natgillin/translations-raw huggingface dataset:
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-vaccination.
Stoga se u male djece (u dobi do približno 6 godina) nakon cijepljenja preporučuje kontrola tjelesne temperature i primjena mjera za snižavanje vrućice (poput antipiretika, prema kliničkoj potrebi).
Single dose N=13
Jednostruka doza N=13
METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use
NAČIN I PUT(EVI) PRIMJENE LIJEKA
Day 21 N=140
21. dan N=140
A 4-fold increase in serum neutralising antibody titres was observed in 79.2% of subjects twenty-one days after the first dose, 95.8% twenty-one days after the second dose and 87.5% six months after the second dose.
79,2% ispitanika, 21 dan nakon druge doze u 95,8% ispitanika i šest mjeseci nakon druge doze u 87,5% ispitanika.
Full dose N=35
Cijela doza N=35
A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2) I.M.
A/Indonesia/05/2005 (H5N1) poput kojeg je korišten soj (PR8-IBCDC-RG2) i.m.
• Sleeplessness
• pospanost • nesanica
Administration of an AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1)
Primjena AS03-adjuvantiranog cjepiva koje sadrži 3,75 µg HA dobivenog iz soja A/Vietnam/1194/2004 (H5N1)
Double dose N=54
Dvostruka doza N=54
Twelve and twenty-four months after vaccination, the neutralising antibody titres were as follows:
Dvanaest i 24 mjeseca nakon cijepljenja, titri neutralizirajućih antitijela bili su sljedeći: Neutralizirajuća protutijela u serumu
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 pandemic preparedness vaccine (H5N1 A/Vietnam/1194/2004 manufactured in Dresden, Germany).
U kliničkom ispitivanju (D-H5N1-009) procijenjena je reaktogenost u djece u dobi od 3 do 5, odnosno od 6 do 9 godina, koja su u razmaku od 21 dan primila ili dvije doze za odrasle (tj. 0,5 ml) ili dvije polovice doze za odrasle (tj. 0,25 ml) cjepiva spremnog protiv pandemijske influence (H5N1 A/Vietnam/1194/2004, proizvedeno u Dresdenu u Njemačkoj).
One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 administered after one or two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004.
Jedna doza AS03-adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Indonesia/05/2005, primijenjena nakon jedne ili dvije doze AS03-adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Vietnam/1194/2004.
Day 42 N=46
42. dan N=46
Full dose (N=41)
Cijela doza (N=41)
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ
Immune response to A/Indonesia/5/2005 3 to 5 years
Imunološki odgovor na A/Indonesia/5/2005 3 do 5 godina
Read the package leaflet before use
Prije uporabe pročitati uputu o lijeku
In the event of other variation being observed, discard the vaccine.
U slučaju da primijetite nekakvo odstupanje od opisanog, bacite cjepivo.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant emulsion for Prepandrix
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Emulzija adjuvansa za Prepandrix i.m.
Half dose (N=50)
Pola doze (N=50)
• Itching, rash
• svrbež, osip
In a clinical study, children 3 to 9 years of age have received either two adult (0.5 ml) or two half adult (0.25 ml) doses of a similar vaccine containing A/Vietnam/1194/2004.
U kliničkom ispitivanju, djeca u dobi od 3 do 9 godina primila su ili dvije doze za odrasle (0,5 ml) ili dvije polovice doze za odrasle (0,25 ml) sličnog cjepiva koje je sadržavalo soj A/Vietnam/1194/2004.
A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
A/Indonesia/05/2005 (H5N1) poput kojeg je korišten soj (PR8-IBCDC-RG2)
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine.
Anafilaktička reakcija (tj. životno ugrožavajuća) u anamnezi na bilo koji sastojak ovog cjepiva ili na tvari koje se u cjepivu nalaze u tragovima (jaja i pileći proteini, ovalbumin, formaldehid, gentamicin sulfat i natrijev deoksikolat).
12 months after vaccination
12 mjeseci nakon cijepljenja
Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1):
Imunološki odgovori križne reaktivnosti izazvani AS03-adjuvantiranim cjepivom koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Vietnam/1194/2004 (H5N1):
These transitory false-positive results may be due to IgM production in response to the vaccine.
