natgillin/translations-raw huggingface dataset:
Male patients should maintain reliable contraceptive methods while taking Miglustat Gen.Orph (see sections 4.4 and 5.3). 
Muški bolesnici trebaju primjenjivati pouzdane metode kontracepcije dok uzimaju Miglustat Gen.Orph (vidjeti dijelove 4.4 i 5.3).
There is limited experience with the use of Miglustat Gen.Orph in Niemann-Pick type C disease patients under the age of 4 years. 
Postoji ograničeno iskustvo u primjeni Miglustat Gen.Orph kod bolesnika s Niemann-Pickovom bolesti tipa C, mlađih od 4 godine.
What Miglustat Gen.Orph contains - The active substance is miglustat 100 mg. - The other ingredients are sodium starch glycolate (type A), povidone (K30), magnesium stearate, gelatin, titanium dioxide (E171). 
Drugi sastojci su: natrijev škroboglikolat (vrsta A), povidon (K30), magnezijev stearat, želatina, titanijev dioksid (E171).
Cases of peripheral neuropathy have been reported in patients treated with miglustat with or without concurrent conditions such as vitamin B12 deficiency and monoclonal gammopathy. 
Kod bolesnika liječenih miglustatom zabilježeni su slučajevi periferne neuropatije prisutne samostalno ili praćene stanjima kao što su, pomanjkanje vitamina B12 i monoklonalna gamopatija.
What you need to know before you take Miglustat Gen.Orph 3. 
Što morate znati prije nego počnete uzimati Miglustat Gen.Orph
Miglustat Gen.Orph should not be taken during breast-feeding. 
Miglustat Gen.Orph se ne smije uzimati tijekom dojenja.
Adverse reactions from clinical trials and spontaneous reporting, occurring in >1% of patients, are listed in the table below by system organ class and frequency (very common: ≥ 1/10, common: ≥ 1/100 < 1/10, uncommon: ≥ 1/1,000 to <1/100, rare: ≥ 1/10,000 to <1/1,000, very rare: <1/10,000). 
≥ 1/100 < 1/10, manje često: ≥ 1/1000 do < 1/100, rijetko: ≥ 1/10 000 do < 1/1000, vrlo rijetko:
Small mean reductions in haemoglobin [-0.95 g/dL (95% CI: -1.38, -0.53)] and platelet count [-44.1 × 109/L (95% CI: -57.6, 
Između početka i kraja ispitivanja uočeno je malo prosječno smanjenje hemoglobina [-0,95 g/dL (95% CI: -1,38, -0,53)] i broja trombocita [-44,1 × 109/L (95% CI:
Miglustat Gen.Orph is only used when a patient is considered unsuitable for treatment with enzyme replacement therapy. 
Miglustat Gen.Orph se primjenjuje samo kada se bolesnik smatra nepodobnim za enzimsko nadomjesno liječenje.
The pharmacokinetics of miglustat is similar in adult type 1 Gaucher disease patients and NiemannPick type C disease patients when compared to healthy subjects. 
Farmakokinetika miglustata slična je onoj u odraslih bolesnika s Gaucherovom bolesti tipa 1 i NiemannPickovom bolesti tipa C kada se usporedi sa zdravim osobama.
Male patients should maintain reliable contraceptive methods while taking Miglustat Gen.Orph. 
Muški bolesnici trebaju primjenjivati pouzdane metode kontracepcije dok uzimaju Miglustat Gen.Orph.
Other medicines and Miglustat Gen.Orph 
Drugi lijekovi i Miglustat Gen.Orph
Nausea, vomiting, abdominal distension/discomfort, constipation, dyspepsia 
Mučnina, povraćanje, abdominalna distenzija/nelagoda, konstipacija, dispepsija
Elderly There is no experience with the use of Miglustat Gen.Orph in patients over the age of 70. 
Nema iskustava s primjenom lijeka Miglustat Gen.Orph u bolesnika starijih od 70 godina.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). 
Lijek se izdaje na ograničeni recept (vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2)
The reason for these tests is that some patients have had tingling or numbness in the hands and feet, or a decrease in body weight, while taking Miglustat Gen.Orph. 
Razlog za te pretrage je taj što što su neki bolesnici, dok su uzimali Miglustat Gen.Orph, osjećali trnce ili obamrlost u šakama i stopalima ili im se smanjila tjelesna težina.
