natgillin/translations-raw huggingface dataset:
In a specific study involving cirrhotic patients with chronic mild (Child-Pugh type A) or moderate (Child-Pugh type B) liver impairment, exposure to agomelatine 25 mg was substantially increased (70times and 140-times, respectively), compared to matched volunteers (age, weight and smoking habit) with no liver failure (see section 4.2, 4.3 and 4.4).
(Child-Pughov tip B) jetrno okvaro se je izpostavljenost agomelatinu po odmerku 25 mg zelo zvečala (70-krat oziroma 140-krat) v primerjavi s prostovoljci brez jetrne okvare, ki so bolnikom ustrezali glede starosti, telesne mase in navad kajenja (glejte poglavja 4.2, 4.3 in 4.4).
- Uncommon side effects (may affect up to 1 in 100 people): migraine, pins and needles in the fingers and toes (paraesthesia), blurred vision, restless legs syndrome (a disorder that is characterized by an uncontrollable urge to move the legs), ringing in the ears, excessive sweating (hyperhidrosis), eczema, pruritus, urticaria (hives), agitation, irritability, restlessness, aggressive behaviour, nightmares, mania/hypomania (see also under “Warnings and precautions” in section 2), suicidal thoughts or behaviour,confusion, weight decreased.
mravljinčenje in zbadanje v prstih na rokah ter nogah (parestezije), zamegljen vid, sindrom nemirnih nog (motnja za katero je značilna nenadzorovana nuja po premikanju nog), zvonjenje v ušesih, prekomerno znojenje (hiperhidroza), ekcemi, srbenje, urtikarija (koprivnica), vznemirjenost, razdraženost, nemir, napadalno vedenje, nočne more, manija/hipomanija (glejte tudi »Opozorila in previdnostni ukrepi« v poglavju 2), razmišljanje o samomoru in samomorilno obnašanje, zmedenost, zmanjšanje telesne mase.
Switching therapy from SSRI/SNRI antidepressant to agomelatine Patients may experience discontinuation symptoms after cessation from an SSRI/ SNRI antidepressant.
Menjava zdravljenja s SSRI/SNRI na agomelatin Po prenehanju zdravljenja z antidepresivom iz skupine SSRI/SNRI se lahko pri bolnikih pojavijo odtegnitveni simptomi.
Valdoxan contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Zdravilo Valdoxan vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni ‘brez natrija'.
Discontinuation symptoms include: dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling sick, being sick and shaking.
Odtegnitveni simptomi vključujejo: omotico, odrevenelost, motnje spanja, vznemirjenost ali anksioznost, glavobole, siljenje na bruhanje, bruhanje in tresavico.
The frequency of benign mammary fibroadenomas observed in the rat was increased with high exposures (60-fold the exposure at the therapeutic dose) but remains in the range of that of controls.
Ob veliki izpostavljenosti (60-krat večji kot ob terapevtskem odmerku) se je pogostnost benignih mamarnih fibroadenomov pri podganah zvečala, vendar je ostala v enakem razponu kot pri kontrolni skupini.
Erythematous rash Face oedema and angioedema*
redki eritematozni izpuščaj edem obraza in angioedem*
Each film-coated tablet contains 61.8 mg lactose (as monohydrate) For the full list of excipients, see section 6.1.
Ena filmsko obložena tableta vsebuje 61,8 mg laktoze (v obliki monohidrata).
The experience of overdoses with Valdoxan is limited but reported symptoms include pain in the upper part of the stomach, somnolence, fatigue, agitation, anxiety, tension, dizziness, cyanosis or malaise.
Izkušnje s prevelikim odmerjanjem zdravila Valdoxan so omejene, poročali pa so o simptomih, kot so bolečine v zgornjem delu želodca, zaspanost, utrujenost, razdraženost, zaskrbljenost, napetost, omotica, cianoza in občutek slabosti.
Electroconvulsive therapy (ECT)
Elektrokonvulzivno zdravljenje
Thoughts of suicide and worsening of your depression If you are depressed you can sometimes have thoughts of harming or killing yourself.
Pri bolnikih z depresijo in/ali anksiozno motnjo se občasno lahko pojavijo misli na samopoškodovanje ali samomor.
