FrancophonIA/ELRC3.0 huggingface dataset:
English: Livensa is a transdermal therapy for HSDD, which improves sexual desire while achieving testosterone concentrations compatible with premenopausal levels.
Slovenian: Livensa je transdermalno zdravilo za HSDD, ki izboljša spolno željo, medtem ko dosega koncentracije testosterona, primerljive s koncentracijami pred menopavzo.
English: There is little information on long-term safety, including effects on breast tissue, the cardiovascular system and increase in insulin resistance.
Slovenian: O dolgotrajni varnosti, vključno z učinki na tkivo dojk, kardiovaskularni sistem in povečanje odpornosti na insulin, je malo podatkov.
English: Non-clinical studies on a relationship between testosterone treatment and cancer suggest that high doses may promote tumour growth in sex organs, mammary glands and liver in laboratory animals.
Slovenian: Predklinične študije povezave med zdravljenjem s testosteronom in rakom kažejo, da pri laboratorijskih živalih veliki odmerki lahko spodbudijo rast tumorjev na spolnih organih, mlečnih žlezah in jetrih.
English: In the combined phase III data, excluding patients taking oral CEE, in whom there was no significant improvement in sexual function, 50.7 % of women (n=274) treated with Livensa and 29.4 % of those treated with placebo (n=269) were responders with regard to total satisfying sexual activity (primary endpoint), when a responder was predefined as having an increase in the 4-week frequency of satisfying activities of > 1.
Slovenian: V kombiniranih podatkih iz študije III. faze, iz katerih so izključili ženske, ki so prejemale peroralne CEE, pri katerih ni bilo pomembnega izboljšanja spolne funkcije, se je glede povsem zadovoljive spolne aktivnosti (primarni cilj) na zdravljenje odzvalo 50,7% žensk, ki so prejemale zdravilo Livensa (n=274), in 29,4% žensk, ki so prejemale placebo (n=269).
English: Livensa did not influence serum concentrations of sex hormone binding globulin (SHBG), estrogens or adrenal hormones.
Slovenian: Zdravilo Livensa ni vplivalo na koncentracije globulina v serumu, ki veže spolne hormone (SHBG, sex hormone binding globulin), estrogenov ali hormonov nadledvične žleze.
English: Livensa is only indicated for women in their menopause after the ovaries and uterus have been removed.
Slovenian: Zdravilo Livensa je indicirano samo za ženske v menopavzi, potem ko so jim odstranili jajčnike in maternico.
English: Livensa should not be used in women on concomitant CEE Whereas Livensa is indicated with concomitant estrogen therapy, the subgroup of patients receiving oral conjugated equine estrogens (CEE) did not demonstrate a significant improvement in sexual function.
Slovenian: Zdravila Livensa se ne sme uporabljati pri ženskah, ki sočasno uporabljajo CEE Čeprav je zdravilo Livensa indicirano za sočasno zdravljenje z estrogenom, podskupina bolnic, ki so prejemale peroralne konjugirane konjske estrogene (CEE, conjugated equine estrogen), ni pokazala pomembnega izboljšanja spolne funkcije.
English: Each patch is sealed in a sachet.
Slovenian: Vsak obliž je v zatesnjeni vrečici.
English: - if you have a history of excessive adult acne, body or facial hair, hair loss, enlargement of the clitoris or voice deepening or hoarseness.
Slovenian: če ste v preteklosti imeli hude akne v odrasli dobi, poraščenost telesa ali obraza, izpadanje las, povečanje klitorisa, znižanje glasu ali hripavost.
English: Less than 1 % of patients withdrew from the studies because of any of these reactions.
Slovenian: Zaradi njih je sodelovanje v študiji prekinilo manj kot 1% bolnic.
English: Do not use scissors as you may accidentally damage the patch.
Slovenian: Ne uporabljate škarij, ker lahko nehote poškodujete obliž.
English: A skin site with minimal wrinkling and not covered by tight clothing is recommended.
Slovenian: Priporočeno je mesto na koži, ki se čim manj guba in ki ni prekrito s tesnimi oblačili.
