natgillin/translations-raw huggingface dataset:
Cross-sensitivity between 5-HT3 antagonists (e.g. dolasetron, ondansetron) has been reported.
Poročali so o navzkrižni preobčutljivosti na antagoniste tipa 5-HT3 (kot sta dolasetron, ondansetron).
What Kytril contains
Kaj vsebuje zdravilo Kytril
4.7 Effects on ability to drive and use machines Kytril is not expected to impair the ability to drive or to use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Ni znano, da bi zdravilo Kytril vplivalo na sposobnost vožnje ali upravljanja strojev.
Very common
Zelo pogosti zaprtje
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
The tablets should not be used after the expiry date which is stated on the {container [TO be completed nationally] } and carton after EXP.
Tablet ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na {vsebniku [izpolni država članica]}in škatli poleg oznake Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika, medicinsko sestro ali farmacevta.
Detailed information on this medicinal product is available on the website of
Podrobne informacije o zdravilu so objavljene na spletni strani
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika, medicinsko sestro ali farmacevta.
• are having problems with your bowel movements because of a blockage of your gut (intestines)
• imate težave z gibanjem črevesja zaradi zapore črevesja (intestinuma);
SPECIAL STORAGE CONDITIONS [To be completed nationally]
POSEBNA NAVODILA ZA SHRANJEVANJE [izpolni država članica]
What Kytril is and what it is used for Before you are given Kytril How Kytril will be given Possible side effects How to store Kytril Further information
Kaj je zdravilo Kytril in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Kytril Kako boste prejeli zdravilo Kytril Možni neželeni učinki
The injection will take between 30 seconds and 5 minutes and the dose will usually be between 1 and 3 mg.
Injekcija v veno bo trajala od 30 sekund do 5 minut, odmerek pa bo običajno med 1 in 3 mg.
PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet.
FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložena tableta [izpolni država članica]
The signs may include red, raised itchy bumps
Znaki lahko vključujejo rdeč, izbokli, srbeči izpuščaj.
Additionally, granisetron has not shown any apparent medicinal product interaction with emetogenic cancer chemotherapies.
Dodatno med granisetronom in emetogenimi kemoterapevtiki za zdravljenje raka ni bilo interakcij.
A dose of 1 mg (10 g/kg) of Kytril solution for injection should be administered by slow intravenous injection.
1-mg odmerek (10 μg/kg) Kytril raztopine za injiciranje je treba dati kot počasno intravensko injekcijo.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULES
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH AMPULE
The vomiting centre is located in the brainstem medullary structures.
Center za bruhanje se nahaja v spodnjem delu možganskega debla.
If you stop taking Kytril
Če ste prenehali jemati zdravilo Kytril
In patients with severe renal failure, data indicate that pharmacokinetic parameters after a single intravenous dose are generally similar to those in normal subjects.
Pri bolnikih s hudo ledvično odpovedjo so po enkratnem intravenskem odmerku farmakokinetični parametri večinoma podobni kot pri zdravih osebah.
Ask your doctor, nurse or pharmacist for advice before taking any medicine.
Posvetujte se z zdravnikom, medicinsko sestro ali s farmacevtom, preden vzamete katerokoli zdravilo.
Granisetron has been shown to block both sodium and potassium channels, which potentially affects both depolarization and repolarization through prolongation of PR, QRS, and QT intervals.
Za granisetron je bilo dokazano, da zavira tako natrijeve kot kalijeve kanalčke, kar potencialno vpliva na depolarizacijo in repolarizacijo s podaljšanjem intervalov PR, QRS in QT. Ti podatki pomagajo razjasniti molekularni mehanizem preko katerega se pojavijo nekatere EKG spremembe (zlasti podaljšanje QT in QRS) povezane s to skupino zdravil.