Prolazne lažno pozitivne reakcije mogu biti posljedica stvaranja
The suspension and emulsion vials once mixed form a multidose container.
Miješanjem sadržaja bočica suspenzije i emulzije dobiva se višedozni spremnik.
General disorders and administration site conditions Very common: induration, swelling, pain and redness at the injection site, fever, fatigue, Common: shivering, influenza like illness, injection site reactions (such as warmth, pruritus) Uncommon: malaise
Često: drhtanje, bolest nalik gripi, reakcije na mjestu injiciranja (poput topline, pruritusa) Manje često: malaksalost
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:
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,
Full dose (N=34)
Cijela doza (N=34)
Half dose (N=44)
Pola doze (N=44)
Skin and subcutaneous tissue disorders Angioedema, generalised skin reactions, urticaria
Angioedem, generalizirane kožne reakcije, urtikarija
Single dose N=91
Jednostruka doza N=91
Musculoskeletal and connective tissue disorders Very common: arthralgia, myalgia
Vrlo često: artralgija, mialgija
One pack containing: - one pack of 50 vials (type I glass) of 2.5 ml suspension with a stopper (butyl rubber).
- jedno pakiranje s 50 bočica (staklo tip I) od 2,5 ml suspenzije, s čepom (butil guma).
Full dose N=26
Cijela doza N=26
Full dose N=27
Cijela doza N=27
Half dose N=38
Pola doze N=38
Sodium chloride Disodium hydrogen phosphate Potassium dihydrogen phosphate Potassium chloride Water for injections
natrijev klorid natrijev hidrogenfosfat kalijev dihidrogenfosfat kalijev klorid voda za injekcije
Half dose N=37
Pola doze N=37
AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
AS03 adjuvans sadrži skvalen (10,69 miligrama), DL-α-tokoferol (11,86 miligrama) i polisorbat 80 (4,86 miligrama)
Immune response to A/Indonesia/5/2005
Imunološki odgovor na A/Indonesia/5/2005
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;
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;
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.
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.
Full dose (N=26)
Cijela doza (N=26)
This can cause bleeding or bruising
• nizak broj trombocita. to može uzrokovati krvarenja ili stvaranje modrica.
Day 42 N=140
42. dan N=140
Seroconversion rate2
Stopa serokonverzije2
Half dose N=36
Pola doze N=36
Single dose N=49
Jednostruka doza N=49
Full dose N=34
Cijela doza N=34
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.
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.
Day 42 N=42
42. dan N=42
Suspension vial:
BOČICA SUSPENZIJE
1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 anti-HA antibody
1stopa seroprotekcije: udio ispitanika s titrom inhibicije hemaglutinacije (HI) ≥1:40 anti-HA protutijelo
The seroprotection rates 6, 12, 24 and 36 months after the first dose were as follows: anti-HA antibody
Stope seroprotekcije u razdobljima 6, 12, 24 i 36 mjeseca nakon prve doze bile su sljedeće:
Talk to your doctor or nurse before you are given Prepandrix:
Odmah obavijestite svog liječnika ili medicinsku sestru ako se pojave bilo koje od niže navedenih nuspojava:
Tel.: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
Slovenská republika GlaxoSmithKline Slovakia s.r.o. Tel.: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
Psychiatric disorders Uncommon: insomnia
Manje često: nesanica
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.
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%.
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.
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.
Month 6 N=48
mjesec N=48
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)
Sadržaj: AS03 adjuvans sadrži skvalen (10,69 miligrama), DL-α-tokoferol (11,86 miligrama) i polisorbat 80 (4,86 miligrama)
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;
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;
Immune response to A/Vietnam/1194/2004 6-9 years
Imunološki odgovor na A/Vietnam/1194/2004 6-9 godina
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.
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.
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:
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
• one pack containing 50 vials of 2.5 ml suspension (antigen)
• jedno pakiranje s 50 bočica s 2,5 ml suspenzije (antigen) • dva pakiranja s 25 bočica s 2,5 ml emulzije (adjuvans)
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.
