FrancophonIA/ELRC3.0 huggingface dataset:
English: Slowly push in the plunger of the syringe all the way, making sure you have injected all the liquid.
Slovenian: Počasi pritiskajte na bat brizge do konca in se prepričajte, da ste injicirali vso tekočino.
English: In such instances, instructions for antibody testing should be considered.
Slovenian: V tovrstnih primerih je treba razmisliti o testiranju protiteles.
English: Figure B: Press (don't rub) with gauze or cotton
Slovenian: Slika B: Pritisnite (ne drgnite) z gazo ali vato
English: • The signs and symptoms of hypoglycaemia.
Slovenian: • Znaki in simptomi hipoglikemije.
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Slovenian: DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 14(8) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet v določenem časovnem okviru izvesti naslednje ukrepe: Opis
English: If the patient is unable to eat, for any reason, this medicinal product should be withheld.
Slovenian: Če bolnik zaradi kateregakoli razloga ne more jesti, je treba zdravljenje s tem zdravilom začasno prekiniti.
English: Preparing the dose
Slovenian: Priprava odmerka
English: Long-term overdose may result in signs and symptoms of acromegaly or gigantism.
Slovenian: Zaradi dolgotrajnega prevelikega odmerjanja se lahko pojavijo znaki in simptomi akromegalije ali gigantizma.
English: Figure 6: Remove air bubbles and refill syringe
Slovenian: Slika 6: Odstranite zračne mehurčke in znova napolnite brizgo
English: • Exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.
Slovenian: • Izključitev sekundarnih oblik pomanjkanja IGF-1, kot so podhranjenost, hipotiroidizem ali kronično zdravljenje s farmakološkimi odmerki kortikosteroidov.
English: INCRELEX may have a major influence on the ability to drive or use machines in case of a hypoglycaemic episode.
Slovenian: Zdravilo INCRELEX ima lahko pomemben vpliv na sposobnost vožnje ali upravljanja strojev v primeru pojava hipoglikemije.
English: No attenuation of growth was observed as a consequence of the development of antibodies.
Slovenian: Upočasnitve rasti kot posledice tvorbe protiteles niso opazili.
English: Reactions at the injection site
Slovenian: Reakcije na mestu injiciranja
English: • Instructions to report the onset or worsening of snoring that may indicate an increase in growth of tonsils and/or adenoids following the beginning of treatment with INCRELEX.
Slovenian: • Navodila za poročanje o pojavu ali poslabšanju smrčanja, kar lahko nakazuje povečano rast tonzil in/ali adenoidnega tkiva kot posledico začetka zdravljenja z zdravilom INCRELEX.
English: Never share needles and syringes.
Slovenian: Igel in brizg ne smete nikoli deliti z drugimi.
English: Your doctor may perform an echocardiogram before, during and after mecasermin treatment.
Slovenian: Zdravnik lahko ehokardiogram izvede pred, med in po zdravljenju z mekazerminom.
English: In addition there will be a dosing guide, and a dose calculator, for use by physician and patients to include information on the individualised dose escalation to minimise the risk of medication errors and hypoglycaemia.
Slovenian: Dodatno bodo na voljo navodila za odmerjanje in kalkulator odmerkov za zdravnike in bolnike, ki vključujejo podatke za prilagoditev odmerka za posameznega bolnika z namenom zmanjšanja tveganja napak pri zdravljenju in hipoglikemije.
English: Precaution to be taken before manipulating or administering the medicinal product The solution should be clear immediately after removal from the refrigerator.
Slovenian: Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila Raztopina mora biti bistra takoj, ko jo vzamete iz hladilnika.
English: • Instructions to change and rotate the site of injection for each injection to avoid the development of lipohypertrophy.
Slovenian: • Navodila za spreminjanje in menjavanje vbodnega mesta za vsako injekcijo, z namenom izogiba razvoja lipohipertrofije.
English: Figure 7: Ready to inject
Slovenian: Slika 7: Brizga pripravljena za injiciranje
English: Special attention should be paid to young children, children with a history of hypoglycaemia and children with inconsistent food intake.
