natgillin/translations-raw huggingface dataset:
The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in > 5% of 800 patients randomly assigned to receive single-agent pemetrexed and 402 patients randomly assigned to receive placebo in the single-agent pemetrexed maintenance (JMEN: N= 663) and continuation pemetrexed maintenance (PARAMOUNT: N=539) studies. 
Spodnja preglednica podaja pogostnost in izraženost neželenih učinkov, ki so jih ocenili kot možno povezane s študijskim zdravilom, o katerih so poročali pri > 5 % od 800 bolnikov z nedrobnoceličnim karcinomom pljuč, ki so naključno prejemali pemetreksed kot edino zdravilo, in 402 bolnikov, ki so naključno prejemali placebo v študijah vzdrževalnega zdravljenja samo s pemetreksedom (JMEN: N=663) ter nadaljevalnega zdravljenja s pemetreksedom (PARAMOUNT: N=539).
Pemetrexed Hospira is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section 
Zdravilo Pemetreksed Hospira je indicirano kot monoterapija za zdravljenje lokalno napredovalega ali metastatskega nedrobnoceličnega pljučnega karcinoma, ki nima pretežno ploščatocelične histologije pri bolnikih, pri katerih bolezen ni napredovala neposredno po kemoterapiji na osnovi platine (glejte poglavje 5.1).
JMEN: Kaplan-Meier plots of progression-free survival (PFS) and overall survival pemetrexed versus placebo in patients with NSCLC other than predominantly squamous cell histology 
JMEN: Kaplan Meier-jeva grafa preživetja brez napredovanja in skupnega preživetja za pemetreksed v primerjavi s placebom pri bolnikih z NSCLC, ki nima pretežno ploščatocelične histologije:
The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in > 5% of 839 patients with NSCLC who were randomised to receive cisplatin and pemetrexed and 830 patients with NSCLC who were randomised to receive cisplatin and gemcitabine. 
Spodnja preglednica podaja pogostnost in resnost neželenih učinkov, ki so jih ocenili kot možno povezane s študijskim zdravilom, o katerih so poročali pri > 5 % od 839 bolnikov z nedrobnoceličnim karcinomom pljuč, ki so naključno prejemali cisplatin in pemetreksed in 830 bolnikov z nedrobnoceličnim karcinomom pljuč, ki so naključno prejemali cisplatin in gemcitabin.
The recommended dose of Pemetrexed Hospira is 500 mg/m2 of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle. 
Zdravilo Pemetreksed Hospira v kombinaciji s cisplatinom Priporočeni odmerek zdravila Pemetreksed Hospira je 500 mg/m2 telesne površine (TP), dan kot intravenska infuzija v 10 minutah prvi dan vsakega 21-dnevnega ciklusa.
EXP Read the package leaflet for the shelf life of the reconstituted product. 
EXP Za informacije o roku uporabnosti rekonstituiranega zdravila preberite navodilo za uporabo.
After reconstitution as directed, the solution contains 25 mg/ml of pemetrexed. 
Po rekonstituciji po navodilu vsebuje raztopina 25 mg/ml pemetrekseda.
The median OS for the overall population (N = 663) was 13.4 months for the pemetrexed arm and 10.6 months for the placebo arm, hazard ratio = 0.79 (95% CI= 0.65-0.95, p = 0.01192). 
Mediana skupnega preživetja za celotno populacijo (N = 663) je bila 13,4 mesece za skupino s pemetreksedom in 10,6 mesecev za skupino s placebom, razmerje tveganja = 0,79 (95 % CI: 0,65 do 0,95; p = 0,01192).
Pemetrexed is incompatible with diluents containing calcium, including lactated Ringer's Injection and Ringer's Injection. 
Pemetreksed je inkompatibilen z vehikli, ki vsebujejo kalcij, vključno z raztopino Ringerjevega laktata za injiciranje in Ringerjevo raztopino za injiciranje.
What Pemetrexed Hospira looks like and contents of the pack Pemetrexed Hospira is a powder for concentrate for solution for infusion in a glass vial. 
Pemetreksed je prašek za koncentrat za raztopino za infundiranje v stekleni viali.
Pemetrexed Hospira in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1). 
Zdravilo Pemetreksed Hospira je v kombinaciji s cisplatinom indicirano kot zdravljenje prvega izbora za bolnike z lokalno napredovalim ali metastatskim nedrobnoceličnim karcinomom pljuč, ki nima pretežno ploščatocelične histologije (glejte poglavje 5.1).