The inhibitory action on glucosylceramide synthase forms the rationale for substrate reduction therapy in Gaucher disease. 
Inhibitorsko djelovanje na glukozilceramid sintazu podloga je za liječenje sa smanjenjem supstrata kod Gaucherove bolesti.
The benefit of treatment with Miglustat Gen.Orph for neurological manifestations in patients with Niemann-Pick type C disease should be evaluated on a regular basis, e.g. every 6 months; continuation of therapy should be re-appraised after at least 1 year of treatment with Miglustat Gen.Orph. 
Korist od liječenja Miglustat Gen.Orph kod neuroloških manifestacija u bolesnika s Niemann-Pickovom bolesti tipa C treba redovito ocjenjivati, npr. svakih 6 mjeseci; nastavak liječenja treba ponovo procijeniti nakon najmanje 1 godine liječenja Miglustat Gen.Orph.
Miglustat Gen.Orph works by inhibiting the enzyme called ‘glucosylceramide synthase' which is responsible for the first step in the synthesis of most glycosphingolipids. 
Miglustat Gen.Orph djeluje kao inhibitor enzima 'glukozilceramid sintaze', odgovornog za prvi korak u sintezi većine glikosfingolipida.
België/Belgique/Belgien Gen.Orph 
België/Belgique/Belgien
Growth should be monitored in paediatric and adolescent patients during treatment with Miglustat Gen.Orph; the benefit/risk balance should be re-assessed on an individual basis for continuation of therapy. 
U tijeku liječenja Miglustat Gen.Orph treba pratiti rast pedijatrijskih bolesnika i adolescenata; omjer koristi/rizika treba ponovo individualno procjenjivati za nastavak liječenja.
Povidone (K30), 
Natrijev škroboglikolat (vrsta A), Povidon (K30),
In 11 clinical trials in different indications 247 patients were treated with miglustat at dosages of 50200 mg t.i.d. 
U 11 kliničkih ispitivanja s različitim indikacijama 247 bolesnika je liječeno miglustatom u dozama od 50200 mg triput dnevno, u prosječnom trajanju od 2,1 godine.
Tel: +39 040 899 2219 
Biovalley Investments Partner (B.I.P.) Tel: +39 040 899 2219
Miglustat has been administered at doses of up to 3000 mg/day for up to six months in HIV positive patients during clinical trials. 
Miglustat je u kliničkim ispitivanjima kod HIV pozitivnih bolesnika primjenjivan u dozama do 3000 mg/dan tijekom šest mjeseci.
The benefit of treatment with Miglustat Gen.Orph for neurological manifestations in patients with Niemann-Pick type C disease should be evaluated on a regular basis, e.g. every 6 months; continuation of therapy should be re-appraised after at least 1 year of treatment with Miglustat Gen.Orph, (see section 4.4). 
Korist od liječenja Miglustat Gen.Orph kod neuroloških manifestacija u bolesnika s Niemann-Pickovom bolesti tipa C treba redovito ocjenjivati, npr. svakih 6 mjeseci; nastavak liječenja treba ponovo procijeniti nakon najmanje 1 godine liječenja Miglustat Gen.Orph (vidjeti dio 4.4).
What Miglustat Gen.Orph is and what it is used for 
Što se nalazi u ovoj uputi: Što je Miglustat Gen.Orph i za što se koristi
Hepatic impairment Miglustat Gen.Orph has not been evaluated in patients with hepatic impairment. 
Oštećenje funkcije jetre Miglustat Gen.Orph nije procjenjivan kod bolesnika s oštećenjem funkcije jetre.
INFORMATION IN BRAILLE Miglustat Gen.Orph 
16. PODACI NA BRAILLEOVOM PISMU Miglustat Gen.Orph
The most common side effects are diarrhoea, flatulence (wind), abdominal (stomach) pain, weight loss and decreased appetite. 
Najčešće nuspojave su proljev, flatulencija (vjetrovi), bol u trbuhu, gubitak težine i smanjen tek.
Miglustat Gen.Orph may make you feel dizzy. 
Miglustat Gen.Orph može uzrokovati omaglicu.
Miglustat Gen.Orph contains the active substance miglustat which belongs to a group of medicines that affect metabolism. 
Što je Miglustat Gen.Orph i za što se koristi Miglustat Gen.Orph sadrži djelatnu tvar miglustat koja pripada skupini lijekova koji djeluju na metabolizam.