Slovenian: Posebna pozornost je potrebna pri majhnih otrocih, otrocih s hipoglikemijo v anamnezi in otrocih z nerednim prehranjevanjem.
English: The bioavailability of mecasermin after subcutaneous administration in healthy subjects has been reported to be approximately 100%.
Slovenian: Biološka uporabnost mekazermina po subkutanem dajanju zdravim osebam je glede na poročila približno 100-odstotna.
English: A dose adjustment may be needed for these medicines.
Slovenian: Zdravnik bo odmerek teh zdravil morda moral prilagoditi.
English: Uncommon: Benign intracranial hypertension
Slovenian: Občasni: benigna intrakranialna hipertenzija
English: Before beginning treatment with INCRELEX the doctor or nurse will explain to you how to treat hypoglycaemia.
Slovenian: Pred začetkom zdravljenja z zdravilom INCRELEX vam bosta zdravnik ali medicinska sestra razložila, kako ukrepati v primeru hipoglikemije.
English: Cell growth: IGF-1 receptors are present on most types of cells and tissues.
Slovenian: Celična rast: receptorji za IGF-1 se nahajajo na večini vrst celic in v večini tkiv.
English: Breast-feeding while taking INCRELEX is not recommended, because there is insufficient information on the excretion of mecasermin in human milk.
Slovenian: Med zdravljenjem z zdravilom INCRELEX dojenje ni priporočljivo, saj ni dovolj podatkov o izločanju mekazermina v materino mleko.
English: Άλιμος
Slovenian: Ελλάδα
English: Skeletal growth is accomplished at the epiphyseal plates at the ends of a growing bone.
Slovenian: Rast okostja, ki se odvija na področju epifiznih plošč na konceh rastoče kosti.
English: The height velocities for years 2 through 8 remained statistically greater than baseline.
Slovenian: Hitrost rasti od 2. do 8. leta je ostala statistično večja v primerjavi z izhodiščem.
English: Active or suspected neoplasia.
Slovenian: Aktivna neoplazija ali sum nanjo.
English: Patients with abnormal echocardiogram findings or cardiovascular symptoms should be followed regularly with echocardiogram procedures.
Slovenian: Bolnike z nenormalnim izvidom ali bolnike s kardiovaskularnimi simptomi je treba redno spremljati z ehokardiogramom.
English: • To perform a routine funduscopic examination prior to beginning treatment and periodically during treatment or at the occurrence of clinical symptoms.
Slovenian: • Izvesti rutinski fundoskopski pregled pred začetkom zdravljenja in redno med terapijo ali pri pojavu kliničnih simptomov.
English: If the solution is cloudy, or contains particulate matter, it must not be injected.
Slovenian: Če je raztopina motna ali vsebuje delce, je ne smete injicirati.
English: Under normal circumstances, growth hormone (GH) binds to its receptor in the liver and other tissues, and stimulates the synthesis/secretion of IGF-1.
Slovenian: V običajnih pogojih se rastni hormon (GH) veže na odgovarjajoče receptorje v jetrih in drugih tkivih ter spodbuja sintezo/izločanje IGF-1.
English: Figure A: Lightly pinch the skin and inject as instructed
Slovenian: Slika A: Kožo rahlo stisnite v gubo in injicirajte kot vam je pokazal zdravnik
English: Reactions observed in the clinical trials
Slovenian: Neželeni učinki, opaženi v kliničnih preskušanjih
English: Especially tell the doctor if you take insulin or other anti-diabetes medicines.
Slovenian: Zdravnika še posebej obvestite, če se zdravite z insulinom ali drugimi zdravili za zdravljenje sladkorne bolezni.
English: Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment.
Slovenian: Hudo primarno pomanjkanje IGF vključuje bolnike z mutacijami receptorjev za GH (GHR), post-GHR signalnih poti in okvar gena za IGF-1; pri teh bolnikih ne gre za pomanjkanje GH in zato ne moremo pričakovati, da se bodo zadostno odzvali na zdravljenje z eksogenim GH.