Dose modification table for Pemetrexed Hospira (as single agent or in combination) and cisplatin - Haematologic toxicities Nadir ANC < 500/mm3 and nadir platelets ≥ 50,000/mm3 
Preglednica 1 - Preglednica za prilagajanje odmerkov zdravila Pemetreksed Hospira (kot edine učinkovine ali v kombinaciji) in cisplatina - Hematološke toksičnosti Najnižji ANC < 500/mm
You must continue taking the folic acid for 21 days after the last dose of Pemetrexed Hospira. 
Po zadnjem odmerku zdravila Pemetreksed Hospira morate še 21 dni jemati folno kislino.
Pemetrexed Hospira 100 mg powder for concentrate for solution for infusion Pemetrexed Hospira 500 mg powder for concentrate for solution for infusion Pemetrexed Hospira 1,000 mg powder for concentrate for solution for infusion pemetrexed 
Pemetreksed Hospira 100 mg prašek za koncentrat za raztopino za infundiranje Pemetreksed Hospira 500 mg prašek za koncentrat za raztopino za infundiranje Pemetreksed Hospira 1.000 mg prašek za koncentrat za raztopino za infundiranje
*** According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2. 
*** V skladu z CTC Nacionalnega inštituta za rakava obolenja (v2.0; NCI 1998), motnje okusa in alopecija morata biti poročana kot stopnja 1 ali 2.
PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial 
Prašek za koncentrat za raztopino za infundiranje 1 viala
Pemetrexed Hospira in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. 
Zdravilo Pemetreksed Hospira je v kombinaciji s cisplatinom indicirano za zdravljenje bolnikov z neresektabilnim malignim plevralnim mezoteliomom, ki jih še nismo zdravili s kemoterapijo.
Pemetrexed Hospira 1,000 mg vials contain approximately 108 mg sodium per vial. 
Pemetreksed Hospira 1.000 mg vsebuje približno 108 mg natrija na vialo.
Each 100 mg vial contains approximately 11 mg sodium. 
Pomožna snov z znanim učinkom Ena 100 mg viala vsebuje približno 11 mg natrija.
Pemetrexed Hospira is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1). 
Zdravilo Pemetreksed Hospira je indicirano kot monoterapija za zdravljenje drugega izbora bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim karcinomom, ki nima pretežno ploščatocelične histologije (glejte poglavje 5.1).
The resulting solution contains 25 mg/ml pemetrexed. 
Tako dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG 
Imetnik dovoljenja za promet z zdravilom Pfizer Europe MA EEIG Boulevard de la Plaine 17
Pemetrexed Hospira 500 mg contains approximately 54 mg sodium per vial. 
Pemetreksed Hospira 500 mg vsebuje približno 54 mg natrija v eni viali.
- if you are breast-feeding; you must discontinue breast-feeding during treatment with 
- če dojite, morate med zdravljenjem z zdravilom Pemetreksed Hospira dojenje prekiniti.
Pemetrexed/Cisplatin (N = 839) 
Pemetreksed/cisplatin (N = 839)
Each 500 mg vial contains approximately 54 mg sodium. 
Pomožna snov z znanim učinkom Ena 500 mg viala vsebuje približno 54 mg natrija.
METHOD AND ROUTE(S) OF ADMINISTRATION Single use only 
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Patients received maintenance 
Bolniki s popolnim dopolnjevanjem
Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy) may occur in patients who are also treated with radiation either before, during or after their pemetrexed therapy. 
Pancitopenija - skupno nizko število belih krvnih celic, rdečih krvnih celic in trombocitov Radiacijska pljučnica (brazgotinjenje pljučnih mešičkov, povezano z obsevanjem) se lahko pojavi pri bolnikih, ki so zdravljeni tudi z obsevanjem pred, med ali po zdravljenju s pemetreksedom.
Pemetrexed Hospira 100 mg powder for concentrate for solution for infusion: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate). 
Pemetreksed Hospira 100 mg prašek za koncentrat za raztopino za infundiranje: Ena viala vsebuje 100 miligramov pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
Pemetrexed / Cisplatin (N = 226) 
Parameter učinkovitosti pemetreksed / cisplatin (N = 226)
Pemetrexed/Cisplatin (N = 168) 
pemetreksed / cisplatin (N = 168)
After reconstitution, each vial contains 25 mg/ml of pemetrexed 
Po rekonstituciji ena viala vsebuje 25 mg/ml pemetrekseda.
