natgillin/translations-raw huggingface dataset:
Due to its nitrate moiety, nicorandil relaxes also vascular smooth muscle, particularly in the venous system via an increase in intracellular cyclic guanosine monophosphate (cGMP). 
Zaradi svoje nitratne skupine nikorandil preko zvišanja znotrajceličnega cikličnega gvanozinmonofosfata (cGMP) sprosti žilne gladke mišice, zlasti v venskem sistemu.
<Invented name> has an influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo <Izmišljeno ime> vpliva na sposobnost vožnje in upravljanja s stroji.
• a rapid phase with a half-life of 1 hour approximately, representing 96% of the plasma exposure; 
- v hitri fazi z razpolovnim časom približno 1 uro, ki predstavlja 96 % izpostavljenost v plazmi, - v počasni fazi izločanja, ki se pojavi približno 12 ur po uporabi 20 mg peroralno dvakrat na dan.
In addition, the activation of the potassium channel leads to cardioprotective effects mimicking ischemic pre-conditioning. 
Poleg tega ima aktiviranje kalijevih kanalčkov zaščiten učinek na srce s posnemanjem ishemičnega prekondicioniranja.
• Nicorandil may cause injuries to your gastrointestinal tract such as ulcers. 
• Nikorandil lahko povzroči poškodbo v prebavilih, na primer razjede.
This results in an increased pooling in capacitance vessels with a decrease in preload. 
To povzroči kopičenje v kapacitivnih žilah in zmanjšanje predobremenitve ("preload").
How to take <Invented name> 
Kako jemati zdravilo <Izmišljeno ime>
Do not take <Invented name>: • if you are allergic to nicorandil or any of the other ingredients of this medicine (listed in section 
• če ste alergični na nikorandil ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Caution is advised when nicorandil is used in combination with other medical products that may increase potassium levels (see sections 4.4 and 4.8). 
Previdnost je potrebna v primeru uporabe nikorandila v kombinaciji z drugimi zdravili, ki lahko povečajo koncentracijo kalija (glejte poglavje 4.4 in 4.8).
<Invented name> 10 mg [To be completed nationally] <Invented name> 20 mg [To be completed nationally] 
Zdravilo <Izmišljeno ime> 20 mg
<Invented name> contains a medicine called nicorandil. 
Zdravilo <Izmišljeno ime> vsebuje zdravilno učinkovino nikorandil.
This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure to which this Commission decision relates. 
Te spremembe zadevnih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo so izid postopka arbitraže.
Method of administration <Invented name> is administered by oral route. 
Zdravilo <Izmišljeno ime> se uporablja peroralno.
• Being sick (vomiting) 
• Dvojni vid (diplopija)
• Medicines that increase blood potassium levels. 
• zdravila, ki zvišajo koncentracijo kalija v krvi.
• Aspirin (acetylsalicylic acid). 
• acetilsalicilno kislino.
Patients with diverticular disease may be at particular risk of fistula formation or bowel perforation during nicorandil treatment. 
Tveganje za nastanek fistule ali perforacije črevesa je med zdravljenjem z nikorandilom je še zlasti prisotno pri bolnikih z divertikularno boleznijo.
Nicorandil should be used with care in combination with other medical products that may increase potassium levels, especially in patients with moderate to severe renal impairment (see sections 4.5 and 4.8). 
Nikorandil je treba uporabljati previdno pri bolnikih z zmerno do hudo okvaro ledvic ter v kombinaciji z drugimi zdravili, ki lahko zvišajo koncentracijo kalija v serumu (glejte poglavji 4.5 in 4.8).
Talk straight away to your doctor if you experience any of the following: Nicorandil may cause injuries to your gastrointestinal tract such as ulcers in the mouth, tongue, stomach, guts (small and large), back passage. 
Nikorandil lahko povzroči poškodbe v prebavilih, na primer razjede v ustih, na jeziku, v želodcu, črevesu
Do not swallow drying agent. 
Ne zaužijte sušila!
Not known (frequency cannot be estimated from the available data) • Double vision (diplopia). 
