natgillin/translations-raw huggingface dataset:
Scientific conclusions and grounds for lifting of the suspension and amendment of the marketing authorisations for aprotinin containing medicinal products presented by the EMA 
Znanstveni zaključki in razlogi za ukinitev začasnega umika in za spremembo dovoljenj za promet z zdravili z vsebnostjo aprotinina, ki jih je predstavila Evropska agencija za zdravila
Taking the totality of data into account it is judged that the previous signal for an increased mortality associated with the use of aprotinin should be refuted provided that the drug is given in the identified target population of adult patients at high risk of major blood loss undergoing isolated coronary artery bypass graft (CABG) surgery and the recommendations for its use are followed. 
Ob upoštevanju vseh podatkov se ocenjuje, da je predhodne znake povečane smrtnosti, povezane z uporabo aprotinina, treba ovreči ob predpostavki, da se aprotinin uporablja pri opredeljeni ciljni populaciji odraslih bolnikih, ki so v veliki nevarnosti za obsežno izgubo krvi med izoliranim kirurškim posegom za vstavitev obvoda koronarne arterije (CABG), in da se upošteva priporočila za njegovo uporabo;
The CHMP considered that a registry should be conducted by MAHs of aprotinin containing medicinal products affected by this review. 
CHMP je menil, da bi morali imetniki dovoljenj za promet z zdravili, ki vsebujejo aprotinin in na katere se nanaša ta pregled, vpeljati register.
The CHMP noted that the findings from other randomised clinical trials and meta-analysis of randomised clinical trials (when the BART study is excluded) do not provide evidence of an association between aprotinin and perioperative mortality. 
Odbor CHMP meni, da izsledki drugih randomiziranih kliničnih preskušanj in metaanaliza randomiziranih kliničnih preskušanj (če je študija BART izključena) niso prinesli dokazov o povezavi med aprotininom in perioperativno smrtnostjo.
• The Committee considered that the available randomised clinical trial and meta-analysis of clinical trials (when the BART study is excluded) do not give evidence of an association between aprotinin and perioperative mortality. 
• odbor CHMP je menil, da razpoložljivo randomizirano klinično preskušanje in metaanaliza kliničnih preskušanj (če je študija BART izključena) ne dokazujeta povezave med aprotininom in perioperativno smrtnostjo.
A restricted distribution of aprotinin is envisaged with aprotinin available only to centres that perform cardiac surgery on cardio-pulmonary bypass and that commit to participate in the registry. 
Predvidena je omejena distribucija aprotinina, tako da bi bil ta na voljo samo v zdravstvenih centrih, ki izvajajo operacije srca z vstavitvijo obvoda koronarne arterije in sodelujejo pri registru;
Grounds for lifting of the suspension and amendment of the marketing authorisations of aprotinin containing medicinal products listed in Annex I 
Podlaga za ukinitev začasnega umika in za spremembo dovoljenj za promet z zdravili, ki vsebujejo aprotinin, naštetimi v Prilogi I
Recommendations on adequate monitoring of the anticoagulative effect of heparin administered in the CABG procedure should be reflected in the product information. 
Informacije o zdravilih morajo vsebovati tudi priporočila za ustrezno spremljanje antikoagulacijskega učinka heparina, uporabljenega med postopkom CABG.
Aprotinin was already indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in those patients undergoing CPB in the course of CABG who were at an increased risk for blood loss and blood transfusion. 
Aprotinin je bil že indiciran za profilaktično uporabo za zmanjšanje izgube krvi po operaciji in potrebe po transfuziji krvi pri bolnikih, ki so prestali obvodno operacijo koronarne arterije pri vstavitvi obvoda koronarne arterije in pri katerih je obstajalo povečano tveganje za izgubo krvi ter transfuzijo krvi.
The CHMP noted that since the initial review in 2007, more data has become available, such as new observational studies, the final study results of the BART study, and more importantly new analyses of the BART study. 
Odbor CHMP je ugotovil, da je od začetnega pregleda v letu 2007 bilo danih na voljo več podatkov, denimo nove opazovalne študije, končni rezultati študije BART in, kar je pomembneje, nove analize študije BART. Ti novi podatki so zdaj omogočili opredelitev glavnih pomanjkljivosti študije BART, ki jih prej ni bilo mogoče prepoznati;
The CHMP noted that since the initial review in 2007, more data has become available, in particular the final study results, and more importantly new analysis of the BART study. 