PARAMOUNT: Kaplan-Meier plot of progression-free survival (PFS) and Overall Survival (OS) for continuation pemetrexed maintenance versus placebo in patients with NSCLC other than predominantly squamous cell histology (measured from randomisation) 
Kaplan Meier-jev graf preživetja brez napredovanja in skupnega preživetja za nadaljevanje vzdrževalnega zdravljenja s pemetreksedom v primerjavi s placebom pri bolnikih z nedrobnoceličnim karcinomom pljuč, ki nima pretežno ploščatocelične histologije (merjeno od randomizacije)
Hospira and cisplatin) a These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) 
50 % predhodnega odmerka (obeh - zdravila Pemetreksed Hospira in cisplatina) Ta merila ustrezajo Merilom pogostih toksičnosti Nacionalnega inštituta za rakava obolenja (National Cancer Institute Common Toxicity Criteria, CTC v2.0; NCI 1998), definiciji za ≥ CTC stopnjo krvavitve 2
For precautions to be taken before handling or administering Pemetrexed Hospira, see section 6.6. 
Za previdnostne varnostne ukrepe pri pripravi in dajanju zdravila Pemetreksed Hospira glejte poglavje
Allergic reaction: skin rash / burning or prickling sensation Infection including sepsis 
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) Alergijske reakcije: kožni izpuščaji/pekoč ali zbadajoč občutek Okužba vključno s sepso
Pemetrexed Hospira 500 mg powder for concentrate for solution for infusion: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate). 
Pemetreksed Hospira 500 mg prašek za koncentrat za raztopino za infundiranje: Ena viala vsebuje 500 miligramov pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
Reconstitute 500 mg vials with 20 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative. 
500 mg viale pripravite z 20 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa.
In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of Pemetrexed Hospira is 500 mg/m2 BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle. 
Zdravilo Pemetreksed Hospira kot samostojno zdravilo Pri bolnikih, pri katerih zdravimo nedrobnocelični pljučni karcinom po predhodni kemoterapiji, je priporočeni odmerek zdravila Pemetreksed Hospira 500 mg/m2 TP, dan kot intravenska infuzija v
Warnings and precautions Talk to your doctor or hospital pharmacist before receiving Pemetrexed Hospira. 
Pred začetkom uporabe zdravila Pemetreksed Hospira se posvetujte z zdravnikom ali bolnišničnim farmacevtom.
What Pemetrexed Hospira contains 
Kaj vsebuje zdravilo Pemetreksed Hospira
Pemetrexed Hospira 1,000 mg powder for concentrate for solution for infusion: Each vial contains 1,000 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate). 
Pemetreksed Hospira 1.000 mg prašek za koncentrat za raztopino za infundiranje: Ena viala vsebuje 1.000 miligramov pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate). 
Ena viala vsebuje 100 mg pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
White to either light yellow or green-yellow lyophilised powder. 
Bel do svetlorumen ali zelenorumen liofiliziran prašek.
Each 1,000 mg vial contains approximately 108 mg sodium. 
Pomožna snov z znanim učinkom Ena 1.000 mg viala vsebuje približno 108 mg natrija.
Reconstitute 1,000 mg vials with 40 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative. 
1.000 mg viale pripravite s 40 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa.
Reconstitute 100 mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative. 
3. 100 mg viale pripravite s 4,2 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa.
NAME OF THE MEDICINAL PRODUCT Pemetrexed Hospira 1,000 mg powder for concentrate for solution for infusion pemetrexed 
Pemetreksed Hospira 1.000 mg prašek za koncentrat za raztopino za infundiranje
Other medicines and Pemetrexed Hospira 
Shranjevanje zdravila Pemetreksed Hospira
After reconstitution (see section 6.6), each vial contains 25 mg/ml of pemetrexed. 
Po rekonstituciji vsebuje ena viala 25 mg/ml pemetrekseda (glejte poglavje 6.6).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton 1,000 mg presentation 
Zunanja škatla 1.000 mg oblike
Pemetrexed Hospira 100 mg powder for concentrate for solution for infusion 
Pemetreksed Hospira 100 mg prašek za koncentrat za raztopino za infundiranje
NAME OF THE MEDICINAL PRODUCT Pemetrexed Hospira 500 mg powder for concentrate for solution for infusion pemetrexed 
Pemetreksed Hospira 500 mg prašek za koncentrat za raztopino za infundiranje
Stomatitis/Pharyngitis 23.2 Nausea 
Stomatitis/ faringitis
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 500 mg presentation 
Zunanja škatla 500 mg oblike
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 100 mg presentation 
Zunanja škatla 100 mg oblike
NAME OF THE MEDICINAL PRODUCT Pemetrexed Hospira 100 mg powder for concentrate for solution for infusion pemetrexed 
Pemetreksed Hospira 100 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 mg 
Pemetreksed kot edino učinkovino so preučevali v odmerku 500 mg/m2 pri
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1,000 mg 
3 ter število trombocitov na ≥ 100.000 celic/mm
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label 1,000 mg presentation 
Nalepka na viali 1.000 mg oblike
London, 14 August 2008 EMEA/CHMP/524284/2008 
London, 14. avgust 2008 EMEA/CHMP/524278/2008
Octegra was initially approved in June 1999. 