English: To prevent interference with the adhesive properties of Livensa, no creams, lotions or powder should be applied to the skin where the patch is to be applied.
Slovenian: Da ne bi ovirali lepilnih lastnosti zdravila Livensa, se na kožo, kamor se obliž aplicira, ne sme nanesti kreme, losjona ali pudra.
English: - if you have cancer of the lining of the womb (endometrial cancer), be aware that there is little information available on the effects of testosterone on the lining of the womb (endometrium).
Slovenian: ki jih vnesete z obližem zdravila Livensa, če imate raka sluznice maternice (rak endometrija), morate vedeti, da je na voljo le malo informacij o učinkih testosterona na sluznico maternice (endometrij).
English: In diabetic patients the metabolic effects of testosterone may decrease blood glucose and therefore insulin requirements.
Slovenian: Pri bolnicah s sladkorno boleznijo lahko učinki testosterona na presnovo zmanjšajo raven glukoze v krvi in posledično potrebo po insulinu.
English: In case of severe application site reaction, the treatment should
Slovenian: Če so reakcije na mestu namestitve hude, je treba zdravljenje prekiniti.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
Slovenian: Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
English: If the patch detaches prematurely, it may be reapplied.
Slovenian: Če se obliž prezgodaj odlepi, se lahko ponovno nalepi.
English: HOW TO USE LIVENSA
Slovenian: KAKO UPORABLJATI ZDRAVILO LIVENSA
English: - if you notice any skin reactions at the site of application (a very common side effect) such as redness, oedema, or blistering.
Slovenian: če opazite kakršnekoli kožne reakcije na mestu namestitve (zelo pogosti neželeni učinek), kot so rdečica, edem ali mehurji.
English: - if you are diabetic, as testosterone may lower blood glucose levels.
Slovenian: če ste sladkorna bolnica, ker testosteron lahko zniža raven glukoze v krvi;
English: Livensa is recommended for use in surgically menopausal women up to the age of 60.
Slovenian: Uporaba zdravila Livensa se priporoča pri ženskah po kirurški menopavzi do 60. leta starosti.
English: Pregnancy Livensa must not be used in women who are or may become pregnant.
Slovenian: Zdravila Livensa ne smejo uporabljati nosečnice ali ženske, ki lahko zanosijo.
English: Like all medicines, Livensa can cause side effects, although not everybody gets them.
Slovenian: MOŽNI NEŽELENI UČINKI Kot vsa zdravila ima lahko tudi zdravilo Livensa neželene učinke, ki pa se ne pojavijo pri vseh bolnicah.
English: - When changing your patch, stick the new patch on to a different area of the skin of your abdomen, otherwise you are more likely to cause skin irritation.
Slovenian: Pri menjavanju obliža nalepite nov obliž na drugo mesto na koži trebuha, sicer je verjetneje,
English: Livensa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.
Slovenian: Zdravilo Livensa je indicirano za zdravljenje motnje hipoaktivne spolne želje (HSDD, hypoactive sexual desire disorder) pri ženskah z bilateralno ooforektomijo in histerektomijo (kirurško sproženo menopavzo), ki sočasno prejemajo zdravljenje z estrogenom.
English: Testosterone is mainly excreted in the urine as glucuronic and sulphuric acid conjugates of testosterone and its metabolites.
Slovenian: Testosteron se izloča v glavnem z urinom v obliki konjugatov glukuronske in žveplove kisline testosterona ter njegovih presnovkov.
English: Testosterone is metabolised primarily in the liver.
Slovenian: Testosteron se presnavlja prvotno v jetrih.
English: Testosterone has been found to be nongenotoxic.
Slovenian: Ugotovili so, da testosteron ni genotoksičen.
English: Two multi-centre, double-blind, placebo-controlled six month studies in 562 (INTIMATE SM1) and 533 (INTIMATE SM2) oophorectomised and hysterectomised women (surgically induced menopause), aged 20 to 70 years, with HSDD on concomitant estrogen were used to evaluate the efficacy and safety of Livensa.
