natgillin/translations-raw huggingface dataset:
The recommended dose is one tablet once a week. 
Priporočeni odmerek zdravila Vantavo je ena tableta enkrat na teden.
Other information about Vantavo: 
Druge informacije o zdravilu Vantavo:
What measures are being taken to ensure the safe and effective use of Vantavo? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vantavo?
The full EPAR for Vantavo 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 Vantavo je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This authorisation was based on the authorisation granted to Fosavance in 2005 (‘informed consent'). 
Ta odobritev je temeljila na dovoljenju za promet z zdravilom Fosavance, izdanemu leta 2005 (uporaba dokumentacije s soglasjem).
The patient must take the tablet with a full glass of water (but not mineral water), at least 30 minutes before any food, drink, or other medicines (including antacids, calcium supplements and vitamins). 
Bolnica mora tableto zaužiti s polnim kozarcem vode (vendar ne mineralne), in sicer najmanj 30 minut pred zaužitjem hrane, pijače ali drugih zdravil (vključno z antacidi, dodatki kalcija in vitamini).
This document is a summary of the European Public Assessment Report (EPAR) for Vantavo. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vantavo.
A risk management plan has been developed to ensure that Vantavo is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Vantavo je bil pripravljen načrt obvladovanja tveganj.
the day, which should be at least 30 minutes after taking the tablet. 
prvega dnevnega obroka hrane, kar pa ne sme biti prej kot 30 minut po zaužitju tablete.
For more information about treatment with Vantavo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Vantavo preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The CHMP decided that Vantavo's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Vantavo večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The tablet should be swallowed whole and not crushed, chewed or allowed to dissolve in the mouth. 
Bolnice morajo tableto pogoltniti celo in je ne smejo zdrobiti, žvečiti ali raztopiti v ustih.
Vitamin D3 is a nutrient that is found in some foods, but is also made in the skin through exposure to natural sunlight. 
Vitamin D3 je hranilna snov, ki jo najdemo v nekaterih vrstah hrane, z izpostavljanjem naravni sončni svetlobi pa nastaja tudi v koži.
Since patients with osteoporosis may not get enough vitamin D3 through exposure to sunlight, it is included in Vantavo. 
Ker bolniki z osteoporozo z izpostavljanjem sončni svetlobi morda ne dobijo dovolj vitamina D3, je ta vključen v zdravilo Vantavo.
What benefit has Vantavo shown during the studies? 
Kakšne koristi je zdravilo Vantavo izkazalo med študijami?
Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall, since oestrogen helps to keep bones healthy. 
Osteoporoza je pogostejša pri ženskah v obdobju po menopavzi, ko raven ženskega hormona estrogena, ki prispeva k ohranjanju zdravih kosti, upade.
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 Vantavo. 
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.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vantavo, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The European Commission granted a marketing authorisation valid throughout the EU for Alendronate Sodium And Colecalciferol, MSD on 16 October 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Alendronate Sodium And Colecalciferol, MSD, veljavno po vsej Evropski uniji, izdala 16. oktobra 2009.
Because alendronic acid and vitamin D3 are already used separately in authorised medicines in the EU, the company presented data obtained in earlier studies and from the published literature from women who had been through the menopause and who were taking alendronic acid and vitamin D as separate tablets. 
Ker se alendronska kislina in vitamin D3 ločeno že uporabljata v zdravilih, odobrenih v EU, je družba predložila podatke iz starejših študij ter iz objavljene literature o ženskah, ki so že prestale menopavzo in so jemale alendronsko kislino in vitamin D kot ločeni tableti.
What is the risk associated with Vantavo? 
Kakšna tveganja so povezana z zdravilom Vantavo?
1 Previously known as Alendronate Sodium And Colecalciferol, MSD. 
1 Prej znano kot Alendronate Sodium and Colecalciferol, MSD.
Vitamin D3, along with other forms of vitamin D, is required for calcium absorption and normal bone formation. 
Skupaj z drugimi vrstami vitamina D je potreben za absorpcijo kalcija in normalno tvorbo kostne mase.
It is available as tablets (70 mg alendronic acid and 2,800 international units [IU] colecalciferol; 70 mg alendronic acid and 5,600 IU colecalciferol). 
Na voljo je v obliki tablet (70 mg alendronske kisline in 2 800 mednarodnih enot [i.e.] holekalciferola; 70 mg alendronske kisline in 5 600 i.e. holekalciferola).
The information presented by the company from earlier studies and the published literature showed that the dose of alendronic acid included in Vantavo was the same as the dose needed to prevent bone loss. 
