FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy of Intrinsa is reduced if your estrogen therapy is of a certain type (‘conjugated equine estrogens').
Slovenian: Učinkovitost zdravila Intrinsa se zmanjša, če se zdravite z določeno vrsto estrogenov (‘konjugirani konjski estrogeni').
English: Intrinsa is designed to systemically deliver 300 micrograms/day.
Slovenian: Zdravilo Intrinsa je oblikovano tako, da sistemsko dovaja 300 mikrogramov/dan.
English: Take special care with Intrinsa - if you have a history of heart, liver or kidney disease.
Slovenian: Bodite posebno pozorni pri uporabi zdravila Intrinsa če ste v preteklosti imeli bolezen srca, ledvic ali jeter.
English: Intrinsa should not be used in women on concomitant CEE Whereas Intrinsa 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 Intrinsa se ne sme uporabljati pri ženskah, ki sočasno uporabljajo CEE Čeprav je zdravilo Intrinsa 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: Intrinsa is only indicated for women in their menopause after the ovaries and uterus have been removed.
Slovenian: Zdravilo Intrinsa je indicirano samo za ženske v menopavzi, potem ko so jim odstranili jajčnike in maternico.
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 Intrinsa 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 Intrinsa (n=274), in 29,4% žensk, ki so prejemale placebo (n=269).
English: Intrinsa did not influence serum concentrations of sex hormone binding globulin (SHBG), estrogens or adrenal hormones.
Slovenian: Zdravilo Intrinsa ni vplivalo na koncentracije globulina v serumu, ki veže spolne hormone (SHBG, sex hormone binding globulin), estrogenov ali hormonov nadledvične žleze.
English: Intrinsa is a transdermal therapy for HSDD, which improves sexual desire while achieving testosterone concentrations compatible with premenopausal levels.
Slovenian: Intrinsa je transdermalno zdravilo za HSDD, ki izboljša spolno željo, medtem ko dosega koncentracije testosterona, primerljive s koncentracijami pred menopavzo.
English: Like all medicines, Intrinsa can cause side effects, although not everybody gets them.
Slovenian: MOŽNI NEŽELENI UČINKI Kot vsa zdravila ima lahko tudi zdravilo Intrinsa neželene učinke, ki pa se ne pojavijo pri vseh bolnicah.
English: Pregnancy Intrinsa must not be used in women who are or may become pregnant.
Slovenian: Nosečnost Zdravila Intrinsa ne smejo uporabljati nosečnice ali ženske, ki lahko zanosijo.
English: To prevent interference with the adhesive properties of Intrinsa, 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 Intrinsa, se na kožo, kamor se obliž aplicira, ne sme nanesti kreme, losjona ali pudra.
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 Intrinsa.
Slovenian: Učinkovitost in varnost zdravila Intrinsa 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: Intrinsa is recommended for use in surgically menopausal women up to the age of 60.
Slovenian: Uporaba zdravila Intrinsa se priporoča pri ženskah po kirurški menopavzi do 60. leta starosti.
English: Intrinsa 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 Intrinsa 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: - sinusitis (inflammation of nasal sinus) - abnormal clotting factor - hypersensitivity (allergic reactions) - increased appetite - agitation
Slovenian: - sinusitis (vnetje nosnih sinusov) - nenormalen faktor strjevanja krvi - preobčutljivost (alergijske reakcije)
English: Testosterone, the primary circulating androgen in women, is a naturally occurring steroid, secreted by the ovaries and adrenal glands.
Slovenian: Testosteron, primarni androgen v krvnem obtoku pri ženskah, je naravni steroid, ki ga izločajo jajčniki in nadledvične žleze.
English: What Intrinsa is and what it is used for Before you use Intrinsa How to use Intrinsa Possible side effects How to store Intrinsa Further information
Slovenian: Kaj je zdravilo Intrinsa in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Intrinsa Kako uporabljati zdravilo Intrinsa
English: Intrinsa 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 Intrinsa je namenjeno za uporabo pri ženskah do 60. leta starosti, ki so jim odstranili jajčnike in maternico.