• Bolečine v trebuhu Neznana (ni mogoče oceniti iz razpoložljivih podatkov)
Rash, pruritus Angioedema, Skin and mucosal ulcerations (mainly peri-anal ulcerations, genital ulcerations and parastomal ulcerations) (see section 
srbenje angioedem, razjede na koži in sluznicah (predvsem perianalne razjede, razjede na spolovilih in parastomalne razjede) (glejte poglavje 4.4)
≥65, diabetes, hypertension, peripheral vascular disease, or cerebrovascular disease. 
hipertrofijo levega prekata na EKG, iztisni delež levega prekata ≤ 45 % ali končno diastolično velikost > 55 mm, starost ≥ 65 let, sladkorno bolezen, hipertenzijo, bolezen perifernih žil ali cerebrovaskularno bolezen.
Uncommon (may affect up to 1 in 100 people) • Decrease in blood pressure. 
Redki (pojavijo se lahko pri največ 1 od 100 oseb) • Izpuščaj
If ulceration(s) develops, nicorandil should be permanently discontinued (see section 4.8). 
Če se pojavi ena ali več razjed, je treba zdravljenje z nikorandilom trajno končati (glejte poglavje 4.8).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister strip/ 10 mg and 20 mg 
Pretisni trak / 10 mg in 20 mg
• If you have low blood potassium level and your doctor has prescribed potassium supplements, 
• če imate nizko koncentracijo kalija v krvi in vam je zdravnik predpisal dodatke kalija, ali če imate okvaro ledvic ali jemljete druga zdravila, ki lahko zvišajo koncentracijo kalija.
Radioactivity passed through the placenta in pregnant rats after administration of radioactively marked nicorandil. 
Embriotoksičnost ter peri- in postnatalna toksičnost Po uporabi radioaktivno označenega nikorandila je radioaktivnost pri brejih podganah prehajala skozi placento.
What you need to know before you take <Invented name> 
Kaj morate vedeti, preden boste vzeli zdravilo <Izmišljeno ime> Ne jemljite zdravila <Izmišljeno ime>:
• Dizziness 
• Bruhanje
• Rash 
• Srbenje
The metabolism of nicorandil appears not to be significantly modified by cimetidine or rifampicine, respectively an inhibitor and an inducer of liver microsomal mixed-function oxidases. 
Cimetidin, ki je zaviralec jetrnih mikrosomskih mešanofunkcijskih oksidaz, in rifampicin, ki je induktor teh encimov, presnove nikorandila po vsem sodeč ne spremenita pomembno.
Gastrointestina l haemorrhage (see section 
Volumen porazdelitve nikorandila po intravenski (i.v.)
Complications of gastrointestinal ulceration such as perforation, fistula, or abscess formation sometimes leading to gastrointestinal haemorrhage and weight loss have been reported (see section 
Opisani so bili zapleti razjed na prebavilih, na primer perforacija, fistula ali nastanek abscesov, včasih s posledično krvavitvijo v prebavilih in hujšanjem (glejte poglavje 4.4).
Heart rate increased 
Srčne bolezni povečana srčna frekvenca
Severe hyperkalaemia has been very rarely reported with nicorandil. 
V zelo redkih primerih je bila med uporabo nikorandila opisana huda hiperkaliemija.
- In case you are particularly prone to headache, a lower dose of 5 mg twice daily might be prescribed by your doctor, for the first few days (2 to 7 days). 
Priporočeni odmerek je: - Običajen začetni odmerek je 10 mg dvakrat na dan. - Če ste posebno nagnjeni h glavobolom, vam bo zdravnik za prvih nekaj dni (od 2 do 7 dni) morda predpisal manjši odmerek 5 mg dvakrat na dan. - Zdravnik vam lahko odmerek poveča do 20 mg dvakrat na dan, odvisno od vaših potreb, odziva na zdravljenje in prenašanje zdravila.
If ulceration(s) develops, nicorandil should be discontinued (see section 4.8). 
Če se pojavi ena ali več razjed, je treba zdravljenje z nikorandilom prekiniti (glejte poglavje 4.8).