Podatki iz starejših študij in objavljene literature, ki jih je predstavila družba, so pokazali, da je odmerek alendronske kisline v zdravilu Vantavo enak odmerku, ki je potreben za preprečevanje izgube kostne mase.
For the full list of all side effects reported with Vantavo, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Vantavo, glejte navodilo za uporabo.
Why has Vantavo been approved? 
Zakaj je bilo zdravilo Vantavo odobreno?
Vantavo must not be used in patients who have abnormalities of the oesophagus, who have hypocalcaemia (low blood calcium levels), or who cannot stand or sit upright for at least 30 minutes. 
Zdravila Vantavo ne smejo uporabljati bolnice z nepravilnostmi v požiralniku, bolnice s hipokalciemijo (nizkimi ravnmi kalcija) ali tiste, ki vsaj 30 minut ne morejo vzravnano stati ali sedeti.
The most common side effects with Vantavo include abdominal pain (stomach ache), dyspepsia (heartburn), oesophageal (gullet) ulcers, dysphagia (difficulty swallowing), abdominal distension (swollen tummy) and acid regurgitation. 
Najpogostejši neželeni učinki zdravila Vantavo so bolečine v trebuhu, dispepsija (zgaga), razjede požiralnika, disfagija (težave pri požiranju), napihnjen trebuh in refluks kisline.
This study was extended in 652 patients for a further 24 weeks to compare the effects of continuing with Vantavo 70 mg/2,800 IU on its own or adding 2,800 IU vitamin D3 (equivalent to using Vantavo 70 mg/5,600 IU). 
Ta študija je bila pri 652 bolnikih podaljšana za nadaljnjih 24 tednov, da bi učinke nadaljevanja zdravljenja samo z zdravilom Vantavo 70 mg/2800 i.e. primerjali z učinki dodajanja 2800 i.e. vitamina D3 (kar je enakovredno uporabi zdravila Vantavo 70 mg/5600 i.e.).
To support the combination of alendronic acid and vitamin D3 in the same tablet, the company also carried out a study in 717 patients with osteoporosis, including 682 women who had been through the menopause, to show Vantavo's ability to increase vitamin D levels. 
V podporo uporabi kombinacije alendronske kisline in vitamina D3 v isti tableti in za pridobitev dokazov, da zdravilo Vantavo lahko poveča ravni vitamina D, je družba izvedla študijo s 717 bolniki z osteoporozo, ki je vključevala 682 žensk, pri katerih se je že pojavila menopavza.
Vantavo is a medicine that contains two active substances: alendronic acid and colecalciferol (vitamin D3). 
Vantavo je zdravilo, ki vsebuje dve zdravilni učinkovini: alendronsko kislino in holekalciferol (vitamin D3).
In the extension study, similar numbers of patients taking Vantavo 70 mg/2,800 IU and Vantavo 70 mg/5,600 IU had low vitamin D levels (below 6%), but the patients taking Vantavo 70 mg/5,600 IU had greater increases in vitamin D levels over the 24 weeks of the study. 
V podaljšani študiji je bilo število bolnic z nizkimi ravnmi vitamina D (pod 6 %) v skupini, ki je jemala zdravilo Vantavo 70 mg/2 800 i.e. podobno številu bolnic v skupini, ki je prejemala zdravilo Vantavo 70 mg/5 600 i.e., vendar pa so se pri tistih, ki so jemale zdravilo Vantavo 70 mg/5 600 i.e., v 24 tednih študije ravni vitamina D bolj povečale.
Patients should also take calcium supplements if they are not getting enough calcium from their diet. For more information, see the package leaflet. 
Bolnice morajo jemati tudi dodatke kalcija, če njegov vnos s prehrano ni zadosten.
Patients received either Vantavo 70 mg/2,800 IU or alendronic acid only once a week. 
Bolnice so enkrat tedensko prejemale bodisi zdravilo Vantavo 70 mg/2 800 i.e. bodisi le alendronsko kislino.
What is Vantavo used for? 
Za kaj se zdravilo Vantavo uporablja?
How has Vantavo been studied? 
Kako je bilo zdravilo Vantavo raziskano?
Vantavo (containing either 2,800 or 5,600 IU colecalciferol) is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of low vitamin D levels. 
Zdravilo Vantavo (ki vsebuje 2 800 ali 5 600 i.e. holekalciferola) se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi, pri katerih obstaja tveganje za pomanjkanje vitamina D. Zdravilo Vantavo 70 mg/5 600 i.e. se uporablja pri bolnikih, ki ne jemljejo dodatkov vitamina D. Zdravilo zmanjšuje tveganje za zlome kosti v hrbtenici in kolkih.