Agomelatine had neutral effect on heart rate and blood pressure in clinical trials.
V kliničnih preskušanjih agomelatin ni imel vpliva na srčno frekvenco in krvni tlak.
Treatment should be discontinued if transaminases exceed 3 X upper limit of normal (see sections 4.3 and 4.4).
Zdravljenje morate prekiniti, če vrednosti aminotransferaz presegajo 3-kratno zgornjo mejo normalnih vrednosti (glejte poglavji 4.3 in 4.4).
Printing ink containing shellac, propylene glycol and indigo carmine aluminium lake (E132).
Črnilo vsebuje šelak, propilenglikol in indigotin (E132).
How to take Valdoxan
Kako jemati zdravilo Valdoxan
LIST OF EXCIPIENTS Contains lactose.
SEZNAM POMOŽNIH SNOVI Zdravilo vsebuje laktozo.
Make sure to tell your doctor if you are taking any of the following medicines: propranolol (a beta-blocker used in the treatment of hypertension), enoxacin (antibiotic) Make sure to tell your doctor if you are smoking more than15 cigarettes/day.
Svojega zdravnika morate obvestiti, če jemljete katero od naslednjih zdravil: propranolol (beta blokator, ki se uporablja za zdravljenje visokega krvnega tlaka), enoksacin (antibiotik).
Treatment should not be initiated if transaminases exceed 3 X upper limit of normal (see sections 4.3 and 4.4).
Zdravljenja ne smete uvesti, če vrednosti aminotransferaz presegajo 3-kratno zgornjo mejo normalnih vrednosti (glejte poglavji 4.3 in 4.4).
Caution should be exercised when Valdoxan is administered to patients with pretreatment elevated transaminases (> the upper limit of the normal ranges and ≤3 times the upper limit of the normal range).
• Previdnost je potrebna pri predpisovanju bolnikom z zvišanimi vrednostmi aminotransferaz pred zdravljenjem (> zgornjo mejo normalnih vrednosti in ≤ 3-kratno zgornjo mejo normalnih vrednosti);
Cases of liver injury, including hepatic failure (few cases were exceptionally reported with fatal outcome or liver transplantation in patients with hepatic risk factors), elevations of liver enzymes exceeding 10 times upper limit of normal, hepatitis and jaundice have been reported in patients treated with agomelatine in the post-marketing setting (see section 4.8).
V času po prihodu zdravila na trg so pri bolnikih, zdravljenih z agomelatinom, poročali o primerih poškodb jeter, vključno z odpovedjo jeter (pri bolnikih s prisotnimi dejavniki tveganja za poškodbo jeter so izjemoma poročali o nekaj primerih s smrtnim izidom ali transplantacijo jeter), zvišanjih jetrnih encimov nad 10-kratno zgornjo mejo normalnih vrednosti, hepatitisu in zlatenici (glejte poglavje 4.8).
Safety pharmacology studies showed no effect of agomelatine on hERG (human Ether à-go-go Related Gene) current or on dog Purkinje cells action potential.
Farmakološke študije o varnosti niso pokazale učinka agomelatina na hERG (human Ether à-go-go
Concomitant use of potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) (see section 4.5).
Sočasno jemanje močnih zaviralcev CYP1A2 (npr. fluvoksamin in ciprofloksacin) (glejte poglavje
Combination of agomelatine with oestrogens (moderate CYP1A2 inhibitors) results in a several fold increased exposure of agomelatine.
Sočasno predpisovanje agomelatina z estrogeni, zmernimi zaviralci CYP1A2, privede do večkratnega zvečanja izpostavljenosti agomelatinu.
Film-coating
Način jemanja
Valdoxan contains lactose.
Zdravilo Valdoxan vsebuje laktozo.
Hyperhidrosis Eczema Pruritus* Urticaria*
Bolezni kože in podkožja občasni prekomerno znojenje ekcem pruritus* urtikarija*
Level of sodium
Vrednost natrija
Consequently, co-administration of Valdoxan with potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) is contraindicated.
Sočasno jemanje agomelatina z močnimi zaviralci CYP1A2 (npr. fluvoksaminom in ciprofloksacinom) je zato kontraindicirano.