English: INFORMATION IN BRAILLE INCRELEX
Slovenian: PODATKI V BRAILLOVI PISAVI INCRELEX
English: Slough, Berkshire SL1 3XE
Slovenian: 190 Bath Road Slough, Berkshire SL1 3XE
English: IH-associated signs and symptoms resolved after interruption of dosing.
Slovenian: Znaki in simptomi, povezani z IH, so po prekinitvi zdravljenja minili.
English: If a vial freezes, dispose appropriately.
Slovenian: Če viala zmrzne, jo ustrezno zavrzite.
English: For the long-term treatment of growth failure in children and adolescents from 2 to 18 years with severe primary insulin-like growth factor-1 deficiency (Primary IGFD).
Slovenian: Dolgotrajno zdravljenje zaostajanja v rasti pri otrocih in mladostnikih, starih od 2 do 18 let, s hudim primarnim pomanjkanjem insulinu podobnega rastnega faktorja-1 (primarno pomanjkanje IGF).
English: If a person with severe hypoglycemia is unconscious or otherwise unable to ingest food normally, an injection of glucagon may be required.
Slovenian: Če je oseba s hudo hipoglikemijo nezavestna ali kako drugače nezmožna na običajen način zaužiti hrano, bo morda potrebna injekcija glukagona.
English: Treatment with mecasermin should be directed by physicians who are experienced in the diagnosis and management of patients with growth disorders.
Slovenian: Zdravljenje z mekazerminom mora voditi zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem bolnikov z motnjami rasti.
English: If the recommended dose is not tolerated by the patient, treatment with a lower dose can be considered.
Slovenian: Če bolnik priporočenega odmerka ne prenaša, je potrebno presoditi o zdravljenju z nižjim odmerkom.
English: A disruption or early ending of treatment with mecasermin may impair the success of the growth therapy.
Slovenian: Posledica vmesnih prekinitev ali prezgodnje dokončne ukinitve zdravljenja z mekazerminom je lahko neuspešno zdravljenje zavrte rasti.
English: Figure 5: Extract correct dose
Slovenian: Slika 5: Izvlecite ustrezen odmerek
English: For the 21 treatment naïve subjects with near-adult height, the mean (± SD) of the difference between observed increase in height versus that expected from Laron was approximately 13 cm (± 8 cm) after an average of 11 years of treatment.
Slovenian: Pri 21 predhodno nezdravljenih osebah s skoraj odraslo telesno višino je povprečna (± SD) razlika med opaženim povečanjem telesne višine v primerjavi s pričakovano po Laronu v povprečju po 11 letih zdravljenja znašala približno 13 cm (± 8 cm).
English: Benzyl alcohol may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Slovenian: Benzilalkohol lahko povzroči toksične in anafilaktoidne reakcije pri dojenčkih in otrocih do 3. leta starosti.
English: Insulin-like growth factor-1 (IGF-1) is the principal hormonal mediator of statural growth.
Slovenian: Insulinu podoben rastni faktor-1 (IGF-1) je glavni hormonski posrednik telesne rasti.
English: Leave the syringe in the vial and turn both upside down.
Slovenian: Brizgo pustite v viali in nato obe skupaj obrnite na glavo.
English: The physician information about INCRELEX should contain the following key elements:
Slovenian: Informacije za zdravnika o zdravilu INCRELEX morajo vsebovati naslednje ključne elemente:
English: The use of this medicine has not been studied in children under 2 years of age and is therefore not recommended.
Slovenian: Uporabe tega zdravila pri otrocih, mlajših od 2 let, niso raziskovali, zato pri njih uporaba tega zdravila ni priporočljiva.
English: Other medicines and INCRELEX
Slovenian: Druga zdravila in zdravilo INCRELEX
English: • INCRELEX is contraindicated in the presence of active or suspected neoplasia, and therapy should be discontinued if evidence of neoplasia develops.
Slovenian: • Zdravilo INCRELEX je kontraindicirano ob prisotnosti aktivne neoplazije ali suma nanjo, zato je treba zdravljenje prekiniti, če se razvije dokazljiva neoplazija.