Vantavo contains two active substances: alendronic acid and colecalciferol (vitamin D3). 
Zdravilo Vantavo vsebuje dve zdravilni učinkovini: alendronsko kislino in holekalciferol (vitamin D3).
Vantavo alendronic acid and colecalciferol 
Vantavo alendronska kislina in holekalciferol
How is Vantavo used? 
Kako se zdravilo Vantavo uporablja?
What is Vantavo? 
Kaj je zdravilo Vantavo?
How does Vantavo work? 
Kako zdravilo Vantavo deluje?
After 15 weeks, fewer patients had low vitamin D levels when they took Vantavo 70 mg/2,800 IU (11%) than when they took alendronic acid only (32%). 
Dodatne študije so pokazale, da lahko vključitev vitamina D3 in alendronske kisline v isto tableto poveča ravni vitamina D. Po 15 tednih zdravljenja je bil delež bolnic z nizko ravnjo vitamina D med bolniki, zdravljenih z zdravilom Vantavo 70 mg/2 800 i.e., nižji (11 %) kot pri tistih, ki so prejemale le alendronsko kislino (32 %).
Strength Pharmaceutical 
Jakost Farmacevtska
EU Number Invented 
EU številka
Packaging 
Ciljna
9 July 2001 
9. julij 2001
See the Module ”All authorised presentations” 
Glej modul »All authorised presentations«
Levviax is indicated for the treatment of the following infections: 
Levviax je indiciran za zdravljenje naslednjih okužb:
Date of issue of Marketing Authorisation valid throughout the European Union: 
Datum izdaje dovoljenja za promet z zdravilom, veljavnega po vsej Evropski uniji:
For detailed conditions for the use of this product, scientific information or procedural aspects please refer to the relevant modules. 
Podrobnosti o pogojih uporabe tega zdravila, informacijah znanstvene narave ter postopkovnih vidikih najdete v ustreznih modulih.
Pharmaco-therapeutic group (ATC Code): 
Farmakološko-terapevtska skupina (ATC klasifikacija):
Telithromycin 
telitromicin
LEVVIAX International Nonproprietary Name (INN): Telithromycin Abstract 
Mednarodno nelastniško ime (INN): telitromicin
Currently approved therapeutic indication(s): 
Trenutno odobrena(e) terapevtska(e) indikacija(e):
EMEA/H/C/0355 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) 
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EUROPEAN PUBLIC ASSESSMENT REPORT - EPAR)
When prescribing Levviax, consideration should be given to official guidance on the appropriate use of antibacterial agents. 
Pri predpisovanju zdravila Levviax je potrebno upoštevati uradne smernice za ustrezno uporabo protibakterijskih zdravil.
The initial approval was based on studies, which showed that the potential benefits with telithromycin particularly relate to its use in the treatment of infections caused by penicillin and/or erythromycin resistant S. pneumoniae. 
Prvotna odobritev zdravila je temeljila na rezultatih študij, ki so pokazale, da so potencialne prednosti telitromicina povezane zlasti z njegovo uporabo pri zdravljenju okužb, povzročenih s S. pneumoniae, odpornimi proti penicilinu in/ali eritromicinu.
Telithromycin interacts with the translation at the 23S ribosomal RNA level and some data also indicate that assembly of the 30S subunit may be impaired. 
Telitromicin ovira ribosomsko translacijo na ravni 23S ribosomske RNA, določeni podatki pa kažejo tudi na to, da zmore zavreti nastanek podenote 30S.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers that the benefit risk ratio for Levviax is favourable in the approved indication 
Na podlagi predloženih podatkov o kakovosti, varnosti in učinkovitosti zdravila CHMP meni, da je zdravilo Levviax izkazalo ugodno razmerje med tveganji in koristmi za odobreno indikacijo.
Orphan medicinal product designation date: 
Datum določitve zdravila kot zdravila sirote:
The most common side effects are, as for macrolides, mainly reported from the digestive and nervous systems, with diarrhoea, nausea, headache and dizziness. 
Najpogostejši stranski učinki so, tako kot pri makrolidih, povezani s prebavnim traktom in živčnim sistemom ter vključujejo drisko, navzeo, glavobol in vrtoglavico.
However, clinical experience is still rather limited in the treatment of these infections, and therefore telithromycin should be used with caution until further experience of emergence of resistance has been gained, especially in areas with a high prevalence of resistant pneumococci. 