The other ingredients are: [To be completed nationally]
Pomožne snovi so: [izpolni država članica]
Common: affects 1 to 10 users in 100
Pogosti: pojavijo se pri 1 do 10 bolnikih od 100 bolnikov
Elderly and renal impairment
Starejši in bolniki z ledvično okvaro
Post-operative nausea and vomiting
Pooperativna slabost in bruhanje
Take special care with Kytril
Bodite posebno pozorni pri jemanju zdravila Kytril
Possible side effects How to store Kytril Further information
Shranjevanje zdravila Kytril Dodatne informacije
Detailed information on this medicinal product is available on the website of the
Podrobne informacije o zdravilu so objavljene na spletni strani .
The medicine may be diluted before it is injected into your veins.
Zdravilo se lahko pred injiciranjem v veno razredči.
HOW TO TAKE KYTRIL
KAKO JEMATI ZDRAVILO KYTRIL
Granisetron administered orally has been shown to be effective for prevention and treatment of post-operative nausea and vomiting in adults.
Za granisetron dan peroralno je bila dokazana učinkovit za preprečevanje in zdravljenje pooperativne slabosti in bruhanja pri odraslih.
- If you have any further questions, ask your doctor, nurse or pharmacist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, medicinsko sestro ali s farmacevtom.
Kytril and associated names (see Annex I) 1 mg/1 ml solution for injection Kytril and associated names (see Annex I) 3 mg/3 ml solution for injection Kytril and associated names (see Annex I) 3 mg/1 ml solution for injection Kytril and associated names (see Annex I) 3 mg/5 ml solution for injection
Kytril in povezana imena (glejte Prilogo I ) 1 mg/1 ml raztopina za injiciranje Kytril in povezana imena (glejte Prilogo I ) 3 mg/3 ml raztopina za injiciranje Kytril in povezana imena (glejte Prilogo I ) 3 mg/1 ml raztopina za injiciranje Kytril in povezana imena (glejte Prilogo I ) 3 mg/5 ml raztopina za injiciranje
Granisetron administered intravenously has been shown to be effective for prevention and treatment of post-operative nausea and vomiting in adults.
Za granisetron dan intravensko je bila dokazana učinkovit za preprečevanje in zdravljenje pooperativne slabosti in bruhanja pri odraslih.
Kytril is not likely to affect your ability to drive or use any tools or machines.
Za zdravilo Kytril ni verjetno, da bi vplivalo na sposobnost vožnje ali upravljanja s stroji.
As for other 5-HT3 antagonists, ECG changes including QT prolongation have been reported with granisetron (see sections 4.4 and 4.5).
Tako kot pri drugih antagonistih tipa 5-HT3, so pri granisetronu poročali o EKG spremembah, vključno s podaljšanjem QT intervala (glejte poglavji 4.4 in 4.5).
Kytril solution for injection is indicated in children aged 2 years and above for the prevention and treatment of acute nausea and vomiting associated with chemotherapy.
Kytril raztopina za injiciranje je pri otrocih, starih 2 leti in več, indicirana za preprečevanje in zdravljenje akutne slabosti in bruhanja, ki sta posledici kemoterapije.
Tabulated summary of adverse reactions
Povzetek neželenih učinkov v tabelarični obliki
Kytril and associated names (see Annex I) 1 mg film-coated tablets Kytril and associated names (see Annex I) 2 mg film-coated tablets
Kytril in povezana imena (glejte Prilogo I ) 1 mg filmsko obložene tablete Kytril in povezana imena (glejte Prilogo I ) 2 mg filmsko obložene tablete
Kytril is used to prevent or treat nausea and vomiting (feeling and being sick) caused by other medical treatments, such as chemotherapy or radiotherapy for cancer, and by surgery.
Zdravilo Kytril prepreči ali odpravi slabost in bruhanje, ki sta posledici drugega zdravljenja, npr. kemoterapije ali radioterapije za zdravljenje raka, in operacije.
A dose of 1-3 mg (10-40 g/kg) of Kytril solution for injection should be administered either as a slow intravenous injection or as a diluted intravenous infusion and administered over 5 minutes.
1 do 3-mg odmerek (10-40 μg/kg) Kytril raztopine za injiciranje je treba dati kot počasno intravensko injekcijo ali 5 minutno razredčeno intravensko infuzijo.
