natgillin/translations-raw huggingface dataset:
Do not use Livensa if you are, or suspect that you may be pregnant or are able to become pregnant, because it may cause harm to the unborn child.
Zdravila Livensa ne uporabljajte, če ste noseči, sumite, da ste noseči ali lahko zanosite, ker lahko škoduje nerojenemu otroku.
Decrease in testosterone has been associated with low sexual desire, reduced sexual thoughts and reduced sexual arousal.
Zmanjšanje koncentracije testosterona je povezano z nizko spolno željo, zmanjšanjem spolnih misli in zmanjšanjem spolnega vzburjenja.
It is a CHMP concern that the data from the THIN (The Health Improvement Database) study suggests that approx 70% of the users are outside indication.
Odbor za zdravila za uporabo v humani medicini skrbi, da morda podatki iz študije THIN (The Health Improvement Database - Banka podatkov o izboljšanju zdravja) kažejo, da približno 70% bolnikov zdravilo uporablja zunaj odobrenih indikacij.
If you forget to use a patch
Če ste pozabili uporabiti obliž
Keep in mind that estrogens should be administered for the shortest possible duration.
Estrogene je treba uporabljati najkrajši možni čas.
Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of Livensa remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Na osnovi podatkov, pridobljenih od pridobitve dovoljenja za promet z zdravilom, Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da ostaja razmerje med koristnostjo in tveganjem za zdravilo Livensa pozitivno, vendar je še vedno potreben skrben nadzor nad varnostnim profilom zdravila zaradi naslednjih razlogov:
All other common adverse reactions resolved in the majority of patients.
Vse druge pogoste neželene reakcije so se pri večini bolnic prenehale.
- if you have other conditions that your doctor may consider not appropriate for the use of estrogen and/or testosterone.
če imate druge bolezni, zaradi katerih vaš zdravnik meni, da ne smete uporabljati estrogena in/ali testosterona.
Patients who do not experience a meaningful benefit should be reevaluated and discontinuation of therapy be considered.
Bolnice, pri katerih ni bistvenega izboljšanja, je treba ponovno oceniti in pretehtati možnost prekinitve zdravljenja.
WHAT LIVENSA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO LIVENSA IN ZA KAJ GA UPORABLJAMO
DHT = dihydrotestosterone, SHBG = sex hormone binding globulin SEM = Standard Error of the Mean
DHT = dihidrotestosteron, SHBG = globulin, ki veže spolne hormone SEM = standardna napaka srednje vrednosti (standard error of the mean)
The amount of SHBG and albumin in serum and the total testosterone concentration determine the distribution of free and bioavailable testosterone.
Količina SHBG in albumina v serumu ter skupna koncentracija testosterona določajo distribucijo prostega in biološko uporabnega testosterona.
Concomitant estrogen treatment
Sočasno zdravljenje z estrogenom
Monday + Thursday o Tuesday + Friday o Wednesday + Saturday o Thursday + Sunday o Friday + Monday o Saturday + Tuesday
o nedelja in sreda ponedeljek in četrtek o torek in petek o sreda in sobota o četrtek in nedelja o petek in ponedeljek o sobota in torek
Livensa has no influence on the ability to drive and use machines.
Zdravilo Livensa nima vpliva na sposobnost vožnje in upravljanja s stroji.
In women, circulating testosterone is primarily bound in the serum to SHBG (65-80 %) and to albumin (20-30 %) leaving only about 0.5-2 % as the free fraction.
Pri ženskah je testosteron v krvnem obtoku vezan v serumu prvotno na SHBG (65-80%) in albumin (20-30%), delež prostega testosterona pa je le približno 0,5-2%.
What if your patch becomes loose, lifts at the edges or falls off?
Kaj, če se obliž odlepi, privzdigne na robovih ali odpade?
Following application of the patch on abdominal skin, maximum serum concentrations of testosterone are reached within 24-36 hours, with a wide inter-individual variability.
Po aplikaciji obliža na kožo trebuha so največje koncentracije testosterona v serumu dosežene v 24-36 urah, z velikimi razlikami med posamezniki.
Make sure that your skin at the application site is: clean and dry (free of lotions, moisturisers, and powders) as smooth as possible (no major creases or skin folds) not cut or irritated (free of rashes or other skin problems) unlikely to be rubbed by clothing excessively preferably free from hair.