Slovenian: Klinična učinkovitost in varnost Učinkovitost in varnost zdravila Livensa so ocenili v dveh multicentričnih, dvojno slepih, s placebom nadzorovanih šestmesečnih študijah pri 562 (INTIMATE SM1) in 533 (INTIMATE SM2) ženskah z ooforektomijo in histerektomijo (kirurško sproženo menopavzo) s HSDD, starih od 20 do 70 let, ki so sočasno prejemale estrogen.
English: Renal impairment No studies have been conducted in patients with renal insufficiency.
Slovenian: Študij pri bolnikih z ledvično insuficienco niso izvajali.
English: INFORMATION IN BRAILLE
Slovenian: PODATKI V BRAILLOVI PISAVI Livensa
English: Known, suspected or past history of cancer of the breast or known or suspected estrogen-dependent neoplasia, or any other condition consistent with the contraindications for the use of estrogen.
Slovenian: Znan rak dojke, rak dojke v anamnezi ali sum nanj, ali znana, od estrogena odvisna neoplazija ali sum nanjo, ali katero koli drugo stanje, skladno s kontraindikacijami za uporabo estrogena.
English: Tell your doctor immediately: - if you experience hair loss (a common side effect which may affect up to 1 in 10 people), enlargement of the clitoris (an uncommon side effect which may affect up to 1 in 100 people), an increase in the amount of hair on the chin or upper lip (a very common side effect which may affect more than 1 in 10 people), voice deepening or hoarseness (a common side effect), although these side effects may be mild.
Slovenian: če vam začnejo izpadati lasje (pogosti neželeni učinek, ki se lahko pojavi pri do 1 od 10 bolnic), se vam poveča klitoris (občasni neželeni učinek, ki se lahko pojavi pri do 1 od 100 bolnic), poveča število dlak na bradi ali zgornji ustnici (zelo pogosti neželeni učinek, ki se lahko pojavi pri več kot 1 od 10 bolnic), če se vam zniža glas ali če ste hripavi (pogosti neželeni učinek), četudi so ti neželeni učinki blagi.
English: Patients with known cardiovascular disease have not been studied.
Slovenian: Bolnice z znano boleznijo kardiovaskularnega sistema niso preučevali.
English: Disturbance in attention, dysgeusia, impaired balance, hyperaesthesia, oral paraesthesia, transient ischemic attack
Slovenian: Bolezni živčevja migrena motnje pozornosti, disgevzija, motnje ravnotežja, hiperestezija, oralna parestezija, tranzitorna ishemična ataka
English: Use of the patch should be discontinued if this occurs.
Slovenian: Če do tega pride, je treba uporabo obliža prekiniti.
English: Continue your treatment for as long as your doctor
Slovenian: Zdravljenje nadaljujte, dokler vam zdravnik tako svetuje.
English: What Livensa is and what it is used for Before you use Livensa How to use Livensa Possible side effects How to store Livensa Further information
Slovenian: Kaj je zdravilo Livensa in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Livensa Kako uporabljati zdravilo Livensa
English: Efficacy versus placebo was significant across a range of subgroups which included patients separated by the following baseline characteristics: age (all subgroups up to age 65 years); body weight (up to 80 kg) and oophorectomy (up to 15 years ago).
Slovenian: Učinkovitost v primerjavi s placebom je bila pomembna v obsegu podskupin, v katerih so bile bolnice, ki so jih ločili glede na naslednje značilnosti: starost (vse podskupine do starosti 65 let), telesna masa
English: If you cannot get the patch to stick successfully, remove the loose patch and use a new patch.
Slovenian: Če vam ne uspe, ga odstranite in uporabite nov obliž.
English: Oedema may be a serious complication from high doses of testosterone, however, this is not expected from low dose of testosterone delivered by the Livensa patch.
Slovenian: Edem je lahko resen zaplet zaradi visokih odmerkov testosterona, vendar pa se ne pričakuje, da bi nastal zaradi nizkih ravni testosterona,
English: Paediatric population There is no relevant use of Livensa in the paediatric population.
