 to 5 years
Croatian: Imunološki odgovor na A/Vietnam/1194/2004 21 dan nakon 2. doze
English: Depending on and after implementation of vaccine strain, when first pandemic will take place.
Croatian: Ovisno o pojavi prve pandemije te soju primijenjenom u cjepivu.
English: Split influenza virus inactivated, containing antigen equivalent to: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Croatian: fragmentirani virus influence,inaktiviran, koji sadrži antigen koji odgovara soju: A/Indonesia/05/2005 (H5N1) poput kojeg je korišten soj (PR8-IBCDC-RG2)
English: A 4-fold increase in serum neutralising antibody against A/Vietnam/1194/2004 was achieved in 44.7% of subjects at day 21, 53.2% at day 42 and 38.3% at day 180.
Croatian: Četverostruki porast neutralizirajućih protutijela protiv A/Indonesia/5/2005 u serumu, postignut je 21. dana u 76,6% ispitanika, 42. dana u 97,9%, te 180. dana u 91,5%, a 100% ispitanika imalo je titar od
English: Presentation of data will take into consideration the following recommendations:
Croatian: uzimajući u obzir službene preporuke.
English: In other clinical studies where children 6 months to 17 years received another pandemic influenza vaccine (H5N1 A/Indonesia/05/2005 manufactured in Dresden, Germany), increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose
Croatian: U drugim kliničkim ispitivanjima, u kojima su djeca u dobi od 6 mjeseci do 17 godina primila drugo cjepivo protiv pandemijske influence (H5N1 A/Indonezija/05/2005, proizvedeno u Dresdenu,
English: Talk to your doctor or nurse before you are given Pumarix:
Croatian: Prije nego što primite Pumarix provjerite sa svojim liječnikom ili medicinskom sestrom:
English: This can cause skin rashes, joint pain and
Croatian: • upala krvnih žila (vaskulitis), što može uzrokovati osipe po koži, bol u zglobovima i probleme s bubrezima
English: Additional side effects in children
Croatian: I DOHVATA DJECE
English: 4.5 Interaction with other medicinal products and other forms of interaction There are no data on co-administration of Pumarix with other vaccines.
Croatian: Nema podataka o istovremenoj primjeni cjepiva Pumarix s drugim cjepivima.
English: In this protection experiment, the ferrets (six ferrets/group) were immunized intramuscularly with vaccine candidate containing four different doses of H5N1 antigen (3.75, 1.5, 0.6 and 0.24 µg of HA antigen) adjuvanted with half dose of AS03.
Croatian: - Model s heterolognim pandemijskim H5N1 sojem (A/Hong Kong/156/97) U tom ispitivanju zaštite, tvorovi (šest tvorova/skupina) su imunizirani intramuskularno predloženim cjepivom koje je sadržavalo četiri različite doze antigena H5N1 (3,75; 1,5; 0,6 i 0,24 µg HA antigena),
English: Fainting can occur following, or even before, any needle injection.
Croatian: Nakon bilo kojeg uboda iglom, a ponekad čak i prije uboda, može doći do gubitka svijesti.
English: 2booster seroconversion rate: proportion of subjects who were either seronegative at pre-booster and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-booster and have a 4
Croatian: 1stopa seroprotekcije (tj. udio ispitanika koji su postigli titar inhibicije hemaglutinacije ≥1:40) 2stopa serokonverzije (tj. udio ispitanika koji su bili seronegativni prije cijepljenja i postigli zaštitni titar ≥1:40 nakon cijepljenja, ili koji su bili seropozitivni prije cijepljenja i imali četverostruki porast
English: Adverse reactions from clinical trials with the mock-up vaccine are listed here below (see section 5.1 for more information on mock-up vaccines).
Croatian: U tekstu koji slijedi navedene su nuspojave iz kliničkih ispitivanja sa 'mock-up' cjepivom (za više
English: The emulsion presents as a whitish appearance.
Croatian: Emulzija je bjelkaste boje.
English: 2seroconversion rate (i.e. proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥ 1:40, or who were seropositive at pre-vaccination and 3seroconversion factor (i.e. ratio of the post-vaccination GMT and the pre-vaccination GMT) Twenty-one days after the second dose, a 4-fold increase in serum neutralising antibody against A/Indonesia/5/2005 was achieved in 94.4% of subjects aged 18-60 years and in 80.4% of subjects over 60 years of age.
Croatian: Dvadeset i jedan dan nakon druge doze, u osoba od 18 do 60 godina postignut je četverostruki porast neutralizirajućih protutijela protiv A/Indonesia/5/2005 u serumu 94,4% ispitanika, a u osoba starijih od 60 godina u 80,4% ispitanika.