Zdravilo Octegra so prvič odobrili junija 1999.
Octegra film-coated tablets contain 400 mg moxifloxacin as hydrochloride. 
Zdravilo Octegra, filmsko obložene tablete, vsebuje 400 mg moksifloksacina v obliki hidroklorida.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 6 (12) REFERRAL Octegra and associated names International non-proprietary name (INN): moxifloxacin BACKGROUND INFORMATION * 
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 6(12) ZA ZDRAVILO Octegra in povezana imena Mednarodno nelastniško ime (INN): moksifloksacin OSNOVNE INFORMACIJE*
In general, safety reviews indicate that about 40% of such reports are in patients over 60 years of age. 
Na splošno varnostni pregledi kažejo, da približno 40 % teh poročil vključuje bolnike, starejše od 60 let.
Contact our press officers Monika Benstetter or Martin Harvey 
Monika Benstetter ali Martin Harvey
Restrictions on the use of domperidone-containing medicines 
Omejitev uporabe zdravil, ki vsebujejo domperidon
The product information has been amended appropriately. 
Informacije o zdravilu so bile ustrezno spremenjene.
The available evidence of efficacy was not sufficient to support its use for other indications. 
Razpoložljivi dokazi o učinkovitosti niso bili zadostni, da bi podprli uporabo pri drugih indikacijah.
• Data in support of other indications were extremely limited. 
• Podatki za podporo drugih indikacij so bili izjemno omejeni.
• Domperidone should be used at the lowest effective dose for the shortest possible duration. 
• Domperidon je treba uporabljati v najmanjšem učinkovitem odmerku in najkrajšem mogočem obdobju.
The injectable form of domperidone was withdrawn in 1985 because of such side effects. 
Domperidon za injiciranje je bil zaradi takih učinkov umaknjen leta 1985.
These recommendations are based on careful consideration of data on the safety and efficacy of domperidone from various sources. 
Ta priporočila temeljijo na skrbni presoji podatkov o varnosti in učinkovitosti domperidona iz različnih virov.
The review of domperidone was initiated on 1 March 2013 at the request of the Belgian medicines authority, the Federal Agency for Medicines and Health Products (FAGG-AFMPS), under Article 31 of Directive 2001/83/EC. 
Pregled domperidona se je na zahtevo belgijske agencije za zdravila (Federal Agency for Medicines and Health Products, FAGG-AFMPS) začel 1. marca 2013, skladno s členom 31 Direktive 2001/83/ES.
Some products will be withdrawn from the market because their strength does not match the new doses. 
Nekatera zdravila bodo umaknjena iz prometa, saj njihova jakost ni skladna z novimi odmerki.
Although the scope of the review did not cover use outside the licensed indications (off-label use) the principles behind these recommendations should be considered whenever domperidone is used. 
Čeprav presoja ni vključevala uporabe zunaj odobrenih indikacij (nenamenska uporaba), je treba načela teh priporočil upoštevati ob vsakršni uporabi domperidona.
The recommendations were originally made by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) at its meeting of 3-6 March, after a careful evaluation of the available evidence on the benefits and risks of such medicines. 
Priporočila je na svojem sestanku od 3. do 6. marca prvotno pripravil Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri agenciji EMA, po skrbni presoji razpoložljivih dokazov o koristih in tveganjih teh zdravil.
This helps to prevent nausea (feeling sick) and vomiting. 
To pomaga preprečevati slabost (navzeo) in bruhanje.
This is in line with the data coming from drug-drug interaction studies, and from spontaneous reporting. 
To je skladno s podatki iz študij medsebojnega delovanja med zdravili in spontanim poročanjem.
The product information for domperidone-containing products has been updated, and a letter has been sent to healthcare professionals explaining the new recommendations. 
Informacije o zdravilih, ki vsebujejo domperidon, so bile posodobljene, zdravstvenim delavcem pa je bilo poslano pismo z razlago novih priporočil.