Odbor CHMP je ugotovil, da je od začetnega pregleda v letu 2007 bilo danih na voljo več podatkov, zlasti končni rezultati študije in, kar je pomembneje, nova analiza študije BART. Ti novi podatki so zdaj omogočili opredelitev glavnih pomanjkljivosti v študiji BART, ki jih prej ni bilo mogoče prepoznati.
The proposed indication is for prophylactic use to reduce blood loss and blood transfusion in adult patients who are at high risk of major blood loss undergoing isolated cardiopulmonary bypass graft surgery (i.e. coronary artery bypass graft surgery that is not combined with other cardiovascular surgery). 
Predlagana indikacija je za profilaktično uporabo za zmanjšanje izgube krvi in transfuzije krvi pri odraslih bolnikih, ki so v veliki nevarnosti za obsežno izgubo krvi med izoliranim kirurškim posegom za vstavitev obvoda koronarne arterije (tj. obvodna operacija koronarne arterije, ki ni kombinirana z drugim kirurškim posegom na srcu in ožilju).
prophylactic use to reduce blood loss and blood transfusion in adult patients who are at high risk of major blood loss undergoing isolated cardiopulmonary bypass graft surgery (i.e. coronary artery bypass graft surgery that is not combined with other cardiovascular surgery). 
profilaktična uporaba za zmanjšanje izgube krvi in transfuzijo krvi pri odraslih bolnikih, ki so v veliki nevarnosti za obsežno izgubo krvi med izoliranim kirurškim posegom za vstavitev obvoda koronarne arterije (tj. obvodna operacija koronarne arterije, ki ni kombinirana z drugim kirurškim posegom na srcu in ožilju).
Aprotinin is indicated for prophylactic use to reduce blood loss and blood transfusion in adult patients who are at high risk of major blood loss undergoing isolated cardiopulmonary bypass graft surgery (i.e. coronary artery bypass graft surgery that is not combined with other cardiovascular surgery). 
Aprotinin je indiciran za profilaktično uporabo za zmanjšanje izgube krvi in transfuzijo krvi pri odraslih bolnikih, ki so v veliki nevarnosti za obsežno izgubo krvi med izoliranim kirurškim posegom za vstavitev obvoda koronarne arterije (tj. obvodna operacija koronarne arterije, ki ni kombinirana z drugim kirurškim posegom na srcu in ožilju).
It may take longer than one month for you to notice an improvement. 
Morda bo trajalo dlje kot en mesec, preden boste opazili izboljšanje.
Your doctor will advise you on what you should do. 
Zdravnik vam bo svetoval, kaj storiti.
All or any of these problems can cause personal distress or relationship difficulties. 
Vsaka od teh težav lahko povzroči osebno stisko ali težave v odnosu.
In either case, the original treatment regimen should be maintained. 
V vsakem primeru je treba upoštevati prvotni režim zdravljenja.
Long-term safety, including breast cancer 
Dolgoročna varnost, vključno z rakom dojke
This will mean that you wear one patch for 3 days and the other for 4 days. 
To pomeni, da boste en obliž nosili 3 dni, drugega pa 4 dni.
For example: If you decide to start treatment on a Monday, then you have to change your patch always on a Thursday and a Monday. 
Na primer: Če ste se odločili, da boste zdravljenje začeli v ponedeljek, morate obliž vedno zamenjati ob četrtkih in ponedeljkih.
The off-label use is a safety risk. 
Uporaba za neodobreno indikacijo predstavlja tveganje za varnost.
The site should not be oily, damaged, or irritated. 
Mesto ne sme biti mastno, poškodovano ali razdraženo.
What about sunbathing? 
Kaj pa sončenje?
More than 90 % of these reports were considered mild. 
Več kot 90% teh učinkov v poročilih je bilo blagih.
Patients should be advised to self assess for androgenic undesirable effects. 
Bolnicam je treba svetovati, da same ocenijo androgene neželene učinke.
The adverse reaction most often reported (30.4 %) was application site reactions. 
Najpogostejši neželeni učinek, o katerem so poročali (30,4%), so bile reakcije na mestu aplikacije.