English: Administration of an AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) manufactured using a different process Paediatric population
Croatian: Primjena cjepiva koja sadrže adjuvans AS03 i 3,75 µg HA dobivenog iz soja A/Vietnam/1194/2004
English: From post-marketing experience with AS03-containing vaccines containing 3.75 µg HA derived from A/California/7/2009 (H1N1), the following adverse reactions have been reported:
Croatian: Iz postmarketinškog iskustva s AS03-cjepivima koja sadrže 3,75 µg hemaglutinina dobivenog iz soja
English: How Pumarix is given
Croatian: Cjepivo se treba davati
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Croatian: Sažetka opisa svojstava lijeka obnavljati prema potrebi.
English: At day 42, the neutralising antibody responses were as follows: Immune response to A/Vietnam/1194/2004 21 days after 2
Croatian: Četverostruki porast neutralizirajućih protutijela protiv A/Vietnam/1194/2004 u serumu postignut je
English: You may need to read it again.
Croatian: I u tim slučajevima možete primiti
English: • They will give Pumarix as an injection into a muscle
Croatian: Za primjenu u mišić
English: There are very limited safety and immunogenicity data available on the administration of an AS03adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) manufactured using a different process and on administration of half a dose of the same vaccine (i.e. 1.875 µg HA and half the amount of AS03 adjuvant) at 0 and 21 days in children aged 3 to 9 years.
Croatian: Za djecu od 3 do 9 godina postoje vrlo ograničeni podaci o sigurnosti i imunogenosti cjepiva s adjuvansom AS03 koje sadrži 3,75 µg HA dobivenog iz soja A/Vietnam/1194/2004 (H5N1)
English: 6.6 Special precautions for disposal and other handling
Croatian: POSEBNE MJERE ČUVANJA
English: Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Tablet container (HDPE)
Croatian: Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Spremnik za tablete (HDPE)
English: 28 tablets 30 tablets 84 tablets 100 tablets 60 tablets
Croatian: 28 tableta 30 tableta 84 tableta 100 tableta 60 tableta
English: Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Croatian: Filmom obložene tablete Filmom obložene tablete Filmom obložene tablete Filmom obložene tablete Filmom obložene tablete
English: Lamivudine Teva Lamivudine Teva Lamivudine Teva Lamivudine Teva Lamivudine Teva
Croatian: Lamivudin Teva Lamivudin Teva Lamivudin Teva Lamivudin Teva Lamivudin Teva
English: Strength Pharmaceutical Form Route of Administration
Croatian: Farmaceutski oblik Put primjene Unutarnje pakovanje Veličina pakovanja
English: This could be serious.
Croatian: To bi moglo biti ozbiljno.
English: • wearing appropriate protective clothing.
Croatian: • nosite prikladnu zaštitnu odjeću.
English: The patients recovered spontaneously.
Croatian: Bolesnici su se spontano oporavili.
English: Any infection that you already have may get worse.
Croatian: Bilo koja infekcija koju već imate mogla bi se pogoršati.
English: Talk to your doctor about reliable methods of contraception.
Croatian: Porazgovarajte sa svojim liječnikom o pouzdanim metodama kontracepcije.
English: Take Gilenya once a day with a glass of water.
Croatian: Uzimajte Gilenyu jedanput na dan uz čašu vode.
English: The following should be considered:
Croatian: Treba razmotriti sljedeće:
English: The dose depends on body weight:
Croatian: Doza ovisi o tjelesnoj težini:
English: Early on, there may not be any symptoms.
Croatian: U početku možda neće biti nikakvih simptoma.
English: Final Study report by 15 December
Croatian: Završno izvješće o ispitivanju do 15. prosinca
English: Children and adolescents (10 years of age and above):
Croatian: Djeca i adolescenti (10 i više godina):
English: You may need to be monitored more closely.
Croatian: Možda će vas trebati pažljivo pratiti.
English: Do not exceed the recommended dose.
Croatian: Nemojte premašiti preporučenu dozu.
English: • With third degree AV block occurring at any time;
Croatian: • S AV blokom trećeg stupnja koji se pojavi u bilo kojem trenutku;
English: • GILENYA is teratogenic.
Croatian: • GILENYA je teratogena.
English: Teriflunomide is also eliminated slowly from the plasma.
Croatian: Teriflunomid se također sporo eliminira iz plazme.
English: Week Monday Tuesday Wednesday Thursday Friday Saturday Sunday
Croatian: Tjedan Ponedjeljak Utorak Srijeda Četvrtak Petak
English: White blood cells fight infection.
Croatian: Bijele krvne stanice bore se protiv infekcije.
English: Your doctor will tell you whether your illness allows you to drive vehicles, including a bicycle, and use machines safely.
Croatian: Liječnik će Vam reći da li Vam bolest dozvoljava da sigurno upravljate vozilima, uključujući bicikl, i strojevima.
English: During the first twelve months of treatment your doctor will request blood tests to monitor your liver function.
Croatian: Tijekom prvih dvanaest mjeseci liječenja, liječnik će zatražiti krvne pretrage da bi pratio funkciju Vaše jetre.
English: Specifically for Pediatric patients:
Croatian: Posebno za pedijatrijske bolesnike: