natgillin/translations-raw huggingface dataset:
EMEND 40 mg hard capsules are supplied in the following pack sizes: • Aluminium blister containing one 40 mg capsule • 5 Aluminium blisters each containing one 40 mg capsule
- 5 aluminijastih pretisnih omotov, ki vsebujejo po eno 40 mg kapsulo.
Hertford Road, Hoddesdon UK - Hertfordshire EN11 9BU United Kingdom
Hertford Road, Hoddesdon UK- Hertfordshire EN 11 9BU Velika Britanija
Manufacturer Merck Sharp & Dohme B.
Izdelovalec Merck Sharp & Dohme B.
Waarderweg 39, Postbus 581 NL-2003 PC Haarlem The Netherlands
Waarderweg 39, Postbus 581 NL- 2003 PC Haarlem Nizozemska
76 Belgique/België/Belgien Merck Sharp & Dohme B.V.
73 Luxembourg/ Luxemburg Belgique/ België/ Belgien Merck Sharp & Dohme B. V.
Ireland Merck Sharp and Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700 medinfo_ireland@merck.com
Slovenija Ireland Merck Sharp and Dohme Ireland (Human Health) Limited Tel: +353 (0) 1 2998700 medinfo_ ireland@ merck. com
Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o.
Merck Sharp & Dohme, inovativna zdravila d. o. o.
Ísland Icepharma hf.Simi: +354 540 8000 ISmail@merck.com
Simi: +354 540 8000
Tel.: +421 2 58282010 msd_sk@merck.com
Tel.: +421 2 58282010
77 Ιtalia Merck Sharp & Dohme (Italia) S.p.A.
74 Suomi/ Finland Ιtalia MSD Finland Oy Merck Sharp & Dohme (Italia) S. p. A.
Tel: +39 06 361911 doccen@merck.com
Puh/ Tel: +358 (0) 9 804650 Tel: +39 06 361911 info@ msd. fi doccen@ merck. com
INFORMATION FOR THE USER
75 NAVODILO ZA UPORABO
Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet.
Pred začetkom jemanja natančno preberite navodilo!
EMEND is used in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment).
Zdravilo EMEND uporabljamo v kombinaciji z drugimi zdravili za preprečevanje navzee (siljenja na bruhanje) in bruhanja zaradi kemoterapije (zdravljenje raka).
By blocking the receptors, EMEND can prevent nausea and vomiting, which often happens during and after chemotherapy.
Z blokado receptorjev lahko zdravilo EMEND prepreči siljenje na bruhanje in bruhanje, kar je pogost zaplet zdravljenja.
• With medicines containing pimozide (used to treat psychiatric illnesses), terfenadine and astemizole (used for hay fever and other allergic conditions), cisapride (used for treating gastrointestinal motility disorders).
terfenadin ali astemizol (uporabljamo ju za zdravljenje senenega nahoda in drugih alergijskih bolezni) ali cisaprid (uporabljamo ga za zdravljenje motenj gibljivosti prebavil).
Tell your doctor if you are taking these medicines since your treatment must be modified before you start taking EMEND.
Če jemljete katerega od teh zdravil, to povejte svojemu zdravniku, saj bo treba vaše zdravljenje pred začetkom jemanja zdravila EMEND spremeniti.
EMEND is not for use in children and adolescents under 18 years.
Zdravilo EMEND se ne uporablja pri otrocih in mladostnikih, mlajših od 18 let.
EMEND can affect other medicines both during and after treatment with EMEND.
Zdravilo EMEND lahko vpliva na druga zdravila, tako med samim jemanjem kot tudi po njem.
There are some medicines that should not be taken with EMEND or that require a dosage adjustment (see also Do not take EMEND).
Nekaterih zdravil med zdravljenjem z zdravilom EMEND ne smete jemati, pri nekaterih pa je treba spremeniti odmerek (glejte tudi "Ne jemljite zdravila EMEND").
EMEND should be used with caution when taken with many other medicines.
Pri sočasnem jemanju številnih drugih zdravil je treba zdravilo EMEND uporabljati previdno.
Taking EMEND with food and drink EMEND can be taken with or without food.
76 Jemanje zdravila EMEND skupaj s harno in pijačo EMEND se lahko jemlje s hrano ali brez.
79 Pregnancy and breast-feeding You should not use EMEND during pregnancy unless clearly necessary.
Nosečnost in dojenje Zdravila EMEND med nosečnostjo ne jemljite, razen če je to izrecno potrebno.
It is important that you tell your doctor if you are pregnant or are planning to become pregnant before taking EMEND.
Pomembno je, da pred začetkom jemanja zdravila EMEND poveste zdravniku, če ste noseči ali če nameravate zanositi.
Birth control medicines (oral contraceptives) may not work adequately; another form of contraception should be used during treatment with EMEND and for up to 2 months after using EMEND.
Ker se zanesljivost kontracepcijskih zdravil (peroralnih kontraceptivov) lahko zmanjša, morate med zdravljenjem in še do 2 meseca po zdravljenju z zdravilom EMEND uporabljati drugo obliko kontracepcije.
It is important that you tell your doctor if you are breast- feeding or are planning to breast-feed before taking EMEND.
Pomembno je, da pred začetkom jemanja zdravila EMEND poveste zdravniku, če dojite ali nameravate dojiti.
Driving and using machines It should be taken into account that some people feel dizzy and sleepy after taking EMEND.
Vpliv na sposobnost upravljanja vozil in strojev Upoštevati je treba, da nekateri ljudje po zaužitju zdravila EMEND postanejo omotični in zaspani.
The recommended oral dose of EMEND is one 125 mg capsule 1 hour before you start your chemotherapy treatment on Day 1 and one 80 mg capsule each morning for the 2 days following your chemotherapy treatment.
Priporočeni peroralni odmerek zdravila EMEND je ena 125 mg kapsula 1 uro pred začetkom kemoterapije na 1. dan, in ena 80 mg kapsula zjutraj v naslednjih 2 dneh po kemoterapiji.
Your doctor may substitute fosaprepitant 115 mg (which is converted to aprepitant in your body) for oral EMEND (125 mg) on Day 1 only of your treatment.
Samo na 1. dan vašega zdravljenja vam bo morda zdravnik dal fosaprepitant 115 mg (ki se v telesu pretvori v aprepitant) namesto peroralnega zdravila EMEND (125 mg).
Fosaprepitant is given via an intravenous infusion (a drip), 30 minutes prior to chemotherapy.
Fosaprepitant se daje s počasno intravensko infuzijo 30 minut pred kemoterapijo.
You will still need to take one 80 mg capsule by mouth of EMEND each morning for the 2 days following your chemotherapy treatment.
Vsako jutro v naslednjih 2 dnevih po zdravljenju s kemoterapijo pa boste še vedno morali vzeti eno 80 mg kapsulo zdravila EMEND skozi usta.
If you take more EMEND than you should Do not take more capsules than the doctor recommends.
Če ste vzeli večji odmerek zdravila EMEND, kot bi smeli Ne jemljite večjega števila kapsul, kot vam jih je predpisal zdravnik.
If you do take too many capsules, contact your doctor immediately.
Če ste vzeli preveč kapsul, se nemudoma posvetujte s svojim zdravnikom.
If you forget to take EMEND If you have missed a dose, contact your doctor for advice.
Če ste pozabili vzeti zdravilo EMEND Če ste pozabili vzeti odmerek, se posvetujte s svojim zdravnikom.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
77 zelo pogosti (se pojavijo pri več kot 1 od 10 uporabnikov) pogosti (se pojavijo pri 1 do 10 od 100 uporabnikov) občasni (se pojavijo pri 1 do 10 od 1. 000 uporabnikov) redki (se pojavijo pri 1 do 10 od 10. 000 uporabnikov) zelo redki (se pojavijo pri manj kot 1 od 10. 000 uporabnikov) neznani (pogostnosti ni mogoče oceniti iz podatkov, ki so na voljo)
80 Common side effects are: burping, constipation, diarrhoea, dizziness, weakness, tiredness, headache, hiccups, indigestion, loss of appetite, and increased liver enzymes.
Pogosti neželeni učinki so: spahovanje, zaprtje, driska, omotica, šibkost, utrujenost, glavobol, kolcanje, slaba prebava, izguba apetita in povečanje vrednosti jetrnih encimov.
Uncommon side effects are: abnormal dreaming, acne, anxiousness, bacterial infection, bloating, blood in the urine, chest discomfort, cough, difficulty thinking, disorientation, dry mouth, eye discharge and itching, euphoria (feeling of extreme happiness), excessive sweating, excessive thirst, fever with increased risk of infection, fungal infection, heartburn, high sugar levels in the blood, hot flush, increased painful or burning urination, inflammation of the small intestine and colon, itching, low sodium levels in the blood, lowering of red blood cells, mucus in back of throat, muscle cramp or pain, nausea, oily skin, passing wind, presence of red blood cells in the urine, rash, reddening of the face, ringing in the ear, sensitivity to light, severe constipation, slow heartbeat, sneezing, sore throat, sores in mouth, sores on skin, stomach pain, stomach ulcer, swelling, taste disturbance, throat irritation, vomiting, and weight gain or loss.
Občasni neželeni učinki so: neobičajne sanje, akne, tesnoba, bakterijske okužbe, napihnjenost, kri v urinu, nelagodje v prsnem košu, kašelj, težave pri mišljenju, dezorientiranost, suha usta, izcedek iz oči in srbenje oči, evforija (občutek čezmerne sreče), prekomerno znojenje, prekomerna žeja, povišana telesna temperatura s povečanim tveganjem za okužbo, glivična okužba, zgaga, povečanje vrednosti krvnega sladkorja, navali vročine, pogostejše, boleče ali pekoče uriniranje, vnetje tankega in debelega črevesja, srbenje, nizke ravni natrija v krvi, zmanjšanje števila rdečih krvničk, sluz na zadnji steni žrela, mišični krči ali bolečine, siljenje na bruhanje, mastna koža, vetrovi, prisotnost rdečih krvničk v urinu, izpuščaj, zardevanje obraza, zvonjenje v ušesih, občutljivost na svetlobo, hudo zaprtje, počasen srčni utrip, kihanje, bolečine v žrelu, razjede v ustih, razjede po koži, bolečine v želodcu, želodčna razjeda, otekanje, motnje okušanja, draženje žrela, bruhanje in povečanje ali zmanjšanje telesne mase.
Stevens-Johnson syndrome (rare severe skin reaction), angioedema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing), serious constipation, small bowel not working properly (sub-ileus), and urticaria (hives).
Poročali so tudi o posameznih primerih Stevens- Johnsonovega sindroma (redka huda kožna reakcija), angioedema (otekanje obraza, ustnic, ust, jezika ali žrela, kar lahko povzroči težave pri požiranju ali dihanju), hudega zaprtja, nepravilnega delovanja tankega črevesja (delne zapore pretoka črevesne vsebine) ter urtikarije (koprivnice).
The other ingredients are: sucrose, microcrystalline cellulose (E 460), hydroxypropyl cellulose (E 463), sodium laurilsulfate, gelatin, titanium dioxide (E 171), shellac, potassium hydroxide, and black iron oxide (E 172).
Pomožne snovi so: saharoza, mikrokristalna celuloza (E460), hidroksipropilceluloza (E463), natrijev lavrilsulfat, želatina, titanov dioksid (E171), šelak, kalijev hidroksid in črni železov oksid (E172).
The capsule shell may also contain sodium laurilsulfate and silica colloidal anhydrous.
Ovojnica kapsule lahko vsebuje natrijev lavrilsulfat in brezvodni, koloidni silicijev dioksid.
What EMEND looks like and contents of the pack The 80 mg hard capsule is opaque with a white cap and body with “461” and “80 mg” printed radially in black ink on the body.
- ena EMEND 80 mg kapsula v aluminijastem pretisnem omotu;
81 EMEND 80 mg hard capsules are supplied in the following pack sizes: • Aluminium blister containing one 80 mg capsule • 2-day treatment pack containing two 80 mg capsules • 5 Aluminium blisters each containing one 80 mg capsule
- 5 aluminijastih pretisnih omotov, ki vsebujejo po eno 80 mg kapsulo.
Deutschland MSD SHARP & DOHME GMBH Tel: +49 (0) 89 4561 2612 Infocenter@msd.de
Norge Deutschland MSD (Norge) AS MSD SHARP & DOHME GMBH Tlf: +47 32 20 73 00 Tel: +49 (0) 89 4561 2612 msdnorge@ msd. no Infocenter@ msd. de
Polska MSD Polska Sp.z o.o.
79 Polska Eλλάδα MSD Polska Sp. z o. o.
España Merck Sharp & Dohme de España, S.A.
Portugal España Merck Sharp & Dohme, Lda Merck Sharp & Dohme de España, S. A.
Tel: +34 91 321 06 00 Emend@msd.es
Tel: +351 21 4465700 Tel: +34 91 321 06 00 informacao_ doente@ merck. com Emend@ msd. es
România Merck Sharp & Dohme Romania S.R.L.
România France Merck Sharp & Dohme Romania S. R. L.
Tel: + 4021 529 29 00 msdromania@merck.com
Laboratoires Merck Sharp & Dohme – Chibret Tel: + 4021 529 29 00 Tél: +33 (0) 1 47 54 87 00 msdromania@ merck. com contact@ msd- france. com
Ιtalia Merck Sharp & Dohme (Italia) S.p.A.
Suomi/ Finland Ιtalia MSD Finland Oy Merck Sharp & Dohme (Italia) S. p. A.
INFORMATION FOR THE USER
80 NAVODILO ZA UPORABO
Take special care with EMEND • if you have liver disease
Bodite posebno pozorni pri uporabi zdravila EMEND:
Taking EMEND with food and drink EMEND can be taken with or without food.
Jemanje zdravila EMEND skupaj s hrano in pijačo Zdravilo EMEND lahko vzamete s hrano ali brez.
84 Pregnancy and breast-feeding You should not use EMEND during pregnancy unless clearly necessary.
81 Nosečnost in dojenje Zdravila EMEND med nosečnostjo ne jemljite, razen če je to izrecno potrebno.
The recommended oral dose of EMEND is one 125 mg capsule 1 hour before you start your chemotherapy treatment on Day 1and one 80 mg capsule each morning for the 2 days following your chemotherapy treatment.
Priporočeni peroralni odmerek zdravila EMEND je ena 125 mg kapsula 1 uro pred začetkom kemoterapije na 1. dan in ena 80 mg kapsula zjutraj v naslednjih 2 dneh po kemoterapiji.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
82 zelo pogosti (se pojavijo pri več kot 1 od 10 uporabnikov) pogosti (se pojavijo pri 1 do 10 od 100 uporabnikov) občasni (se pojavijo pri 1 do 10 od 1. 000 uporabnikov) redki (se pojavijo pri 1 do 10 od 10. 000 uporabnikov) zelo redki (se pojavijo pri manj kot 1 od 10. 000 uporabnikov) neznani (pogostnosti ni mogoče oceniti iz podatkov, ki so na voljo)
85 Common side effects are: burping, constipation, diarrhoea, dizziness, weakness, tiredness, headache, hiccups, indigestion, loss of appetite, and increased liver enzymes.
Pogosti neželeni učinki so: spahovanje, zaprtje, driska, omotica, šibkost, utrujenost, glavobol, kolcanje, slaba prebava, izguba apetita in povečanje vrednosti jetrnih encimov.
The other ingredients are: sucrose, microcrystalline cellulose (E 460), hydroxypropyl cellulose (E 463), sodium laurilsulfate, gelatin, titanium dioxide (E 171), shellac, potassium hydroxide, black iron oxide (E 172), red iron oxide (E 172) and yellow iron oxide (E 172).
Pomožne snovi so: saharoza, mikrokristalna celuloza (E460), hidroksipropilceluloza (E463), natrijev lavrilsulfat, želatina, titanov dioksid (E171), šelak, kalijev hidroksid, črni železov oksid (E172), rdeči železov oksid (E172) in rumeni železov oksid (E172).
The capsule shell may also contain sodium laurilsulfate and silica colloidal anhydrous.
Ovojnica kapsule lahko vsebuje tudi natrijev lavril sulfat in brezvodni, koloidni silicijev dioksid.
What EMEND looks like and contents of the pack The 125 mg hard capsule is opaque with a white body and pink cap with “462” and “125 mg” printed radially in black ink on the body.
- ena EMEND 125 mg kapsula v aluminijastem pretisnem omotu;
86 EMEND 125 mg hard capsules are supplied in the following pack sizes: • Aluminum blister containing one 125 mg capsule • 5 Aluminum blisters each containing one 125 mg capsule
- 5 aluminijastih pretisnih omotov, ki vsebujejo po eno 125 mg kapsulo.
Polska MSD Polska Sp.z o.o.
84 Polska Eλλάδα MSD Polska Sp. z o. o.
Ísland Icepharma hf.Simi: +354 540 8000 Ismail@merck.com
Simi: +354 540 8000
There are some medicines that should not be taken with EMEND or that require a dosage adjustment (see also Do not take EMEND).
Nekaterih zdravil med zdravljenjem z zdravilom EMEND ne smete jemati, pri nekaterih pa je treba
89 Pregnancy and breast-feeding You should not use EMEND during pregnancy unless clearly necessary.
Nosečnost in dojenje Zdravila EMEND med nosečnostjo ne jemljite razen, če ni to izrecno potrebno.
The recommended oral dose of EMEND is one 125 mg capsule 1 hour before you start your chemotherapy treatment on Day 1 and one 80 mg capsule each morning for the 2 days following your chemotherapy treatment.
Priporočeni peroralni odmerek zdravila EMEND je ena 125 mg kapsula 1 uro pred začetkom kemoterapije na 1. dan in ena 80 mg kapsula zjutraj v naslednjih 2 dneh po kemoterapiji.
Like all medicines, EMEND can cause side effects, although not everybody gets them.
87 Kot vsa zdravila ima lahko tudi zdravilo EMEND neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
90 Common side effects are: burping, constipation, diarrhoea, dizziness, weakness, tiredness, headache, hiccups, indigestion, loss of appetite, and increased liver enzymes.
Pogosti neželeni učinki so: spahovanje, zaprtje, driska, omotica, šibkost, utrujenost, glavobol, kolcanje, slaba prebava, izguba apetita in povečanje vrednosti jetrnih encimov.
What EMEND contains The active substance is aprepitant.
88 Zdravilna učinkovina je aprepitant.
The other ingredients are: sucrose, microcrystalline cellulose (E 460), hydroxypropyl cellulose (E 463), sodium laurilsulfate, gelatin, titanium dioxide (E 171), shellac, potassium hydroxide, and black iron oxide (E 172); the 125 mg hard capsule also contains red iron oxide (E 172) and yellow iron oxide (E 172).
Pomožne snovi so: saharoza, mikrokristalna celuloza (E460), hidroksipropilceluloza (E463), natrijev lavrilsulfat, želatina, titanov dioksid (E171), šelak, kalijev hidroksid in črni železov oksid (E172); 125 mg trda kapsula vsebuje še rdeči železov oksid (E172) in rumeni železov oksid (E172).
91 What EMEND looks like and contents of the pack The 125 mg hard capsule is opaque with a white body and pink cap with “462” and “125 mg” printed radially in black ink on the body.
Izgled zdravila EMEND in vsebina pakiranja 125 mg trda kapsula je neprozorna; telo je bele barve, pokrovček rožnate barve; na sredini ima odtisnjeni črni oznaki "462" in "125 mg".
The 80 mg hard capsule is opaque with a white cap and body with “461” and “80 mg” printed radially in black ink on the body.
80 mg trda kapsula je neprozorna; telo je bele barve, pokrovček bele barve; na sredini ima odtisnjeni črni oznaki "461" in "80 mg".
EMEND 125 mg and 80 mg hard capsules are supplied in the following pack sizes: • 3-day treatment pack containing one 125 mg capsule and two 80 mg capsules
- v pakiranju za 3- dnevno zdravljenje, ki vsebuje eno 125 mg kapsulo in dve 80 mg kapsuli.
Deutschland MSD SHARP & DOHME GMBH Tel: +49 (0) 89 4561 2612 Infocenter@msd.de
89 MSD SHARP & DOHME GMBH Tel: +49 (0) 89 4561 2612 Infocenter@ msd. de
Latvija SIA “Merck Sharp & Dohme Latvija” Tel: +371 67364 224 msd_lv@merck.com
Tel: +371 67364 224 msd_ lv@ merck. com
This leaflet was last approved in
90 Navodilo je bilo odobreno:
93
91
What is EMSELEX?
Kaj je zdravilo EMSELEX?
EMSELEX are white (7.5 mg) or light peach (15 mg) round prolonged-release tablets that contain the active substance darifenacin (prolonged-release means that darifenacin is released slowly from the tablet over a few hours).
Zdravilo EMSELEX so bele (7, 5 mg) ali svetlomarelične (15 mg) okrogle tablete s podaljšanim sproščanjem, ki vsebujejo darifenacin (podaljšano sproščanje pomeni, da se darifenacin počasi sprošča iz tablete, kar traja nekaj ur).
What is EMSELEX used for?
Za kaj se zdravilo EMSELEX uporablja?
EMSELEX is used in adult patients with overactive bladder syndrome to treat the urge incontinence (sudden lack of control over urination), increased urinary frequency (need to urinate frequently) and urgency (sudden urge to pass urine) that are associated with the syndrome.