Blister - [To be completed nationally]
Ampule - [izpolni država članica]
• medicines used to treat an irregular heartbeat, other ‘5-HT3 receptor antagonist' medicines such as dolasetron or ondansetron (see “Take special care with Kytril” above)
• druge antagoniste receptorjev 5-HT3, kot sta dolasetron ali ondansetron (glejte ''Bodite posebno pozorni pri uporabi zdravila Kytril'' zgoraj);
Kytril and associated names (see Annex I) 1 mg/1 ml solution for injection Kytril and associated names (see Annex I) 3 mg/3 ml solution for injection Kytril and associated names (see Annex I) 3 mg/1 ml solution for injection Kytril and associated names (see Annex I) 3 mg/5 ml solution for injection [See Annex I - To be completed nationally]
Kytril in povezana imena (glejte Prilogo I ) 1 mg/1 ml raztopina za injiciranje Kytril in povezana imena (glejte Prilogo I ) 3 mg/3 ml raztopina za injiciranje Kytril in povezana imena (glejte Prilogo I ) 3 mg/1 ml raztopina za injiciranje Kytril in povezana imena (glejte Prilogo I ) 3 mg/5 ml raztopina za injiciranje [glejte Prilogo I - izpolni država članica]
ECG changes including QT prolongation have been reported with Kytril (see sections 4.4 and 4.5).
Pri zdravilu Kytril so poročali o spremembah EKG, vključno a podaljšanjem QT intervala (glejte poglavji 4.4 in 4.5).
Granisetron administered orally has been shown to prevent nausea and vomiting associated with cancer chemotherapy in adults.
Za granisetron dan peroralno je bilo dokazano, da prepreči slabost in bruhanje, ki sta posledici zdravljenja raka s kemoterapijo pri odraslih.
Very common: 1/10;
Zelo pogosti ≥ 1/10;
The injections will be diluted and be given before radio- or chemotherapy and will take 5 minutes.
Injekcija bo razredčena in bo dana pred radio- ali kemoterapijo.
What Kytril is and what it is used for Before you take Kytril How to take Kytril.
Kaj je zdravilo Kytril in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Kytril Kako jemati zdravilo Kytril Možni neželeni učinki
If you are not sure, talk to your doctor, nurse or pharmacist before taking these tablets.
Če niste gotovi, se pred jemanjem teh tablet posvetujte s svojim zdravnikom, medicinsko sestro ali s farmacevtom.
The solution for injection should not be use after the expiry date which is stated on the carton and/or ampoule after EXP.
Raztopino za injiciranje ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
STATEMENT OF ACTIVE SUBSTANCE(S)
SEZNAM POMOŽNIH SNOVI [izpolni država članica]
Rare (1/10,000 to <1/1,000)
Redki ≥ 1/10.000 do < 1/1.000
Clearance is predominantly by hepatic metabolism.
Izločanje v glavnem poteka prek jetrne presnove.
Kytril is used to prevent or treat nausea and vomiting (feeling and being sick) caused by other medical treatments, such as chemotherapy or radiotherapy for cancer.
Zdravilo Kytril prepreči ali odpravi slabost in bruhanje, ki sta posledici drugega zdravljenja, kot sta kemoterapija ali radioterapija za zdravljenje raka.
You will be given the injection before your radio- or chemotherapy starts.
Preprečevanje slabosti ali bruhanja po radio- ali kemoterapiji Injekcijo boste prejeli pred začetkom radio- ali kemoterapije.
Kytril has no or negligible affect on your ability to drive or use any tools or machines.
Zdravilo Kytril nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Common 1/100 to <1/10;
Občasni ≥ 1/1.000 do < 1/100;
Hypersensitivity reactions e.g. anaphylaxis, urticaria
Občasni preobčutljivostne reakcije kot sta anafilaksija, koprivnica
If you think you have taken too many of the tablets talk to your doctor or nurse.