Slovenian: Zdravilo Livensa ni primerno za uporabo pri pediatrični populaciji.
English: Driving and using machines You can drive and use machines while using Livensa.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Med uporabo zdravila Livensa lahko vozite in uporabljate stroje.
English: Livensa is intended for use by women up to the age of 60 years who have had both their ovaries and their womb removed.
Slovenian: Zdravilo Livensa je namenjeno za uporabo pri ženskah do 60. leta starosti, ki so jim odstranili jajčnike in maternico.
English: There are limited data about the use in women above the age of 60.
Slovenian: Podatki o uporabi pri bolnicah, starejših od 60 let, so omejeni.
English: Therefore, Livensa should not be used in women on concomitant CEE (see sections 4.2 and
Slovenian: Zato zdravila Livensa ne smejo uporabljati ženske, ki sočasno prejemajo CEE (glejte poglavji 4.2 in 5.1).
English: Thin, clear, oval matrix-type transdermal patch consisting of three layers: a translucent backing film, an adhesive matrix drug layer, and a protective release liner that is removed prior to application.
Slovenian: Tanek, prozoren, ovalen matriksni transdermalni obliž, sestavljen iz treh plasti: prosojne zunanje folije, lepljive matriksne plasti, ki vsebuje zdravilo, in zaščitne plasti, ki se pred aplikacijo odstrani.
English: Do not use Livensa in case of breast-feeding because it may cause harm to the child.
Slovenian: Zdravila Livensa ne uporabljajte, če dojite, ker lahko škoduje otroku.
English: - if you are allergic (hypersensitive) to testosterone or any of the other ingredients of Livensa (see section ‘Further information' at the end of this leaflet).
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO LIVENSA Ne uporabljajte zdravila Livensa če ste alergični (preobčutljivi) na testosteron ali katerokoli sestavino zdravila Livensa (glejte poglavje „Dodatne informacije“ na koncu tega navodila).
English: Abnormal blood fibrinogen, increased heart rate, increased alanine aminotransferase, increased aspartate aminotransferase, increased blood bilirubin, abnormal liver function test, increased blood triglycerides
Slovenian: Preiskave povečanje telesne mase nenormalne vrednosti fibrinogena v krvi, povečanje srčnega utripa, povečana vrednost alanin aminotransferaze, povečana vrednost aspartat aminotransferaze, povečana vrednost bilirubina v krvi, nenormalni rezultati testov delovanja jeter, povečana vrednost trigliceridov v krvi
English: Serum concentration of SHBG is influenced by the route of administration of concomitant estrogen therapy.
Slovenian: Na koncentracijo SHBG v serumu vpliva pot uporabe sočasnega zdravljenja z estrogenom.
English: How and when to change your patch - You will need to change your patch every 3 to 4 days, which means using two patches each week.
Slovenian: Obliž boste morali zamenjati vsake 3 do 4 dni, kar pomeni, da boste vsak teden uporabili dva obliža.
English: However, this is not expected from the low dose of testosterone delivered by the Livensa patch.
Slovenian: Vendar teh učinkov pri nizkih odmerkih testosterona, ki se sproščajo iz obližev Livensa, ni pričakovati.
English: If you have any of the above, tell your doctor before you start to use Livensa.
Slovenian: Če imate karkoli od navedenega, povejte svojemu zdravniku, preden začnete uporabljati zdravilo
English: Testosterone, the primary circulating androgen in women, is a naturally occurring steroid, secreted by the ovaries and adrenal glands.
Slovenian: Mehanizem delovanja Testosteron, primarni androgen v krvnem obtoku pri ženskah, je naravni steroid, ki ga izločajo jajčniki in nadledvične žleze.
English: However, patients should be informed that migraine, insomnia, disturbance in attention and diplopia have been reported during treatment with Livensa.
Slovenian: Vendar je treba bolnicam povedati, da so med zdravljenjem z zdravilom Livensa poročali o migreni, nespečnosti, motnjah pozornosti in diplopiji.
English: If you have applied more than one patch at a time Remove all the patches sticking on to your skin and consult your doctor or pharmacist for further information on how to continue treatment with Livensa.
