FrancophonIA/ELRC3.0 huggingface dataset:
English: Although the systemic availability of prilocaine by cutaneous absorption of Senstend is low, caution should be exercised in patients with anaemia, congenital or acquired methaemoglobinaemia or patients on concomitant therapy known to produce such conditions.
Croatian: Unatoč niskoj sistemskoj raspoloživosti prilokaina putem kožne apsorpcije lijeka Senstend, potreban je oprez u pacijenata s anemijom, urođenom ili stečenom methemoglobinemijom te u pacijenata koji istodobno primaju terapiju za koju je poznato da može potaknuti takva stanja.
English: There is no relevant use of Senstend in the paediatric population for the indication of treatment of primary premature ejaculation in adult men.
Croatian: Nema relevantne primjene lijeka Senstend u pedijatrijskoj populaciji za indikaciju liječenja primarne preuranjene ejakulacije u odraslih muškaraca.
English: - if you or your sexual partner are allergic to lidocaine or prilocaine or any of the other ingredients of this medicine (listed in section 6); - if you or your sexual partner have a history of allergy or sensitivity to other local anaesthetics with a similar structure (known as amide-type local anaesthetics).
Croatian: Nemojte primjenjivati Senstend - ako ste vi ili vaša seksualna partnerica alergični na lidokain ili prilokain ili neki drugi sastojak ovog lijeka (naveden u dijelu 6), - ako vi ili vaša seksualna partnerica imate povijest alergija ili osjetljivosti na druge lokalne anestetike slične strukture (poznati i kao lokalni anestetici amidnog tipa).
English: The effectiveness of Senstend in treating PE was assessed by measuring IELT and the co primary endpoints of ejaculatory control, sexual satisfaction, and distress using the IPE.
Croatian: Učinkovitost lijeka Senstend u liječenju PE procijenjena je mjerenjem IELT-a i ko-primarnih mjera ishoda kontrole ejakulacije, spolnog zadovoljstva i tjeskobe korištenjem indeksa IPE.
English: • feeling of burning in and around the vagina • reduced feeling in and around the vagina
Croatian: • osjećaj pečenja u i oko vagine • smanjeni osjet u i oko vagine
English: Senstend is not indicated for use by women.
Croatian: Senstend nije indiciran za primjenu u žena.
English: After 5 minutes any excess spray should be wiped off prior to intercourse.
Croatian: Nakon 5 minuta ako postoji višak spreja treba ga obrisati prije snošaja.
English: The following side effects have been reported with Senstend in female partners:
Croatian: Sljedeće nuspojave opažene su kod primjene lijeka Senstend u ženskih partnerica:
English: Senstend provides topical anaesthesia to the glans penis.
Croatian: Senstend pruža topikalnu anesteziju glavića penisa.
English: Cutaneous spray, solution Colourless to light yellow solution
Croatian: OBLIK Sprej za kožu, otopina Bezbojna do svijetlo žuta otopina
English: Uncommon Genital erythema, ejaculation failure, paraesthesia of male genital, penile pain, penis disorder, pruritus genital
Croatian: Manje često Genitalni eritem, neuspješna ejakulacija, parestezija muških genitalija, bol penisa, poremećaji penisa, genitalni pruritis
English: Deterioriation was observed when Senstend was used with polyurethane-based female and male condoms (see section 4.4).
Croatian: Kad se Senstend koristio s muškim i ženskim kondomima izrađenim od poliuretana primijećeno je da dolazi do njihova oštećenja (vidjeti dio 4.4).
English: As Senstend is applied topically to the glans penis the risk of overdose is low.
Croatian: Budući da se Senstend primjenjuje topikalno na glavić penisa, rizik od predoziranja je malen.