Če ste vzeli večji odmerek zdravila Kytril, kot bi smeli Če menite, da ste vzeli preveč tablet, se posvetujte z vašim zdravnikom ali medicinsko sestro.
QT prolongation
Srčne bolezni Občasni podaljšanje QT intervala
Treatment of feeling or being sick
Zdravljenje slabosti in bruhanja
Hepatic impairment
Zelo pogosti glavobol
• medicines used to treat an irregular heartbeat other ‘5-HT3 receptor antagonist' medicines such as dolasetron or ondansetron (see “Take special care with Kytril” above)
• druge antagoniste receptorjev 5-HT3, kot je dolasetron ali ondansetron (glejte zgornji odstavek ''Bodite posebno pozorni pri uporabi zdravila Kytril'');
• constipation.
• zaprtje.
The solution should be diluted to 5ml per mg. Further maintenance doses of Kytril solution for injection may be administered at least 10 minutes apart.
Nadaljnje vzdrževalne odmerke Kytril raztopine za injiciranje lahko damo v vsaj 10 minutnih presledkih.
Children should not be given this injection to treat sickness or the feeling of sickness after surgery.
Uporaba pri otrocih za preprečevanje ali zdravljenje slabosti in bruhanja po operaciji Otroci ne smejo prejeti teh injekcij za zdravljenje slabosti ali bruhanja po operaciji.
As for other 5-HT3 antagonists, ECG changes including QT interval prolongation have been reported with granisetron.
Tako kot pri drugih antagonistih tipa 5-HT3, so tudi pri granisetronu poročali o spremembah EKG, vključno s podaljšanjem intervala QT.
Uncommon: affects 1 to 10 users in 1,000
Občasni: pojavijo se pri 1 do 10 bolnikih od 1.000 bolnikov
Prevention of feeling or being sick
Preprečevanje slabosti in bruhanja
Always take Kytril exactly as your doctor has told you.
Pri jemanju zdravila Kytril natančno upoštevajte zdravnikova navodila.
PHARMACEUTICAL FORM AND CONTENTS Solution for injection.
FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje [izpolni država članica]
In elderly subjects after single intravenous doses, pharmacokinetic parameters were within the range found for non-elderly subjects.
Po enkratnem intravenskem odmerku so bili farmakokinetični parametri pri starejših v podobnih mejah kot pri odraslih.
Kytril solution for injection is indicated for the prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.
Kytril raztopina za injiciranje je indicirana za preprečevanje zapoznele slabosti in bruhanja, ki sta posledici kemoterapije in radioterapije.
Marketing Authorisation Holder and Manufacturer [To be completed nationally]
Imetnik dovoljenja za promet z zdravilom in izdelovalec [izpolni država članica]
A dose of 1-3 mg (10-40 g/kg) of Kytril solution for injection should be administered either as a slow intravenous injection or as a diluted intravenous infusion 5 minutes prior to the start of chemotherapy.
Preprečevanje (akutne in zapoznele slabosti): 1 do 3-mg odmerek (10-40 μg/kg) Kytril raztopine za injiciranje je treba dati 5 minut pred začetkom kemoterapije kot počasno intravensko injekcijo ali razredčeno intravensko infuzijo.
Kytril film-coated tablets are indicated in adults for the prevention and treatment of acute nausea and vomiting associated with chemotherapy and radiotherapy.
Kytril filmsko obložene tablete so pri odraslih indicirane za preprečevanje in zdravljenje akutne slabosti in bruhanja, ki sta posledici zdravljenja s kemoterapijo in radioterapijo.
The injection into your veins will take between 30 seconds and 5 minutes and the dose will usually be 1 mg.
Zdravljenje slabosti ali bruhanja po operaciji Injekcija v veno bo trajala med 30 sekund in 5 minut, odmerek pa bo običajno 1 mg.
LIST OF EXCIPIENTS Lactose monohydrate See the leaflet for further information.