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%.
Immune response to A/Vietnam/1194/2004 12 months after vaccination
Imunološki odgovor na A/Vietnam/1194/2004 12 mjeseci nakon cijepljenja
Full dose (N=29)
Cijela doza (N=29)
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.
Prepandrix koji sadrži 3,75 mikrograma HA/AS03 iz soja A/Indonesia/05/2005 (H5N1) bile su komparabilne onima navedenima u nastavku.
Half dose (N=27)
Pola doze (N=27)
Half dose (N=37)
Pola doze (N=37)
Double dose N=43
Dvostruka doza N=43
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.
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.
GlaxoSmithKline Biologicals Branch of SmithKline Beecham Pharma GmbH & Co. KG Zirkusstraße 40, D-01069 Dresden Germany
KG Zirkusstraße 40, D-01069 Dresden
Full dose N=44
Cijela doza N=44
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.
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%.
NAME OF THE MEDICINAL PRODUCT Prepandrix suspension and emulsion for emulsion for injection.
Prepandrix suspenzija i emulzija za emulziju za injekciju.
Half dose (N=47)
Pola doze (N=47)
Full dose (N=27)
Cijela doza (N=27)
Half dose N=49
Pola doze N=49
Immune response to A/Vietnam/1194/2004 3 to 5 years
Imunološki odgovor na A/Vietnam/1194/2004 3 do 5 godina
Immune response to A/Vietnam/1194/2004 6 months after vaccination
Imunološki odgovor na A/Vietnam/1194/2004 6 mjeseci nakon cijepljenja
METHOD OF ADMINISTRATION Mix with adjuvant emulsion before use
Prije primjene pomiješati s emulzijom adjuvansa.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PACK OF 50 VIALS OF SUSPENSION
PAKIRANJE S 50 BOČICA SUSPENZIJE
Immune response to A/Vietnam/1194/2004 3-5 years
Imunološki odgovor na A/Vietnam/1194/2004 3-5 godina
Nervous system disorders Febrile convulsions
Febrilne konvulzije
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.
Međutim, ako se istodobna primjena ne može izbjeći, drugo cjepivo treba primijeniti u drugu ruku.
Full dose N=42
Cijela doza N=42
METHOD OF ADMINISTRATION Mix into Antigen suspension before use
Prije primjene pomiješati u suspenziju antigena.
Half dose N=42
Pola doze N=42
Half dose N=47
Pola doze N=47
Month 6 N=40
mjesec N=40
Half dose N=43
Pola doze N=43
Half dose N=40
Pola doze N=40
It is essentially sodium- and potassium-free.
zanemarive količine natrija i kalija.
The per-dose frequency of adverse reactions was as follows:
Učestalost nuspojava prema dozi bila je sljedeća:
3 % of subjects reaching a serum neutralising antibody titre of at least 1:80
2 % ispitanika s titrom ≥1:28 3 % ispitanika koji su dosegnuli titar neutralizirajućih protutijela u serumu od najmanje 1:80
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.
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.
Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Magnesium chloride (MgCl2) Water for injections
polisorbat 80 oktoksinol 10 tiomersal natrijev klorid (NaCl) natrijev hidrogenfosfat (Na2HPO4) kalijev dihidrogenfosfat (KH2PO4) kalijev klorid (KCl) magnezijev klorid (MgCl2) voda za injekcije
• Warmth, itching or bruising where the injection was given
• osjećaj topline, svrbež ili stvaranje modrica na mjestu davanja injekcije • pojačano znojenje, drhtanje, simptomi nalik gripi
minutes) before each withdrawal.
Protresti prije primjene.
Fainting can occur following, or even before, any needle injection.
Nakon bilo kojeg uboda iglom, ili čak i prije uboda, može doći do gubitka svijesti.