English: The following side effects have been reported with Senstend in male patients:
Croatian: Sljedeće nuspojave opažene su kod primijene lijeka Senstend u muških bolesnika:
English: • Nitrofurantoin - an antibiotic used to treat urinary and kidney infections
Croatian: • Nitrofurantoin - antibiotik koji se koristi za liječenje infekcije mokraćnog sustava i bubrežne infekcije
English: Due to the risk of partner transfer, patients hoping to achieve conception should either avoid using Senstend, or, if it is essential to achieve penetration, should wash the glans penis as thoroughly as possible 5 minutes after applying the spray but prior to intercourse (see section 4.6).
Croatian: Uslijed rizika od prijenosa na partnericu, pacijenti koji nastoje postići oplodnju bi trebali izbjegavati primjenu lijeka Senstend, ili, ako je on nužan za postizanje penetracije, trebaju oprati glavić penisa što je temeljitije moguće 5 minuta nakon nanošenja spreja, ali prije snošaja (vidjeti dio 4.6).
English: • discomfort in the anus and rectum
Croatian: • nelagoda u anusu i rektumu
English: Holding the can upright (valve up), apply 1 dose (3 sprays) of Senstend to the entire head of the penis, by covering one third with each spray.
Croatian: Držite spremnik uspravno (potisnik s gornje strane), a zatim nanesite 1 dozu (3 potiska spreja) Senstend na cijelu površinu glavića penisa, pokrivajući svakim potiskom po jednu trećinu površine.
English: Senstend sprayed onto a damaged tympanic membrane may cause ototoxicity of the middle ear.
Croatian: Kad se Senstend rasprši po oštećenom bubnjiću, može doći do ototoksičnosti srednjeg uha.
English: Common Hypoaesthesia of male genital, erectile dysfunction, genital burning sensation
Croatian: Hipoestezija muških genitalija, erektilna disfunkcija, osjet pečenja u genitalijama
English: Senstend is indicated for the treatment of primary premature ejaculation in adult men.
Croatian: Senstend indiciran je za liječenje primarne preuranjene ejakulacije u odraslih muškaraca.
English: Patients hoping to achieve conception should either avoid using Senstend, or, if it is essential to achieve penetration, should wash the glans penis as thoroughly as possible prior to intercourse.
Croatian: Pacijenti koji nastoje postići oplodnju bi trebali izbjegavati Senstend, ili, ako je on nužan za postizanje penetracije, trebaju oprati glavić penisa što je temeljitije moguće prije snošaja.
English: Absorption of Senstend in conjunctival tissues has not been determined.
Croatian: Nije utvrđeno koliko se Senstend apsorbira u tkivu konjunktive.
English: - The active substances are lidocaine and prilocaine.
Croatian: Što Senstend sadrži - Djelatne tvari su lidokain i prilokain.
English: Therefore, patients hoping to achieve conception should either avoid using Senstend, or, if this medicine is essential to achieve penetration, should wash the penis as thoroughly as possible five minutes after Senstend has been applied, but prior to intercourse.
Croatian: Stoga, bolesnici koji nastoje postići oplodnju trebaju izbjegavati Senstend, ili, ako je on nužan za postizanje penetracije, trebaju oprati glavić penisa što je temeljitije moguće pet minuta nakon što su nanijeli Senstend, ali prije snošaja.
English: Senstend 150 mg/ml + 50 mg/ml cutaneous spray, solution lidocaine/prilocaine
Croatian: Senstend 150 mg/mL + 50 mg/mL sprej za kožu, otopina lidokain/prilokain
English: Each ml of solution contains 150 mg lidocaine and 50 mg prilocaine.
Croatian: Jedan mL otopine sadržava 150 mg lidokaina i 50 mg prilokaina.
English: INFORMATION IN BRAILLE 17.
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Senstend
English: Senstend is indicated for the treatment of lifelong premature ejaculation in adult men.
Croatian: Senstend je indiciran za liječenje stalne preuranjene ejakulacije u odraslih muškaraca.
English: Each pack contains 1 spray container with 6.5 ml or 5 ml of solution.
Croatian: Svako pakiranje sadržava 1 spremnik spreja sa 6,5 mL ili 5 mL otopine.