English: You should be monitored for progression of scoliosis.
Slovenian: Napredovanje skolioze je treba nadzirati.
English: Instructions on the treatment of hypoglycaemia.
Slovenian: Navodila za zdravljenje hipoglikemije.
English: 5 ml vial (type I glass) closed with a stopper (bromobutyl/isoprene polymer) and a seal (lacquered plastic).
Slovenian: 5-ml viala (steklo tipa I), ki je zaprta z zamaškom (bromobutil/izoprenski polimer) in zapečatena (lakirana plastika).
English: The doctor should regularly examine your tonsils/adenoids.
Slovenian: Zdravnik mora stanje tonzil/adenoidnega tkiva redno nadzirati.
English: • That patients should have examinations of the ears, nose and throat periodically and at the occurrence of clinical symptoms to rule out such potential complications or to initiate appropriate treatment.
Slovenian: • Bolniki morajo imeti redne preglede ušes, nosu in grla in pri pojavu kliničnih simptomov je treba preprečiti tovrstne morebitne zaplete ali začeti z ustreznim zdravljenjem.
English: Final report by
Slovenian: Zaključno poročilo do leta
English: The dose of mecasermin should never be increased to make up for one or more omitted doses.
Slovenian: Odmerka mekazermina se ne sme nikoli zvišati, da bi se tako nadoknadil eden ali več izpuščenih odmerkov.
English: If you have scoliosis, you will need to be checked often for an increase in the curve of the spine.
Slovenian: Če imate skoliozo, bo treba pogosto preverjati morebitno preveliko ukrivljenost hrbtenice.
English: The effects of mecasermin on the unborn child have not been studied.
Slovenian: Vplivov mekazermina na nerojenega otroka niso raziskovali.
English: - if you have symptoms of increased pressure in the brain (intracranial hypertension), such as visual changes, headache, nausea and/or vomiting, contact the doctor for advice.
Slovenian: - če imate simptome povišanega tlaka v možganih (intrakranialna hipertenzija), kot so spremembe vida, glavobol, slabost in/ali bruhanje, se posvetujte z zdravnikom.
English: It is recommended that the dose be individualised for each patient as described under posology
Slovenian: Odmerek je priporočljivo prilagoditi vsakemu bolniku posebej, kot je opisano pod odmerjanjem.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40mg/4ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 40 mg/4 ml
English: The next dose should be taken as usual, with a meal or snack.
Slovenian: Naslednjič uporabite običajni odmerek ob običajnem času, skupaj z obrokom hrane ali s prigrizkom.
English: 6.6 Special precautions for disposal and other handling INCRELEX is supplied as a multi-dose solution.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Zdravilo INCRELEX je na voljo v obliki večodmerne sterilne raztopine.
English: Pharmacodynamic effects The following actions have been demonstrated for endogenous human IGF-1:
Slovenian: Farmakodinamični učinki Dokazani so bili naslednji učinki endogenega humanega IGF-1:
English: The most frequently reported adverse reactions from the clinical trials were headache (44%), hypoglycaemia (28%), vomiting (26%), injection site hypertrophy (17%), and otitis media (17%).
Slovenian: V kliničnih preskušanjih so najpogosteje poročali o naslednjih neželenih učinkih: glavobolu (44 %), hipoglikemiji (28 %), bruhanju (26 %), hipertrofiji na mestu injiciranja (17 %) in vnetju srednjega ušesa (17 %).
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, somatropin and somatropin agonists, ATC code: H01AC03
Slovenian: Farmakoterapevtska skupina: Hipofizni in hipotalamični hormoni ter sorodne učinkovine, somatropin in sorodne učinkovine, oznaka ATC: H01AC03
English: Mecasermin may cause hypoglycaemia (very common side effect, see section 4) that may impair your ability to drive and use machines because your ability to concentrate or react may be reduced.