MARKETING AUTHORISATION NUMBER(S) EU/1/06/351/001-003 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/06/351/001-003
Choose your two days and tick the box. 
Izberite dneva in označite na škatli.
The usual dose is one patch twice weekly (each 3 to 4 days), see below ‘How and when to change your patch'. 
Običajni odmerek je en obliž dvakrat na teden (vsake 3 do 4 dni), glejte spodaj „Kako in kdaj zamenjati obliž“.
Tell your doctor if you are taking blood-thinning (anticoagulant) treatment. 
Obvestite svojega zdravnika, če jemljete zdravila za redčenje krvi (antikoagulanti).
A particular application site should be rotated with an interval of at least 7 days between applications. 
Interval zamenjave za določeno mesto aplikacije naj bo vsaj 7 dni med dvema aplikacijama.
Toxicological studies of testosterone have only revealed effects which can be explained based on the hormone profile. 
Toksikološke študije testosterona so odkrile samo učinke, ki jih lahko razložimo na podlagi hormonskega profila.
Each patch surface is stamped with T001. 
Na površini vsakega obliža je natisnjen napis T001.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28-July-2006 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja za promet: 28. julij 2006
In clinical trials these reactions were reversible in the majority of patients (see section 4.8). 
V kliničnih študijah so bile te reakcije reverzibilne pri večini bolnic (glejte poglavje 4.8).
When testosterone is given concomitantly with anticoagulants, the anticoagulant effect may increase. 
Kadar se testosteron uporablja sočasno z antikoagulanti, se lahko učinek antikoagulantov poveča.
Returning to your regular schedule will help you remember when to change your patch. 
Če se boste vrnili na redni razpored, si boste lažje zapomnili, kdaj morate obliž zamenjati.
Hirsutism was reversible in the majority of patients. 
Hirsutizem je bil pri večini bolnic reverzibilen.
- if you know that you have had in the past, currently have, or think that you might have, breast cancer or any other cancer which your doctor has described as being caused or stimulated by the female hormone estrogen, also called ‘estrogen-dependent' cancers. 
če veste, da ste v preteklosti imeli, trenutno imate ali mislite, da bi lahko imeli rak dojke ali katerikoli drugi rak, za katerega zdravnik meni, da ga je povzročil ali spodbudil ženski hormon estrogen; tak rak se imenuje tudi "od estrogena odvisni rak".
If the same patch cannot be reapplied, a new patch should be applied to another location. 
Če istega obliža ni mogoče ponovno nalepiti, je treba nov obliž aplicirati na drugo mesto.
Patients with cardiovascular risk factors, in particular hypertension, and patients with known cardiovascular disease should be carefully monitored, specifically regarding changes in blood pressure and weight. 
Bolnice s kardiovaskularnimi dejavniki tveganja, zlasti hipertenzijo, in bolnice z znano kardiovaskularno boleznijo je treba pozorno spremljati, zlasti spremembe krvnega tlaka in telesne mase.
Removal of the patch results in a rapid decrease in serum testosterone levels (see section 5.2). 
Odstranitev obliža povzroči hitro zmanjšanje ravni testosterona v serumu (glejte poglavje 5.2).
Your doctor will carefully monitor you with regard to breast cancer and endometrium cancer. 
Zdravnik vas bo skrbno spremljal z ozirom na raka dojke in raka endometrija.
The patch should be replaced with a fresh patch every 3 to 4 days. 
Obliž je treba zamenjati z novim obližem vsake 3 do 4 dni.
The long-term effect of testosterone treatment on the breast is currently unknown, therefore patients should be carefully monitored with regard to breast cancer in accordance with currently accepted screening practises and individual patient needs. 
Dolgotrajni učinek zdravljenja s testosteronom na dojke za sedaj ni znan, zato je treba skrbno spremljati bolnice z ozirom na raka dojke v skladu z veljavno prakso presejalnih pregledov in potrebami posamezne bolnice.
PHARMACEUTICAL FORM AND CONTENTS 2 transdermal patches 
FARMACEVTSKA OBLIKA IN VSEBINA 2 transdermalna obliža
At regular intervals during treatment, physicians should monitor patients for potential androgenic undesirable reactions (e.g. acne, changes in hair growth or hair loss). 