English: Common Vulvovaginal burning sensation, hypoaesthesia Uncommon Vulvovaginal discomfort, vaginal pain,
Croatian: Manje često Vulvovaginalna nelagoda, vaginalna bol, vulvovaginalni pruritis
English: Before initial use, briefly shake the spray container and then prime the pump mechanism by spraying the valve three times into the air.
Croatian: Prije prve uporabe spremnik spreja je potrebno nakratko protresti i pripremiti mehanizam spreja za rad tako što ćete tri puta istisnuti po jedan potisak u zrak.
English: Symptoms of using too much Senstend are listed below.
Croatian: U nastavku su popisani simptomi predoziranja Senstend lijekom.
English: Each pack contains one spray container with 6.5 ml or 5 ml solution.
Croatian: Svako pakiranje sadržava jedan spremnik spreja koji sadržava 6,5 mL ili 5 mL otopine.
English: As this medicine is applied to the surface of the head of the penis the risk of overdose is low.
Croatian: Ako primijenite više lijeka Senstend nego što ste trebali Budući da se ovaj lijek primjenjuje na površinu glavića penisa, rizik od predoziranja je malen.
English: For all of the three monthly assessments completed by the subjects, there was a significant difference between Senstend and placebo (p < 0.0001).
Croatian: Statistički značajna razlika između skupina liječenih lijekom Senstend i placebom javila se kod sve tri mjesečne ocjene (p < 0,0001).
English: Each container of 5 ml delivers a minimum of 12 doses.
Croatian: Jedan spremnik od 5 mL sadržava najmanje 12 doza.
English: Senstend 150 mg/ml + 50 mg/ml cutaneous spray, solution
Croatian: NAZIV LIJEKA Senstend 150 mg/mL + 50 mg/mL sprej za kožu, otopina
English: senstend
Croatian: Nuspojave
English: Cutaneous spray, solution 6.5 ml
Croatian: OBLIK I SADRŽAJ Sprej za kožu, otopina 6,5 mL
English: A higher rate of erectile dysfunction and male genital hypoaesthesia may be experienced when using Senstend with male condoms.
Croatian: Kad se Senstend koristi s muškim kondomima, moguća je veća stopa erektilne disfunkcije i muške genitalne hipoestezije.
English: Each container of 6.5 ml delivers a minimum of 20 doses.
Croatian: Jedan spremnik od 6,5 mL sadržava najmanje 20 doza.
English: Deterioriation was observed when Senstend was used with polyurethane-based female and male condoms.
Croatian: Kad se Senstend koristio s muškim i ženskim kondomima izrađenim od poliuretana primijećeno je da dolazi do njihovog oštećenja.
English: Patients allergic to paraaminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine and/or prilocaine; however, Senstend should be used with caution in patients with a history (or partner with a history) of sensitivities to medicinal products, especially if the aetiologic medicinal product is uncertain.
Croatian: Bolesnici koji su alergični na derivate paraaminobenzoatne kiseline (prokain, tetrakain, benzokain itd.) nisu pokazali ukriženu osjetljivost na lidokain i/ili prilokain.
English: - Each spray container of 5 ml delivers a minimum of 12 doses.
Croatian: - Jedan spremnik od 5 mL sadržava najmanje 12 doza.
English: vulvovaginal pruritus
Croatian: Prijavljivanje nuspojava
English: - Each spray container of 6.5 ml delivers a minimum of 20 doses.
Croatian: - Jedan spremnik od 6,5 mL sadržava najmanje 20 doza.
English: Once the can is held upright (valve up), 1 dose of Senstend should be applied to the entire glans penis, by actuating the valve 3 times.
Croatian: Senstend se primjenjuje tako da se spremnik drži uspravno, a zatim se 1 doza nanese na cijelu površinu glavića penisa s pomoću 3 potiska na potisnik raspršivača.
English: • Feeling light-headed or dizzy
Croatian: • osjećaj ošamućenosti ili omaglice
English: Plethora Pharma Solutions Ltd. Puh/Tel: +44 (0)20 3077 5400
Croatian: Puh/Tel: +44 (0)20 3077 5400
English: (methaemoglobinaemia).
