natgillin/translations-raw huggingface dataset:
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: 
Pri preiskovancih, starih od 3 do 5 in od 6 do 9 let, ki so dvakrat dobili bodisi polni bodisi polovični odmerek cepiva z adjuvansom AS03, z vsebnostjo 3,75 µg HA, pridobljenega iz A/Vietnam/1194/2004 (H5N1), so bili odzivi anti-HA protiteles proti A/Indonesia/5/2005 na 42. dan naslednji:
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: 
Po dveh odmerkih cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz A/Indonesia/05/2005, uporabljenih na dan 0 in 21 pri 140 preiskovancih, starih od 18 do 60 let, je bil odziv anti-HA protiteles proti A/Vietnam/1194/2004 naslednji:
• Allergic reactions leading to a dangerously low blood pressure. 
• alergijske reakcije, ki nevarno znižajo krvni tlak; Če ta ni zdravljen, lahko povzroči šok.
3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the prevaccination GMT. 
3Faktor serokonverzije: razmerje geometrične sredine titra (GMT) po cepljenju in GMT pred cepljenjem.
4.8 Undesirable effects 
Seznam neželenih učinkov
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 
Splošne težave in spremembe na mestu aplikacije Zelo pogosti: induracija, oteklina, bolečina in rdečina na mestu injiciranja, zvišana telesna temperatura, utrujenost
Prepandrix contains sodium and potassium 
Cepivo Prepandrix vsebuje natrij in kalij
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELAVALEC
Month 6 N=40 
6. mesec n=40
Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be allowed to reach room temperature (for a minimum of 15 minutes); each vial should be shaken and inspected visually for any foreign particulate matter and/or abnormal physical appearance. 
Preden obe komponenti zmešate skupaj, morate emulzijo (adjuvans) in suspenzijo (antigen) vsaj 15 minut pustiti, da dosežeta sobno temperaturo.
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. 
Odziv anti-HA in odziv nevtralizirajočih protiteles proti A/Indonesia/05/2005, ki ju povzroči cepivo z adjuvansom AS03 in vsebnostjo 3,75 µg HA pridobljeno iz istega seva, sta primerljiva imunskemu odzivu na A/Vietnam/1194/2004, ki ga povzroči cepivo z adjuvansom AS03 z vsebnostjo 3,75 µg HA
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) and on administration of half a dose of the 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. 
Pri otrocih, starih od 3 do 9 let, je zelo malo podatkov o varnosti in imunogenosti cepiva z adjuvansom AS03, z vsebnostjo 3,75 µg HA, pridobljenega iz A/Vietnam/1194/2004 (H5N1) in polovičnega odmerka istega cepiva (tj. 1,875 µg HA in pol količine adjuvansa AS03), uporabljenih na dan 0 in 21.
One dose of 0.5 ml at an elected date. 
Odrasli, starejši od 18 let: En odmerek 0,5 ml na izbrani dan.
Cross-reactive immune response elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1) 
Navzkrižni imunski odziv na cepivo z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz A/Indonesia/05/2005 (H5N1)
Twenty-one days after the second dose, the seroprotection rate and the vaccine response rate against A/Vietnam/1194/2004 in subjects who received the vaccine 6 months apart were 89.6% and 95.7%, respectively. 
Enaindvajset dni po drugem odmerku je bil pri preiskovancih, ki so dobili cepivo v presledku 6 mesecev, delež serološke zaščite proti A/Vietnam/1194/2004 89,6 % in delež odziva na cepivo 95,7 %.
3 % of subjects reaching a serum neutralising antibody titre of at least 1:80 
3% preiskovancev, ki so dosegli titer nevtralizirajočih protiteles v serumu vsaj 1:80 Drugačna shema cepljenja
Rare: may affect up to 1 in 1,000 people 
Redki: pojavijo se lahko pri največ 1 od 1.000 oseb
No post-marketing surveillance data are available following Prepandrix administration. 