Prepričajte se, da je koža na mestu namestitve obliža: čista in suha (brez losjonov, sredstev za vlaženje kože in pudrov); čim bolj gladka (brez večjih pregibov ali kožnih gub); ni poškodovana ali razdražena (brez izpuščajev ali drugih težav s kožo); da je oblačila ne bodo pretirano drgnila;
Other androgenic reactions commonly reported were acne, voice deepening and alopecia.
Druge androgene reakcije, o katerih so poročali pogosto, so bili akne, znižan glas in alopecija.
The safety of Livensa has not been evaluated in double blind placebo controlled studies of longer than 1 year duration.
Varnost zdravila Livensa ni bila ocenjena v dvojno slepih, s placebom nadzorovanih študijah, ki bi trajale dlje kot 1 leto.
Livensa treatment response should be evaluated within 3-6 months of initiation, to determine if continued therapy is appropriate.
Trajanje zdravljenja Odziv na zdravljenje z zdravilom Livensa je treba oceniti v 3-6 mesecih po začetku zdravljenja, da bi določili, ali je nadaljevanje zdravljenja primerno.
However, the subgroup of patients receiving oral CEE did not demonstrate a significant improvement in sexual activity compared to placebo (see sections 4.2 and 4.4).
Vendar se pri podskupini bolnic, ki so prejemale peroralne CEE, ni pokazalo pomembno izboljšanje spolne aktivnosti v primerjavi s placebom (glejte poglavji 4.2 in 4.4).
In premenopausal women, the rate of production of testosterone is 100 to 400 micrograms/24 hours, of which half is contributed by the ovary as either testosterone or a precursor.
Pri ženskah v premenopavzi je stopnja nastanka testosterona 100 do 400 mikrogramov/24 ur, od tega polovico prispevajo jajčniki v obliki testosterona ali njegovega prekurzorja.
Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Kljub temu ostanejo ravni prostih hormonov ščitnice nespremenjene in ni kliničnih podatkov za nepravilno delovanje ščitnice.
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, predložen v modulu 1.8.1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
In the combined study analysis at 24 weeks, the difference in the mean frequency of total satisfying episodes between Livensa and placebo was 1.07 per 4 weeks.
Pri analizi kombinirane študije po 24 tednih je bila razlika srednje vrednosti skupne pogostosti zadovoljivih epizod med zdravilom Livensa in placebom 1,07 na 4 tedne.
Step 2 While holding the patch, remove half of the protective liner that covers the sticky part of the patch.
2. korak Medtem ko obliž držite, odstranite polovico zaščitne plasti, ki pokriva lepljivo stran obliža.
The recommended daily dose of testosterone is 300 micrograms.
Priporočen dnevni odmerek testosterona je 300 mikrogramov.
The active metabolites of testosterone are estradiol and dihydrotestosterone (DHT).
Aktivna presnovka testosterona sta estradiol in dihidrotestosteron (DHT).
Hirsutism was also very commonly reported.
Zelo pogosto so poročali tudi o hirsutizmu.
After removal of the ovaries, testosterone drops to half of the levels compared to before the operation.
Po odstranitvi jajčnikov se raven testosterona zmanjša na polovico v primerjavi z ravnjo pred operacijo.
Patches should not be applied to the breasts or other body regions.
Obližev se ne sme aplicirati na dojke ali druge predele telesa.
Then continue with your regular schedule of patch-change days, even if this means discarding a patch after you have worn it for less than 3-4 days.
Nato nadaljujte reden razpored menjave obliža, tudi če boste obliž zavrgli potem, ko ste ga imeli manj kot 3-4 dni.
The adhesive side of the patch should be applied to a clean, dry area of skin on the lower abdomen below the waist.
Lepljivo stran obliža je treba aplicirati na čisto in suho mesto na koži na spodnjem delu trebuha, pod pasom.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the Risk Management Plan (RMP) dated 19-September-2010, presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Načrt za obvladovanje tveganja (RMP) Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v načrtu za obvladovanje tveganja (RMP) z dne 19. septembra 2010, predloženem v modulu 1.8.2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (Box of 2, 8 or 24 patches)
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA (škatla z 2, 8 ali 24 obliži)
DHT has a greater affinity to SHBG than does testosterone.
DHT ima večjo afiniteto do SHBG kot testosteron.