Caution should be exercised when prescribing Valdoxan with moderate CYP1A2 inhibitors (e.g. propranolol, enoxacin) which may result in increased exposure of agomelatine.
Pri sočasnem predpisovanju zdravila Valdoxan z zmernimi zaviralci CYP1A2 (npr. propranololom, enoksacinom) morate biti previdni, saj se lahko zveča izpostavljenost agomelatinu.
Macrogol (6000) Magnesium stearate Titanium dioxide (E171)
Filmska obloga - hipromeloza - rumeni železov oksid (E172) - glicerol - makrogol (6000) - magnezijev stearat - titanov dioksid (E171)
You may experience discontinuation symptoms related to stopping of your previous medicine for a few weeks, even if the dose of your previous antidepressant medicine is decreased gradually.
Kljub postopnemu zmanjševanju odmerka prejšnjega antidepresiva se pri vas lahko pojavijo nekaj tednov trajajoči neželeni učinki, ki so posledica prenehanja predhodnega zdravljenja.
The Marketing Authorisation Holder shall agree the format and content of the physician's guide to prescribing with the National Competent Authority prior to launch in the Member State.
• Dodatni ukrepi za zmanjševanje tveganj Imetnik dovoljenja za promet z zdravilom se bo z nacionalnim pristojnim organom, preden da zdravilo v promet v državi članici, dogovoril o obliki in vsebini priročnika o predpisovanju za zdravnike.
There were mild non dose dependent decreases in body weight related to the pharmacological properties and some minor effects on male reproductive tract without any impairment on reproductive performances.
povezanih s farmakološkimi lastnostmi, in nekaj manjših učinkov na reproduktivni trakt pri samcih,
7 MARKETING AUTHORISATION HOLDER
IMETNIK DOVOLJENJA ZA PROMET
Reproduction studies in the rat and the rabbit showed no effect of agomelatine on fertility (see section
Študije o razmnoževanju na podganah in kuncih niso pokazale nikakršnega učinka agomelatina na plodnost (glejte poglavje 5.3).
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3).
It is not advisable to drink alcohol while you are being treated with Valdoxan.
Med zdravljenjem z zdravilom Valdoxan ni priporočljivo piti alkohola.
However, only limited clinical data on the use of agomelatine in depressed patients with severe or moderate renal impairment with major depressive episodes is available.
Klinični podatki o predpisovanju agomelatina pri bolnikih z depresijo in hudo ali zmerno ledvično okvaro pa so omejeni, zato morate biti pri predpisovanju agomelatina tem bolnikom previdni.
Agomelatine is metabolised mainly by cytochrome P450 1A2 (CYP1A2) (90%) and by CYP2C9/19 (10%).
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Možna medsebojna delovanja, ki vplivajo na agomelatin Agomelatin se presnavlja predvsem preko citokroma P450 1A2 (CYP1A2) (90 %) in CYP2C9/19
Akathisia*
redki akatizija*
Valdoxan contains lactose
Zdravilo Valdoxan vsebuje laktozo
Diarrhoea Constipation Abdominal pain Vomiting*
Bolezni prebavil pogosti navzea diareja zaprtje bolečine v trebuhu bruhanje*
- If you are diabetic, ask your doctor for advice.
- Če imate sladkorno bolezen, se posvetujte s svojim zdravnikom.
- if you are a young adult.
- če ste že kdaj razmišljali o samomoru ali samopoškodovanju; - če ste mlajša odrasla oseba.
- If you are suffering from dementia, your doctor will make an individual evaluation of whether it is right for you to take Valdoxan.
- Če imate demenco, bo vaš zdravnik individualno presodil, ali je za vas zdravljenje z zdravilom
on one side.
(logotip podjetja) na eni strani.
4.7 Effects on ability to drive and use machines Agomelatine has minor influence on the ability to drive and use machines.Considering that dizziness and somnolence are common adverse reactions, patients should be cautioned about their ability to drive or operate machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Agomelatin ima blag vpliv na sposobnost vožnje in upravljanja strojev.