White opaque cap and body, hard gelatin capsules size 4 of about 14.0 mm length. 
Tvrde želatinske kapsule s bijelom neprozirnom kapicom i tijelom, veličine 4 i duljine otprilike 14,0 mm.
If you stop taking Miglustat Gen.Orph 
Ako prestanete uzimati Miglustat Gen.Orph
The benefit to the patient of treatment with Miglustat Gen.Orph should be evaluated on a regular basis (see section 4.4). 
Potrebno je redovito procjenjivati korist za bolesnika od liječenja Miglustat Gen.Orph (vidjeti dio 4.4).
Male patients should use reliable birth control methods during their treatment with Miglustat Gen.Orph, and for 3 months after finishing treatment. 
Muški bolesnici trebaju primjenjivati pouzdane metode kontracepcije tijekom liječenja lijekom Miglustat Gen.Orph, te tijekom 3 mjeseca nakon završetka liječenja.
NAME OF THE MARKETING AUTHORISATION HOLDER Gen.Orph (logo) 
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Gen.Orph (logo)
Miglustat Gen.Orph 100 mg hard capsules miglustat 
Miglustat Gen.Orph 100 mg tvrde kapsule miglustat
Until further information is available, before seeking to conceive, male patients should cease Miglustat Gen.Orph and maintain reliable contraceptive methods for a further 3 months. 
Do dostupnosti daljnjih informacija, prije pokušaja začeća djeteta, muški bolesnici trebaju prekinuti uzimanje lijeka Miglustat Gen.Orph i primjenjivati pouzdane metode kontracepcije daljnja 3 mjeseca.
Miglustat Gen.Orph is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease. 
Miglustat Gen.Orph je indiciran za peroralno liječenje odraslih bolesnika s blagom do umjerenom Gaucherovom bolesti tipa 1.
for an average duration of 2.1 years. 
6.3 Rok valjanosti 3 godine.
If any of these side effects cause problems, consult your doctor. 
Ako bilo koja od tih nuspojava potraje, obratite se Vašem liječniku.
Although no direct comparisons with Enzyme Replacement Therapy (ERT) have been performed in treatment-naive patients with type 1 Gaucher disease, there is no evidence of miglustat having an efficacy or safety advantage over ERT. ERT is the standard of care for patients who require treatment for type 1 Gaucher disease (see section 5.1). 
Iako nije bilo neposredne usporedbe s enzimskim nadomjesnim liječenjem (Enzyme Replacement Therapy - ERT) u liječenju bolesnika s Gaucherovom bolesti tipa 1, nema dokaza da je miglustat djelotvorniji ili sigurniji od ERT.
Capsule contents 
Sadržaj kapsule
Other possible side effects are muscular spasms or weakness, fatigue, chills and malaise, depression, difficulty sleeping, forgetfulness and less libido. 
Ostale moguće nuspojave su grčevi u mišićima ili slabost, umor, zimica ili malaksalost, depresija,
• For type 1 Gaucher disease: for adults, the usual dose is one capsule (100 mg) three times a day (morning, afternoon and evening). 
• Za Gaucherovu bolest tipa 1: za odrasle je uobičajena doza jedna kapsula (100 mg) tri puta dnevno
Until further information is available, it is advised that before seeking to conceive, male patients should cease Miglustat Gen.Orph and maintain reliable contraceptive methods for 3 months thereafter. 
Do dostupnosti daljnjih informacija, savjetuje se muškim bolesnicima da prije pokušaja začeća djeteta prekinu uzimanje lijeka Miglustat Gen.Orph i primjenjuju pouzdane metode kontracepcije daljnja 3 mjeseca.
Do not breastfeed while you are taking Miglustat Gen.Orph. 
Nemojte dojiti tijekom uzimanja lijeka Miglustat Gen.Orph.
Common side effects of treatment include headache, dizziness, paraesthesia (tingling or numbness), abnormal coordination, hypoaesthesia (reduced sensation to touch), dyspepsia (heartburn), nausea (feeling sick), constipation and vomiting, swelling or discomfort in the abdomen (stomach) and thrombocytopenia (reduced levels of blood platelets). 