Patients treated with conjugated equine estrogen (CEE) are not recommended to use Livensa, as efficacy has not been demonstrated (see sections 4.4 and 5.1).
Bolnicam, ki prejemajo konjugirani konjski estrogen (CEE, conjugated equine estrogen), se uporaba zdravila Livensa ne priporoča, kajti učinkovitosti še niso dokazali (glejte poglavji 4.4 in 5.1).
In case of inadvertent exposure during pregnancy, use of Livensa must be discontinued.
V primeru nenamerne izpostavitve med nosečnostjo je treba zdravljenje z zdravilom Livensa prekiniti.
What Livensa looks like and contents of the pack Livensa is a thin, clear, oval patch with T001 stamped on the back.
Izgled zdravila Livensa in vsebina pakiranja Livensa je tanek, prozoren, ovalen obliž z napisom T001, natisnjenim na zadnji strani.
Testosterone is metabolised to various 17-ketosteroids and further metabolism results in inactive glucuronides and other conjugates.
Testosteron se presnavlja v različne 17-ketosteroide in naprej v neaktivne glukuronide in druge konjugate.
Children and adolescents Livensa is not for use in children and adolescents.
Zdravilo Livensa ni namenjeno uporabi pri otrocih in mladostnikih.
Change your patch as soon as you remember, and then continue with your regular schedule of patchchange days, even if this means discarding a patch after you have worn it for less than 3-4 days.
Obliž zamenjajte takoj, ko se spomnite, nato nadaljujte reden razpored menjave obliža, tudi če boste obliž zavrgli potem, ko ste ga imeli manj kot 3-4 dni.
There is no information on the safety of Livensa beyond 12 months.
Podatkov o varnosti uporabe zdravila Livensa, daljše od 12 mesecev, ni.
Consistent with the prevalence of HSDD, there are limited data above the age of 60.
V skladu s prevalenco HSDD je podatkov o bolnicah, starejših od 60 let, malo.
Endometrial effects
Učinki na endometrij
A significantly higher percentage of women who received Livensa reported a benefit in the three endpoints, that they considered clinically meaningful compared to women who received placebo.
Pomembno večji odstotek žensk, ki so prejemale zdravilo Livensa, je poročal pri treh ciljih o izboljšanju, za katero so udeleženke raziskave menile, da je klinično pomembno, v primerjavi z ženskami, ki so prejemale placebo.
The affinity of binding to serum SHBG is relatively high and the SHBG bound fraction is regarded as not contributing to biological activity.
Afiniteta za vezanje na SHBG v serumu je razmeroma velika, delež, vezan na SHBG, pa ne prispeva k biološki dejavnosti.
If you stop estrogen therapy you must also stop using Livensa.
Če prekinete zdravljenje z estrogenom, morate prenehati uporabljati tudi zdravilo Livensa.
The patch needs to be changed twice weekly.
Obliž morate zamenjati dvakrat tedensko.
Data in the literature regarding the influence of testosterone on the risk of breast cancer in women are limited, inconclusive and conflicting.
Podatki v literaturi o vplivu testosterona na tveganje raka dojke pri ženskah so omejeni, ne dovoljujejo zaključkov in so si nasprotujoči.
However, do not scrub the area where the patch has been placed too hard.
Vendar mesta, kjer je nameščen obliž, ne drgnite premočno.
In women, who have undergone bilateral oophorectomy, serum levels of testosterone decline by approximately 50 % within days after surgery.
Pri ženskah, ki so jim opravili bilateralno ooforektomijo, se ravni testosterona v dneh po kirurškem posegu zmanjšajo za približno 50%.
Cardiovascular disease
Kardiovaskularne bolezni
Siliconised polyester film.
Silikonizirana poliestrska folija.
Medicines should not be disposed of via wastewater (do not flush it down the toilet).
Zdravila ne smete odvreči v odpadne vode (ne smete ga odplakniti v stranišče).
Livensa is a transdermal patch which constantly releases small amounts of testosterone that is absorbed through your skin into the bloodstream.
Livensa je transdermalni obliž, ki neprekinjeno sprošča majhne količine testosterona, ki se skozi kožo vpijejo v krvni obtok.
- Fold the used patch in half, sticking the patch to itself, and discard it in a safe way in order to keep it away from children (e.g. in a rubbish bin).