English: Do not use Intrinsa in case of breast-feeding because it may cause harm to the child.
Slovenian: Zdravila Intrinsa ne uporabljajte, če dojite, ker lahko škoduje otroku.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo,
English: - if you are allergic (hypersensitive) to testosterone or any of the other ingredients of Intrinsa (see section ‘Further information' at the end of this leaflet).
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO INTRINSA Ne uporabljajte zdravila Intrinsa če ste alergični (preobčutljivi) na testosteron ali katerokoli sestavino zdravila Intrinsa (glejte poglavje „Dodatne informacije“ na koncu tega navodila).
English: Driving and using machines You can drive and use machines while using Intrinsa.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Med uporabo zdravila Intrinsa lahko vozite in uporabljate stroje.
English: However, patients should be informed that migraine, insomnia, disturbance in attention and diplopia have been reported during treatment with Intrinsa.
Slovenian: Vendar je treba bolnicam povedati, da so med zdravljenjem z zdravilom Intrinsa poročali o migreni, nespečnosti, motnjah pozornosti in diplopiji.
English: Serum concentrations of testosterone and SHBG in patients receiving Intrinsa in clinical safety and
Slovenian: Koncentracije testosterona in SHBG v serumu pri bolnicah, ki so prejemale zdravilo Intrinsa v kliničnih študijah varnosti in učinkovitosti Izhodiščna vrednost
English: Testosterone is mainly excreted in the urine as glucuronic and sulphuric acid conjugates of testosterone and its metabolites.
Slovenian: Izločanje Testosteron se izloča v glavnem z urinom v obliki konjugatov glukuronske in žveplove kisline testosterona ter njegovih presnovkov.
English: Therefore, Intrinsa should not be used in women on concomitant CEE (see sections 4.2 and
Slovenian: Zato zdravila Intrinsa ne smejo uporabljati ženske, ki sočasno prejemajo CEE (glejte poglavji 4.2 in 5.1).
English: However, this is not expected from the low dose of testosterone delivered by the Intrinsa patch.
Slovenian: Vendar teh učinkov pri nizkih odmerkih testosterona, ki se sproščajo iz obližev Intrinsa, ni pričakovati.
English: Renal impairment No studies have been conducted in patients with renal insufficiency.
Slovenian: Okvarjeno delovanje ledvic Študij pri bolnikih z ledvično insuficienco niso izvajali.
English: Intrinsa should not be used in naturally menopausal women Efficacy and safety of Intrinsa in naturally menopausal women with HSDD on concomitant estrogen, with or without progestogen, have not been evaluated.
Slovenian: Učinkovitosti in varnosti zdravila Intrinsa pri ženskah po naravni menopavzi s HSDD, ki sočasno uporabljajo estrogen, s progestagenom ali brez njega, niso ocenili.
English: The mode of administration of Intrinsa makes overdose unlikely.
Slovenian: Zaradi načina odmerjanja zdravila Intrinsa preveliko odmerjanje ni verjetno.
English: Fertility No data is available of the effect of Intrinsa on fertility.
Slovenian: Plodnost Ni podatkov o vplivu zdravila Intrinsa na sposobnost razmnoževanja.
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 Intrinsa.
Slovenian: Odstranite vse obliže in se posvetujte z zdravnikom ali s farmacevtom o tem, kako nadaljevati zdravljenje z zdravilom Intrinsa.
English: If an adverse reaction occurred at a higher frequency in the integrated phase III studies (Intrinsa patients n=1,498, placebo patients n=1,297), this frequency is reported in the table.
Slovenian: Intrinsa: n = 1.498, bolnice, ki so prejemale placebo: n = 1.297), je pogostnost navedena v tabeli.
English: Breast pain Breast cyst, clitoral engorgement, enlarged clitoris, genital pruritus, vaginal burning sensation
Slovenian: Motnje reprodukcije in dojk bolečine v dojkah cista na dojki, nabrekanje klitorisa, povečanje klitorisa, genitalni pruritus, občutek pečenja v vagini
English: The appropriate use and restrictions associated with estrogen therapy should be considered before Intrinsa therapy is initiated and during routine re-evaluation of treatment.
Slovenian: Pred zdravljenjem z zdravilom Intrinsa in med rutinskimi ponovnimi ocenitvami zdravljenja je treba upoštevati ustrezno uporabo in omejitve, povezane z zdravljenjem z estrogenom.
English: On removal of an Intrinsa patch, testosterone serum concentrations return to near baseline values within 12 hours due to its short terminal exponential half-life (approximately 2 hours).
Slovenian: Po odstranitvi obliža Intrinsa se zaradi kratke končne eksponentne razpolovne dobe (približno 2 uri) koncentracije testosterona v serumu v 12 urah vrnejo skoraj na izhodiščno vrednost.
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 Intrinsa.
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 Intrinsa.
English: There were no significant differences in serum estradiol and estrone levels in patients treated with Intrinsa for up to 52 weeks compared to baseline.
Slovenian: ki so prejemale zdravljenje z zdravilom Intrinsa, po 52 tednih ni bilo pomembnih razlik v koncentracijah estradiola in estrona, v primerjavi z izhodiščno vrednostjo.
English: Marketing Authorisation Holder Warner Chilcott UK Limited Old Belfast Road Millbrook, Larne
Slovenian: Imetnik dovoljenja za promet z zdravilom Warner Chilcott UK Limited Old Belfast Road
English: DHT concentrations increased in parallel with testosterone concentrations during Intrinsa treatment.
Slovenian: Med zdravljenjem z zdravilom Intrinsa se koncentracije DHT povečajo skupaj s koncentracijami testosterona.
English: Agitation, anxiety
Slovenian: - vznemirjenost - anksioznost - motnje pozornosti
English: Intrinsa is intended for use by women up to the age of 60 years who: - have a low sexual desire which is causing distress or concern, and - have had both of their ovaries removed, and - have had their womb removed (hysterectomy), and - are receiving estrogen therapy.
Slovenian: imajo nizko spolno željo, ki povzroča stisko ali skrbi in so jim odstranili oba jajčnika in so jim odstranili maternico (histerektomija) in prejemajo zdravljenje z estrogenom.
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: ki so jih ločili glede na naslednje značilnosti: starost (vse podskupine do starosti 65 let), telesna masa
English: HOW TO STORE INTRINSA
Slovenian: SHRANJEVANJE ZDRAVILA INTRINSA
English: Hepatic impairment No studies have been conducted in patients with hepatic impairment.
Slovenian: Okvarjeno delovanje jeter Študij pri bolnikih z okvarjenim delovanjem jeter niso izvajali.
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 Intrinsa patch.
Slovenian: Edem je lahko resen zaplet zaradi visokih odmerkov testosterona, vendar pa se ne pričakuje, da bi nastal zaradi nizkih ravni testosterona, ki jih vnesete z obližem zdravila Intrinsa, če imate raka sluznice maternice (rak endometrija), morate vedeti, da je na voljo le malo informacij o učinkih testosterona na sluznico maternice (endometrij).
English: What Intrinsa contains
Slovenian: DODATNE INFORMACIJE Kaj vsebuje zdravilo Intrinsa
English: Intrinsa 300 micrograms/24 hours transdermal patch Testosterone
Slovenian: Intrinsa 300 mikrogramov/24 ur transdermalni obliž Testosteron
English: A responder analysis of the pivotal phase II and III studies showed significant improvements in all three major clinical endpoints versus placebo in patients on concomitant transdermal and oral non-CEE estrogens.
Slovenian: ki so sočasno prejemale transdermalne in druge peroralne estrogene kot CEE, pokazala pomembno izboljšanje v primerjavi s placebom pri vseh treh kliničnih končnih točkah.