Podatki o spremljanju cepiva Prepandrix po pridobitvi dovoljenja za promet niso na voljo.
Administration of an AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) 
Uporaba cepiva z adjuvansom AS03, z vsebnostjo 3,75 µg HA, pridobljenega iz A/Vietnam/1194/2004 (H5N1)
Very common: headache Uncommon: paraesthesia, somnolence, dizziness 
Občasni: parestezije, somnolenca, omotica
Very rare: may affect up to 1 in 10,000 people 
Zelo redki:pojavijo se lahko pri največ 1 od 10.000 oseb
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. 
En odmerek cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz A/Indonesia/05/2005, uporabljen po enem ali dveh odmerkih cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz A/Vietnam/1194/2004.
Therefore, the data that have been generated with AS03adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 are considered to be relevant to the use of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005. 
Zato so podatki za cepivo z adjuvansom AS03 in vsebnostjo 3,75 µg HA pridobljeno iz A/Vietnam/1194/2004 relevantni tudi za uporabo cepiva z adjuvansom AS03 in vsebnostjo 3,75 µg HA pridobljeno iz A/Indonesia/05/2005.
• Sleepiness 
• zaspanost,
• Generally feeling unwell 
Občasni: splošno slabo počutje
Prepandrix should not be given: 
S cepivom Prepandrix ne smete biti cepljeni:
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). 
S klinično študijo (D-H5N1-009) so ocenili reaktogenost pri otrocih, starih od 3 do 5 in od 6 do 9 let, ki so dobili v presledku 21 dni bodisi dva odmerka za odrasle (tj. 0,5 ml) bodisi dva polovična odmerka za odrasle (tj. 0,25 ml) cepiva za pripravljenost na pandemijo (H5N1 A/Vietnam/1194/2004,
• Warmth, itching or bruising where the injection was given 
• občutek toplote, srbenje ali modrica na mestu injiciranja,
In a second study, 49 subjects aged 18-60 years received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 on days 0 and 21. 
V drugi študiji je 49 preiskovancev, starih od 18 do 60 let, na dan 0 in 21 dobilo dva odmerka cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz A/Indonesia/05/2005.
Gastrointestinal disorders Uncommon: gastro-intestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea) 
Občasni: prebavni simptomi (kot so driska, bruhanje, bolečine v trebuhu, navzea)
Although an adequate immune response was achieved at day 42 following two administrations of a single dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1), a higher response was observed following two administrations of a double dose of vaccine. 
Po dvakratni uporabi enega odmerka cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz A/Vietnam/1194/2004 (H5N1) je bil 42. dan sicer dosežen ustrezen imunski odziv, vendar so po dvakratni uporabi dvojnega odmerka cepiva opazili večji odziv.
Excipients: 
Otroci:
In clinical studies that evaluated the immunogenicity of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) in subjects 18-60 years old, the anti-haemagglutinin (anti-HA) antibody responses were as follows: 
V kliničnih študijah, ki so pri preiskovancih v starosti od 18 do 60 let ocenile imunogenost cepiva z adjuvansom AS03 in vsebnostjo 3,75 µg HA pridobljeno iz A/Vietnam/1194/2004 (H5N1), so bili odzivi protiteles na anti-hemaglutinin (anti-HA) naslednji:
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. 
Enaindvajset dni po drugem odmerku je bil pri preiskovancih, ki so dobili cepivo v presledku 6 mesecev, delež serološke zaščite 83,3 % in delež odziva na cepivo 100 %.
• 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. 
• če se je pri vas kdaj pojavila kakršnakoli alergijska reakcija (poleg nenadne, življenjsko ogrožajoče alergijske reakcije) na katerokoli sestavino tega cepiva (navedeno v poglavju 6), ali na tiomersal, jajčne in piščančje beljakovine, ovalbumin, formaldehid, gentamicinijev sulfat (antibiotik) ali natrijev deoksiholat.