Croatian: I kao što je meksiletin.
English: Nervous system disorders
Croatian: Oštećenje jetre
English: Plethora Pharma Solutions Ltd. Tél: +44 (0)20 3077 5400
Croatian: Tél/Tel: +44 (0)20 3077 5400
English: Plethora Pharma Solutions Ltd. Tlf: +44 (0)20 3077 5400
Croatian: Tlf: +44 (0)20 3077 5400
English: The recommended dose is 2 inhalations twice a day.
Croatian: Preporučena doza iznosi dvije inhalacije dvaput na dan.
English: Further information on Bevespi Aerosphere can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Bevespi-Aerosphere.
Croatian: Više informacija o lijeku Bevespi Aerosphere nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Bevespi-Aerosphere.
English: Patients who received placebo (a dummy treatment), on the other hand, had increases of up to 8 ml or reductions of up to 20 ml.
Croatian: S druge strane, kod bolesnika koji su primali placebo (prividno liječenje) zabilježeno je povećanje do 8 ml ili smanjenje do 20 ml.
English: This means that it blocks muscarinic receptors (targets) in muscle cells in the lungs.
Croatian: To znači da blokira muskarinske receptore (ciljna mjesta) u mišićnim stanicama u plućima.
English: Bevespi Aerosphere (glycopyrronium bromide / formoterol) EMA/752588/2018
Croatian: Bevespi Aerosphere (glikopironijev bromid / formoterol) EMA/752588/2018
English: The combination has been shown to be effective at improving patients' lung function, with both components contributing to this effect.
Croatian: Kombinacija ovih sastavnica pokazala se učinkovitom u poboljšanju plućne funkcije u bolesnika, a obje sastavnice lijeka doprinose tom učinku.
English: In these studies, patients treated with Bevespi Aerosphere for 24 weeks had FEV1 increases of around 135 to 150 ml.
Croatian: U tim se ispitivanjima FEV1 u bolesnika liječenih lijekom Bevespi Aerosphere tijekom 24 tjedna povećao za otprilike 135 do 150 ml.
English: Other information about Bevespi Aerosphere
Croatian: Ostale informacije o Bevespi Aerosphere
English: The most common side effects with Bevespi Aerosphere (which may affect up to 1 in 10 people) include headache, nausea (feeling sick), muscle spasms and dizziness.
Croatian: Najčešće nuspojave lijeka Bevespi Aerosphere (mogu se javiti u do 1 na 10 osoba) jesu glavobolja, mučnina (slabost), proljev, mišićni grčevi i omaglica.
English: The medicine has also shown some effect on symptoms such as breathlessness although this appears modest.
Croatian: Lijek je donekle utjecao i na simptome kao što su nedostatak zraka premda je taj učinak bio vrlo skroman.
English: Glycopyrronium bromide is a muscarinic receptor antagonist.
Croatian: Glikopironijev bromid antagonist je muskarinskih receptora.
English: It works by attaching to receptors known as beta-2 receptors found in the muscles of the airways.
Croatian: Djeluje tako da se spaja na receptore koji se zovu beta-2 receptori, a nalaze se u mišićima dišnih putova.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bevespi Aerosphere have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Bevespi Aerosphere nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Bevespi Aerosphere (glycopyrronium bromide / formoterol)
Croatian: Bevespi Aerosphere (glikopironijev bromid / formoterol)
English: What measures are being taken to ensure the safe and effective use of Bevespi Aerosphere?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Bevespi Aerosphere?
English: Side effects reported with Bevespi Aerosphere are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Bevespi Aerosphere pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Three main studies in over 5,000 patients with COPD have shown that Bevespi Aerosphere is effective at improving patients' FEV1 (the maximum volume of air they can breathe out in one second).
Croatian: Tri glavna ispitivanja na više od 5 000 bolesnika s KOPB-om pokazala su da je Bevespi Aerosphere učinkovit u poboljšanju vrijednosti FEV1 (forsiranog izdisajnog volumena u jednoj sekundi) u bolesnika.