• Patients or carers who have any concerns should speak to a healthcare professional. 
• Bolniki ali negovalci, ki imajo pomisleke, naj se posvetujejo z zdravstvenim delavcem.
There have been concerns that it might increase the risk of side effects on the heart, including dangerously irregular heartbeats in some patients. 
Prisotni so bili pomisleki, da bi lahko povečal tveganje neželenih učinkov na srce, vključno z nevarno nerednim srčnim utripom pri nekaterih bolnikih.
Some of these studies also supported a greater risk in patients over 60 years of age or who were taking high doses (over 30 mg/day). 
Nekatere od teh študij so prav tako podprle večje tveganje pri bolnikih, starejših od 60 let, ali bolnikih, ki jemljejo velike odmerke (nad 30 mg/dan).
In addition, it should not be used with other medicines that have similar effects on the heart or reduce the breakdown of domperidone in the body (thus increasing the risk of side effects). 
Poleg tega se ne sme uporabljati skupaj z drugimi zdravili, ki imajo podobne učinke na srce ali zmanjšajo razgradnjo domperidona v telesu (in s tem povečajo tveganje neželenih učinkov).
The review of domperidone was carried out at the request of the Belgian medicines authority over concerns about the medicine's effects on the heart. 
Presojo domperidona so izvedli na zahtevo belgijske agencije za zdravila zaradi pomislekov, povezanih z učinki zdravila na srce.
In particular, there was little evidence in support of the long-term efficacy of domperidone in dyspepsia and gastro-oesophageal reflux disorder. 
Predvsem je bilo malo dokazov, ki bi podpirali dolgotrajno učinkovitost domperidona pri dispepsiji in gastroezofagealnem refluksu.
However, cases of heart problems in patients using the medicine continued to be reported, and the PRAC was therefore asked to examine whether the benefits still outweighed the risks for these medicines in their approved uses and forms, and whether their marketing authorisations should be maintained or changed across the EU. 
Vendar pa so pri bolnikih, ki so uporabljali ta zdravila, še naprej poročali o primerih srčnih težav, zato so odbor PRAC zaprosili, naj preveri, ali so koristi teh zdravil za odobreno uporabo in v odobrenih oblikah še vedno večje od z njimi povezanih tveganj ter ali je treba dovoljenja za promet z njimi ohraniti ali spremeniti po celotni EU.
The benefits in these indications were therefore not considered to outweigh the risk. 
Posledično je bil sprejet sklep, da koristi pri teh indikacijah niso večje od tveganj.
• Patients with certain existing heart problems, or who are taking certain other medicines that enhance the effects of domperidone or reduce its breakdown in the body, should not take domperidone. 
• Bolniki z nekaterimi obstoječimi srčnimi težavami ali bolniki, ki jemljejo nekatera druga zdravila, ki okrepijo učinke domperidona ali zmanjšajo njegovo razgradnjo v telesu, ne smejo jemati domperidona.
• Formulations not consistent with the new dosage recommendations will be withdrawn from the market, as will combinations of domperidone with cinnarizine. 
• Formulacije, ki niso skladne s priporočili za novo odmerjanje, bodo umaknjene iz prometa, kar velja tudi za kombinacije domperidona in cinarizina.
Domperidone-containing medicines have been authorised in most EU Member States via national procedures since the 1970s and are widely available as over-the-counter or prescription-only medicines. 
Zdravila, ki vsebujejo domperidon, so v večini držav članic EU z nacionalnimi postopki odobrena že od 70-tih let 20. stoletja in so široko razpoložljiva kot zdravila brez recepta ter zdravila na recept.
The medicine should not normally be used for longer than one week. 
Zdravilo se navadno ne sme uporabljati dlje kot en teden.
• Domperidone is a medicine that has been used for various stomach and digestive problems. 
• Domperidon je zdravilo, ki se uporablja pri različnih težavah z želodcem in prebavo.
The maximum treatment duration should not usually exceed one week. 
Najdaljše trajanje zdravljenja običajno ne sme preseči enega tedna.
• Although the results of the thorough QT study with domperidone indicate that it does not significantly prolong the QTc interval when administered to healthy subjects at 10 mg and 20 mg four times daily, there are limitations in the study that restrict the conclusions that can be drawn. 
• Čeprav rezultati podrobne študije QT z domperidonom kažejo, da ne povzroča pomembnega podaljšanja intervala QTc, če se daje zdravim preizkušancem v odmerkih 10 mg in 20 mg štirikrat na dan, je bila študija omejena, zato ni mogoče sprejeti dokončnih sklepov.