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. 
V drugi klinični študiji (D-Pan-H5N1-010) je 297 preiskovancev, starejših od 60 let (razdeljenih v skupine od 61 do 70, 71 do 80 ter > 80 let), dobilo ali en ali dva odmerka cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz A/Vietnam/1194/2004 (H5N1) na dan 0 in 21.
Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Water for injections 
Viala z emulzijo: natrijev klorid (NaCl) natrijev hidrogenfosfat (Na2HPO4) kalijev dihidrogenfosfat (KH2PO4) kalijev klorid (KCl) voda za injekcije
Prepandrix suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) 
Prepandrix suspenzija in emulzija za emulzijo za injiciranje prepandemsko cepivo proti gripi (H5N1) z delci virionov, inaktivirano (z adjuvansom)
Skin and subcutaneous tissue disorders Common: ecchymosis at the injection site, sweating increased Uncommon: pruritus, rash 
Pogosti: ekhimoza na mestu injiciranja, močnejše znojenje Občasni: srbenje, izpuščaj
“Possible side effects” may affect your ability to drive or use tools or machines. 
Vpliv na sposobnost upravljanja vozil in strojev Nekateri neželeni učinki, našteti v poglavju 4, "Možni neželeni učinki", lahko vplivajo na vašo sposobnost vožnje in upravljanja z orodji in s stroji.
Month N=38 
24. mesec n=38
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. 
Enaindvajset dni po drugem odmerku je bil pri preiskovancih, ki so dobili cepivo v presledku 12 mesecev, delež serološke zaščite 84,0 % in delež odziva na cepivo 100 %.
STATEMENT OF ACTIVE SUBSTANCE(S) Split influenza virus, inactivated, containing antigen* equivalent to 3.75 micrograms haemagglutinin/dose *Antigen: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2) 
razcepljen virus influence, inaktiviran, ki vsebuje antigene*, ki ustrezajo 3,75 mikrogramom hemaglutinina/odmerek *Antigen: uporabljen sev (PR8-IBCDC-RG2), ki je podoben sevu A/Indonesia/05/2005 (H5N1)
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. 
V klinični študiji (D-Pan-H5N1-012) so preiskovanci, stari od 18 do 60 let, dobili cepivo z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno bodisi iz A/Vietnam/1194/2004 bodisi Indonesia/5/2005 šest mesecev po enem ali dveh primarnih odmerkih cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz A/Vietnam/1194/2004 na dan 0 (en odmerek) oz. na dan 0 in 21 (dva odmerka).
An extended dosing interval was investigated in study D-H5N1-012 in which a group of subjects 1860 years of age received two doses of Prepandrix containing the A/Vietnam/1194/2004 strain 6 months or 12 months apart. 
V študiji D-H5N1-012 so raziskali podaljšan presledek med odmerki: skupina preiskovancev, starih od 18 do 60 let, je v tej študiji dobila dva odmerka cepiva Prepandrix v presledku 6 mesecev ali 12 mesecev.
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 children. 
Razen nekaterih neželenih učinkov, ki so se bolj pojavili po drugem odmerku, zlasti kar zadeva deleže zvišane telesne temperature pri otrocih, starih < 6 let, povečanja po drugem odmerku ni bilo, ne glede na to, ali so otroci prejeli polovični odmerek za odrasle ali odmerek za odrasle.
Talk to your doctor or nurse before you are given Prepandrix: 
Preden dobite cepivo Prepandrix, se posvetujte z zdravnikom ali medicinsko sestro:
NAME OF THE MEDICINAL PRODUCT Prepandrix suspension and emulsion for emulsion for injection. 
FARMACEVTSKA OBLIKA suspenzija in emulzija za emulzijo za injiciranje
The following information is intended for healthcare professionals only: 
Naslednje informacije so namenjene samo zdravstvenemu osebju: Cepivo Prepandrix je na voljo v dveh vsebnikih:
3booster factor: ratio of the post-booster geometric mean titre (GMT) and the pre-booster GMT. 
