FrancophonIA/ELRC3.0 huggingface dataset:
English: In the subjects aged 3 to 5 and 6 to 9 years old who received two doses of either a full or a half dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1), the anti-HA antibody responses against A/Indonesia/5/2005 at day 42 were as follows:
Croatian: U ispitanika u dobi od 3 do 5 i 6 do 9 godina koji su primili dvije doze i to ili dvije cijele doze ili dvije polovine doze AS03-adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Vietnam/1194/2004 (H5N1), odgovori anti-HA protutijela na soj A/Indonesia/5/2005, na 42. dan,
English: Full dose (N=34)
Croatian: Cijela doza (N=34)
English: Half dose (N=44)
Croatian: Pola doze (N=44)
English: Skin and subcutaneous tissue disorders Angioedema, generalised skin reactions, urticaria
Croatian: Angioedem, generalizirane kožne reakcije, urtikarija
English: Single dose N=91
Croatian: Jednostruka doza N=91
English: Musculoskeletal and connective tissue disorders Very common: arthralgia, myalgia
Croatian: Vrlo često: artralgija, mialgija
English: One pack containing: - one pack of 50 vials (type I glass) of 2.5 ml suspension with a stopper (butyl rubber).
Croatian: - jedno pakiranje s 50 bočica (staklo tip I) od 2,5 ml suspenzije, s čepom (butil guma).
English: Full dose N=26
Croatian: Cijela doza N=26
English: Full dose N=27
Croatian: Cijela doza N=27
English: Half dose N=38
Croatian: Pola doze N=38
English: Sodium chloride Disodium hydrogen phosphate Potassium dihydrogen phosphate Potassium chloride Water for injections
Croatian: natrijev klorid natrijev hidrogenfosfat kalijev dihidrogenfosfat kalijev klorid voda za injekcije
English: Half dose N=37
Croatian: Pola doze N=37
English: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Croatian: AS03 adjuvans sadrži skvalen (10,69 miligrama), DL-α-tokoferol (11,86 miligrama) i polisorbat 80 (4,86 miligrama)
English: Immune response to A/Indonesia/5/2005
Croatian: Imunološki odgovor na A/Indonesia/5/2005
English: 1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40; 2seroconversion rate: 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 have a 4fold increase in titre;
Croatian: 1stopa seroprotekcije: udio ispitanika s titrom inhibicije hemaglutinacije (HI) ≥1:40 2stopa serokonverzije: udio ispitanika koji su bili seronegativni prije cijepljenja pa su nakon cijepljenja postigli zaštitni titar od ≥1:40, ili koji su bili seropozitivni prije cijepljenja pa su nakon cijepljenja postigli četverostruko povećanje titra;
English: In another clinical study (D-Pan-H5N1-038), 387 subjects aged 18-60 years received 1 dose of AS03adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 36 months after they had received two doses of A/Vietnam/1194/2004.
Croatian: U drugom kliničkom ispitivanju (D-Pan-H5N1-038), 387 ispitanika u dobi od 18-60 godina primili su jednu dozu AS03-adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Indonesia/5/2005, 36 mjeseci nakon što su primili dvije doze A/Vietnam/1194/2004.
English: Full dose (N=26)
Croatian: Cijela doza (N=26)
English: This can cause bleeding or bruising
Croatian: • nizak broj trombocita. to može uzrokovati krvarenja ili stvaranje modrica.
English: Day 42 N=140
Croatian: 42. dan N=140
English: Seroconversion rate2
Croatian: Stopa serokonverzije2
English: Half dose N=36
Croatian: Pola doze N=36
English: Single dose N=49
Croatian: Jednostruka doza N=49
English: Full dose N=34
Croatian: Cijela doza N=34
English: In a clinical study (D-Pan-H5N1-009), 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 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days.
Croatian: U kliničkom ispitivanju (D-Pan-H5N1-009), djeca u dobi 3 do 5 i 6 do 9 godina primila su dvije doze i to ili cijelu (0,5 ml) ili polovice doze (0,25 ml) AS03-adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Vietnam/1194/2004 (H5N1) na 0. i 21. dan.