Česte nuspojave liječenja uključuju glavobolju, omaglicu, paresteziju (trnci ili obamrlost), nenormalnu koordinaciju, hipoesteziju (oslabljen osjet na dodir), dispepsiju (žgaravica), mučninu, zatvor i povraćanje,
Your doctor may reduce your dose, e.g., to one capsule (100 mg) once or twice a day, if you suffer from diarrhoea when taking Miglustat Gen.Orph (see section 4). 
npr. na jednu kapsulu (100 mg) jednom ili dvaput dnevno, ako imate proljev dok uzimate Miglustat
What you need to know before you take Miglustat Gen.Orph Do not take Miglustat Gen.Orph - if you are allergic to miglustat or any of the other ingredients of this medicine 
Nemojte uzimati Miglustat Gen.Orph ako ste alergični na miglustat ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6.)
NAME OF THE MEDICINAL PRODUCT Miglustat Gen.Orph 100 mg hard capsules 
NAZIV LIJEKA Miglustat Gen.Orph 100 mg tvrde kapsule
How to take Miglustat Gen.Orph 
Kako uzimati Miglustat Gen.Orph
Pharmacokinetic data were obtained in paediatric patients with type 3 Gaucher disease aged 3 to 15 years, and patients with Niemann-Pick type C disease aged 5-16 years. 
do 15 godina i bolesnika s Niemann-Pickovom bolesti tipa C u dobi od 5 do 16 godina.
Mild reductions in platelet counts without association with bleeding were observed in patients with type 1 Gaucher disease who were switched from ERT to miglustat. 
Kod bolesnika s Gaucherovom bolesti tipa 1 primijećena su mala smanjenja broja trombocita, a koja nisu povezana s krvarenjem, u bolesnika koji su s ERT prešli na miglustat.
Miglustat Gen.Orph 100 mg hard capsules are white opaque cap and body, hard gelatin capsules size 4 of 14.0 mm length. 
Kako Miglustat Gen.Orph izgleda i sadržaj pakiranja Miglustat Gen.Orph 100 mg tvrde kapsule su tvrde želatinske kapsule s bijelom neprozirnom kapicom i tijelom veličine 4 i duljine 14,0 mm.
Keep this medicine out of the sight and reach of children. 
Kako čuvati Miglustat Gen.Orph Lijek čuvajte izvan pogleda i dohvata djece.
In patients with an adjusted creatinine clearance of 50-70 ml/min/1.73 m2, administration should commence at a dose of 100 mg twice daily in patients with type 1 Gaucher disease and at a dose of 200 mg twice daily (adjusted for body surface area in patients below the age of 12) in patients with Niemann-Pick type C disease. 
Kod bolesnika s prilagođenim klirensom kreatinina od 50-70 ml/min/1,73 m2, primjenu treba početi s dozom od 100 mg dvaput dnevno u bolesnika s Gaucherovom bolesti tipa 1, te dozom od
Due to limited experience, Miglustat Gen.Orph should be used with caution in patients with renal or hepatic impairment. 
Zbog ograničenog iskustva, kod bolesnika s poremećajem funkcije bubrega ili jetre, Miglustat Gen.Orph treba koristiti oprezno.
The tests will help the doctor decide whether these effects are due to your disease or other existing conditions, or due to side effects of Miglustat Gen.Orph (see section 4 for further details). 
Ove pretrage će pomoći liječniku ustanoviti jesu li ti učinci posljedica bolesti ili drugih postojećih bolesti ili su posljedica nuspojava lijeka
Summary of the safety profile 
4.8 Nuspojave Sažetak profila sigurnosti
QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg miglustat For the full list of excipients, see section 6.1. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna kapsula sadržava 100 mg miglustata
Marketing Authorisation Holder Gen.Orph 
Nositelj odobrenja za stavljanje lijeka u promet Gen.Orph
• Miglustat Gen.Orph is also used to treat progressive neurological symptoms in NiemannPick type C disease in adults and in children. 
• Milgustat Gen.Orph se također primjenjuje za liječenje progresivnih neuroloških simptoma kod
• Miglustat Gen.Orph is used to treat mild to moderate type 1 Gaucher disease in adults. 
Primjenjuje se za liječenje dvije bolesti: • Milgustat Gen.Orph seprimjenjuje za liječenje blage do umjerene Gaucherove bolesti tipa 1 u odraslih.
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 100 mg miglustat 
Jedna kapsula sadržava 100 mg miglustata
The pivotal trial of miglustat was conducted in patients unable or unwilling to receive ERT. Reasons for not receiving ERT included the burden of intravenous infusions and difficulties in venous access. 