Slovenian: Mekazermin lahko povzroči hipoglikemijo (zelo pogost neželeni učinek, glejte poglavje 4), ki lahko vpliva na sposobnost koncentracije in reagiranja ter tako zmanjša sposobnost za vožnjo in upravljanje strojev.
English: The dose of 120 μg/kg given subcutaneously (SC) and twice daily (BID) was associated with the greatest growth responses.
Slovenian: Odmerek 120 μg/kg subkutano dvakrat na dan je bil povezan z največjim odzivom rasti.
English: The recommended starting dose of mecasermin is 0.04 mg/kg of body weight twice daily by subcutaneous injection.
Slovenian: Priporočeni začetni odmerek mekazermina je 0,04 mg/kg telesne mase dvakrat na dan v obliki subkutane injekcije.
English: If no significant adverse reactions occur for at least one week, the dose may be raised in increments of 0.04 mg/kg to the maximum dose of 0.12 mg/kg given twice daily.
Slovenian: Če vsaj en teden ne pride do pojava neželenih učinkov, se lahko odmerek postopno povečuje za 0,04 mg/kg do največjega dovoljenega odmerka 0,12 mg/kg dvakrat na dan.
English: If bubbles are in the syringe, hold the vial and syringe with needle straight up and tap the side of the syringe until the bubbles float to the top.
Slovenian: Če so mehurčki prisotni v brizgi, pridržite vialo in brizgo z iglo v navpičnem položaju in rahlo udarjajte po brizgi, dokler se mehurčki ne dvignejo na vrh.
English: - if you have a localised reaction at the injection site or generalised allergic reaction with INCRELEX.
Slovenian: - če se pojavi reakcija na mestu injiciranja ali splošna alergijska reakcija na zdravilo INCRELEX.
English: Persons with a history of severe hypoglycemia should have glucagon available.
Slovenian: Osebe s hudo hipoglikemijo v anamnezi morajo imeti na voljo glukagon.
English: INCRELEX contains benzyl alcohol as a preservative which may cause toxic reactions and allergic reactions in infants and children up to 3 years old.
Slovenian: Zdravilo INCRELEX vsebuje kot konzervans benzilalkohol, ki lahko povzroči toksične in alergijske reakcije pri dojenčkih in otrocih do 3. leta starosti.
English: Pre-treatment height velocity data were available for 75 subjects.
Slovenian: Podatki o hitrosti rasti pred začetkom zdravljenja so bili na voljo za 75 oseb.
English: Persons who have allergic reactions to injected IGF-1, who have unexpectedly high blood values of IGF-1 after injection, or who fail to show a growth response without any identified cause may be having an antibody response to injected IGF-1.
Slovenian: Pri osebah, pri katerih injiciranje IGF-1 povzroči alergijske reakcije, ki imajo po vbrizganju IGF-1 nepričakovano visoko raven IGF-1 v krvi ali se brez kakršnegakoli znanega vzroka ne odzovejo z rastjo, je morda ob vbrizganju IGF-1 prišlo do odziva s protitelesi.
English: What INCRELEX is and what it is used for
Slovenian: Kaj je zdravilo INCRELEX in za kaj ga uporabljamo
English: During clinical trials in other indications (totaling approximately 300 patients) 8% of patients reported a local and/or systemic hypersensitivity reactions.
Slovenian: Med kliničnimi preskušanji uporabe zdravila pri drugih indikacijah (vsega skupaj pri približno 300 bolnikih) so pri 8 % bolnikov poročali o pojavu lokalnih in/ali sistemskih preobčutljivostnih reakcij.
English: Only use INCRELEX that is clear and colourless.
Slovenian: Uporabite le zdravilo INCRELEX, ki je bistro in brezbarvno.
English: • To educate parents on the signs, symptoms and treatment of hypoglycaemia, including injection of glucagon.
Slovenian: • Poučiti starše o znakih, simptomih in zdravljenju hipoglikemije, vključno z injekcijo glukagona.
English: If you are using a new vial, remove the protective cap. Do not remove the rubber stopper.
Slovenian: Če uporabljate novo vialo, odstranite zaščitni pokrovček.