English: Day 42 N=42
Croatian: 42. dan N=42
English: Suspension vial:
Croatian: BOČICA SUSPENZIJE
English: 1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 anti-HA antibody
Croatian: 1stopa seroprotekcije: udio ispitanika s titrom inhibicije hemaglutinacije (HI) ≥1:40 anti-HA protutijelo
English: The seroprotection rates 6, 12, 24 and 36 months after the first dose were as follows: anti-HA antibody
Croatian: Stope seroprotekcije u razdobljima 6, 12, 24 i 36 mjeseca nakon prve doze bile su sljedeće:
English: Talk to your doctor or nurse before you are given Prepandrix:
Croatian: Odmah obavijestite svog liječnika ili medicinsku sestru ako se pojave bilo koje od niže navedenih nuspojava:
English: Tel.: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
Croatian: Slovenská republika GlaxoSmithKline Slovakia s.r.o. Tel.: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
English: Psychiatric disorders Uncommon: insomnia
Croatian: Manje često: nesanica
English: Twenty-one days after the second dose, the seroprotection rate and the vaccine response rate in subjects who received the vaccine 12 months apart were 92.0% and 100%, respectively.
Croatian: Dvadeset i jedan dan nakon druge doze, stopa seroprotekcije u ispitanika koji su primili cjepivo u razmaku od 12 mjeseci iznosila je 92,0%, a stopa odgovora na cjepivo 100%.
English: In another clinical study (D-Pan-H5N1-010), 297 subjects aged > 60 years (stratified in ranges from 61 to 70, 71 to 80 and > 80 years of age) received either a single or a double dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days.
Croatian: U drugom kliničkom ispitivanju (D-Pan-H5N1-010), 297 ispitanika u dobi > 60 godina (stratificirani u raspone od 61 do 70, 71 do 80 i > 80 godina) primilo je ili jednostruku ili dvostruku dozu AS03adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Vietnam/1194/2004 (H5N1) na 0. i 21. dan.
English: Month 6 N=48
Croatian: mjesec N=48
English: STATEMENT OF ACTIVE SUBSTANCE(S) Content: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Croatian: Sadržaj: AS03 adjuvans sadrži skvalen (10,69 miligrama), DL-α-tokoferol (11,86 miligrama) i polisorbat 80 (4,86 miligrama)
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 4fold increase in titre;
Croatian: 2stopa serokonverzije: udio ispitanika koji su bili seronegativni prije cijepljenja pa su nakon cijepljenja postigli zaštitni titar od ≥1:40, ili koji su bili seropozitivni prije cijepljenja pa su nakon cijepljenja postigli četverostruko povećanje titra;
English: Immune response to A/Vietnam/1194/2004 6-9 years
Croatian: Imunološki odgovor na A/Vietnam/1194/2004 6-9 godina
English: A 4-fold increase in serum neutralising antibody titres against A/Vietnam was obtained in 49% of subjects twenty-one days after the first dose, 67.3% twenty-one days after the second dose and 44.9% six months after the second dose.
Croatian: 21 dan nakon prve doze kod 49% ispitanika, 21 dan nakon druge doze kod 67,3% ispitanika i šest mjeseci nakon druge doze kod 44,9% ispitanika.
English: After two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 administered on days 0 and 21 to 140 subjects aged 18-60 years, the anti-HA antibody responses to A/Vietnam/1194/2004 were as follows:
Croatian: Nakon primjene dvije doze AS03-adjuvantiranog cjepiva koje sadrži 3,75 µg HA dobivenog iz soja A/Indonesia/05/2005, na 0. i 21. dan kod 140 ispitanika u dobi od 18-60 godina, odgovor anti-HA
English: • one pack containing 50 vials of 2.5 ml suspension (antigen)
Croatian: • jedno pakiranje s 50 bočica s 2,5 ml suspenzije (antigen) • dva pakiranja s 25 bočica s 2,5 ml emulzije (adjuvans)
English: Twenty-one days after the second dose, the seroprotection rate and the vaccine response rate in subjects who received the vaccine 6 months apart were 83.3% and 100%, respectively.
Croatian: Dvadeset i jedan dan nakon druge doze, stopa seroprotekcije u ispitanika koji su primili cjepivo u razmaku od 6 mjeseci iznosila je 83,3%, a stopa odgovora na cjepivo 100%.
English: Immune response to A/Vietnam/1194/2004 12 months after vaccination
Croatian: Imunološki odgovor na A/Vietnam/1194/2004 12 mjeseci nakon cijepljenja
English: Full dose (N=29)
Croatian: Cijela doza (N=29)
English: In clinical trials in which subjects (N=201) received Prepandrix containing 3.75 microgram HA/AS03 of A/Indonesia/05/2005 (H5N1) strain, the types and frequencies of adverse reactions were comparable with those reported below.