Zdravilo EMSELEX se uporablja pri odraslih bolnikih s sindromom čezmerno aktivnega sečnega mehurja za zdravljenje urgentne inkontinence (nenadna nezmožnost nadzora nad mokrenjem), zvečane pogostnosti mokrenja (potreba po pogostejšem mokrenju) in urgence (nenadna močna nuja po mokrenju), ki so povezane s tem sindromom.
How is EMSELEX used?
Kako se zdravilo EMSELEX uporablja?
The recommended starting dose is 7.5 mg once daily.
Priporočeni začetni odmerek je 7, 5 mg enkrat dnevno.
For those patients requiring greater symptom relief, the dose may be increased to 15 mg.
Za bolnike, ki potrebujejo večje lajšanje simptomov, je odmerek mogoče povečati na 15 mg.
The tablets can be taken with or without food, and should be swallowed whole, with some liquid, and not chewed, divided or crushed.
Tablete lahko bolnik jemlje s hrano ali brez nje; bolnik jih mora pogoltniti cele, z nekaj tekočine, ne da bi jih žvečil, razdelil na več delov ali zdrobil.
How does EMSELEX work?
Kako zdravilo EMSELEX deluje?
The active substance in EMSELEX, darifenacin, is an anticholinergic medicine.
Zdravilna učinkovina zdravila EMSELEX je darifenacin, ki je antiholinergično zdravilo.
It blocks a receptor in the body, the muscarinic M3 receptor, and in the bladder, this causes the muscles which pushes urine out of the bladder to relax.
Blokira receptor v telesu, tj. muskarinski receptor M3, in v sečnem mehurju, zaradi česar se sprostijo mišice ki potiskajo urin iz mehurja.
This leads to an increased capacity of the bladder, to changes in the way the bladder contracts, and to less bladder contractions.
To vodi do povečanja zmogljivosti sečnega mehurja, do sprememb v načinu krčenja mišic mehurja in zmanjšanja pogostnosti krčenja sečnega mehurja.
This helps EMSELEX to prevent unwanted urination.
Na ta način zdravilo EMSELEX preprečuje neželeno mokrenje.
How has EMSELEX been studied?
Kako je bilo zdravilo EMSELEX raziskano?
EMSELEX has been studied in four main studies in a total of 2,078 male and female patients with symptoms of overactive bladder.
Zdravilo EMSELEX je bilo preučeno v 4 glavnih raziskavah pri skupno 2078 moških in ženskah s simptomi čezmerno aktivnega sečnega mehurja.
EMSELEX was used at different dosages (from 3.75 mg to 30 mg daily) and compared with placebo (dummy treatment) or with tolterodine (another medicine used in this condition).
Zdravilo EMSELEX so uporabili v različnih odmerkih (od 3, 75 mg do 30 mg dnevno) in ga primerjali s placebom (navideznim zdravilom) ali s tolterodinom (drugim zdravilom za to zdravstveno stanje).
The main measure was the effect of the treatment on the number of incontinence episodes per week.
Glavno merilo je bil učinek zdravljenja na število inkontinenčnih dogodkov na teden.
What benefit has EMSELEX shown during the studies?
Kakšne koristi je zdravilo EMSELEX izkazalo med raziskavami?
Patients receiving EMSELEX 7.5 mg or 15 mg had
Združitev vseh štirih raziskav je pokazala, da je zdravilo EMSELEX učinkovitejše pri zniževanju števila inkontinenčnih dogodkov v primerjavi s placebom.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Bolniki, ki so prejemali zdravilo EMSELEX 7, 5 mg, so imeli tedensko 10, 6 (68%) inkontinenčnih dogodkov manj; bolniki, ki so 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int  EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged 10.6 (68%) or 12.5 (77%) less episodes of incontinence per week, respectively, when patients receiving placebo had 7 or 7.5 (54 or 58%) less episodes per week.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged prejemali zdravilo EMSELEX 15 mg, pa so imeli tedensko 12, 5 (77%) inkontinenčnih dogodkov manj; bolniki, ki so prejemali placebo, pa so imeli tedensko 7 ali 7, 5 (54 ali 58%) inkontinenčnih dogodkov manj.
What is the risk associated with EMSELEX?
Kakšna tveganja so povezana z zdravilom EMSELEX?
The most common side effects (seen in more than 1 patient in 10) are dry mouth and constipation.
Najpogostejša neželena učinka (opažena pri več kot 1 bolniku od 10) sta bila suha usta in zapeka.