English: Some patients may develop antibodies to mecasermin.
Slovenian: Pri nekaterih bolnikih se lahko pojavijo protitelesa proti mekazerminu.
English: Severe hypoglycaemia may cause unconsciousness, seizures/fits or death.
Slovenian: Huda hipoglikemija lahko povzroči nezavest, krče ali smrt.
English: Adverse reaction data was taken from a total of 413 clinical trial patients with severe Primary IGFD.
Slovenian: Podatki o neželenih učinkih so bili pridobljeni v kliničnih preskušanjih pri skupno 413 bolnikih s hudim primarnim pomanjkanjem IGF.
English: In target tissues the Type 1 IGF-1 receptor, which is homologous to the insulin receptor, is activated by IGF-1, leading to intracellular signaling which stimulates multiple processes leading to statural growth.
Slovenian: V ciljnem tkivu IGF-1 aktivira receptor za IGF-1 tipa 1, ki je homologen z receptorji za insulin, kar pripelje do znotrajceličnega signaliziranja, kar spodbudi številne procese, ki vodijo v telesno rast.
English: If the patient is not awake or alert enough to drink sugarcontaining fluids, an injection of glucagon into the muscle may be necessary to reverse the low blood sugar.
Slovenian: Če bolnik ni buden ali dovolj pozoren, da bi lahko požiral tekočino s sladkorjem, bo morda potrebna injekcija glukagona v mišico, da bi se vrednost krvnega sladkorja povečala.
English: In some patients treated with mecasermin, an ultrasound examination of the heart (echocardiogram) showed an increased size of the heart muscle and abnormalities of heart valve function.
Slovenian: Pri nekaterih bolnikih, zdravljenih z mekazerminom, je pregled srca z ultrazvokom (ehokardiogram) razkril povečanje srčne mišice in motnje delovanja srčnih zaklopk.
English: IGF-1 suppresses hepatic glucose production, stimulates peripheral glucose utilization, and can reduce blood glucose and cause hypoglycaemia.
Slovenian: IGF-1 zavira sintezo glukoze v jetrih in spodbuja porabo glukoze v perifernih tkivih ter lahko zmanjša koncentracijo glukoze v krvi in povzroči hipoglikemijo.
English: Signs of low blood sugar are: dizziness, tiredness, restlessness, hunger, irritability, trouble concentrating, sweating, nausea and fast or irregular heartbeats.
Slovenian: Znaki nizkega krvnega sladkorja so: omotica, utrujenost, nemirnost, lakota, razdražljivost, težave s koncentracijo, znojenje, slabost in hitro ali nepravilno bitje srca.
English: Before you take the needle out of the vial, check the syringe for air bubbles.
Slovenian: Preden iglo izvlečete iz viale, preverite, če so v brizgi prisotni zračni mehurčki.
English: • To inform parents and patients that systemic allergic reactions are possible and that if this occurs treatment should be interrupted and prompt medical attention should be sought.
Slovenian: • Obvestiti starše in bolnike, da so sistemske alergijske reakcije mogoče in da je treba zdravljenje prekiniti ter takoj poiskati ustrezno zdravniško pomoč, če do njih pride.
English: • Possible occurrence of malignancies as well as other risks The interim reports will be submitted every two years until the final patient is followed for 5 years.
Slovenian: Vmesna poročila bodo predložena vsaki 2 leti, dokler ne bo zadnji bolnik spremljan 5 let.
English: INCRELEX should be administered using sterile disposable syringes and injection needles which could be provided by your doctor, pharmacist or nurse.
Slovenian: Pri injiciranju zdravila INCRELEX morate uporabljati sterilne injekcijske brizge in igle za enkratno uporabo, ki jih lahko dobite pri zdravniku, farmacevtu ali medicinski sestri.
English: Five clinical studies (4 open-label and 1 double-blind, placebo-controlled) were conducted with INCRELEX.
Slovenian: Z zdravilom INCRELEX je bilo izvedenih pet kliničnih študij (4 odprte študije in 1 dvojno slepa, s placebom nadzorovana študija).