English: NAME OF THE MEDICINAL PRODUCT Intrinsa 300 micrograms/24 hours transdermal patch
Slovenian: IME ZDRAVILA Intrinsa 300 mikrogramov/24 ur transdermalni obliž
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Intrinsa 300 micrograms/24 hours transdermal patch Testosterone
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Intrinsa 300 mikrogramov/24 ur transdermalni obliž Testosteron
English: The significance of these data for the use of Intrinsa in patients is not known.
Slovenian: Pomen teh podatkov za uporabo zdravila
English: Therefore, based on the safety profile in Intrinsa, which requires the submission of 6 monthly PSURs, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.
Slovenian: odločil, da mora imetnik dovoljenja za promet z zdravilom čez 5 let predložiti eno dodatno podaljšanje dovoljenja za promet z zdravilom.
English: 6.2 Incompatibilities
Slovenian: 4.3 Kontraindikacije
English: Breastfeeding Intrinsa must not be used by breast-feeding women.
Slovenian: Previdnostni ukrepi Zdravila Intrinsa se ne sme uporabljati pri ženskah po naravni menopavzi
English: Intrinsa is not recommended in naturally
Slovenian: Uporaba zdravila Intrinsa se ne priporoča ženskam po naravni menopavzi.
English: - Keep out of the reach and sight of children - Do not use Intrinsa after the expiry date which is stated on the carton and sachet after EXP.
Slovenian: Zdravila Intrinsa ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in zaščitni vrečici poleg oznake EXP/Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: NAME OF THE MEDICINAL PRODUCT Intrinsa 300 micrograms/24 hours transdermal patch Testosterone
Slovenian: NAVODILO ZA UPORABO Intrinsa 300 mikrogramov/24 ur transdermalni obliž Testosteron
English: They are usually reversible if Intrinsa treatment is
Slovenian: Če se zdravljenje z zdravilom Intrinsa prekine, so ti neželeni učinki navadno prehodni.
English: Insomnia
Slovenian: Intrinsa.
English: Always use Intrinsa exactly as your doctor has told you.
Slovenian: Pri uporabi zdravila Intrinsa natančno upoštevajte zdravnikova navodila.
English: Nasal congestion, throat tightness
Slovenian: Psihiatrične motnje nespečnost razdražljivost, tesnoba
English: Oral use blister OPA/alu/PVC/alu 7 tablets
Slovenian: 3 mg filmsko obložena tableta peroralna uporaba pretisni omot OPA/alu/PVC/alu
English: 3 mg
Slovenian: 7 tablet
English: Lutathera lutetium (
Slovenian: Lutathera lutecijev (
English: Lu) oxodotreotide
Slovenian: Lu) oksodotreotid
English: It is a radiopharmaceutical (a medicine that emits a small amount of radioactivity).
Slovenian: Je radiofarmak (zdravilo, ki oddaja majhno količino radioaktivnosti).
English: The patient cannot leave the controlled areas until told to do so by the doctor.
Slovenian: Bolnik ne sme zapustiti nadzorovanega okolja, dokler mu tega ne dovoli zdravnik.
English: What measures are being taken to ensure the safe and effective use of Lutathera?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lutathera?
English: Lutathera must not be given to women who are pregnant or in whom pregnancy has not been excluded.
Slovenian: Zdravila Lutathera ne smejo prejemati nosečnice ali ženske, pri katerih nosečnost ni bila izključena.
English: The usual treatment involves 4 infusions 8 weeks apart, but the gap between infusions can be increased to up to 16 weeks if the patient gets severe side effects.
Slovenian: Običajno zdravljenje vključuje štiri infuzije v osemtedenskem razmiku, vendar se razmik med infuzijami lahko podaljša na do 16 tednov, če se pri bolniku pojavijo resni neželeni učinki.
English: This is a summary of the European public assessment report (EPAR) for Lutathera.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Lutathera.
English: The radioactivity it emits then kills the tumour cells it is attached to but has little effect on neighbouring cells.
Slovenian: Radioaktivnost, ki jo oddaja, nato uniči tumorske celice, na katere je vezan, na sosednje celice pa ima le malo vpliva.