Med zdravljenjem morajo zdravniki v rednih presledkih nadzorovati bolnice zaradi morebitnih androgenih neželenih reakcij (npr. akne, spremembe rasti dlake ali izpadanje las).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription. 
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Androgens may decrease levels of thyroxin-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. 
Androgeni lahko znižajo raven globulina, ki veže tiroksin, kar povzroča zmanjšanje celotne ravni T4 v serumu ter povečano stopnjo vezave T3 in T4.
Livensa is used to treat HSDD. 
Zdravilo Livensa se uporablja za zdravljenje HSDD.
The patch should be applied immediately after opening the sachet and removing both parts of the protective release liner. 
Obliž je treba aplicirati neposredno po odprtju zaščitne vrečice in odstranitvi obeh delov zaščitne plasti.
The testosterone in Livensa is the same hormone as that produced naturally in men and women. 
Testosteron v zdravilu Livensa je enak hormon kot tisti, ki se naravno proizvaja pri moških in ženskah.
There was no evidence of accumulation of testosterone over 52 weeks of treatment. 
Podatkov o kopičenju testosterona v 52 tednih zdravljenja ni bilo.
Therefore, you need to discuss your type of estrogen with your doctor, who could advise you which type of estrogen is suitable together with Livensa. 
O vrsti estrogena se morate torej posvetovati z zdravnikom, ki vam lahko svetuje, katera vrsta estrogena je ustrezna za uporabo skupaj z zdravilom Livensa.
As a reminder, mark on the outer carton your chosen patch-change days. 
Za opomnik si na zunanji škatli označite izbrana dneva za menjavo obliža.
Continued use of Livensa is only recommended while concomitant use of estrogen is considered appropriate (i.e. the lowest effective dose for the shortest possible duration). 
Neprekinjena uporaba zdravila Livensa se priporoča samo, dokler se ocenjuje, da je sočasna uporaba estrogena ustrezna (tj. najnižji možni učinkoviti odmerek v najkrajšem možnem času).
Use Livensa only as long as you experience a positive effect of the treatment. 
Zdravilo Livensa uporabljajte samo, dokler opažate ugodne učinke zdravljenja.
What about showering, bathing and exercising? 
Kaj pa prhanje, kopanje in telesna vadba?
Effects of Livensa were observed at 4 weeks after initiation of therapy (the first measured time point) and at all monthly efficacy time points thereafter. 
Učinke zdravila Livensa so opazili 4 tedne po začetku zdravljenja (prva točka merjenja) in pri vseh naslednjih mesečnih točkah merjenja učinkovitosti.
It is not known whether Livensa increases the risk of breast cancer and endometrium cancer. 
Ni znano, ali zdravilo Livensa poveča tveganje za rak dojke in raka endometrija.
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), or very rare (< 1/10,000), not known (cannot be estimated from the available data). 
občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) ali neznane pogostnosti (ni mogoče oceniti iz razpoložljivih podatkov).
The following pack sizes are available: 2, 8 and 24 patches. 
Na voljo so naslednje velikosti pakiranj: 2, 8 in 24 obližev.
The patch should be pressed firmly in place for about 10 seconds, making sure there is good contact with the skin, especially around the edges. 
Obliž je treba močno pritisniti in držati 10 sekund, pri čemer se je treba prepričati, da se je dobro oprijel kože, zlasti ob robovih.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report 
V skladu s smernico CHMP o sistemih za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen RMP predložen hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
Total satisfying sexual activity (primary endpoint), sexual desire, and distress associated with low sexual desire (secondary endpoints) were evaluated with validated instruments. 
Povsem zadovoljiva spolna aktivnost (primarni cilj), spolna želja in stiska, povezana z nizko spolno željo (sekundarna cilja), so ocenili s preverjenimi metodami.
Binding to albumin is of relatively low affinity and is reversible. 
Vezava na albumin ima razmeroma nizko afiniteto in je reverzibilna.
If you forget to change your patch 
Če ste pozabili zamenjati obliž
If you have not experienced a positive effect of Livensa within 3-6 months, you should inform your doctor, who will suggest that treatment be discontinued. 
Livensa ne opazite v 3-6 mesecih, morate obvestiti svojega zdravnika, ki vam bo predlagal, da zdravljenje prekinete.
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.