natgillin/translations-raw huggingface dataset:
Therefore, taking the totality of data into account it is judged that the previous signal for an increased mortality associated with the use of aprotinin is refuted provided that aprotinin is given in the identified target population and the recommendations for its use are followed.
Zato se ob upoštevanju vseh podatkov ocenjuje, da je predhodne znake povečane smrtnosti, povezane z uporabo aprotinina, mogoče ovreči ob predpostavki, da se aprotinin uporablja pri opredeljeni ciljni populaciji in da se upošteva priporočila za njegovo uporabo.
• The Committee considered all data provided by the MAHs in writing and at the oral explanation, including data available from literature reviews and the outcome of a scientific advisory group.
• odbor je preučil vse podatke, ki so jih predložili imetniki dovoljenj za promet z zdravili pisno in z ustnimi obrazložitvami, vključno s podatki iz pregledov strokovne literature in z mnenjem znanstvene svetovalne skupine;
Taking into account all the data available on the efficacy and safety of aprotinin to date, the CHMP considered that there is clear evidence of a patient population in which the efficacy of systemic aprotinin clearly outweighs its risks.
Z upoštevanjem vseh podatkov o učinkovitosti in varnosti aprotinina, ki so trenutno na voljo, je CHMP menil, da ni dvomov o populaciji bolnikov, pri katerih koristi sistemskega aprotinina jasno odtehtajo z njim povezana tveganja.
The results of re-analysis of two of these studies did not show a statistically significant association between aprotinin treatment and myocardial infarction, and other cardiovascular endpoints; methodological questions were raised over a third observational study where a supplementary analysis also did not show a significant association between aprotinin and seven-day in-hospital mortality.
Rezultati ponovne analize dveh od teh študij niso pokazali statistično pomembne povezave med zdravljenjem z aprotininom in srčnim infarktom ter drugimi opazovanimi srčno-žilnimi dogodki; glede tretje opazovalne študije, v kateri dodatna analiza prav tako ni pokazala pomembne povezave med aprotininom in sedemdnevno smrtnostjo v bolnišnici, so se pojavili metodološki pomisleki.
On the basis of the above, the Committee recommended the lifting of the suspension and the amendment of the marketing authorisations for the medicinal products containing aprotinin referred to in Annex I for which the amendments to the product information are set out in annex III of the opinion.
Na podlagi navedenega je Odbor priporočil ukinitev začasnega umika in spremembo dovoljenj za promet z zdravili, ki vsebujejo aprotinin, naštetimi v Prilogi I. Spremembe informacij o zdravilih so navedene v Prilogi III tega mnenja.
No firm conclusion on cardiovascular risks can be made on the BART study due to several serious methodological issues identified.
Na podlagi študije BART ni trdnih zaključkov o tveganjih za srce in ožilje, ker so ugotovili več resnih metodoloških pomanjkljivosti.
Overall, the CHMP considered that the BART study was not designed to reliably determine the risk of death associated with aprotinin in relation to EACA or TXA and the results of higher mortality initially observed in aprotinin treated patients may be due to chance.
V splošnem je odbor CHMP menil, da zasnova študije BART ni omogočila zanesljivih ugotovitev o tveganju za smrt, povezanem z aprotininom v primerjavi z aminokaprojsko ali traneksamično kislino, in da je večjo umrljivost, ki so jo najprej opazili pri bolnikih, zdravljenih z aprotininom, mogoče pripisati naključju.
A review of the product information was undertaken to specify the agreed target population and update the clinical part of the product information to ensure that the information to healthcare professionals and patients is up to date.
Opravljena sta bila pregled informacij o zdravilih z namenom določitve soglasne ciljne populacije in posodobitve kliničnega dela informacij o zdravilih, da bi imeli zdravstveni delavci in bolniki v vseh državah članicah na voljo najnovejše informacije.
The product has been used outside its indication, with several trials where risks were observed conducted in a wider patient population.
Zdravilo se je uporabljalo za neodobrene indikacije, pri čemer je bilo izvedenih več preskušanj pri širši populaciji, v katerih so opazili tveganja.
The observational studies have provided conflicting results related to mortality as discussed above.
V opazovalnih študijah so si bili rezultati v zvezi z omenjeno smrtnostjo nasprotujoči.
The scientific conclusions and the grounds for the lifting of the suspension and amendment of the marketing authorisation are set out in annex II of the opinion.
Znanstveni zaključki in razlogi za ukinitev začasnega umika in spremembo dovoljenj za promet z zdravili so navedeni v Prilogi II tega mnenja.
The CHMP considered that a clarification should be included in the wording of the indication to reflect that the product should be used in patients undergoing CPB in the course of ‘isolated CABG' surgery, as efficacy and safety of aprotinin in more extensive surgery has not been sufficiently characterised.
CHMP je menil, da je treba v besedilni opis indikacije vključiti pojasnilo, da se lahko zdravilo uporablja pri bolnikih, ki so prestali obvodno operacijo koronarne arterije med izoliranim kirurškim posegom za vstavitev obvoda koronarne arterije, ker učinkovitost in varnost aprotinina pri obsežnejših operacijah nista dovolj raziskani.
A direct healthcare professional communication (DHPC) was agreed to provide prescribers with information on the review and an update on the safety information for aprotinin.
Vpeljana je bila neposredna komunikacija z zdravstvenimi delavci, da bi bili zdravniki, ki predpisujejo zdravila, seznanjeni z informacijami o pregledu in s posodobitvijo informacij o varnosti aprotinina.
The CHMP considered that the efficacy of aprotinin has been clearly demonstrated in prospective randomised trials and meta-analysis of clinical trials which show that aprotinin reduces the incidence of massive bleeding, reduces the need for transfusion of blood products and reduces the need for resurgery for bleeding in patients undergoing cardiac surgery requiring cardiopulmonary bypass (CPB).
CHMP je menil, da je bila učinkovitost aprotinina jasno dokazana v prospektivnih randomiziranih preskušanjih in z metaanalizo kliničnih preskušanj, ki kaže, da aprotinin zmanjšuje pojavnost obsežnih krvavitev, zmanjšuje potrebo po transfuziji krvnih produktov in zmanjšuje potrebo po ponovni operaciji zaradi krvavitve pri bolnikih, ki imajo operacijo srca z vstavitvijo obvoda koronarne arterije.
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.