SEZNAM POMOŽNIH SNOVI laktoza monohidrat
HOW TO STORE KYTRIL
SHRANJEVANJE ZDRAVILA KYTRIL
NAME OF THE MEDICINAL PRODUCT Kytril and associated names (see Annex I) 1 mg film-coated tablets Kytril and associated names (see Annex I) 2 mg film-coated tablets [See Annex I - To be completed nationally] Granisetron
Kytril in povezana imena (glejte Prilogo I ) 1 mg filmsko obložene tablete Kytril in povezana imena (glejte Prilogo I ) 2 mg filmsko obložene tablete [glejte Prilogo I - izpolni država članica] granisetron
NAME OF THE MEDICINAL PRODUCT Kytril and associated names (see Annex I) 1 mg film-coated tablets Kytril and associated names (see Annex I) 2 mg film-coated tablets [See Annex I - To be completed nationally]
Kytril in povezana imena (glejte Prilogo I ) 1 mg filmsko obložene tablete Kytril in povezana imena (glejte Prilogo I ) 2 mg filmsko obložene tablete [glejte Prilogo I - izpolni država članica]
Kytril film-coated tablets are indicated in adults for prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.
Kytril filmsko obložene tablete so pri odraslih indicirane za preprečevanje zapoznele slabosti in bruhanja, ki sta posledici zdravljenja s kemoterapijo in radioterapijo.
Each film-coated tablet contains 2 mg granisetron (as hydrochloride).
Ena filmsko obložena tableta vsebuje 2 mg granisetrona (v obliki granisetronijevega klorida).
Check with your doctor, nurse or pharmacist before using Kytril if you:
Pred uporabo zdravila Kytril se posvetujte s svojim zdravnikom, medicinsko sestro ali s farmacevtom če:
Each ml solution for injection contains 0.6 mg granisetron (as hydrochloride).
En ml raztopine za injiciranje vsebuje 0,6 mg granisetrona (v obliki granisetronijevega klorida).
Each film-coated tablet contains 1 mg granisetron (as hydrochloride).
Ena filmsko obložena tableta vsebuje 1 mg granisetrona (v obliki granisetronijevega klorida).
4.4 Special warnings and precautions for use As granisetron may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored following its administration.
Bolnike, ki imajo znake subakutne črevesne zapore, je treba skrbno nadzorovati, ker lahko granisetron zmanjša motiliteto spodnjega dela črevesja.
6.1 List of excipients [To be completed nationally]
6.1 Seznam pomožnih snovi [izpolni država članica]
These include dolasetron, ondansetron used like Kytril in the treatment and prevention of nausea and vomiting.
• jemljete druge antagoniste receptorjev 5-HT3 kot sta dolasetron, ondansetron, ki se uporabljata kot zdravilo Kytril za zdravljenje in preprečevanje slabosti in bruhanja;
If you are not sure, talk to your doctor, nurse or pharmacist before having the injection.
Če ste negotovi, se predno prejmete injekcijo, posvetujte s svojim zdravnikom, medicinsko sestro ali s farmacevtom.
HOW KYTRIL WILL BE GIVEN
KAKO BOSTE PREJELI ZDRAVILO KYTRIL
Check with your doctor, nurse or pharmacist before using these tablets, if you:
Pred uporabo teh tablet se posvetujte s svojim zdravnikom, medicinsko sestro ali s farmacevtom če:
Each ml solution for injection contains 3 mg granisetron (as hydrochloride).
En ml raztopine za injiciranje vsebuje 3 mg granisetrona (v obliki granisetronijevega klorida).
4.5 Interaction with other medicinal products and other forms of interaction As for other 5-HT3 antagonists, cases of ECG modifications including QT prolongation have been reported with granisetron.
Tako kot pri drugih antagonistih tipa 5-HT3, so tudi pri granisetronu poročali o EKG spremembah, vključno s podaljšanjem QT intervala.
BEFORE YOU ARE GIVEN KYTRIL
KAJ MORATE VEDETI, PREDEN BOSTE PREJELI ZDRAVILO KYTRIL
Each ml solution for injection contains 1 mg granisetron (as hydrochloride).