In life-threatening situations, administration of vasopressors must be considered. 
V smrtno nevarnih okoliščinah pride v poštev uporaba vazopresorskih zdravil.
How to store <Invented name> 
Shranjevanje zdravila <Izmišljeno ime>
Gastrointestinal ulcerations, skin and mucosal ulcerations have been reported with nicorandil (see section 4.8). 
Med uporabo nikorandila so bile opisane razjede na prebavilih ter razjede na koži in sluznicah (glejte poglavje 4.8).
The volume of distribution of nicorandil after intravenous (iv) dosing is 1.04 L/kg of body weight. 
uporabi je 1,04 l/kg telesne mase.
Dizziness 
Razjede
• Acute pulmonary oedema 
• Akutni pljučni edem.
Gastrointestina l ulcerations (stomatitis, aphtosis, mouth ulcer, tongue ulcer, small intestinal ulcer, large intestinal ulcer, anal ulcer) (see below and section 4.4) 
Neznana jeziku, razjede na tankem črevesu, razjede na debelem črevesu, analne razjede) (glejte spodaj in poglavje 4.4)
Angioedema 
(angioedem)
In addition, serious adverse reactions including ulcerations and their complications (see section 4.4) were reported during the post marketing surveillance of nicorandil. 
Poleg tega so bili med obdobjem spremljanja po začetku trženja nikorandila opisani resni neželeni učinki, med njimi razjede in njihovi zapleti (glejte poglavje 4.4).
Ulcerations 
Absorpcija
DATE OF REVISION OF THE TEXT [To be completed nationally] 
DATUM ZADNJE REVIZIJE BESEDILA
Gastrointestinal perforations in context of concomitant use of nicorandil and corticosteroids have been reported. 
Med sočasno uporabo nikorandila in kortikosteroidov so bile opisane perforacije prebavil.
• Use of phosphodiesterase 5 inhibitors, since this can lead to a serious drop in blood pressure 
• Uporaba zaviralcev fosfodiesteraze 5, ker lahko povzroči resen padec krvnega tlaka (glejte poglavje 4.5).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg nicorandil. 
Ena tableta vsebuje 10 mg nikorandila.
Gastroinstestina l disorders 
- Razjede na prebavilih
Decrease in blood pressure (see section 
Žilne bolezni vazodilatacija v koži z zardevanjem znižan krvni tlak (glejte poglavje 4.4)
Talk to your doctor or pharmacist before taking <Invented name>: 
Pred začetkom jemanja zdravila <Izmišljeno ime> se posvetujte s svojim zdravnikom ali s farmacevtom:
No clinically relevant modifications of the nicorandil pharmacokinetic profile is evidenced in population at risk such as elderly people, liver disease patients and chronic renal failure patients. 
Posebne skupine bolnikov Pri populaciji, pri kateri obstaja tveganje (na primer pri starejših osebah, bolnikih z boleznijo jeter in bolnikih s kronično odpovedjo ledvic), niso ugotovili klinično pomembnih sprememb farmakokinetičnih značilnosti nikorandila.
Summary of product characteristics, labelling and package leaflet 
Spremembe ustreznih poglavij v povzetku glavnih značilnosti zdravila in navodilu za uporabo
OTHER SPECIAL WARNING(S), IF NECESSARY Contains a drying agent in each blister strip. 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
SPECIAL STORAGE CONDITIONS [To be completed nationally] 
POSEBNA NAVODILA ZA SHRANJEVANJE
This leaflet was last revised in. [To be completed nationally] 
Navodilo je bilo nazadnje revidirano dne.
Uncommon 
• Omotica
Gastroinstestinal disorders 
nikorandil Peroralna uporaba
General disorders and administration site conditions 
Splošne težave in spremembe na mestu aplikacije občutek šibkosti
EU/2/04/044/014 Aivolsin 625 mg/g Granules for use in drinking water 
EU/2/04/044/013 Aivlosin 42,5 mg/g peroralni prašek prašiči
42.5 mg/g 20 kg Meat and offal 2 days 
42,5 mg/g 500 g meso in organi: 2 dni
Chickens and turkeys 
Ovojnina
If a second treatment is necessary, this should take place at least four weeks later. 