Uporabljeni obliž prepognite, tako da se zalepi sam nase in ga zavrzite na varen način, tako da bo zunaj dosega otrok (npr. v koš za smeti).
- For at least one week after removing a patch, do not place a new patch in the same area.
Potem ko odstranite obliž, novega vsaj en teden ne namestite na isto mesto.
These reactions were reversible in the majority of patients.
Pri večini bolnic so bile te reakcije reverzibilne.
During 6-month double blind exposure the following adverse reactions occurred in the treatment group (n=549) at a greater incidence than placebo (n=545) and were assessed by the investigators as possibly or probably related to Livensa treatment.
Med šestmesečnim dvojno slepo raziskavo so bili v skupini, ki je prejemala zdravilo (n = 549), naslednji neželeni učinki pogostejši kot v skupini, ki je prejemala placebo (n = 545), in za katere so raziskovalci ocenili, da so morda ali verjetno povezani z zdravljenjem z zdravilom Livensa.
Patients receiving oral anticoagulants require close monitoring, especially when testosterone therapy is started or stopped.
Bolnice, ki prejemajo peroralne antikoagulante, bo treba pozorno nadzorovati, zlasti ob začetku in prenehanju zdravljenja s testosteronom.
Step 3 Apply the sticky side of the patch to the selected area onto your skin.
3. korak Lepljivo stran obliža namestite na izbrano mesto na koži.
Testosterone from Livensa is transported across intact skin by a passive diffusion process that is primarily controlled by permeation across the stratum corneum.
Testosteron iz zdravila Livensa se transportira prek nepoškodovane kože s pasivno difuzijo, ki jo nadzoruje predvsem prepuščanje skozi stratum corneum.
Cartons of 2, 8 and 24 patches.
Škatle z 2, 8 in 24 obliži.
Each patch is packed in a sealed laminated sachet.
Vsak obliž je pakiran v zatesnjeno laminirano zaščitno vrečico.
- Medicines should not be disposed of via wastewater (do not flush it down the toilet) or household waste.
Zdravila ne smete odvreči v odpadne vode (ne odplaknite ga v stranišče) ali med gospodinjske odpadke.
Date of latest renewal: 28-July-2011
Datum zadnjega podaljšanja dovoljenja za promet: 28. julij 2011
Press the entire patch firmly against your skin with the palm of your hand for about 10 seconds.
Celoten obliž z dlanjo močno pritisnite ob kožo in držite približno 10 sekund.
The patch is designed to remain in place during a shower, bath, swimming or exercising.
Obliž je oblikovan tako, da se ne odstrani med prhanjem, kopanjem, plavanjem ali telesno vadbo.
Avoid touching the sticky side of the patch with your fingers.
Lepljive strani obliža se ne dotikajte s prsti.
- If you are also using estrogen patches, make sure that the Livensa patch and the estrogen patch do not overlap.
− Če uporabljate tudi estrogenske obliže, pazite, da se ta obliž zdravila Livensa in estrogenski obliž ne prekrivata.
Serum levels of androgens fall as women age.
Pri ženskah se ravni androgenov v serumu s starostjo zmanjšajo.
Thyroid hormone levels
Ravni hormonov ščitnice
Step 4 Fold back the patch and carefully remove the other half of the liner.
4. korak Obliž prepognite in previdno odstranite drugo polovico zaščitne plasti.
Do not stick the patch on the breasts or bottom.
Obliža ne nalepite na dojke ali zadnjico.
Take special care with Livensa - if you have a history of heart, liver or kidney disease.
Bodite posebno pozorni pri uporabi zdravila Livensa če ste v preteklosti imeli bolezen srca, ledvic ali jeter.
Always make sure your patch is covered by clothing.
Obliž mora biti pokrit z oblačili.
MARKETING AUTHORISATION HOLDER Warner Chilcott Deutschland GmbH Dr.-Otto-Röhm-Strasse 2-4
IMETNIK DOVOLJENJA ZA PROMET Warner Chilcott Deutschland GmbH Dr.-Otto-Röhm-Strasse 2-4
The efficacy of Livensa is reduced if your estrogen therapy is of a certain type (‘conjugated equine estrogens').
Učinkovitost zdravila Livensa se zmanjša, če se zdravite z določeno vrsto estrogenov (‘konjugirani konjski estrogeni').
The majority of these adverse reactions consisted of mild erythema and itching and did not result in patient withdrawal.