English: In a main study of 229 patients with GEP-NETs that contained somatostatin receptors, patients given Lutathera lived for an average of 28 months without their disease getting worse.
Slovenian: V glavni študiji z 229 bolniki z gastroenteropankreatičnimi nevroendokrinimi tumorji, ki so vsebovali somatostatinske receptorje, so bolniki, ki so prejemali zdravilo Lutathera, v povprečju živeli 28 mesecev, ne da bi se njihova bolezen poslabšala.
English: Other common side effects affecting more than 1 in 10 patients are thrombocytopenia (low platelet counts), lymphopenia (low levels of lymphocytes, a type of white blood cell), anaemia (low red cell counts), pancytopenia (low levels of all types of blood cells), tiredness and reduced appetite.
Slovenian: Drugi pogosti neželeni učinki, ki se pojavijo pri več kot 1 bolniku od 10, so trombocitopenija (nizko število trombocitov), limfopenija (nizka raven limfocitov, vrste belih krvnih celic), anemija (nizko število rdečih krvnih celic), pancitopenija (nizka raven vseh vrst krvnih celic), utrujenost in zmanjšan apetit.
English: Other information about Lutathera
Slovenian: Druge informacije o zdravilu Lutathera
English: The company that markets Lutathera will put in place an educational programme for patients to ensure they understand the risk of radioactivity and precautions they should take to limit exposure to themselves and people around them.
Slovenian: Družba, ki trži zdravilo Lutathera, bo pripravila izobraževalni program za bolnike, s katerim bo zagotovila, da bodo dobro razumeli tveganja radioaktivnosti in previdnostne ukrepe, ki jih morajo upoštevati, da omejijo izpostavljenost sebe in ljudi okrog sebe.
English: It must also not be given to patients with severely reduced kidney function.
Slovenian: Prav tako se ne sme uporabljati pri bolnikih s hudo okvaro delovanja ledvic.
English: Before starting treatment, the doctor will have checked that the patient's tumours have somatostatin receptors on their cell surfaces.
Slovenian: Pred začetkom zdravljenja bo zdravnik preveril, ali imajo bolnikovi tumorji na celični površini somatostatinske receptorje.
English: For further information, including information on the precise method for giving the infusions, see the package leaflet.
Slovenian: Za več informacij, vključno z informacijami o konkretnem načinu dajanja infuzij, glejte navodilo za uporabo.
English: Because Lutathera emits some radioactivity, it is only used in special controlled areas and must be handled and given to patients by qualified personnel.
Slovenian: Ker zdravilo Lutathera oddaja določeno količino radioaktivnosti, se daje samo v posebnih, nadzorovanih okoljih, z njim pa mora ravnati in ga bolnikom dajati usposobljeno osebje.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Lutathera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Lutathera je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The patient should also be given an infusion of an amino acid solution which helps protect their kidneys.
Slovenian: Bolnik mora prejeti tudi infuzijo raztopine aminokislin, ki zaščiti njegove ledvice.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lutathera have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Lutathera upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: What benefits of Lutathera have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Lutathera izkazalo v študijah?
English: The most common side effects seen with Lutathera treatment are nausea and vomiting, which occurred at the start of the infusions in around half of patients and may be related to the amino acid infusion.
Slovenian: Najpogostejša neželena učinka zdravljenja z zdravilom Lutathera sta navzea in bruhanje, ki sta se pojavila na začetku dajanja infuzij pri približno polovici bolnikov in sta morda povezana z infuzijo aminokislin.
English: It is not intended to provide practical advice on how to use Lutathera.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Lutathera is used is to treat GEP-NETs that cannot be removed by surgery, have spread to other parts of the body or are not responding to treatment.
Slovenian: Zdravilo Lutathera se uporablja za zdravljenje gastroenteropankreatičnih nevroendokrinih tumorjev, ki jih ni mogoče kirurško odstraniti, ki so se že razširili na druge dele telesa ali se ne odzivajo na zdravljenje.
English: What is Lutathera and what is it used for?
Slovenian: Kaj je zdravilo Lutathera in za kaj se uporablja?