Če je potrebno ponovno zdravljenje, ga je treba izvesti vsaj štiri tedne pozneje.
The dose is 0.15 mg per kilogram body weight. 
Odmerek je 0,15 mg na kilogram telesne mase.
Around a quarter of the patients in this study also had a reduction in tumour size. 
Pri približno četrtini bolnikov v tej študiji je bilo opaženo tudi zmanjšanje velikosti tumorja.
The European Commission granted a marketing authorisation valid throughout the European Union for Foscan on 24 October 2001. 
Evropska komisija je dovoljenje za promet z zdravilom Foscan, veljavno po vsej Evropski uniji, odobrila dne 24. oktobra 2001.
Further care must be taken for up to six months. 
Glede tega morajo biti previdni najmanj 6 mesecev.
However, in the study looking at improving symptoms of advanced head and neck cancer, 28 (22%) of the 128 patients assessed had a significant improvement in their most troubling symptom. 
Vendar pa je v študiji, v kateri so proučevali izboljšanje simptomov napredovalega raka glave in vratu, 28 (22 %) od 128 obravnavanih bolnikov izkazalo pomembno izboljšanje najhujšega simptoma.
The full EPAR for Foscan 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 Foscan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Other information about Foscan 
Druge informacije o zdravilu Foscan
This is a summary of the European public assessment report (EPAR) for Foscan. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Foscan.
In all studies, the response was assessed between 12 and 16 weeks after the final treatment with Foscan, but Foscan was not compared with any other treatment. 
V vseh študijah so odziv ocenjevali 12 do 16 tednov po zadnjem zdravljenju z zdravilom Foscan, vendar pa zdravila Foscan niso primerjali z nobenim drugim zdravilom.
When it is illuminated with laser light of a specific wavelength, temoporfin is activated and reacts with oxygen in the cells to create a highly reactive and toxic type of oxygen. 
Ko ga osvetlimo z lasersko svetlobo specifične valovne dolžine, se temoporfin aktivira in reagira s kisikom v celicah, pri čemer se tvori visoko reaktivna in toksična vrsta kisika.
Each area of the tumour should be illuminated only once during each treatment. 
Vsako območje tumorja se lahko med vsakim ciklom zdravljenja osvetli samo enkrat.
Four days later, the entire surface of the tumour and the surrounding 0.5 cm margin is illuminated with light from a laser at a specific wavelength, using a fibre-optic cable. 
Štiri dni pozneje je treba celotno površino tumorja in območje 0,5 cm okoli tumorja osvetljevati s svetlobo specifične valovne dolžine iz laserskega vira prek kabla iz optičnih vlaken.
This kills the cells by reacting with and destroying their components, such as their proteins and DNA. 
Ta ubije celice tako, da reagira z njihovimi komponentami, na primer z njihovimi beljakovinami in DNK, in te komponente uniči.
What benefit has Foscan shown during the studies? 
Kakšne koristi je zdravilo Foscan izkazalo med študijami?
Therefore, the Committee decided that Foscan's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Zato je zaključil, da so koristi zdravila Foscan večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
It is used in patients in whom other treatments have stopped working, and who are not suitable for radiotherapy (treatment with radiation), surgery or systemic chemotherapy (medicines used to treat cancer; ‘systemic' means that they are given as treatments throughout the body). 
Uporablja se pri bolnikih, pri katerih so druga zdravila prenehala učinkovati in ki niso primerni za radioterapijo (zdravljenje z obsevanjem), operacijo ali sistemsko kemoterapijo (zdravili za zdravljenje raka; „sistemska“ pomeni, da zdravila delujejo po celem telesu).
For more information about treatment with Foscan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Foscan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Treatment with Foscan is a two-step process: the medicine is given first, and then it is activated using a laser. 
Zdravljenje z zdravilom Foscan poteka v dveh korakih: najprej se zdravilo injicira, nato pa se aktivira z laserjem.