Toda klinične izkušnje s telitromicinom za zdravljenje teh okužb so še vedno skromne, zato je potrebno telitromicin uporabljati previdno dokler ne pridobimo nadaljnjih izkušenj v povezavi z odpornostjo bakterij, zlasti na področjih z visoko prevalenco odpornih pnevmokokov.
The active substance of Levviax is telithromycin, an antibacterial medicinal product which is a novel semi-synthetic antibacterial agent belonging to a new family of antibiotics, the ketolides, closely related to the well-known macrolide antibiotics. 
Učinkovina zdravila Levviax je telitromicin, novo, protibakterijsko zdravilo, ki je dejansko novo polsintetično protibakterijsko zdravilo in spada v novo družino antibiotikov, imenovanih ketolidi, ki so tesno povezani z znanimi makrolidnimi antibiotiki.
Aventis Pharma S.A. 20 avenue Raymond Aron F-92160 Antony France 
Imetnik dovoljenja za promet z zdravilom: Aventis Pharma S.A. 20 avenue Raymond Aron
Not applicable 
Navedba smiselno ni potrebna
Adverse events assessed as possibly related to study treatment were reported for 35.8% of the telithromycin patients, versus 28.3% of the comparators. 
Pri 35,8 % bolnikov, ki so bili zdravljeni s telitromicinom, so poročali o stranskih učinkih, ki bi bili lahko povezani z uporabo telitromicina, medtem ko je ta odstotek pri zdravljenju s primerljivimi učinkovinami znašal 28,3 %.
The frequency and severity of increased hepatic enzyme activity and liver disease appear similar to clarithromycin but justify close post-marketing surveillance, as does the potential prolongation of the QT-interval 
Pogostost in resnost povečane aktivnosti jetrnih encimov ter bolezni jeter se zdita podobna kot pri klaritromicinu, toda navkljub temu je potrebno skrbno postmarketinško spremljanje teh stranskih učinkov kot tudi drugega možnega stranskega učinka, podaljšanja intervala QT.
Clinical trials, in general, support similar efficacy of telithromycin and comparators in the indications investigated (CAP not clinically serious enough to warrant parenteral therapy but efficacy has been demonstrated in a limited number of patients with risk factors such as pneumococcal bacteraemia or age higher than 65 years, AECB, sinusitis, and pharyngotonsillitis caused by S. pyogenes). 
Klinične raziskave v splošnem potrjujejo podobno učinkovitost telitromicina in primerjalnih učinkovin za raziskane indikacije (pljučnica, pridobljena v domačem okolju, ki glede na resnost kliničnega stanje ne potrebuje parenteralnega zdravljenja; po drugi strani pa se je telitromicin izkazal kot učinkovit pri določenem številu bolnikov s pljučnico, pridobljeno v domačem okolju, in dejavniki tveganja kot sta pnevmokokna bakteriemija ali starost nad 65 let).
In patients of 18 years and older: - Community-acquired pneumonia, mild or moderate, - Acute exacerbation of chronic bronchitis, - Acute sinusitis, - Tonsillitis/pharyngitis caused by Group A beta streptococci, as an alternative when beta lactam antibiotics are not appropriate. 
Pri bolnikih, starejših od 18 let: - plučnica, dobljena v domačem okolju, blaga ali zmerna, - akutno poslabšanje kroničnega bronhitisa, - akutni sinuzitis, - tonzilitis/faringitis, ki ga povzročajo beta streptokoki skupine A, kot alternativno zdravilo,
Antibacterial for systemic use JO1 
Zdravila za sistemsko zdravljenje bakterijskih infekcij
Tonsillitis/pharyngitis caused by Group A beta streptococci, as an alternative when beta lactam antibiotics are not appropriate 
Pri bolnikih, starih od 12 do 18 let: tonzilitis/faringitis, ki ga povzročajo beta-streptokoki skupine A, kot alternativno zdravilo, kadar betalaktamski antibiotiki niso primerni.
The pharmacological action of telithromycin involves inhibition of bacterial protein synthesis and is similar to that of macrolides, but 
Farmakološko delovanje telitromicina temelji na zaviranju sinteze proteinov v bakterijah in je podobno delovanju makrolidov, vendarle naj bi med skupinama na molekularnem nivoju obstajale razlike v delovanju.
Authorised presentations: 
Odobrene farmacevtske oblike:
London, 15 November 2007 Doc. 
London, 15. november 2007 Sklic dok.
This could have had an impact on the types of treatment chosen by doctors if they had relied on the test's results. 