Slovenian: Odstranite vse obliže in se posvetujte z zdravnikom ali s farmacevtom o tem, kako nadaljevati zdravljenje z zdravilom Livensa.
English: Fertility No data is available of the effect of Livensa on fertility.
Slovenian: Plodnost Ni podatkov o vplivu zdravila Livensa na sposobnost razmnoževanja.
English: The sachet material comprises of food grade paper/LDPE/aluminium foil/ethylene methacrylic acid copolymer (outer to inner layer).
Slovenian: Material zaščitne vrečice je sestavljen iz papirja/LDPE/aluminijaste folije/etilenskega kopolimera z metakrilno kislino, primerno za živila (od zunanje proti notranji plasti).
English: The patch is designed to remain in place during these times.
Slovenian: da v takih primerih ostane na mestu.
English: - On the patch-change day, remove the used patch and immediately stick the new patch on to a different area of skin of your abdomen.
Slovenian: Na dan, ko menjavate obliž, odstranite uporabljeni obliž in takoj nalepite novega na drugo mesto na koži trebuha.
English: The albumin-bound fraction and the unbound fraction are collectively termed ‘bioavailable' testosterone.
Slovenian: Delež, vezan na albumin, in nevezan delež skupaj sestavljata “biološko uporaben” testosteron.
English: If a patch does begin to come off, you may be able to make it stick again by pressing on it firmly.
Slovenian: Če se obliž začne dvigovati, ga boste morda z močnim pritiskom nalepili nazaj.
English: Most reports concerned the chin and upper lip, were mild (≥ 90 %), and less than 1 % of all patients withdrew from the studies due to hirsutism.
Slovenian: učinki so bili blagi (≥ 90%), zaradi hirsutizma pa je zdravljenje prekinilo manj kot 1% vseh bolnic.
English: If you use more patches than you should
Slovenian: Če ste uporabili več obližev, kot bi smeli Če ste nalepili več kot en obliž hkrati
English: The limited data evaluating the effect of testosterone on the endometrium neither allow conclusions nor reassurances on the incidence of endometrial cancer.
Slovenian: Na podlagi omejenih podatkov o učinku testosterona na endometrij ni mogoče sklepati ali dajati zagotovil glede pogostosti raka endometrija.
English: As the efficacy and safety of Livensa have not been evaluated in studies of longer duration than 1 year, it is recommended that an appraisal of the treatment is undertaken every 6 months.
Slovenian: Ker učinkovitost in varnost zdravila Livensa nista bili ocenjeni v študijah, ki bi trajale dlje kot 1 leto,
English: Serum concentrations of testosterone and SHBG in patients receiving Livensa in clinical safety and
Slovenian: Koncentracije testosterona in SHBG v serumu pri bolnicah, ki so prejemale zdravilo Livensa v kliničnih študijah varnosti in učinkovitosti Izhodiščna vrednost
English: Decide which two days each week you are going to change your patch, and change the patch on the same two days each week.
Slovenian: Odločite se, ob katerih dveh dnevih v tednu boste zamenjali obliž.
English: Livensa should not be used in naturally menopausal women Efficacy and safety of Livensa in naturally menopausal women with HSDD on concomitant estrogen, with or without progestogen, have not been evaluated.
Slovenian: Učinkovitosti in varnosti zdravila Livensa pri ženskah po naravni menopavzi s HSDD, ki sočasno uporabljajo estrogen, s progestagenom ali brez njega, niso ocenili.
English: The ethylene methacrylic acid copolymer (Surlyn) is the heat seal layer which allows the two laminate sachet stocks to be heat-sealed together to form the sachet.
Slovenian: Etilenski kopolimer z metakrilno kislino (Surlyn) je toplotno zatesnjena plast, ki omogoča toplotno tesnjenje dveh delov zaščitne vrečice v eno zaščitno vrečico.
English: - sinusitis (inflammation of nasal sinus) - abnormal clotting factor - hypersensitivity (allergic reactions) - increased appetite - agitation
Slovenian: - preobčutljivost (alergijske reakcije) - povečanje apetita
English: Little information is available on the effects of testosterone on the endometrium.