Večina teh neželenih učinkov sta bila blagi eritem in srbenje, zaradi njiju pa zdravljenja niso prekinili.
Livensa is designed to systemically deliver 300 micrograms/day.
Zdravilo Livensa je oblikovano tako, da sistemsko dovaja 300 mikrogramov/dan.
Continue to use for as long as your doctor prescribes.
Uporabo zdravila nadaljujte, dokler vam predpiše zdravnik.
This is achieved by applying the patch twice weekly on a continuous basis.
Odmerek se dosega z neprekinjenim apliciranjem obliža dvakrat tedensko.
Overdosing with Livensa is unlikely when used as directed, because once the patch is taken off testosterone is quickly removed by the body.
Pri zdravilu Livensa preveliko odmerjanje ni verjetno, kadar se uporablja skladno z navodili, ker se po odstranitvi obliža testosteron hitro odstrani iz telesa.
Livensa is a transdermal therapy for HSDD, which improves sexual desire while achieving testosterone concentrations compatible with premenopausal levels.
Livensa je transdermalno zdravilo za HSDD, ki izboljša spolno željo, medtem ko dosega koncentracije testosterona, primerljive s koncentracijami pred menopavzo.
There is little information on long-term safety, including effects on breast tissue, the cardiovascular system and increase in insulin resistance.
O dolgotrajni varnosti, vključno z učinki na tkivo dojk, kardiovaskularni sistem in povečanje odpornosti na insulin, je malo podatkov.
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.
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.
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.
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).
Livensa did not influence serum concentrations of sex hormone binding globulin (SHBG), estrogens or adrenal hormones.
Zdravilo Livensa ni vplivalo na koncentracije globulina v serumu, ki veže spolne hormone (SHBG, sex hormone binding globulin), estrogenov ali hormonov nadledvične žleze.
Livensa is only indicated for women in their menopause after the ovaries and uterus have been removed.
Zdravilo Livensa je indicirano samo za ženske v menopavzi, potem ko so jim odstranili jajčnike in maternico.
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.
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.
Each patch is sealed in a sachet.
Vsak obliž je v zatesnjeni vrečici.
- if you have a history of excessive adult acne, body or facial hair, hair loss, enlargement of the clitoris or voice deepening or hoarseness.
če ste v preteklosti imeli hude akne v odrasli dobi, poraščenost telesa ali obraza, izpadanje las, povečanje klitorisa, znižanje glasu ali hripavost.
Less than 1 % of patients withdrew from the studies because of any of these reactions.
Zaradi njih je sodelovanje v študiji prekinilo manj kot 1% bolnic.
Do not use scissors as you may accidentally damage the patch.
Ne uporabljate škarij, ker lahko nehote poškodujete obliž.
A skin site with minimal wrinkling and not covered by tight clothing is recommended.
Priporočeno je mesto na koži, ki se čim manj guba in ki ni prekrito s tesnimi oblačili.
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.
Da ne bi ovirali lepilnih lastnosti zdravila Livensa, se na kožo, kamor se obliž aplicira, ne sme nanesti kreme, losjona ali pudra.
- 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).
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).
In diabetic patients the metabolic effects of testosterone may decrease blood glucose and therefore insulin requirements.
Pri bolnicah s sladkorno boleznijo lahko učinki testosterona na presnovo zmanjšajo raven glukoze v krvi in posledično potrebo po insulinu.
In case of severe application site reaction, the treatment should
Če so reakcije na mestu namestitve hude, je treba zdravljenje prekiniti.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
If the patch detaches prematurely, it may be reapplied.
Če se obliž prezgodaj odlepi, se lahko ponovno nalepi.
HOW TO USE LIVENSA
KAKO UPORABLJATI ZDRAVILO LIVENSA
- if you notice any skin reactions at the site of application (a very common side effect) such as redness, oedema, or blistering.
če opazite kakršnekoli kožne reakcije na mestu namestitve (zelo pogosti neželeni učinek), kot so rdečica, edem ali mehurji.
- if you are diabetic, as testosterone may lower blood glucose levels.
če ste sladkorna bolnica, ker testosteron lahko zniža raven glukoze v krvi;
Livensa is recommended for use in surgically menopausal women up to the age of 60.
Uporaba zdravila Livensa se priporoča pri ženskah po kirurški menopavzi do 60. leta starosti.