Croatian: Prepandrix koji sadrži 3,75 mikrograma HA/AS03 iz soja A/Indonesia/05/2005 (H5N1) bile su komparabilne onima navedenima u nastavku.
English: Half dose (N=27)
Croatian: Pola doze (N=27)
English: Half dose (N=37)
Croatian: Pola doze (N=37)
English: Double dose N=43
Croatian: Dvostruka doza N=43
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.
Croatian: U kliničkom ispitivanju (D-Pan-H5N1-012), ispitanici u dobi od 18-60 godina primili su dozu AS03adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog ili iz soja A/Vietnam/1194/2004 ili Indonesia/5/2005 i to šest mjeseci nakon što su primili jednu ili dvije početne doze AS03adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Vietnam/1194/2004 i to na 0. dan ili na 0. i 21. dan.
English: GlaxoSmithKline Biologicals Branch of SmithKline Beecham Pharma GmbH & Co. KG Zirkusstraße 40, D-01069 Dresden Germany
Croatian: KG Zirkusstraße 40, D-01069 Dresden
English: Full dose N=44
Croatian: Cijela doza N=44
English: Twenty-one days after the second dose, the seroprotection rate and the vaccine response rate in subjects who received the vaccine 12 months apart were 84.0% and 100%, respectively.
Croatian: Dvadeset i jedan dan nakon druge doze, stopa seroprotekcije u ispitanika koji su primili cjepivo u razmaku od 12 mjeseci iznosila je 84,0%, a stopa odgovora na cjepivo 100%.
English: NAME OF THE MEDICINAL PRODUCT Prepandrix suspension and emulsion for emulsion for injection.
Croatian: Prepandrix suspenzija i emulzija za emulziju za injekciju.
English: Half dose (N=47)
Croatian: Pola doze (N=47)
English: Full dose (N=27)
Croatian: Cijela doza (N=27)
English: Half dose N=49
Croatian: Pola doze N=49
English: Immune response to A/Vietnam/1194/2004 3 to 5 years
Croatian: Imunološki odgovor na A/Vietnam/1194/2004 3 do 5 godina
English: Immune response to A/Vietnam/1194/2004 6 months after vaccination
Croatian: Imunološki odgovor na A/Vietnam/1194/2004 6 mjeseci nakon cijepljenja
English: METHOD OF ADMINISTRATION Mix with adjuvant emulsion before use
Croatian: Prije primjene pomiješati s emulzijom adjuvansa.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PACK OF 50 VIALS OF SUSPENSION
Croatian: PAKIRANJE S 50 BOČICA SUSPENZIJE
English: Immune response to A/Vietnam/1194/2004 3-5 years
Croatian: Imunološki odgovor na A/Vietnam/1194/2004 3-5 godina
English: Nervous system disorders Febrile convulsions
Croatian: Febrilne konvulzije
English: However, if this needs to happen, the other vaccine will be injected into the other arm. Any side effects that happen may be more serious.
Croatian: Međutim, ako se istodobna primjena ne može izbjeći, drugo cjepivo treba primijeniti u drugu ruku.
English: Full dose N=42
Croatian: Cijela doza N=42
English: METHOD OF ADMINISTRATION Mix into Antigen suspension before use
Croatian: Prije primjene pomiješati u suspenziju antigena.
English: Half dose N=42
Croatian: Pola doze N=42
English: Half dose N=47
Croatian: Pola doze N=47
English: Month 6 N=40
Croatian: mjesec N=40
English: Half dose N=43
Croatian: Pola doze N=43
English: Half dose N=40
Croatian: Pola doze N=40
English: It is essentially sodium- and potassium-free.
Croatian: zanemarive količine natrija i kalija.
English: The per-dose frequency of adverse reactions was as follows:
Croatian: Učestalost nuspojava prema dozi bila je sljedeća:
English: 3 % of subjects reaching a serum neutralising antibody titre of at least 1:80
Croatian: 2 % ispitanika s titrom ≥1:28 3 % ispitanika koji su dosegnuli titar neutralizirajućih protutijela u serumu od najmanje 1:80
English: The anti-HA and neutralising antibody responses to A/Indonesia/05/2005 elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from this same strain have been shown to be comparable with the immune responses to A/Vietnam/1194/2004 elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from this same strain.
Croatian: AS03-adjuvantiranim cjepivom koje sadrži 3,75 µg hemaglutinina dobivenog iz tog istog soja komparabilni imunološkom odgovoru na soj A/Vietnam/1194/2004 izazvanom AS03-adjuvantiranim cjepivom koje sadrži 3,75 µg hemaglutinina dobivenog iz tog istog soja.