Slovenian: O učinkih testosterona na endometrij je na voljo malo podatkov.
English: You may shower, bath, swim and exercise as normal while wearing the patch.
Slovenian: Med nošenjem obliža se lahko normalno prhate, kopate, plavate in telovadite.
English: If an adverse reaction occurred at a higher frequency in the integrated phase III studies (Livensa patients n=1,498, placebo patients n=1,297), this frequency is reported in the table.
Slovenian: Livensa: n = 1.498, bolnice, ki so prejemale placebo: n = 1.297), je pogostnost navedena v tabeli.
English: Also contains: Sorbitan oleate, 2-Ethylhexylacrylate - 1-Vinyl-2-pyrrolidone copolymer, E110, E180, copper phthalocyanine blue pigment, polyethylene, siliconised polyester film.
Slovenian: Vsebuje tudi: sorbitanoleat, 2-etilheksilakrilat - 1-vinil-2-pirolidonski kopolimer, E 110, E 180, modri pigment bakrovega ftalocianina, polietilen, silikonizirani poliestrski film.
English: Signs of virilisation, such as voice deepening, hirsutism or clitoromegaly, may be irreversible and discontinuation of treatment should be considered.
Slovenian: hirsutizem ali klitoromegalija, so lahko ireverzibilni, zato je treba pretehtati možnost prekinitve zdravljenja.
English: If an area of the patch lifts, pressure should be applied to that area.
Slovenian: Če se del obliža odlepi, je treba na ta del pritisniti.
English: The active substance is testosterone.
Slovenian: Zdravilna učinkovina je testosteron.
English: Other uncommon side effects Most of them are mild in nature and reversible.
Slovenian: Drugi pogosti neželeni učinki Večina teh učinkov je blagih in prehodnih:
English: The active substance is released from the patch constantly over 3 to 4 days (corresponding to 300 micrograms per 24 hours) and is absorbed through your skin.
Slovenian: Zdravilna učinkovina se 3 do 4 dni neprekinjeno sprošča iz obliža (to ustreza 300 mikrogramom na
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva artritis
English: You should self assess for increased acne (a common side effect), increased hair growth on your face, loss of hair, deepening of your voice or enlargement of your clitoris, which all could be signs of side effects of testosterone, which is the active substance in Livensa.
Slovenian: Opazujte te znake povečanja pojava aken (pogosti neželeni učinek), povečane rasti dlak na obrazu, izpadanja las, znižanja glasu ali povečanja klitorisa, ker so lahko znaki neželenih učinkov testosterona, ki je zdravilna učinkovina v zdravilu Livensa.
English: - anxiety - disturbance in attention - dysgeusia (distorted sense of taste) - impaired balance - hyperaesthesia (abnormal increase in sensitivity to stimuli of the senses) - oral paraesthesia (tingling or numb sensation in the mouth) - transient ischemic attack (mini stroke) - diplopia (double vision) - eye redness - palpitations (rapid and irregular heart beat) - nasal congestion - throat tightness - diarrhoea - dry mouth - nausea - eczema - increased sweating - rosacea (redness of the face) - arthritis - breast cyst - clitoral engorgement - genital pruritus (genital itching sensation) - vaginal burning sensation - anasarca (widespread swelling of the skin) - asthenia (lack of energy and strength) - chest tightness - chest discomfort - abnormal blood fibrinogen (abnormal blood clotting) - increased heart rate - increased alanine aminotransferase, increased aspartate aminotransferase, increased blood bilirubin, abnormal liver function test, increased blood triglycerides (all measures of liver
Slovenian: - palpitacije (hitro in nepravilno utripanje srca) - kongestija nosne sluznice (zamašen nos) - stiskanje v grlu - driska - suha usta - navzea (slabost) - ekcem - obilnejše potenje - rozacea (pordelost obraza) - artritis - cista na dojki - nabrekanje klitorisa - genitalni pruritus (občutek srbenja spolovil)