English: For more information about using Bevespi Aerosphere, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Bevespi Aerosphere pogledajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: The European Medicines Agency therefore decided that Bevespi Aerosphere's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Bevespi Aerosphere nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: As for all medicines, data on the use of Bevespi Aerosphere are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Bevespi Aerosphere kontinuirano se prate.
English: Because these receptors help control the contraction of muscles, when glycopyrronium is inhaled, it causes the muscles of the airways to relax, helping to keep the airways open.
Croatian: Budući da ti receptori pomažu u kontroli stezanja mišića, kad se glikopironij udahne, on uzrokuje opuštanje mišića dišnih puteva, čime pomaže držati dišne puteve otvorenima.
English: It contains the active substances glycopyrronium bromide and formoterol.
Croatian: Sadrži djelatne tvari glikopironijev bromid i formoterol.
English: Finally, the studies showed that Bevespi Aerosphere can lead to modest improvements in symptoms such as breathlessness.
Croatian: Konačno, ispitivanja su pokazala da lijek Bevespi Aerosphere može dovesti do skromnih poboljšanja simptoma poput nedostatka zraka.
English: Patients should be shown how to use the inhaler correctly by a doctor or other healthcare professional.
Croatian: Liječnik ili drugo zdravstveno osoblje bolesnicima trebaju pokazati kako ispravno upotrebljavati inhalator.
English: When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open.
Croatian: Prilikom spajanja na te receptore uzrokuje opuštanje mišića, što održava dišne putove otvorenima.
English: Bevespi Aerosphere is a medicine used in adults to relieve the symptoms of chronic obstructive pulmonary disease (COPD).
Croatian: Bevespi Aerosphere je lijek koji se primjenjuje za ublažavanje simptoma kronične opstruktivne plućne bolesti (KOPB) u odraslih osoba.
English: What is Bevespi Aerosphere and what is it used for?
Croatian: Što je Bevespi Aerosphere i za što se primjenjuje?
English: Why is Bevespi Aerosphere authorised in the EU?
Croatian: Zašto je Bevespi Aerosphere odobren u EU-u?
English: Bevespi Aerosphere is available as a liquid in a portable inhaler device.
Croatian: Lijek Bevespi Aerosphere dostupan je u obliku tekućine u prijenosnom inhalatoru.
English: Side effects are considered mild to moderate in severity and are similar to other COPD medicines.
Croatian: Nuspojave se smatraju blagima do umjerenima i slične su ostalim lijekovima za liječenje KOBD-a.
English: The studies also showed that Bevespi Aerosphere improved FEV1 more than the single components in the medicine.
Croatian: Ispitivanja su pokazala i da je lijek Bevespi Aerosphere poboljšao FEV1 više od pojedinačnih sastavnica lijeka.
English: An overview of Bevespi Aerosphere and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Bevespi Aerosphere i zašto je odobren u EU-u
English: What are the risks associated with Bevespi Aerosphere?
Croatian: Koji su rizici povezani s lijekom Bevespi Aerosphere?
English: The two active substances in Bevespi Aerosphere work in different ways to widen the airways and improve breathing in COPD.
Croatian: Bevespi Aerosphere sadrži dvije djelatne tvari koje na različit način proširuju dišne puteve i olakšavaju disanje u bolesnika s KOPB-om.
English: Bevespi Aerosphere is used for maintenance (regular) treatment.
Croatian: Lijek Bevespi Aerosphere primjenjuje se kao (redovita) terapija održavanja.
English: The components in Bevespi Aerosphere are well established treatments of COPD.
Croatian: Sastavnice lijeka Bevespi Aerosphere dobro su poznate terapije za liječenje KOPB-a.
English: For the full list of side effects and restrictions of Bevespi Aerosphere, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Bevespi Aerosphere potražite u uputi o lijeku.
English: How does Bevespi Aerosphere work?
Croatian: Kako djeluje Bevespi Aerosphere?
English: What benefits of Bevespi Aerosphere have been shown in studies?