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 Foscan. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Foscan, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The results of the first three studies were insufficient to support the use of Foscan in the eradication of head and neck cancer tumours. 
Rezultati prvih treh študij niso zadostovali, da bi podprli uporabo zdravila Foscan pri odpravljanju rakavih tumorjev glave in vratu.
Foscan must also not be used in patients who have an operation planned in the next 30 days, who have an eye disease that is likely to need examination using a ‘slit lamp' (an instrument used by eye specialists to look into the eye) in the next 30 days, or who are already being treated with a photosensitising agent. 
Zdravila Foscan prav tako ne smejo uporabljati bolniki, pri katerih je v naslednjih 30 dneh načrtovana operacija, bolniki z očesno boleznijo, pri katerih bo v naslednjih 30 dneh verjetno potreben pregled s špranjsko svetilko (instrumentom, ki ga uporabljajo specialisti za oči za pregled očesa), ali bolniki, ki se že zdravijo z drugim fotosenzitivnim sredstvom.
The medicine is given by an indwelling intravenous cannula (a thin tube permanently inserted into a vein) as a single slow injection over at least six minutes. 
Zdravilo se daje skozi stalno vensko kanilo (tanko cevko, ki je stalno vstavljena v veno) z enkratnim počasnim injiciranjem, ki mora trajati vsaj šest minut.
Foscan has been studied in four main studies involving a total of 409 patients with head or neck cancer. 
Zdravilo Foscan so proučevali v štirih glavnih študijah s skupno 409 bolniki z rakom glave ali vratu.
What is the risk associated with Foscan? 
Kakšna tveganja so povezana z zdravilom Foscan?
By restricting the illumination to the tumour, cell damage is limited to the tumour cells, leaving other areas of the body unaffected. 
Z omejitvijo osvetlitve samo na tumor so tudi poškodbe celic omejene samo na tumorske celice, druga območja telesa pa ostanejo neprizadeta.
The fourth study looked at the reduction of symptoms in 220 patients with advanced head or neck cancer who could not receive surgery or radiotherapy. 
V četrti študiji so proučevali zmanjšanje simptomov pri 220 bolnikih z napredovalim rakom glave ali vratu, ki niso bili primerni za operacijo ali obsevanje.
Foscan is a solution for injection containing the active substance temoporfin (1 mg/ml). 
Zdravilo Foscan je raztopina za injiciranje, ki vsebuje zdravilno učinkovino temoporfin (1 mg/ml).
The most common side effects with Foscan (seen in more than 1 patient in 10) are pain in the illuminated area (such as pain in the face), headache, pain at the injection site, haemorrhage (bleeding), scarring, necrotising stomatitis (death of cells or tissue in the mouth), dysphagia (difficulty swallowing), oedema (swelling) in the illuminated area (such as swelling of the face and tongue) and constipation. 
Najpogostejši neželeni učinki zdravila Foscan (opaženi pri več kot 1 bolniku izmed 10) so bolečine na območju osvetlitve (kot so npr. bolečine na obrazu), glavobol, bolečine na mestu inijiciranja, krvavitve, brazgotine, nekrotizirajoči stomatitis (odmiranje celic ali tkiva v ustih), disfagija (težave pri požiranju), edem (oteklina) na območju osvetlitve (kot je npr. otekel obraz ali jezik) in zaprtje.
Foscan is used to relieve the symptoms of advanced head and neck squamous cell carcinoma (a type of cancer that starts in the cells lining the mouth, nose, throat or ear). 
Zdravilo Foscan se uporablja za blaženje simptomov napredovalega ploščatoceličnega raka glave in vratu (vrste raka, ki se začne v celicah sluznice ust, nosu, grla ali ušesa).
The CHMP concluded that Foscan's effects on relieving the symptoms associated with advanced head and neck cancer were of interest. 
CHMP je menil, da so učinki zdravila Foscan na lajšanje simptomov, povezanih z napredovalim rakom glave in vratu, pomembni.
Foscan must only be given in a specialist cancer centre where a team can assess the patient's treatment under the supervision of a doctor who has experience in photodynamic therapy (treatment that uses light). 