• printing ink : shellac, propylene glycol and indigo carmine aluminium lake (E132)
- črnilo: šelak, propilenglikol in indigotin (E132).
Blood tests
Laboratorijske preiskave
If you have trouble with your kidneys, your doctor will make an individual evaluation of whether it is safe for you to take Valdoxan.
Če imate težave z ledvicami, bo zdravnik individualno presodil, ali je za vas zdravljenje z zdravilom
(>3 times the upper limit of the normal range) Hepatic failure*(1)
redki hepatitis zvišana alkalna fosfataza* (> 3-kratno zgornjo mejo normalnih vrednosti) odpoved jeter*(1) zlatenica*
• Information about the risk of hepatic reactions and clinical signs of liver problems
Brošura za bolnike mora vsebovati naslednja ključna sporočila: • informacije o tveganju za jetrne reakcije in o kliničnih znakih težav z jetri
During treatment period Valdoxan treatment should be discontinued immediately if: ‐ patient develops symptoms or signs of potential liver injury (such as dark urine, light coloured stools, yellow skin/eyes, pain in the upper right belly, sustained new-onset and unexplained fatigue).
Med zdravljenjem Zdravljenje z zdravilom Valdoxan je treba takoj prekiniti: ‐ če se pri bolniku pojavijo simptomi ali znaki možne poškodbe jeter (kot je temen urin,
Warnings and precautions There could be some reasons why Valdoxan may not be suitable for you:
V nekaterih primerih zdravilo Valdoxan ni primerno za vas:
Valdoxan is for oral use.
Valdoxan primerno.
A specific controlled, 3-week trial has been conducted in patients suffering from major depressive disorder and insufficiently improved with paroxetine (a SSRI) or venlafaxine (a SNRI).
Bolniki z veliko depresivno epizodo, pri katerih zdravljenje s paroksetinom (SSRI) ali venlafaksinom
The recommended dose of Valdoxan is one tablet (25 mg) at bedtime.
Običajen odmerek je ena tableta (25 mg) zdravila Valdoxan pred spanjem.
Agitation and related symptoms* (such as irritability and restlessness) Aggression*
občasni razmišljanje o samomoru ali samomorilno obnašanje (glejte poglavje 4.4) agitacija in z njo povezani simptomi* (kot sta razdražljivost in vznemirjenost) napadalnost*
You have been given Valdoxan to treat your depression.
Zdravnik vam ga je predpisal za zdravljenje depresije.
Valdoxan 25 mg film-coated tablets agomelatine
Valdoxan 25 mg filmsko obložene tablete agomelatin
- alcohol use disorder and /or substantial alcohol intake and in patients receiving concomitant medicinal products associated with risk of hepatic injury.
- motnja uporabe alkohola in/ali uživanje znatnih količin alkohola,
At the end of treatment (over 6 or 8 weeks), significant efficacy of agomelatine 25-50 mg was demonstrated in 6 out of the ten short-term double-blind placebo-controlled trials.
25 do 50 mg dokazali v šestih od desetih kratkoročnih, dvojno slepih, s placebom nadzorovanih preskušanjih.
Patients responding to 8/10-weeks of acute treatment with open-label agomelatine 25-50 mg once daily were randomised to either agomelatine 25-50 mg once daily or placebo for further 6-months.
ki so se odzivali na odprto 8- do 10-tedensko akutno zdravljenje z agomelatinom v odmerku 25 do
These side effects include: - Very common side effects (may affect more than 1 in 10 people) :headache - Common side effects (may affect up to 1 in 10 people): dizziness, sleepiness (somnolence), difficulty in sleeping (insomnia), feeling sick (nausea), diarrhoea, constipation, abdominal pain, back pain, tiredness, anxiety, abnormal dreams, increased levels of liver enzymes in your blood, vomiting, weight increased.
- Pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov): omotica, zaspanost (somnolenca), težave s spanjem (nespečnost), siljenje na bruhanje (navzea), driska, zaprtje,
In a pharmacokinetic study in elderly patients (≥ 65 years), it was showed that at a dose of 25 mg the mean AUC and mean Cmax were about 4-fold and 13-fold higher for patients ≥ 75 years old compared to patients < 75 years old.