3Obnovitveni dejavnik: razmerje geometrične sredine titra (GMT) po obnovitvenem odmerku in GMT pred obnovitvenim odmerkom.
Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1): 
Navzkrižni imunski odzivi na cepivo z adjuvansom AS03 in vsebnostjo 3,75 µg HA, pridobljenega iz A/Vietnam/1194/2004 (H5N1)
There are no data with Prepandrix using the subcutaneous route. 
Podatkov o subkutani uporabi cepiva Prepandrix ni.
Prepandrix may be used in lactating women. 
Cepivo Prepandrix se lahko uporabi v obdobju dojenja.
NAME OF THE MEDICINAL PRODUCT Suspension for emulsion for injection for Prepandrix Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) 
Suspenzija za emulzijo za injiciranje za Prepandrix prepandemsko cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom)
Immune response to A/Vietnam/1194/2004 3-5 years 21 days after 2nd dose 6 months after vaccination 
Imunski odziv proti A/Vietnam/1194/2004 3 do 5 let 21 dni po 2. odmerku 6 mesecev po cepljenju
NAME OF THE MEDICINAL PRODUCT Prepandrix suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) 
Navodilo za uporabo Prepandrix suspenzija in emulzija za emulzijo za injiciranje prepandemsko cepivo proti gripi (H5N1) z delci virionov, inaktivirano (z adjuvansom)
Seroprotection rate1 Booster seroconversion rate2 Booster factor3 
Delež serokonverzije2 Faktor serokonverzije3
Full dose N=42 
Polni odmerek n=42
Seroconversion rate 
Delež serokonverzije2
The vaccine should be administered in accordance with the recommended posology (see section 4.2). 
Po mešanju je količina cepiva Prepandrix v viali vsaj 5 ml. Cepivo je treba uporabiti v skladu s priporočenim odmerjanjem (glejte poglavje 4.2).
Shivering NA=not available 
drgetanje NP = ni podatka
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. 
V klinični študiji (D-Pan-H5N1-009) so otroci, stari od 3 do 5 in od 6 do 9 let, dvakrat dobili bodisi polni odmerek (0,5 ml) bodisi polovični odmerek (0,25 ml) cepiva z adjuvansom AS03, z vsebnostjo
In another clinical study (D-Pan-H5N1-015), 39 subjects aged 18-60 years received a dose of AS03adjuvanted 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. 
V drugi klinični študiji (D-Pan-H5N1-015) je 39 preiskovancev, starih od 18 do 60 let, dobilo cepivo z adjuvansom AS03 z vsebnostjo 3,75 µg HA, pridobljenega iz A/Indonesia/05/2005 štirinajst mesecev potem, ko so dobili dva odmerka cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz
Prepandrix contains thiomersal as a preservative and it is possible that you may experience an allergic reaction. 
Cepivo Prepandrix vsebuje tiomersal kot konzervans.
Split influenza virus, inactivated, containing antigen equivalent to: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2) 
razcepljen virus influence, inaktiviran, ki vsebuje antigene*, ki ustrezajo: uporabljenemu sevu (PR8-IBCDC-RG2) podobnemu sevu A/Indonesia/05/2005 (H5N1) 3,75 mikrogramov**na 0,5 ml odmerek
• Swollen glands in your neck, armpit or groin 
• oteklina vratnih, podpazdušnih ali dimeljskih bezgavk.
1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40; 
1Delež serološke zaščite: delež preiskovancev s titrom inhibicije hemaglutinacije (HIhaemagglutination inhibition ) ≥ 1:40;
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; 
2Delež serokonverzije: delež preiskovancev, ki so bili pred cepljenjem seronegativni in imajo po cepljenju zaščitni titer ≥ 1:40, ali so bili pred cepljenjem seropozitivni in imajo 4-kraten porast titra; 3Faktor serokonverzije: razmerje med geometrično sredino titra (GMT) po cepljenju in GMT pred cepljenjem.