English: Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Magnesium chloride (MgCl2) Water for injections
Croatian: polisorbat 80 oktoksinol 10 tiomersal natrijev klorid (NaCl) natrijev hidrogenfosfat (Na2HPO4) kalijev dihidrogenfosfat (KH2PO4) kalijev klorid (KCl) magnezijev klorid (MgCl2) voda za injekcije
English: • Warmth, itching or bruising where the injection was given
Croatian: • osjećaj topline, svrbež ili stvaranje modrica na mjestu davanja injekcije • pojačano znojenje, drhtanje, simptomi nalik gripi
English: minutes) before each withdrawal.
Croatian: Protresti prije primjene.
English: Fainting can occur following, or even before, any needle injection.
Croatian: Nakon bilo kojeg uboda iglom, ili čak i prije uboda, može doći do gubitka svijesti.
English: List of adverse reactions Adverse reactions reported are listed according to the following frequency:
Croatian: Prijavljene nuspojave navedene su prema sljedećoj učestalosti: Kategorije učestalosti su:
English: Seroprotection rate1 1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40
Croatian: Stopa seroprotekcije1 1stopa seroprotekcije: udio ispitanika s titrom inhibicije hemaglutinacije (HI) ≥1:40
English: QUALITATIVE AND QUANTITATIVE COMPOSITION After mixing, 1 dose (0.5 ml) contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Nakon miješanja, 1 doza (0,5 ml) cjepiva sadrži: fragmentirani virus influence, inaktiviran, koji sadrži antigen* koji odgovara soju:
English: Pain
Croatian: Nuspojave
English: Full dose N=43
Croatian: Cijela doza N=43
English: Seroprotection rate1 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40
Croatian: Stopa seroprotekcije1 stopa seroprotekcije: udio ispitanika s titrom inhibicije hemaglutinacije (HI) ≥1:40
English: Common: may affect up to 1 in 10 people
Croatian: • bol u mišićima, bol u zglobovima Česte: mogu se javiti u do 1 na 10 osoba
English: Immune response to A/Vietnam/1194/2004 6 months after the 1st dose
Croatian: Imunološki odgovor na A/Vietnam/1194/2004 6 mjeseci nakon 1. doze N=256
English: Sodium chloride Disodium hydrogen phosphate Potassium dihydrogen phosphate Potassium chloride Magnesium chloride Water for injections
Croatian: polisorbat 80 oktoksinol 10 tiomersal natrijev klorid natrijev hidrogenfosfat kalijev dihidrogenfosfat kalijev klorid magnezijev klorid voda za injekcije
English: 1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40
Croatian: 1stopa seroprotekcije: udio ispitanika s titrom inhibicije hemaglutinacije (HI) ≥1:40
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PACK OF 25 VIALS OF EMULSION
Croatian: PAKIRANJE S 25 BOČICA S EMULZIJOM
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, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego primite Prepandrix: • ako ste imali bilo koju alergijsku reakciju, izuzev iznenadne životno ugrožavajuće alergijske reakcije, na bilo koji sastojak ovog cjepiva (naveden u dijelu 6) ili na tiomersal, jaja i pileće proteine, ovalbumin, formaldehid, gentamicinsulfat (antibiotik) ili natrijev deoksikolat.
English: Induration
Croatian: Doziranje
English: Immune response to A/Vietnam/1194/2004 Day 21
Croatian: Imunološki odgovor na A/Vietnam/1194/2004 21. dan N=140
English: PHARMACEUTICAL FORM AND CONTENTS Adjuvant emulsion for injection 25 vials: emulsion
Croatian: OBLIK I SADRŽAJ Emulzija adjuvansa za injekciju
English: • Feeling dizzy
Croatian: - učestalost prema dozi
English: GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
Croatian: Tel:+ 39 (0)45 9218 111
English: This can cause skin rashes, joint pain and kidney problems
Croatian: Poremećaji kože i potkožnog tkiva
English: GlaxoSmithKline Pharmaceuticals s.a./n.v.
Croatian: GlaxoSmithKline Biologicals s.a.
English: Uncommon: may affect upt o 1 in 100 people
Croatian: • otečene žlijezde na vratu, u pazusima ili preponama Manje česte: mogu se javiti u do 1 na 100 osoba
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 cjepivima koja sadrže AS03 i 3,75 µg HA dobivenih od soja
English: It should be given at the same time each day.
