natgillin/translations-raw huggingface dataset:
The PSUR cycle for the medicinal product should follow a twice-yearly cycle until otherwise agreed 
• Redno posodobljena poročila o varnosti zdravila (PSUR) Cikel PSUR za zdravilo mora slediti polletnemu ciklu dokler CHMP ne odloči drugače.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 
Neuporabljeno cepivo in drug odpadni material zavrzite v skladu z lokalnimi predpisi za
• Fainting can occur following, or even before, any needle injection. 
• po katerem koli injiciranju z iglo ali celo pred njim se lahko pojavi omedlevica.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK - Inner Carton Box for 10 pre-filled syringes with needles - Inner Carton Box for 10 pre-filled syringes without needles Inner carton box will not include “Blue Box”. 
VEČKRATNO PAKIRANJE - Notranja kartonska škatla za 10 napolnjenih injekcijskih brizg z iglami - Notranja kartonska škatla za 10 napolnjenih injekcijskih brizg brez igel Notranja kartonska škatla ne vključuje podatke za tako imenovano »modro okence«.
Uncommon (affects 1 to 10 users in 1,000): • generalised skin reactions such as itching, bumps on the skin or non-specific rash 
Občasni (pojavijo se pri 1 do 10 od 1.000 cepljenih): • splošne kožne reakcije, kot so srbenje, bule na koži ali neznačilni izpuščaj.
Note that the side effects of the vaccines may be intensified. 
Neželeni učinki cepiv so lahko okrepljeni.
Detailed information on this medicinal product is available on the website of the European Medicines 
DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila
For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy. 
Za nosečnice z boleznimi, ki povečujejo tveganje za pojav zapletov pri gripi, je uporaba cepiva proti gripi priporočena, ne glede na fazo nosečnosti.
0.5 ml suspension in pre-filled syringes (type I glass), with a plunger stopper (bromobutyl rubber). 
0,5 ml suspenzije v napolnjenih injekcijskih brizgah (steklo vrste I) z batnim zamaškom iz bromobutilne gume.
4.8 Undesirable effects a) Summary of safety profile 
4.8 Neželeni učinki
Optaflu is injected into the muscle on the top of the upper arm (deltoid muscle). 
Cepivo Optaflu se injicira v mišico na vrhu nadlakti (deltoidna mišica).
Injection site pain and headache were common in the elderly. 
Pri starejših sta bila bolečina na mestu injiciranja in glavobol pogosta.
15 micrograms HA** 15 micrograms HA** per 0.5 ml dose 
15 mikrogramov HA** 15 mikrogramov HA** na 0,5-mililitrski odmerek
The persistence of postvaccination antibodies to strains included in the vaccine is usually 6-12 months, as shown by studies performed during the clinical development of this vaccine. 
Kot so pokazale študije, opravljene pri kliničnem razvoju tega cepiva, obstojnost protiteles proti sevom, vključenim v cepivo, po cepljenju navadno traja 6 do 12 mesecev.
Safety and reactogenicity evaluations were performed for all subjects during the first 3 weeks following vaccination and SAEs have been collected for approximately 6700 vaccinees during six 
Pri vseh osebah v prvih treh tednih po cepljenju ter pri približno 6700 cepljenih osebah med šestmesečnim obdobjem sledenja so ocenili varnost in reaktogenost ter zbrali podatke o resnih
The other ingredients are: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections. 
Druge sestavine cepiva so: natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat, natrijev hidrogenfosfat dihidrat, kalijev dihidrogenfosfat in voda za injekcije.
The expiry date refers to the last day of that month. 
Navodilo je bilo nazadnje revidirano dne.
INFORMATION IN BRAILLE Justification for not using Braille accepted. 
PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna
Optaflu should under no circumstances be administered intravascularly. 
Cepivo Optaflu se pod nobenim pogojem ne sme dajati intravaskularno.
Uncommon ≥ 1/1000 to 
Občasni ≥ 1/1.000 do
Optaflu is a clear to slightly opalescent suspension. 
Cepivo Optaflu je bistra do rahlo motna suspenzija.
After an episode of ILI, nose and throat swab samples were collected for analysis. 
Po epizodi ILI so za preiskavo odvzeli brise nosu in žrela.
Animal data have not shown effects on female fertility (see section 5.3). 
Podatki, pridobljeni na živalih, ne kažejo vplivov na plodnost samic (glejte poglavje 5.3).