What Prepandrix contains 
Prepandrix.
1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 
1Delež serološke zaščite: delež preiskovancev s titrom inhibicije hemaglutinacije (HI) ≥ 1:40;
It should be given at the same time each day. 
Kapljice je treba dajati vsak dan ob istem času.
The values were lowered by about 8-10 mmHg. 
Vrednosti so se znižale za približno 8-10 mmHg.
The European Commission granted a marketing authorisation valid throughout the European Union for Ganfort on 19 May 2006. 
Evropska komisija je dovoljenje za promet z zdravilom Ganfort, veljavno po vsej Evropski uniji, izdala 19. maja 2006.
What measures are being taken to ensure the safe and effective use of Ganfort? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ganfort?
The full EPAR for Ganfort can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ganfort je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Other information about Ganfort 
Druge informacije o zdravilu Ganfort
Four main studies have been performed involving 1,964 adults with ocular hypertension or glaucoma. 
Opravljene so bile štiri glavne študije, v katere je bilo vključenih 1 964 odraslih z očesno hipertenzijo ali glavkomom.
This is a summary of the European public assessment report (EPAR) for Ganfort. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ganfort.
Ganfort is given as one drop in the affected eye(s) once a day, either in the morning or the evening. 
Zdravilo Ganfort se daje po eno kapljico v prizadeto(-i) oko(očesi) enkrat dnevno, zjutraj ali zvečer.
In addition, more patients given Ganfort had a drop in pressure of more than 20% (67.9% against 48.9%). 
Poleg tega je bilo pri več bolnikih, ki so jim dajali zdravilo Ganfort, zabeleženo znižanje tlaka za več kot 20 % (67,9 % v primerjavi z 48,9 %).
For more information about treatment with Ganfort, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Ganfort preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Ganfort lowered the pressure to less than 18 mmHg in 18.7% of these patients compared with 10.2% with bimatoprost only. 
Zdravilo Ganfort je znižalo tlak na manj kot 18 mmHg pri 18,7 % teh bolnikov v primerjavi z 10,2 % pri samostojni uporabi bimatoprosta.
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. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ganfort upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
If more than one type of eye drop is being used, each one should be given at least five minutes apart. 
Če bolnik uporablja več vrst kapljic za oči, je treba zdravila uporabiti v razmiku najmanj pet minut.
What benefit has Ganfort shown during the studies? 
Kakšne koristi je zdravilo Ganfort izkazalo med študijami?
The CHMP decided that Ganfort's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Ganfort večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
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). 
Glavno merilo učinkovitosti je bilo povprečno znižanje tlaka v očesu ali število bolnikov, pri katerih se je tlak v očesu znižal pod ciljno vrednost 18 mmHg (znižanje na običajno vrednost).
Ganfort is an eye drops solution that contains two active substances: bimatoprost (0.3 mg/ml) and timolol (5 mg/ml). 
Zdravilo Ganfort je raztopina v obliki kapljic za oči, ki vsebuje dve zdravilni učinkovini: bimatoprost (0,3 mg/ml) and 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. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Ganfort, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The studies compared Ganfort with bimatoprost, timolol, or bimatoprost and timolol given at the same time after three weeks to four months of treatment. 
V študijah so zdravilo Ganfort primerjali z bimatoprostom, timololom ali bimatoprostom in timololom, uporabljenima sočasno, po treh tednih do štirih mesecih zdravljenja.
Ganfort was, however, more effective than bimatoprost in patients whose pressure was not controlled with eye drops containing prostaglandins alone. 
Vendar pa je bilo zdravilo Ganfort učinkovitejše od bimatoprosta pri bolnikih, pri katerih tlak ni bil nadzorovan s kapljicami za oči, ki vsebujejo samo prostaglandine.