Ključno ispitivanje miglustata bilo je provedeno na bolesnicima koji nisu mogli ili nisu željeli primati ERT.
Capsule shell 
Ovojnica kapsule Želatina,
If you take more Miglustat Gen.Orph than you should If you take more capsules than you were told to, consult your doctor immediately. 
Ako uzmete više lijeka Miglustat Gen.Orph nego što ste trebali
Mild reductions in platelet counts without association to bleeding were observed in some patients with Niemann-Pick type C disease treated with miglustat. 
Kod nekih bolesnika s Niemann-Pickovom bolesti tipa C liječenih miglustata primijećena su mala smanjenja broja trombocita, a koja nisu povezana s krvarenjem.
NAME OF THE MEDICINAL PRODUCT Miglustat Gen.Orph 100 mg hard capsules miglustat 
Uputa o lijeku: Informacija za korisnika Miglustat Gen.Orph 100 mg tvrde kapsule miglustat
adjusted for body surface area resulted in Cmax and AUCτ values which were approximately twofold those attained after 100 mg t.i.d. 
200 mg triput dnevno prilagođeno veličini površine tijela dalo je vrijednosti Cmax i AUCτ koje su približno dvostruke od onih dobivenih nakon 100 mg triput dnevno u bolesnika s Gaucherovom bolesti tipa 1, što je sukladno farmakokinetici miglustata linearno ovisnoj o dozi.
If you forget to take Miglustat Gen.Orph Take the next capsule at the usual time. 
Uzmite sljedeću kapsulu u uobičajeno vrijeme.
What Miglustat Gen.Orph looks like and contents of the pack 
Što Miglustat Gen.Orph sadrži
How to store Miglustat Gen.Orph 
Moguće nuspojave Kako čuvati Miglustat Gen.Orph
You must use effective birth control while taking Miglustat Gen.Orph. 
Dok uzimate Miglustat Gen.Orph morate primjenjivati učinkovitu kontracepciju.
Therapy should be directed by physicians who are knowledgeable in the management of Gaucher disease or Niemann-Pick type C disease, as appropriate. 
4.2 Doziranje i način primjene Liječenje trebaju voditi liječnici s odgovarajućim iskustvom u liječenju Gaucherove bolesti Niemann
Your doctor will perform the following tests before treatment and during treatment with Miglustat Gen.Orph: - an examination to check the nerves in your arms and legs - measurement of vitamin B12 levels - monitoring growth if you are a child or adolescent with Niemann-Pick type C disease - monitoring of blood platelet counts 
pregled za provjeru živaca Vaših ruku i nogu mjerenje razine vitamina B12
Most of these reactions occurred most likely in the first week during treatment. 
Većina ovih reakcija najčešće se pojavljivala u prvom tjednu liječenja.
The highest risk for occurrence of this serious skin reaction is within the first week of treatment. 
Rizik od pojavljivanja ove ozbiljne kožne reakcije najviši je u prvom tjednu liječenja.
Adopted at the 5-8 March 2018 PRAC 
Usvojeno na sjednici PRAC-a 5. - 8. ožujka 2018.
What do you need to know before you use cefalexin 
Što morate znati prije nego što počnete uzimati cefaleksin
The most common location: mainly localized on the skin folds, trunk, and upper extremities. 
Najčešće mjesto pojave: uglavnom lokaliziran na kožnim pregibima, trupu i gornjim udovima.
TELL YOUR DOCTOR BEFORE TAKING CEFALEXIN: 
OBRATITE SE SVOM LIJEČNIKU PRIJE NEGO UZMETE CEFALEKSIN:
New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/136578/2018 
Novi tekst informacija o lijeku - izvadci iz preporuka PRAC-a vezanih uz signale EMA/PRAC/165781/2018
• If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking cefalexin or other antibacterials 
• Ako ste ikada razvili teški kožni osip ili ljuštenje kože, mjehuriće i/ili ranice u ustima nakon uzimanja cefaleksina ili drugih antibakterijskih lijekova
Warnings and precautions - Take special care with cefalexin: 
Upozorenja i mjere opreza - Potreban je poseban oprez pri primjeni cefaleksina:
AGEP appears at the initiation of treatment as a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. 
AGEP se pojavljuje na početku liječenja u obliku crvenog, ljuskavog, široko rasprostranjenog osipa s kvržicama ispod kože i mjehurićima popraćenima vrućicom.
Cefalexin - Acute generalised exanthematous pustulosis (AGEP) (EPITT no 18911) 
Cefaleksin - akutna generalizirana egzantematozna pustuloza (AGEP)(EPITT br. 18911)
Stop using cefalexin if you develop these symptoms and contact your doctor or seek medical attention immediately. 
Prestanite uzimati cefaleksin u slučaju nastanka ovih simptoma i odmah se obratite svojem liječniku ili potražite medicinsku pomoć.
At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. 
U trenutku propisivanja lijeka bolesnike je potrebno savjetovati o znakovima i simptomima te pomno motriti imaju li kožne reakcije.
If signs and symptoms suggestive of these reactions appear, cefalexin should be withdrawn immediately and an alternative treatment considered. 
U slučaju pojavljivanja znakova i simptoma koji upućuju na te reakcije, potrebno je odmah prestati s primjenom cefaleksina i razmotriti zamjensku terapiju.
A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). 
Crveni, ljuskavi, široko rasprostranjeni osip s kvržicama ispod kože i mjehurićima popraćenima vrućicom, koji se javlja na početku liječenja (akutna generalizirana egzantematozna pustoloza).
Frequency ‘not known': Stress cardiomyopathy 
Učestalost „nepoznato”: Stres kardiomiopatija
Skin and subcutaneous tissue disorders (frequency: not known) Acute generalised exanthematous pustulosis (AGEP) 
Poremećaji kože i potkožnog tkiva (učestalost: nepoznato) Akutna generalizirana egzantematozna pustuloza (AGEP)
Undesirable effects Cardiac disorders 
Srčani poremećaji
If you develop a serious rash or another of these skin symptoms, stop taking cefalexin and contact your doctor or seek medical attention immediately. 
U slučaju nastanka ozbiljnog osipa ili drugih kožnih simptoma, prestanite uzimati cefaleksin i odmah se obratite svojem liječniku ili potražite medicinsku pomoć.
Acute generalised exanthematous pustulosis (AGEP) has been reported in association with cefalexin treatment. 
Akutna generalizirana egzantematozna pustoloza (AGEP) prijavljena je vezano uz liječenje cefaleksinom.
Norepinephrine - Stress cardiomyopathy (EPITT no 
Noradrenalin - stres kardiomiopatija (EPITT br. 19172)
Acute generalised exanthematous pustulosis (AGEP) has been reported with the use of cefalexin. 
Akutna generalizirana egzantematozna pustoloza (AGEP) prijavljena je kod primjene cefaleksina.
Table of ADRs: 
Tablica nuspojava lijeka:
Strength Pharmaceutical Form Route of administration Packaging 
Doza Farmaceutski oblik
The marketing authorisation application was submitted to the United Kingdom as reference Member State and Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Poland, Portugal, Slovakia, Spain and The Netherlands as concerned Member States. 
Zahtjev za izdavanje odobrenja za stavljanje VMP-a u promet dostavljen je u Ujedinjenoj Kraljevini kao referentnoj državi članici te Austriji, Belgiji, Češkoj Republici, Danskoj, Francuskoj, Njemačkoj, Grčkoj, Mađarskoj, Irskoj, Italiji, Luksemburgu, Poljskoj, Portugalu, Slovačkoj, Španjolskoj i Nizozemskoj kao državama članicama sudionicama u postupku.
In drinking water use. 
Za primjenu u vodi za piće.
Having considered all the data submitted the CVMP concluded that: 
Budući da su razmotreni svi dostavljeni podaci, CVMP je zaključio da je:
Advice for prudent use 
Savjeti o razumnoj uporabi
Any unused medicated water should be discarded after 12 hours. 
Svu neupotrijebljenu vodenu otopinu lijeka treba baciti nakon 12 sati.
Prepare the solution with fresh tap water immediately before use. 
Pripremite otopinu sa svježom vodovodnom vodom neposredno prije primjene.
Each of these excipients is well-established and widely used in medicinal products and foodstuffs. 
Svaka je od tih pomoćnih tvari dobro poznata i široko rasprostranjena u medicinskim i prehrambenim proizvodima.
During the decentralised procedure Denmark, as a concerned Member State, considered that Solamocta may present a potential serious risk to human and animal health. 
Tijekom decentraliziranog postupka, Danska, kao država članica sudionica u postupku, zaključila je da Solamocta može predstavljati potencijalan ozbiljan rizik za zdravlje ljudi i životinja.