Croatian: Koje su koristi od lijeka Bevespi Aerosphere utvrđene u ispitivanjima?
English: How is Bevespi Aerosphere used?
Croatian: Kako se Bevespi Aerosphere primjenjuje?
English: The marketing authorisation application (MAA) for Myoson was submitted under Article 10(1) of Directive 2001/83/EC (i.e. a generic application), vis-à-vis the reference medicinal product Mydeton (Gedeon Richter Plc).
Croatian: Zahtjev za stavljanje u promet lijeka Myoson podnesen je u skladu s člankom 10. stavkom 1. Direktive 2001/83/EZ (zahtjev za generički lijek) u odnosu na referentni lijek Mydeton (Gedeon Richter Plc).
English: The active substance of Myoson is tolperisone hydrochloride, which is a centrally acting muscle relaxant indicated for the symptomatic treatment of post-stroke spasticity in adults.
Croatian: Djelatna tvar lijeka Myoson je tolperizon hidroklorid, mišićni relaksans koji djeluje na središnji živčani sustav, a indiciran je za simptomatsko liječenje spastičnosti u odraslih nakon moždanog udara.
English: • The Committee reviewed the responses submitted by the applicant to address the issues raised with regard to the bioequivalence of Myoson with respect to the reference medicinal product;
Croatian: • Povjerenstvo je pregledalo sve odgovore koje je dostavio podnositelj zahtjeva vezano za problem bioekvivalencije lijeka Myoson u odnosu na referentni lijek;
English: The CHMP has recommended the granting of the marketing authorisation for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group, for Myoson and associated names (see Annex I).
Croatian: CHMP je preporučio izdavanje odobrenja za stavljanje u promet za koje sažetak opisa svojstava lijeka, označavanje i uputa o lijeku ostaju u skladu sa završnim inačicama donesenim tijekom postupka koordinacijske grupe za lijek Myoson i povezana imena (vidjeti Prilog I.).
English: • Therefore, the Committee concluded by majority that the bioequivalence studies conducted in the fasting state give sufficient evidence to conclude on the bioequivalence also in the fed state since Myoson contains a highly soluble and highly permeable active substance, and pharmacokinetic principles and convincing experimental evidence suggest that the food effect of this active substance is formulation independent.
Croatian: • Stoga je Povjerenstvo većinom glasova zaključilo da rezultati ispitivanja bioekvivalencije u uvjetima natašte pružaju dovoljno dokaza iz kojih se može zaključiti da je lijek bioekvivalentan i u stanju sitosti, budući da Myoson sadrži vrlo topivu i vrlo propusnu djelatnu tvar, a farmakokinetska načela i uvjerljivi eksperimentalni dokazi ukazuju na to da učinak hrane na djelatnu tvar ne ovisi o formulaciji.
English: Since the summary of product characteristics (SmPC) of the reference medicinal product did not make any recommendations regarding food and did not mention a food effect, the MAA that was submitted for Myoson included two bioequivalence studies with 50 and 150 mg tolperisone film-coated tablets conducted under fasting conditions with 52 volunteers each.
Croatian: Budući da SmPC referentnog lijeka nije sadržavao preporuke vezane za hranu i nije spominjao učinak hrane, zahtjev za stavljanje lijeka u promet koji je podnesen za Myoson uključivao je dva ispitivanja bioekvivalencije s filmom obloženim tabletama od 50 i 150 mg tolperizona provedena u uvjetima natašte s po 52 dobrovoljca.
English: • The Committee was of the view that results of the submitted bioequivalence studies showed that Myoson 50 and 150 mg tablets was bioequivalent to the reference medicinal product Mydeton 50 and 150-mg tablets under fasting conditions;
Croatian: • Povjerenstvo smatra da su rezultati dostavljenih ispitivanja bioekvivalencije pokazali da su tablete Myoson od 50 i 150 mg bioekvivalenti referentnog lijeka Mydeton u obliku tableta od 50 i 150 mg u uvjetima natašte;