• fever, headache, vomiting and drowsiness progressing to coma or fits (convulsions) which are symptoms of an inflammation of the brain and spinal cord 
• zvišana telesna temperatura, glavobol, bruhanje in dremavost, ki se stopnjuje v komo ali epileptične napade (konvulzije), ki so simptomi vnetja možganov in hrbtenjače
Tell your doctor or nurse if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription or if you have recently received any other 
Obvestite zdravnika ali medicinsko sestro, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. 
Po katerem koli cepljenju ali celo pred njim, se lahko kot psihogeni odziv na injiciranje z iglo, pojavi sinkopa (omedlevica).
Optaflu is given to you by your doctor or nurse. 
Cepivo Optaflu vam da zdravnik ali medicinska sestra.
15 micrograms HA** per 0.5 ml dose 
15 mikrogramov HA** na 0,5-mililitrski odmerek
10 pre-filled syringes without needle. 
10 napolnjenih injekcijskih brizg brez igle.
Tell your doctor immediately if you experience any of the following side effects - you may need 
Takoj povejte zdravniku, če opazite kateregakoli od naslednjih neželenih učinkov; morda boste
Non-clinical data reveal no special hazard for humans based on conventional repeat dose toxicity studies. 
Predklinični podatki na osnovi običajnih študij toksičnosti pri ponavljajočih odmerkih ne kažejo posebnega tveganja za človeka.
None of the ingredients in the vaccine can 
Nobena od sestavin cepiva ne more gripe povzročiti.
- Paraesthesia 
- Parestezija
Not known (cannot be estimated from the available data) 
Neznana (ni mogoče oceniti iz razpoložljivih podatkov)
Optaflu has minor influence on the ability to drive and use machines. 
Cepivo Optaflu ima blag vpliv na sposobnost vožnje in upravljanja s stroji.
No case of overdose has been reported for Optaflu. 
Ni poročil o prevelikem odmerjanju cepiva Optaflu.
There is no human data on use of Optaflu during lactation. 
Podatkov o uporabi cepiva Optaflu med dojenjem ni.
Optaflu is used to prevent flu in adults, especially in those who run an increased risk of experiencing associated complications in case they fall ill with flu. 
Cepivo Optaflu se uporablja za preprečevanje gripe pri odraslih, zlasti tistih, ki so izpostavljeni povečanemu tveganju za zaplete, povezane z gripo.
Optaflu efficacy was defined as the prevention of culture-confirmed symptomatic influenza illness caused by viruses antigenically matched to those in the vaccine compared to placebo. 
Učinkovitost cepiva Optaflu je bila opredeljena kot preprečitev (v primerjavi s placebom) laboratorijsko potrjene simptomatske gripe, ki jo povzročijo virusi, ki se ujemajo s cepilnimi sevi.
Not known (cannot be estimated from the available data): 
Neznana (ni mogoče oceniti iz razpoložljivih podatkov):
Also, tell your doctor immediately if you experience any of the following side effects - you may need 
Prav tako takoj povejte zdravniku, če opazite kateregakoli od naslednjih neželenih učinkov; morda
Multipack: 20 (2 packs of 10) pre-filled syringes (0.5 ml) without needle Multipack: 20 (2 packs of 10) pre-filled syringes (0.5 ml) with needle 
Večkratno pakiranje: 20 (2 pakiranji po 10) napolnjenih injekcijskih brizg (0,5 ml) brez igle Večkratno pakiranje: 20 (2 pakiranji po 10) napolnjenih injekcijskih brizg (0,5 ml) z iglo
* produced in Madin Darby Canine Kidney (MDCK) cells (this is the special cell culture in which the influenza virus is grown) ** haemagglutinin 
* razmnoženi v celicah pasjih ledvic Madin Darby (MDCK) (to je posebna celična kultura,
Animal data have not shown effects on female fertility. 
Podatkov o učinkih na plodnost pri človeku ni.
Common (affects 1 to 10 users in 100): 
Pogosti (pojavijo se pri 1 do 10 od 100 cepljenih):
Very rare (affects less than 1 user in 10,000): 
Zelo redki (pojavijo se pri manj kot 1 od 10.000 cepljenih):
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Prefilled syringe 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH Napolnjena injekcijska brizga
4.5 Interaction with other medicinal products and other forms of interaction Optaflu may be given at the same time as other vaccines. 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
• injection site pain, reddening. 
• bolečina na mestu injiciranja, rdečica.
The immunological response may be diminished if the patient is undergoing immunosuppressant 
Če bolnik prejema imunosupresijsko zdravljenje, se lahko zmanjša imunološki odziv.