List of adverse reactions Adverse reactions reported are listed according to the following frequency:
Prijavljene nuspojave navedene su prema sljedećoj učestalosti: Kategorije učestalosti su:
Seroprotection rate1 1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40
Stopa seroprotekcije1 1stopa seroprotekcije: udio ispitanika s titrom inhibicije hemaglutinacije (HI) ≥1:40
QUALITATIVE AND QUANTITATIVE COMPOSITION After mixing, 1 dose (0.5 ml) contains:
KVALITATIVNI I KVANTITATIVNI SASTAV Nakon miješanja, 1 doza (0,5 ml) cjepiva sadrži: fragmentirani virus influence, inaktiviran, koji sadrži antigen* koji odgovara soju:
Pain
Nuspojave
Full dose N=43
Cijela doza N=43
Seroprotection rate1 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40
Stopa seroprotekcije1 stopa seroprotekcije: udio ispitanika s titrom inhibicije hemaglutinacije (HI) ≥1:40
Common: may affect up to 1 in 10 people
• bol u mišićima, bol u zglobovima Česte: mogu se javiti u do 1 na 10 osoba
Immune response to A/Vietnam/1194/2004 6 months after the 1st dose
Imunološki odgovor na A/Vietnam/1194/2004 6 mjeseci nakon 1. doze N=256
Sodium chloride Disodium hydrogen phosphate Potassium dihydrogen phosphate Potassium chloride Magnesium chloride Water for injections
polisorbat 80 oktoksinol 10 tiomersal natrijev klorid natrijev hidrogenfosfat kalijev dihidrogenfosfat kalijev klorid magnezijev klorid voda za injekcije
1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40
1stopa seroprotekcije: udio ispitanika s titrom inhibicije hemaglutinacije (HI) ≥1:40
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PACK OF 25 VIALS OF EMULSION
PAKIRANJE S 25 BOČICA S EMULZIJOM
• 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.
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.
Induration
Doziranje
Immune response to A/Vietnam/1194/2004 Day 21
Imunološki odgovor na A/Vietnam/1194/2004 21. dan N=140
PHARMACEUTICAL FORM AND CONTENTS Adjuvant emulsion for injection 25 vials: emulsion
OBLIK I SADRŽAJ Emulzija adjuvansa za injekciju
• Feeling dizzy
- učestalost prema dozi
This can cause skin rashes, joint pain and kidney problems
Poremećaji kože i potkožnog tkiva
GlaxoSmithKline Pharmaceuticals s.a./n.v.
GlaxoSmithKline Biologicals s.a.
Uncommon: may affect upt o 1 in 100 people
• otečene žlijezde na vratu, u pazusima ili preponama Manje česte: mogu se javiti u do 1 na 100 osoba
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:
Iz postmarketinškog iskustva s cjepivima koja sadrže AS03 i 3,75 µg HA dobivenih od soja
It should be given at the same time each day.
Treba se primjenjivati u isto vrijeme svakog dana.
The values were lowered by about 8-10 mmHg.
Vrijednosti su snižene za oko 8-10 mmHg.
The full EPAR for Ganfort can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Cjeloviti EPAR za lijek Ganfort nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What measures are being taken to ensure the safe and effective use of Ganfort?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ganfort?
If more than one type of eye drop is being used, each one should be given at least five minutes apart.
Ako se koristi više vrsta kapi, između njihove primjene mora proći barem pet minuta.
Ganfort lowered the pressure to less than 18 mmHg in 18.7% of these patients compared with 10.2% with bimatoprost only.
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.
This is a summary of the European public assessment report (EPAR) for Ganfort.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Ganfort.
In addition, more patients given Ganfort had a drop in pressure of more than 20% (67.9% against 48.9%).
Nadalje, kod dodatnog broja bolesnika koji su primali Ganfort očni je tlak snižen za više od 20 % (67,9 % u odnosu na 48,9 %).
The European Commission granted a marketing authorisation valid throughout the European Union for Ganfort on 19 May 2006.
Europska komisija izdala je odobrenje za stavljanje u promet lijeka Ganfort koje vrijedi na prostoru Europske unije od 19. svibnja 2006.
Ganfort is an eye drops solution that contains two active substances: bimatoprost (0.3 mg/ml) and timolol (5 mg/ml).
Ganfort je otopina kapi za oči koja sadrži dvije djelatne tvari: bimatoprost (0,3 mg/ml) i timolol (5 mg/ml).
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.
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.