To bi lahko imelo vpliv na tip zdravljenja, ki bi ga izbrali zdravniki, če bi se zanašali na rezultat testa.
These included healthy volunteers and patients with stomach problems. 
Študiji sta vključevali zdrave prostovoljce in bolnike z želodčnimi težavami.
If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you. 
Če ste vključeni v klinično preskušanje ali program sočutne uporabe ter potrebujete več podatkov o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
The letter from the company notifying the EMEA of the withdrawal of the application is available here 
Dopis podjetja, s katerim je bila EMEA obveščena o umiku vloge, je na voljo tukaj.
This labelled carbon dioxide can be detected in breath samples taken every 15 to 30 minutes in the four hours after the test meal. 
Tak označen ogljikov dioksid lahko nato zaznavamo v vzorcih izdihanega zraka, ki jih vzamemo vsakih 15 do 30 minut v štirih urah po testnem obroku.
In both studies, the main measure of effectiveness was how long it took for half of the stomach's solid contents to be emptied. 
Glavno merilo učinkovitosti je bil v obeh študijah čas, ki je bil potreben za izpraznitev polovice trdne vsebine želodca.
International non-proprietary name (INN): 1-13C-caprylic acid 
Mednarodno nelastniško ime (INN): 1-13C-kaprilna kislina
Gastromotal is a diagnostic test. 
Zdravilo Gastromotal je diagnostični test.
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for GASTROMOTAL 
VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo GASTROMOTAL
This means that it contains 13C, a non-radioactive, rare form of the carbon atom, instead of carbon-12 (12C), the form that is the most common in nature. 
To pomeni, da vsebuje ogljik 13C, neradioaktivno, redko obliko ogljikovih atomov, namesto v naravi najpogosteje prisotnega ogljika-12 (12C).
The rate of stomach emptying can then be determined by looking at the speed at which labelled carbon dioxide is released in the breath. 
Hitrost praznjenja želodca je nato mogoče določiti z ugotavljanjem hitrosti sproščanja označenega ogljikovega dioksida v izdihanem zraku.
In the main studies, the level of agreement between Gastromotal and the standard test was too low to be acceptable, resulting in a considerable risk of false positive and false negative results. 
Raven skladnosti med zdravilom Gastromotal in standardnim testom je bila v glavnih študijah prenizka, da bi bilo zdravilo sprejemljivo, saj bi povzročilo znatno tveganje za napačne pozitivne ali negativne rezultate.
When a patient takes a dose of Gastromotal mixed into a test meal, it enters the stomach with the food. 
Če bolnik vzame odmerek zdravila Gastromotal, vmešanega v testni obrok, zdravilo vstopi v želodec skupaj s hrano.
On 5 November 2007, INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Gastromotal, for in vivo diagnosis of solidphase gastric half emptying time in gastric motility disorders. 
Podjetje INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH je 5. novembra 2007 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti svojo vlogo za dovoljenje za promet z zdravilom Gastromotal, namenjeno za in vivo diagnozo časa praznjenja polovice vsebine želodca v trdni fazi pri motnjah z gibanjem želodca.
The effects of Gastromotal were first tested in experimental models before being studied in humans. 
Učinki zdravila Gastromotal so bili najprej preizkušeni s pomočjo izkustvenih modelov, nato pa so jih raziskali pri ljudeh.
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Gastromotal? 
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih/programih sočutne uporabe zdravila Gastromotal?
As the food in the stomach is gradually emptied into the gut, it takes the Gastromotal with it, where it is absorbed into the blood and then broken down, releasing carbon dioxide gas labelled with 13C into the breath. 
Ko hrana v želodcu počasi prehaja v črevo, s seboj prenese tudi zdravilo Gastromotal, ki se tam vsrka v kri in nato razgradi, pri tem pa sprošča ogljikov dioksid, označen z ogljikom 13C, v izdihan zrak.
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Gastromotal had not been sufficiently demonstrated and any benefits did not outweigh the identified risks. 
Zato je bil v času umika CHMP mnenja, da koristi zdravila Gastromotal niso zadostno dokazane in da morebitne koristi niso večje od znanih tveganj.
The active substance in Gastromotal, 1-13C-caprylic acid, is a natural chemical called caprylic acid that has been labelled with carbon-13 (13C). 
Zdravilna učinkovina v zdravilu Gastromotal, 1-13C-kaprilna kislina, je naravna kemikalija, imenovana kaprilna kislina, ki je označena z ogljikom-13 (13C).