En ml raztopine za injiciranje vsebuje 1 mg granisetrona (v obliki granisetronijevega klorida).
BATCH NUMBER Batch
ŠTEVILKA SERIJE Serija
PACKAGE LEAFLET
Ledvična odpoved
Chemo- and radiotherapy-induced nausea and vomiting (CINV and RINV) Prevention (acute and delayed nausea)
- akutne slabosti in bruhanja, ki sta posledici kemoterapije in radioterapije, - pooperativne slabosti in bruhanja.
Cross-sensitivity between 5-HT3 antagonists (e.g. dolasteron, ondansetron) has been reported.
• jemljete druge antagoniste 5-HT3, kot sta dolasteron, ondansetron, ki se uporabljata kot
The injection into your veins will take between 30 seconds and 5 minutes and the dose will usually be between 1 and 3 mg.
Zdravljenje slabosti ali bruhanja po radio- ali kemoterapiji Injekcija bo trajala od 30 sekund do 5 minut, odmerek pa bo običajno med 1 in 3 mg.
4.2 Posology and method of administration Posology
4.2 Odmerjanje in način uporabe
LIST OF EXCIPIENTS [To be completed nationally]
Pretisni Omoti - [izpolni država članica]
Therefore, the Committee considered that these effects need to be closely monitored and managed.
Zato je menil, da je treba te učinke natančno spremljati in nadzirati.
The patient's disease should be confirmed by genetic testing whenever possible.
Kadar je mogoče, je treba bolnikovo bolezen potrditi z genetskimi preiskavami.
However, the CHMP noted that the long-term benefit for the heart and circulatory system still needed to be confirmed.
Kljub temu pa je opozoril, da je še treba potrditi dolgoročno korist za srce in krvožilni sistem.
It is available as capsules (5, 10, 20, 30, 40 and 60 mg) to be taken by mouth on an empty stomach, at least two hours after the evening meal.
Na voljo je v obliki kapsul (5, 10, 20, 30, 40 in 60 mg), ki se jih jemlje peroralno na prazen želodec, najmanj dve uri po večernem obroku.
The European Commission granted a marketing authorisation valid throughout the European Union for Lojuxta on 31 July 2013.
Evropska komisija je dovoljenje za promet z zdravilom Lojuxta, veljavno po vsej Evropski uniji, izdala 31. julija 2013.
On average, the patients' LDL cholesterol levels were reduced by 40%.
V povprečju so se ravni LDL-holesterola pri bolnikih znižale za 40 %.
It will also contain educational materials to be given to patients, including a brochure and an alert card.
Vsebovalo bo tudi izobraževalno gradivo za bolnike, vključno z brošuro in opozorilno kartico.
This is a summary of the European public assessment report (EPAR) for Lojuxta.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Lojuxta.
The full EPAR for Lojuxta 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 Lojuxta je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Lojuxta's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Lojuxta večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Treatment should begin at a dose of 5 mg once per day, and if well tolerated may be steadily increased to a maximum dose of 60 mg per day.
Zdravljenje je treba začeti z odmerkom 5 mg enkrat na dan in ga je mogoče postopoma povečevati do najvišjega odmerka 60 mg na dan, če ga bolnik dobro prenaša.
The most common side effects are problems with the gut, which may affect as many as 9 out of 10 people: diarrhoea and nausea (feeling sick) were each seen in around 7 out of 10 people, dyspepsia (heartburn) and vomiting were each seen in more than 3 out of 10 people, while pain, discomfort and bloating of the abdomen (belly), constipation and flatulence were each seen in at least 2 out of 10 people.
Najpogostejši neželeni učinki so težave s prebavili, ki se lahko pojavijo pri 9 ljudeh od 10: drisko in navzejo (slabost) so opazili pri približno 7 osebah od 10, dispepsijo (zgago) in bruhanje so opazili pri več kot 3 osebah od 10, medtem ko so bolečino, neugodje in napihnjenost trebuha, zaprtje in flatulenco opazili pri vsaj 2 osebah od 10.