(površina pod krivuljo) 4-krat in srednja Cmax (največja koncentracija) 13-krat višji pri bolnikih ≥ 75 let kot pri bolnikih < 75 let.
You should discuss with your doctor on the best way of stopping your previous antidepressant medicine when starting Valdoxan.
Ob začetku zdravljenja z zdravilom Valdoxan se morate posvetovati z zdravnikom o najboljšem možnem načinu prenehanja jemanja prejšnjega antidepresiva.
There is limited experience with agomelatine overdose.
O prevelikem odmerjanju z agomelatinom je le malo izkušenj.
The calendar printed on the blister containing the tablets should help you remembering when you last took a tablet of Valdoxan.
Da ne bi pozabili, kdaj ste nazadnje vzeli tableto zdravila Valdoxan, si lahko pomagate s koledarčkom, natisnjenim na pretisnem omotu s tabletami.
- If you get any side effects ,talk to your doctor or pharmacist.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
- Rare side effects (may affect up to 1 in 1,000 people): serious skin eruption (erythematous rash), face oedema (swelling) and angioedema (swelling of the face, lips, tongue and/or throat that may cause difficulty in breathing or swallowing), hepatitis, yellow coloration of the skin or the whites of the eyes (jaundice), hepatic failure*, hallucinations, inability to remain still (due to physical and mental unrest), inability to completely empty the bladder.
jezika in/ali žrela, kar lahko povzroči težave pri dihanju ali požiranju), hepatitis, rumeno obarvanje kože in beločnic (zlatenica), odpoved jeter*, halucinacije, nesposobnost biti pri miru
What Valdoxan looks like and contents of the pack Valdoxan 25 mg film-coated tablets (tablet) are oblong, orange-yellow with a blue imprint of ‘company logo'
Valdoxan 25 mg filmsko obložene tablete (tablete) so podolgovate, oranžnorumene z modrim odtisom
- after around 3 weeks, - after around 6 weeks (end of acute phase), - after around 12 and 24 weeks (end of maintenance phase), - and thereafter when clinically indicated.
• Pogostnost pregledovanja delovanja jeter - pred uvedbo zdravljenja - in nato: - po približno 3 tednih, - po približno 6 tednih (na koncu akutne faze), - po približno 12 in 24 tednih (na koncu vzdrževalne faze)
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti bolečine v hrbtu
There is no data on the influence of race on agomelatine pharmacokinetics.
Podatkov o vplivu etnične pripadnosti na farmakokinetiko agomelatina ni. 5.3 Predklinični podatki o varnosti
NAME OF THE MEDICINAL PRODUCT Valdoxan 25 mg tablets agomelatine
IME ZDRAVILA Valdoxan 25 mg tablete agomelatin
How to store Valdoxan
Shranjevanje zdravila Valdoxan
1 NAME OF THE MEDICINAL PRODUCT Valdoxan 25 mg film-coated tablets
IME ZDRAVILA Valdoxan 25 mg filmsko obložene tablete
• A blood tests appointments reminder.
• navodila v obliki sheme spremljanja delovanja jeter • opomnik za dogovorjene datume laboratorijskih preiskav.
- The other ingredients are:
Pojav takšnih misli je verjetnejši:
Back pain
PET SOB NED
Migraine
Zdravljenje
No hepatotoxicity was observed in rodents and monkeys in the repeat dose toxicity studies.
Toksikološke študije z večkratnim odmerjanjem pri glodalcih in opicah niso pokazale hepatotoksičnosti.
You should not take Valdoxan together with certain medicines (see also under “Do not take Valdoxan” in section 2): fluvoxamine (another medicine used in the treatment of depression), ciprofloxacin (an antibiotic) can modify the expected dose of agomelatine in your blood.
Valdoxan« v poglavju 2): fluvoksamin (še enim zdravilom za zdravljenje depresije), ciprofloksacin
Following oral administration, agomelatine is rapidly metabolised mainly via hepatic CYP1A2; CYP2C9 and CYP2C19 isoenzymes are also involved but with a low contribution.
Izoencima CYP2C9 in CYP2C19 prav tako sodelujeta, vendar v manjši meri.