Rare (affects 1 to 10 users in 10,000): 
Redki (pojavijo se pri 1 do 10 od 10.000 cepljenih):
The vaccine targets three strains of influenza virus following the recommendations by the World Health Organisation for the 2015/2016 season. 
Cepivo je usmerjeno na tri seve virusa gripe z upoštevanjem priporočil Svetovne zdravstvene
• sweating, joint pain, chills, hardening or swelling at the site of the injection, bruising, fever, 
• potenje, bolečina v sklepih, mrzlica, otrditve ali otekanje na mestu injiciranja, modrice, zvišana telesna temperatura, tresenje;
Pack sizes of 1, 10 or multipacks containing 20 (2 packs of 10) pre-filled syringes, each with or 
Velikosti pakiranja po 1, 10 ali večkratna pakiranja po 20 (2 pakiranji po 10) napolnjenih injekcijskih brizg; z iglo ali brez nje.
Visually inspect the contents of each Optaflu syringe for particulate matter and/or change in colour prior to administration. 
Vsebino vsake brizge cepiva Optaflu pred uporabo vizualno preglejte in se prepričajte, da v njej ni delcev in da barva ni spremenjena.
Sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections. 
Natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat, natrijev hidrogenfosfat dihidrat, kalijev
Optaflu is a vaccine against flu (influenza). 
Kaj je cepivo OPTAFLU in za kaj ga uporabljamo Optaflu je cepivo proti gripi (influenci).
So far there is limited post-marketing experience with Optaflu. 
Izkušnje s cepivom Optaflu v obdobju trženja so omejene.
Vaccine efficacies against vaccine-matched influenza viral strains, against all influenza viral strains, and against individual influenza viral subtypes were 
Izračunali so učinkovitost cepiva proti sevom virusa gripe, ki so se ujemali s cepilnimi sevi, proti vsem sevom virusa gripe in posameznim podtipom virusa gripe (preglednici 2 in 3).
Very rare (affects less than 1 user in 10,000): • skin rashes, fever, joint pain or kidney problems which are symptoms of an inflammation of the 
Zelo redki (pojavijo se pri manj kot 1 od 10.000 cepljenih): • kožni izpuščaji, zvišana telesna temperatura, bolečina v sklepih ali težave z ledvicami,
• weakness beginning in the legs and progressing to the arms with numbness and tingling sensation which are symptoms of an inflammation of the nerves 
• šibkost, ki se začenja v nogah in napreduje v roke, z otrplostjo in mravljinčenjem, ki so
The vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for 
Cepivo je v skladu s priporočili SZO (za severno poloblo) in z odločbo EU za sezono 2015/2016.
10 pre-filled syringes with needle. 
10 napolnjenih injekcijskih brizg z iglo.
- Extensive swelling of injected limb 
- Obsežno otekanje uda, v katerega je bilo injicirano cepivo
Organ class 
Organski sistem
Optaflu was well tolerated and immunogenic in mice and ferrets. 
Cepivo Optaflu so miši in beli dihurji dobro prenašali in pri njih je bilo imunogeno.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 
Preobčutljivost na zdravilne učinkovine ali katero koli pomožno snov.
Very common (affects more than 1 user in 10): 
Zelo pogosti (pojavijo se pri več kot 1 od 10 cepljenih):
What Optaflu looks like and contents of the pack Optaflu is a suspension for injection in a pre-filled syringe (ready-to-use syringe). 
Cepivo Optaflu je suspenzija za injiciranje v napolnjeni injekcijski brizgi (brizga, pripravljena za uporabo).
Optaflu suspension for injection in a pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 
Optaflu suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti gripi iz kulture celic, s površinskimi antigeni, inaktivirano
1 pre-filled syringe (0.5 ml) with needle 10 pre-filled syringes (0.5 ml) with needle 1 pre-filled syringe (0.5 ml) without needle 10 pre-filled syringes (0.5 ml) without needle 
1 napolnjena injekcijska brizga (0,5 ml) z iglo 10 napolnjenih injekcijskih brizg (0,5 ml) z iglo 1 napolnjena injekcijska brizga (0,5 ml) brez igle 10 napolnjenih injekcijskih brizg (0,5 ml) brez igle
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK - Outer carton box for containing 2 carton boxes with 10 syringes each (with or without needles) 
VEČKRATNO PAKIRANJE - Zunanja kartonska škatla, ki vsebuje 2 kartonski škatli s po 10 injekcijskimi brizgami
The active substances are influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following strains: 
Zdravilne učinkovine so površinski antigeni virusa influence (hemaglutinin in nevraminidaza)*,
Not known (cannot be estimated from the available data) • swelling most apparent in the head and neck, including the face, lips, tongue, throat or any other 
• otekanje, ki je najbolj izrazito na glavi in vratu, lahko pa zajame obraz, ustnice, jezik, žrelo in kateri koli drug del telesa (angioedem).
QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Sevi virusa influence s površinskimi antigeni (hemaglutinin in nevraminidaza)*, inaktivirani: Sevu A/California/7/2009 (H1N1)pdm09 podoben sev
Carton box for syringe(s) without needle - 1 pre-filled syringe (0.5 ml) without needle - 10 pre-filled syringes (0.5 ml) without needle 
Kartonska škatla za brizgo/brizge brez igle - 1 napolnjena injekcijska brizga (0,5 ml) brez igle - 10 napolnjenih injekcijskih brizg (0,5 ml) brez igle
Carton Box for syringe(s) with needle - 1 pre-filled syringe (0.5 ml) with needle - 10 pre-filled syringes (0.5 ml) with needle 
Kartonska škatla za brizgo/brizge z iglo - 1 napolnjena injekcijska brizga (0,5 ml) z iglo - 10 napolnjenih injekcijskih brizg (0,5 ml) z iglo
Adults from the age of 18 years: 
Odrasli od starosti 18 let: En odmerek 0,5 ml
Table 3: Comparative Efficacy of Optaflu versus Placebo against Culture-Confirmed 
Preglednica 3: Primerjava učinkovitosti cepiva Optaflu in placeba proti laboratorijsko potrjeni gripi po posameznih podtipih virusa gripe
No evidence of reproductive or developmental toxicity was seen in a study where the human dose of Optaflu was administered prior to and during gestatioin to female rabbits. 
V študiji, v kateri so odmerek cepiva Optaflu za ljudi dajali samicam kuncev pred brejostjo in med njo, niso našli dokazov za učinke na sposobnost razmnoževanja ali razvoja.
Keep the pre-filled syringe in the outer carton in order to protect 
Napolnjeno injekcijsko brizgo shranjujte v zunanji škatli za
5.3 Preclinical safety data 
6.4 Posebna navodila za shranjevanje
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
Izgled cepiva Optaflu in vsebina pakiranja
If either condition exists, do not administer the vaccine. 
Ne uporabite cepiva, če kar koli opazite.
PHARMACOLOGICAL PROPERTIES 
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
The following additional adverse reactions were reported from post-marketing surveillance with 
Iz spremljanja v obdobju trženja so poročali o naslednjih dodatnih neželenih učinkih s sezonskimi trivalentnimi cepivi na osnovi jajc:
MARKETING AUTHORISATION HOLDER 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
Keep this vaccine out of the sight and reach of children. 
Zdravilo shranjujte nedosegljivo otrokom!
It is available as tablets (1 and 2 mg). 
Na voljo je v obliki tablet (1 in 2 mg).
The European Commission granted a marketing authorisation valid throughout the European Union for Resolor on 15 October 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Resolor, veljavno po vsej Evropski uniji, izdala 15. oktobra 2009.
What measures are being taken to ensure the safe and effective use of Resolor? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Resolor?
The full EPAR for Resolor 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 Resolor je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What benefit has Resolor shown during the studies? 
Kakšne koristi je zdravilo Resolor izkazalo med študijami?
A risk management plan has been developed to ensure that Resolor is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Resolor je bil pripravljen načrt obvladovanja tveganj.
This is a summary of the European public assessment report (EPAR) for Resolor. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Resolor.
Other information about Resolor 
Druge informacije o zdravilu Resolor
For more information about treatment with Resolor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Resolor preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The patients had not responded well enough to previous treatment with laxatives. 
Bolniki se niso zadostno odzvali na predhodna zdravljenja z odvajali.
It must also not be used in patients with intestinal perforation or obstruction, severe inflammatory conditions of the intestines such as Crohn's disease, ulcerative colitis (inflammation of the large intestine causing ulceration and bleeding) and toxic megacolon and megarectum (very serious complications of colitis). 
Ne sme se uporabljati niti pri bolnikih s perforacijo ali zaporo črevesja, hudimi vnetnimi stanji črevesja, kot je Crohnova bolezen, ulcerativnim kolitisom (vnetjem debelega črevesja, ki povzroči razjede in krvavitve) in toksičnim megakolonom in megarektumom (zelo hudim zapletom kolitisa).
This means that it works like a substance in the body called 5-hydroxytryptamine (5-HT, also known as serotonin) and attaches to receptors for 5-HT in the gut called ‘5-HT4 receptors'. 
To pomeni, da deluje enako kot snov v telesu, imenovana 5-hidroksitriptamin (5-HT, znana tudi kot serotonin), in se veže na iste receptorje v črevesju, imenovane receptorji 5-HT4.
The result from patients who received Resolor at the higher dose of 4 mg was similar to those who took the 2 mg dose. 
Rezultati pri bolnikih, ki so jemali višji 4-miligramski odmerek, so bili podobni kot pri tistih, ki so jemali 2-miligramski odmerek.
The CHMP decided that Resolor's benefits are greater than its risks and recommended that it be given marketing authorisation.. 
CHMP je zaključil, da so koristi zdravila Resolor večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
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 Resolor. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Resolor was more effective than placebo at treating chronic constipation. 
Zdravilo Resolor je bilo pri zdravljenju kroničnega zaprtja učinkovitejše od placeba.
What is the risk associated with Resolor? 
Kakšna tveganja so povezana z zdravilom Resolor?
Resolor is a medicine that contains the active substance prucalopride. 
Resolor je zdravilo, ki vsebuje zdravilno učinkovino prukaloprid.
The main measure of effectiveness in the studies was the number of patients who completely emptied their bowels at least three times a week over a 12 week period without the help of laxatives. 
Glavno merilo učinkovitosti v vseh študijah je bilo število bolnikov, ki so vsaj trikrat na teden v 12-tedenskem obdobju popolnoma izpraznili črevesje brez pomoči odvajal.
In the same way, when prucalopride attaches to and stimulates these receptors, it increases this movement and allows the bowels to empty faster. 
Prukaloprid se na enak način veže na te receptorje in jih spodbudi ter tako poveča dejavnost črevesja in mu pomaga, da se hitreje izprazni.
The most common side effects with Resolor (seen in more than 1 patient in 10) are headache, nausea (feeling sick), diarrhoea and abdominal (tummy) pain. 
Najpogostejši neželeni učinki zdravila Resolor (opaženi pri več kot 1 bolniku od 10) so glavobol, navzeja (siljenje na bruhanje), driska in bolečine v trebuhu.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Resolor, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu z njim so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
When 5-HT binds to these receptors, it normally stimulates movement in the gut. 
Pri vezavi na te receptorje 5-HT običajno spodbudi dejavnost črevesja.
The active substance in Resolor, prucalopride, is a ‘5-HT4 receptor agonist'. 
Zdravilna učinkovina v zdravilu Resolor, prukaloprid, je agonist za receptor 5-HT4.
Resolor must not be used in patients with kidney problems requiring dialysis (a blood clearance technique). 
Zdravilo Resolor se ne sme uporabljati pri bolnikih, ki imajo obolenje ledvic, pri katerem je potrebna dializa (tehnika čiščenja krvi).
Resolor is used to treat symptoms of chronic (long-term) constipation in adults for whom laxatives (medicines that trigger bowel movements) do not work well enough. 
Zdravilo Resolor se uporablja za zdravljenje simptomov kroničnega (dolgotrajnega) zaprtja pri odraslih, pri katerih odvajala (zdravila, ki pospešijo delovanje črevesja) ne delujejo dovolj dobro.
Over the 12-week period, 24% (151 out of 640) of patients who received Resolor 2 mg completely emptied their bowels at least three times a week, compared with 11% (73 out of 645) of patients who received placebo. 
V 12-tedenskem obdobju je 24 % (151 od 640) bolnikov, ki so prejemali 2 mg zdravila Resolor, popolnoma izpraznilo svoje črevesje vsaj trikrat na teden, v primerjavi z 11 % (73 od 645) bolnikov, ki so prejemali placebo.
Why has Resolor been approved? 
Zakaj je bilo zdravilo Resolor odobreno?
Patients aged over 65 years should start with a 1 mg dose once a day, and this can be increased to 2 mg once a day if needed. 
Priporočeni odmerek zdravila Resolor je 2 mg enkrat na dan. Bolniki, starejši od 65 let, naj začnejo z 1-miligramskim odmerkom enkrat na dan, po potrebi pa se lahko odmerek zviša na 2 mg enkrat na dan.
For the full list of all side effects reported with Resolor, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Resolor, glejte navodilo za uporabo.