Croatian: Treba se primjenjivati u isto vrijeme svakog dana.
English: The values were lowered by about 8-10 mmHg.
Croatian: Vrijednosti su snižene za oko 8-10 mmHg.
English: The full EPAR for Ganfort can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Ganfort nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What measures are being taken to ensure the safe and effective use of Ganfort?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ganfort?
English: If more than one type of eye drop is being used, each one should be given at least five minutes apart.
Croatian: Ako se koristi više vrsta kapi, između njihove primjene mora proći barem pet minuta.
English: Ganfort lowered the pressure to less than 18 mmHg in 18.7% of these patients compared with 10.2% with bimatoprost only.
Croatian: Ganfort je snizio očni tlak na manje od 18 mmHg u 18,7 % tih bolesnika u usporedbi s 10,2 % onih koji su primali samo bimatoprost.
English: This is a summary of the European public assessment report (EPAR) for Ganfort.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Ganfort.
English: In addition, more patients given Ganfort had a drop in pressure of more than 20% (67.9% against 48.9%).
Croatian: Nadalje, kod dodatnog broja bolesnika koji su primali Ganfort očni je tlak snižen za više od 20 % (67,9 % u odnosu na 48,9 %).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ganfort on 19 May 2006.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet lijeka Ganfort koje vrijedi na prostoru Europske unije od 19. svibnja 2006.
English: Ganfort is an eye drops solution that contains two active substances: bimatoprost (0.3 mg/ml) and timolol (5 mg/ml).
Croatian: Ganfort je otopina kapi za oči koja sadrži dvije djelatne tvari: bimatoprost (0,3 mg/ml) i timolol (5 mg/ml).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ganfort.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu ocijenio lijek da bi donio svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke za primjenu lijeka Ganfort.
English: It is used in adults with ‘open angle glaucoma' or ocular hypertension who do not respond sufficiently to eye drops containing beta-blockers or prostaglandin analogues (other medicines used for these conditions).
Croatian: Koristi se u odraslih s „glaukomom otvorenog kuta” ili očnom hipertenzijom koji dovoljno ne reagiraju na kapi za oči koje sadrže analogne lijekove beta blokatorima ili prostaglandinima (druge lijekove za liječenje tih stanja).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ganfort have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Ganfort nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: For more information about treatment with Ganfort, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Ganfort pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Ganfort contains two active substances, bimatoprost and timolol, which lower the pressure in the eye in different ways.
Croatian: Ganfort sadrži dvije djelatne tvari, bimatoprost i timolol, koje smanjuju očni tlak na različite načine.
English: The main measures of effectiveness were the average reduction in eye pressure or the number of patients whose eye pressure fell below the target of 18 mmHg (making it within the normal range).
Croatian: Glavna mjera djelotvornosti bilo je prosječno smanjenje očnog tlaka ili broj bolesnika čiji je očni tlak snižen na vrijednost manju od ciljane vrijednosti od 18 mmHg (odnosno na normalan raspon tlaka).
English: Four main studies have been performed involving 1,964 adults with ocular hypertension or glaucoma.
Croatian: Provedena su četiri glavna ispitivanja na 1964 odraslih osoba s očnom hipertenzijom ili glaukomom.
English: ‘Ocular hypertension' is when the pressure in the eye is higher than normal.
Croatian: „Očna hipertenzija” je očni tlak koji je viši od normalnog.
English: Ganfort is given as one drop in the affected eye(s) once a day, either in the morning or the evening.
Croatian: Lijek Ganfort primjenjuje se ukapavanjem jedne kapi u oboljelo oko ili oči jedanput dnevno, ujutro ili navečer.
English: Ganfort was, however, more effective than bimatoprost in patients whose pressure was not controlled with eye drops containing prostaglandins alone.
Croatian: Međutim, Ganfort je bio djelotvorniji od bimatoprosta u bolesnika čiji se očni tlak nije mogao kontrolirati kapima za oči koje su sadržavale samo prostaglandine.
English: Ganfort is used to reduce the pressure inside the eye.
Croatian: Ganfort se koristi za snižavanje tlaka u oku.
English: Ganfort must not be used in patients who have asthma or severe lung disease, or in patients with some heart conditions.
Croatian: Ganfort se ne smije primjenjivati u bolesnika s astmom ili ozbiljnim bolestima pluća kao ni u bolesnika s određenim srčanim problemima.
English: What is the risk associated with Ganfort?
Croatian: Koji su rizici povezani s lijekom Ganfort?