Povidone (K30) Sodium starch glycolate type A Stearic acid
Jedro tablete - laktoza monohidrat - koruzni škrob - povidon (K30) - natrijev karboksimetilškrob (vrsta A) - stearinska kislina - magnezijev stearat - brezvoden koloidni silicijev dioksid
Experience with agomelatine in overdose has indicated that epigastralgia, somnolence, fatigue, agitation, anxiety, tension, dizziness, cyanosis or malaise have been reported.
Pri izkušnjah s prevelikim odmerjanjem agomelatina so poročali o bolečini v epigastričnem predelu, somnolenci, utrujenosti,
No relevant modification of pharmacokinetic parameters in patients with severe renal impairment has been observed (n=8, single dose of 25 mg), but caution should be exercised in patients with severe or moderate renal impairment as only limited clinical data are available in these patients (see section 4.2).
Pri bolnikih s hudo ledvično okvaro niso opazili pomembnih sprememb farmakokinetičnih parametrov (n = 8, enkratni odmerek 25 mg).
Breastfeeding should be discontinued if you take Valdoxan.
Če jemljete zdravilo Valdoxan, morate prenehati z dojenjem.
Close supervision of patients and in particular those at high risk should accompany treatment especially in early treatment and following dose changes.
Med zdravljenjem, še posebej pri uvedbi zdravljenja in pri vsaki spremembi odmerka, je treba bolnike skrbno nadzirati.
There is no experience of concurrent use of agomelatine with ECT.
Ni izkušenj z jemanjem agomelatina sočasno z elektrokonvulzivnim zdravljenjem.
Ear and labyrinth disorders
Ušesne bolezni, vključno z motnjami labirinta občasni tinitus*
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton
PODATKI NA ZUNANJI OVOJNINI Škatla
United Kingdom Servier Laboratories Ltd
France Les Laboratoires Servier
Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (aged less than 25 years) with psychiatric conditions who were being treated with an antidepressant.
(mlajših od 25 let) z motnjami razpoloženja med zdravljenjem z antidepresivi obstaja večje tveganje za pojav samomorilnega vedenja.
In clinical trials among children and adolescents treated with other antidepressants, suicide-related behaviour (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed compared to those treated with placebo (see section 4.2).
Samomorilno vedenje (poskuse samomora in samomorilne misli) ter sovražnost (predvsem napadalnost,
• A guidance on the scheme of hepatic monitoring
• Navodila v primeru, ko pregled delovanja jeter pokaže nepravilnosti;
BATCH NUMBER Batch
ŠTEVILKA SERIJE Lot:
- If you are obese or overweight, ask your doctor for advice.
Posvetujte se z zdravnikom, katera zdravila so to. - Če ste debeli ali imate prekomerno telesno maso, se posvetujte s svojim zdravnikom.
Dizziness Somnolence Insomnia
Očesne bolezni občasni zamegljen vid
Urinary retention*
Bolezni sečil redki zadrževanje urina*
Further information on Edistride can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Edistride.
Nadaljnje informacije o zdravilu Edistride so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Edistride.
This authorisation was based on the authorisation granted for Forxiga in 2012.
Izdaja tega dovoljenja je temeljila na dovoljenju za promet z zdravilom Forxiga, ki je bilo izdano leta 2012.
What measures are being taken to ensure the safe and effective use of Edistride?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Edistride?
Edistride received a marketing authorisation valid throughout the EU on 9 November 2015.
Za zdravilo Edistride je bilo 9. novembra 2015 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
Other information about Edistride
Druge informacije o zdravilu Edistride
An overview of Edistride and why it is authorised in the EU
Pregled zdravila Edistride in zakaj je odobreno v EU
As for all medicines, data on the use of Edistride are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Edistride stalno spremljajo.
For type 2 diabetes, the dose of Edistride is 10 mg once a day.
Pri sladkorni bolezni tipa 2 znaša odmerek Edistride 10 mg enkrat na dan.
Why is Edistride authorised in the EU?
Zakaj je zdravilo Edistride odobreno v EU?
The Agency concluded that the benefits of Edistride outweigh its risks and recommended that it be granted marketing authorisation.
Agencija je zaključila, da so koristi zdravila Edistride večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.