Zdravilo Foscan se sme dajati samo v specialističnih onkoloških klinikah, kjer lahko ekipa zdravstvenih delavcev spremlja bolnikovo zdravljenje pod nadzorom zdravnika, ki ima izkušnje s fotodinamičnim zdravljenjem (zdravljenjem, pri katerem se uporablja svetloba).
When Foscan is injected, temoporfin is distributed within the body, including within the tumour. 
Ko zdravilo Foscan injiciramo, se temoporfin porazdeli po celem telesu, tudi v tumorju.
Foscan must not be used in patients with porphyria (an inability to break down porphyrins), other diseases made worse by light, allergy to porphyrins, or tumours that are spreading into a main blood vessel in or next to the area where the laser is to be shone. 
Zdravila Foscan ne smejo uporabljati bolniki s porfirijo (nezmožnostjo razgradnje porfirinov), drugimi boleznimi, ki jih svetloba poslabša, alergijo na porfirine ali tumorji, ki se širijo v glavno krvno žilo na mestu, osvetljevanem z laserjem, ali v njegovi bližini.
Patients receiving Foscan should take care to avoid exposure to sun light or bright light for two weeks after injection to avoid skin burns. 
Bolniki, ki prejemajo zdravilo Foscan, se morajo dva tedna po injiciranju izogibati izpostavljenosti sončni ali drugi močni svetlobi, sicer lahko pride do kožnih opeklin.
Foscan must not be used in people who are hypersensitive (allergic) to temoporfin or any of the other ingredients. 
Zdravila Foscan ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) temoporfin ali katero koli drugo sestavino zdravila.
Foscan temoporfin 
Povzetek EPAR za javnost temoporfin
During treatment, other areas of the body should be shielded from the light so that the activation of the medicine is limited to the tumour. 
Druga območja telesa morajo biti med terapijo zaščitena pred svetlobo, tako da se zdravilo aktivira samo na območju tumorja.
For the full list of all side effects reported with Foscan, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Foscan, glejte navodilo za uporabo.
The active substance in Foscan, temoporfin, is a photosensitising agent (a substance that changes when exposed to light). 
Zdravilna učinkovina zdravila Foscan je temoporfin, ki je na svetlobo občutljiva snov (snov, ki se spremeni, kadar je izpostavljena svetlobi).
Why has Foscan been approved? 
Zakaj je bilo zdravilo Foscan odobreno?
The first three studies looked at whether the tumour was eradicated after up to three treatments with Foscan in a total of 189 patients. 
V prvih treh študijah so pri skupno 189 bolnikih proučevali, ali je bil tumor po največ treh ciklih zdravljenja z zdravilom Foscan uničen.
What is Foscan used for? 
Za kaj se zdravilo Foscan uporablja?
How has Foscan been studied? 
Kako je bilo zdravilo Foscan raziskano?
How is Foscan used? 
Kako se zdravilo Foscan uporablja?
How does Foscan work? 
Kako zdravilo Foscan deluje?
What is Foscan? 
Kaj je zdravilo Foscan?
This is particularly important with regards back pain model due to the expected high rate of spontaneous remission. 
To je še zlasti pomembno pri vzorcu bolečin v hrbtu zaradi pričakovane visoke stopnje spontane remisije.
Other dosages and pharmaceutical forms are available in Germany only. 
Ostali odmerki in farmacevtske oblike so na voljo samo v Nemčiji.
Flupirtine-containing medicinal products are currently approved in 11 Member States (MSs) of the Union on prescription only: Bulgaria, Estonia, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Portugal, Romania and Slovak Republic. 
Zdravila, ki vsebujejo flupirtin, so trenutno odobrena v 11 državah članicah Evropske unije, kjer se izdajajo le na recept: v Bolgariji, Estoniji, Nemčiji, na Madžarskem, v Italiji, Latviji, Litvi, na Poljskem, Portugalskem, v Romuniji in Slovaški republiki.
The CMDh therefore reworded this section, as follows: 
Zato je CMDh spremenila besedilo tega poglavja, kot sledi: