FrancophonIA/ELRC3.0 huggingface dataset:
English: It states that “for a new combination of oestrogen/progestogen (e.g. new administration scheme or new strength) or a new progestogen in a fixed combination, endometrial data are required, except for a known progestogen, with the same administration route and the same progestogen dose as in known fixed combination with oestrogen, where data on endometrial safety can be extrapolated from the fixed combination if exposure to the oestrogen is similar or lower”.
Slovenian: Smernice navajajo, da so „za novo kombinacijo estrogena/progestogena (npr. nova shema dajanja zdravila ali nova jakost) ali novo količino progestogena v fiksni kombinaciji potrebni podatki o endometriju, z izjemo za znane količine progestogena ob isti poti uporabe in istemu odmerku progestogena kot pri znani fiksni kombinaciji z estrogenom, kjer je podatke o endometrijski varnosti mogoče ekstrapolirati iz fiksne kombinacije, če je izpostavljenost estrogenu podobna ali nižja“.
English: Taking into account the points above, the some CHMP were of the opinion that endometrial safety of Activelle 0.5 mg/0.1 mg could not be supported by the KLIM/PD/7/USA trial.
Slovenian: Ob upoštevanju zgoraj naštetih točk so bili nekateri člani CHMP mnenja, da endometrijske varnosti zdravila Activelle 0,5 mg/0,1 mg ni mogoče podpreti s preskušanjem KLIM/PD/7/USA.
English: Very common side effects • Vaginal bleeding.
Slovenian: Zelo pogosti neželeni učinki • krvavitev iz nožnice
English: USER INSTRUCTIONS
Slovenian: NAVODILO ZA UPORABNICO
English: If you want to stop taking Activelle, talk to your doctor first.
Slovenian: Če želite opustiti jemanje zdravila Activelle, se najprej posvetujte z zdravnikom.
English: It substitutes for the loss of oestrogen production in menopausal women, and alleviates menopausal symptoms.
Slovenian: Nadomešča upad nastajanja estrogena pri ženskah v menopavzi in blaži menopavzne simptome.
English: Amenorrhoea (no bleeding or spotting) was seen in 89% of the women in month 6 of treatment.
Slovenian: V 6. mesecu zdravljenja je imelo amenorejo (nobenih krvavitev ali krvavkastega izcedka) 89 % žensk.
English: Therefore, it is uncertain whether these findings also extend to other HRT products.
Slovenian: Zato ni gotovo, ali ti izsledki veljajo tudi za druga zdravila za HNZ.
English: You can only turn the transparent dial after the tablet in the opening has been removed.
Slovenian: Prozorno kazalno ploščico je mogoče zavrteti naprej šele, ko ste tableto vzeli iz odprtine.
English: According to the guideline on clinical investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in postmenopausal women (EMEA/CHMP/021/97 Rev. 1) endometrial safety has to be demonstrated unequivocally before approval.
Slovenian: Skladno s smernicami za klinično preskušanje zdravil za hormonsko nadomestno zdravljenje simptomov pomanjkanja estrogena pri ženskah v obdobju postmenopavze (EMEA/CHMP/021/97 Rev. 1) je treba pred odobritvijo nedvoumno dokazati endometrijsko varnost.
English: Moreover, one endometrial sample from a woman who received the E2 1 mg/NETA 0.1 mg combination was evaluated as “disordered proliferative” state.
Slovenian: Poleg tega so enega od vzorcev endometrija, odvzetega ženski, ki je prejemala kombinacijo 1 mg E2/0,1 mg NETA, ocenili kot „moteno proliferativno“ stanje.
English: Adding a progestagen, such as in Activelle, greatly reduces this increased risk.
Slovenian: Dodatek progestagena, kot ga vsebuje zdravilo Activelle, močno zmanjša to povečanje tveganja.
English: Patients with terminal renal insufficiency should be closely observed, since it is expected that the level of circulating active ingredients in Activelle will increase.
Slovenian: Bolnice s končno odpovedjo ledvic je treba natančno spremljati, ker je treba pričakovati, da se bo koncentracija učinkovin zdravila Activelle v obtoku povečala.
English: In addition to the above mentioned adverse drug reactions, those presented below have been spontaneously reported, and are by an overall judgement considered possibly related to Activelle 1 mg/0.5 mg treatment.
Slovenian: Poleg zgoraj navedenih neželenih učinkov na zdravilo so bile spontano prijavljene spodaj opisane; po splošni presoji so lahko povezane z uporabo zdravila Activelle 1 mg/0,5 mg.
English: There was no significant difference in the rate of endometrial hyperplasia of continuous oestrogenprogestogen combinations in comparison with placebo after 12 and 24 months.
Slovenian: Razlike v stopnji hiperplazije endometrija med kontinuiranimi kombinacijami estrogena in progestogena v primerjavi s placebom po 12 in 24 mesecih niso bile pomembne.
English: The risk seems to be higher for women, who use oestrogen in combination with progestagen as compared to oestrogen alone.
Slovenian: Kot kaže, je tveganje večje pri ženskah, ki uporabljajo estrogen v kombinaciji s progestagenom, kakor pri tistih, ki uporabljajo samo estrogen.
English: If more than 12 hours have gone by, start again as normal the next day.
Slovenian: Če je minilo že več kot 12 ur od tedaj, ko bi morali vzeti tableto, nadaljujte z jemanjem naslednji dan kot ponavadi.
English: Animal studies have shown embryo-lethal effects of estradiol or estradiol valerate even at relatively low doses; malformations of the urogenital tract and feminization of male fetuses were observed.
Slovenian: Pri eksperimentalnih živalih sta estradiol ali estradiolvalerat že v razmeroma majhnih odmerkih učinkovala embrioletalno; opažali so malformacije urogenitalnega trakta in feminizacijo moških plodov.
English: However, the some members of the CHMP noted that this trial failed to demonstrate the endometrial safety of the combination of E2 1 mg and NETA 0.1 mg, as the upper limit of the two-sided 95% confidence interval of the observed frequency of endometrial hyperplasia was 2.90% and then exceeded the acceptable limit of 2%.
Slovenian: Vendar pa so nekateri člani CHMP opazili, da s tem preskušanjem niso uspeli dokazati endometrijske varnosti kombinacije 1 mg E2 in 0,1 mg NETA, ker je bila zgornja meja dvostranskega 95 % intervala zaupanja ugotovljene pogostosti hiperplazije endometrija enaka 2,90 % in je tako presegala sprejemljivo mejo 2 %.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Slovenian: Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: Active substances that inhibit the activity of hepatic microsomal drug metabolizing enzymes e.g. ketoconazole, may increase circulating levels of the active substances in Activelle.
Slovenian: Učinkovine, ki zavrejo aktivnost jetrnih mikrosomskih encimov, udeleženih v presnovi zdravil, npr. ketokonazol, lahko povečajo koncentracijo učinkovin zdravila Activelle v obtoku.
English: HRT, especially oestrogen-progestagen combined treatment, may increase the density of mammographic images which may adversely affect the radiological detection of breast cancer.
Slovenian: HNZ, zlasti kombinirano estrogensko-progestagensko zdravljenje, povečuje gostoto na mamografskih posnetkih; to lahko neugodno vpliva na radiološko odkrivanje raka na dojki.
English: Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Denmark
Slovenian: Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Danska
English: • Porphyria
Slovenian: • porfirija.
English: • Medicines used for tuberculosis (such as rifampicin, rifabutin)
Slovenian: • zdravila proti tuberkulozi (npr. rifampicin, rifabutin),
English: A randomised placebo-controlled trial, the Women's Health Initiative study (WHI), and epidemiological studies, including the Million Women Study (MWS), have reported an increased risk of breast cancer in women taking oestrogens, oestrogen-progestagen combinations or tibolone for HRT for several years (see section 4.8).
Slovenian: V randomiziranem, s placebom kontroliranem preskušanju WHI (Women's Health Initiative) in v epidemioloških študijah, vključno s študijo MWS (Million Women Study), so ugotovili večje tveganje za raka na dojki pri ženskah, ki so za HNZ več let jemale estrogene, estrogensko-progestagenske kombinacije ali tibolon (glejte poglavje 4.8).
English: - on the level of endometrial hyperplasia, the trial on the 1 mg estradiol/0.1 mg NETA product indicates an adequate protective effect, albeit with an upper confidence limit of the hyperplasia rate estimate exceeding recommendation in the guideline.
Slovenian: - o stopnji hiperplazije endometrija, preskušanje z zdravilom, ki vsebuje 1 mg estradiola/0,1 mg NETA, kaže primeren zaščitni učinek, čeprav ocena zgornje meje zaupanja za stopnjo hiperplazije presega priporočilo v smernicah,
English: 1 x 28 film-coated tablets 3 x 28 film-coated tablets
Slovenian: 1 x 28 filmsko obloženih tablet 3 x 28 filmsko obloženih tablet
English: HRT is associated with a higher relative risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism.
Slovenian: HNZ je povezano z večjim relativnim tveganjem za vensko trombembolijo (VTE), tj. globoko vensko trombozo ali pljučno embolijo.
English: For other HRT products there are only limited data from randomised controlled trials examining effects in cardiovascular morbidity or mortality.
Slovenian: O drugih zdravilih za HNZ je le malo podatkov iz randomiziranih kontroliranih preskušanj, ki so proučevala učinke na srčnožilno obolevnost ali umrljivost.
English: • Systemic lupus erythematosus
Slovenian: • sistemski eritematozni lupus,
English: • Epilepsy
Slovenian: • epilepsija,
English: Ritonavir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones.
Slovenian: Ritonavir in nelfinavir, ki sta sicer znana kot močna zaviralca, med sočasno uporabo s steroidnimi hormoni delujeta nasprotno, kot induktorja.
English: At high doses of norethisterone embryo-lethal effects were observed.
Slovenian: Po velikih odmerkih noretisterona so opažali embrioletalne učinke.
English: Data on a limited number of exposed pregnancies indicate adverse effects of norethisterone on the foetus.
Slovenian: Podatki, zbrani pri omejenem številu nosečnic, izpostavljenih zdravilu, kažejo na možnost škodljivih vplivov noretisterona na plod.
English: In women transferring from sequential HRT regimens, treatment should start right after their withdrawal bleeding has ended.
Slovenian: Pri ženskah, ki preidejo s sekvenčnih shem za HNZ, se mora zdravljenje začeti takoj po koncu odtegnitvene krvavitve.
English: If you forget to take Activelle
Slovenian: Če ste pozabili vzeti zdravilo Activelle
English: - Pooled data from several recently authorized sequential and continuous oestrogen/progestin HRT combinations in Europe show that the incidence of hyperplasia or more serious adverse endometrial outcomes was approximately 0.26% during the first year of treatment, that is well under the observed hyperplasia incidence of 0.8% in the KLIM/PD/7/USA trial.
Slovenian: - Podatki, zbrani iz več v Evropi nedavno odobrenih kombinacij estrogena/progestina za sekvenčno ali kontinuirano HNZ kažejo, da je pojavnost hiperplazije ali resnejših neželenih endometrijskih rezultatov znašala približno 0,26 % v prvem letu zdravljenja, kar je precej nižje od pojavnosti hiperplazije v preskušanju KLIM/PD/7/USA, kjer je ta znašala 0,8 %.
English: a. the proliferative effect of unopposed oestrogens on the endometrium is dose-dependant, b. this proliferative effect of unopposed oestrogens is time-dependant, especially for high oestrogen doses, c. continuous combined therapy over long duration is more protective that sequential therapy in the prevention of endometrial hyperplasia or carcinoma.
Slovenian: a. proliferativni učinek estrogenov, ki niso modificirani z učinki progestogena, na endometrij je odvisen od odmerka, b. ta proliferativni učinek estrogenov, ki niso modificirani z učinki progestogena, je časovno pogojen še posebej pri visokih odmerkih estrogena, c. dolgoročna kontinuirana kombinirana terapija omogoča pri preprečevanju endometrijske hiperplazije ali karcinoma večjo zaščito kot sekvenčna terapija.
English: It undergoes first-pass metabolism in the liver and other enteric organs, and reaches a peak plasma concentration of approximately 2.4 ng/ml CV 41 % (after administration of two Activelle tablets) within 0.5 -1.5 hour.
Slovenian: Podvržen je presnovi prvega prehoda v jetrih in drugih enteričnih organih; največjo koncentracijo v plazmi - približno 2,4 ng/ml (KV 41 %) - doseže (po uporabi dveh tablet Activelle) v 0,5 do 1,5 ure.
English: The sample size of the KLIM/PD/11/USA study may be considered too small to draw any definite conclusion regarding endometrial safety of E2 0,5 mg, even for 2 yeartreatment.
Slovenian: Velikost vzorca v študiji KLIM/PD/11/USA lahko razumemo kot premajhno, da bi lahko prišli do jasnih zaključkov glede endometrijske varnosti 0,5 mg E2, tudi če zdravljenje traja dve leti.
English: - The endometrial safety data is not in accordance with the European guideline on clinical investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in post menopausal women (EMEA/CHMP/021/97 rev1).
Slovenian: - Podatki o endometrijski varnosti niso skladni z evropskimi smernicami o kliničnem preskušanju zdravil za hormonsko nadomestno zdravljenje simptomov pomanjkanja estrogena pri ženskah v postmenopavzalnem obdobju (EMEA/CHMP/021/97 rev 1).
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila Activelle, se posvetujte z zdravnikom ali s farmacevtom.
English: • Psychiatric disorders: Insomnia, anxiety, libido decreased, libido increased
Slovenian: • Psihiatrične motnje: nespečnost, anksioznost, zmanjšanje libida, zvečanje libida
English: According to data from epidemiological studies, the best estimate of the risk is that for women not using HRT about 5 in every 1000 are expected to have endometrial cancer diagnosed between the ages of 50 and 65.
Slovenian: Po podatkih epidemioloških študij je najboljša ocena tveganja, da je mogoče med neuporabnicami HNZ pričakovati diagnosticiranega raka na endometriju v starosti od 50 do 65 let pri približno 5 na 1.000 žensk.
English: You may be at risk of having a blood clot if you get:
Slovenian: Nevarnost, da imate krvni strdek, obstaja, če se vam pojavijo:
English: This risk increases with the duration of intake of HRT, but returns to normal within a few (at most five) years of having stopped HRT.
Slovenian: Tveganje se povečuje s trajanjem HNZ, a se normalizira v nekaj (največ petih) letih po koncu HNZ.
English: Taking the above arguments on board, the majority of CHMP members were of the opinion that the data presented demonstrate the importance of types of oestrogen-progestogen regimens for the association with endometrial cancer risk.
Slovenian: Večina članov CHMP je bila ob upoštevanju zgoraj navedenih argumentov mnenja, da predstavljeni podatki kažejo pomembnost vrst režimov zdravljenja s kombinacijo estrogena in progestogena za povezavo s tveganjem pojava raka endometrija.
English: However, the CHMP noted that the strengths studied did not include E2 0.5 mg/NETA 0.1 mg.
Slovenian: Vendar pa je CHMP ugotovil, da raziskovane jakosti niso vključevale 0,5 mg E2/0,1 mg NETA.
English: - For the calculation of the incidence rate of endometrial hyperplasia and the two-sided 95 % confidence interval, in case of insufficient tissue obtained by biopsy and endometrial thickness ≥ 5 mm, the biopsy should be repeated or patient excluded from the calculation.
Slovenian: - Za izračun ravni pojavnosti hiperplazije endometrija in dvostranskega 95 % intervala zaupanja je treba biopsijo ponoviti ali bolnico izključiti iz izračunov, če pri biopsiji niso zajeli zadostne količine tkiva in je debelina endometrijske plasti ≥ 5 mm.
English: For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life.
Slovenian: Za zdravljenje pomenopavznih simptomov je dovoljeno HNZ uvesti le, če ti simptomi neugodno vplivajo na kakovost življenja.
English: - the addition of a progestogen for 12 days of a monthly treatment cycle is considered sufficient to protect the endometrium from an excess risk of hyperplasia (and ultimately endometrial cancer), and even longer periods, and a continuous combination will confer increasing protective effects.
Slovenian: - da se dodajanje progestogena 12 dni ali dlje med celotnim mesečnim ciklom zdravljenja upošteva kot zadostno za zaščito endometrija pred čezmernim tveganjem pojava hiperplazije (in v končni fazi raka endometrija), ter kontinuirana kombinacija omogočita večanje zaščitnih učinkov,
English: • If any of your immediate family has had breast cancer, or other cancers related to oestrogen
Slovenian: • če je kdo od vaših bližnjih sorodnikov imel raka na dojki ali druge vrste raka, povezane z estrogenom (rak na endometriju),
English: Physical (including pelvic and breast) examination should be guided by this and, by the contraindications and warnings for use.
Slovenian: Klinični pregled (vključno z ginekološkim pregledom in pregledom dojk) se mora opirati na tako dobljene podatke ter na kontraindikacije in opozorila za uporabo.
English: However, if you are switching from an HRT product where you have monthly bleeding, start your treatment straight after the bleeding has ended.
Slovenian: Če pa ste doslej uporabljali zdravilo za HNZ, pri katerem ste imeli mesečne krvavitve, začnite zdravljenje z zdravilom Activelle takoj po koncu krvavitve.
English: DATE OF REVISION OF THE TEXT [To be completed nationally]
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA [Izpolni država članica]
English: Do not use Activelle after the expiry date which is stated on the label and outer carton after “EXP”.
Slovenian: Zdravila Activelle ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini za oznako "Upor.
English: • If you have or have had breast cancer, or if it is suspected
Slovenian: • imate ali ste kdaj imeli raka na dojki, ali če obstaja sum nanj,
English: In conclusion, the CHMP agreed that the proliferative effect of unopposed oestrogens on endometrium is dependent on the dose of oestrogens.
Slovenian: V zaključku se je CHMP strinjal, da so proliferativni učinki estrogenov, ki niso modificirani z učinki progestogena, na endometrij odvisni od odmerka estrogenov.
English: • If you develop yellow skin or eyes (jaundice) or other liver problems
Slovenian: • vam porumenijo koža ali očesna beločnica (zlatenica) ali se pojavijo druge težave z jetri,
English: • Diabetes mellitus with or without vascular involvement
Slovenian: • diabetes mellitus s prizadetostjo žil ali brez nje,
English: For all HRT, an excess risk becomes apparent within a few years of use and increases with duration of intake but returns to baseline within a few (at most five) years after stopping treatment.
Slovenian: Dodatno tveganje se pri vseh HNZ pokaže v nekaj letih uporabe in narašča s trajanjem jemanja, a se v nekaj (največ petih) letih po koncu zdravljenja vrne na izhodiščno raven.
English: • Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)
Slovenian: • aktivna ali nedavna arterijska trombembolična bolezen (npr. angina pektoris, miokardni infarkt),
English: Estonia - Activelle low 0,5 mg/0,1 mg õhukese polümeerikattega tablett Finland - Activelle 0,5 mg/0,1 mg tabl.
Slovenian: Estonija - Activelle low 0,5 mg/0,1 mg õhukese polümeerikattega tablett Finska - Activelle 0,5 mg/0,1 mg tabl.
English: • Otosclerosis
Slovenian: • otoskleroza.
English: • Swelling of arms and legs (peripheral oedema)
Slovenian: • otekanje rok in nog (periferni edemi)
English: If pregnancy occurs during medication with Activelle, treatment should be withdrawn immediately.
Slovenian: Če ženska med uporabo zdravila Activelle zanosi, je treba zdravljenje takoj prekiniti.
English: What Activelle is and what it is used for Before you take Activelle How to use Activelle Possible side effects How to store Activelle Further information
Slovenian: Kaj je zdravilo Activelle in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Activelle Kako jemati zdravilo Activelle Možni neželeni učinki
English: • Previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism)
Slovenian: • predhodna idiopatska ali trenutna venska trombembolija (globoka venska tromboza, pljučna embolija),
English: There was no evidence of a difference in risk between the different routes of administration.
Slovenian: Razlik v tveganju pri različnih načinih uporabe niso ugotovili.
English: There is no consensus about the possible role of varicose veins in VTE.
Slovenian: O morebitni vlogi varikoznih ven pri VTE ni soglasja.
English: CONTENT BY WEIGHT, BY VOLUME OR BY UNIT 28 film-coated tablets
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 28 filmsko obloženih tablet
English: • If you get a migraine-type headache for the first time
Slovenian: • se vam prvič pojavi migrenski glavobol,
English: Important information about some of the ingredients of Activelle: Activelle contains lactose.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Activelle Zdravilo Activelle vsebuje laktozo.
English: • Nervousness
Slovenian: • živčnost
English: In a systematic review of 30 randomized controlled trials, unopposed moderate or high dose oestrogen therapy, when compared to placebo, was associated with a significant increase in rates of endometrial hyperplasia with increasing rates at longer duration of treatment (Lethaby et al. Cochrane database of systematic reviews 2004;3).
Slovenian: V sistematskem pregledu 30 randomiziranih in kontroliranih preskušanj so zmerne ali velike odmerke estrogena, ki ni modificiran z učinki progestogena, v primerjavi s placebom povezali z znatnim povečanjem ravni hiperplazije endometrija, te ravni pa so se še povečale s trajanjem zdravljenja (Lethaby et al. Cochrane, baza podatkov o sistematskih pregledih 2004;3).
English: • Investigations: Weight decreased, blood pressure increased
Slovenian: • Preiskave: zmanjšanje telesne mase, zvišanje krvnega tlaka
English: • Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal
Slovenian: • akutna bolezen jeter ali anamneza o bolezni jeter, če se testi jetrne funkcije niso normalizirali,
English: This observation is also consistent with the known pharmacodynamic effects of added progestogens on the endometrium, e.g. down regulation of oestrogen receptor (ER) levels and endometrial atrophy.
Slovenian: To je skladno tudi z znanimi farmakodinamičnimi učinki dodajanja progestogenov endometriju, npr. regulacijsko zmanjšanje ravni receptorjev za estrogen (ER) in atrofijo endometrija.
English: et al, the relationship between treatment duration and incidence of hyperplasia was also observed with the low dose of 0.3 mg CEE.
Slovenian: et al je bila pojavnost hiperplazije odvisna od trajanja zdravljenja tudi pri odmerku, ki je znašal samo 0,3 mg CEE.
English: Women with pre-existing hypertriglyceridemia should be followed closely during oestrogen replacement or hormone replacement therapy, since rare cases of large increases of plasma triglycerides leading to pancreatitis have been reported with oestrogen therapy in this condition.
Slovenian: Ženske s hipertrigliceridemijo je treba med nadomeščanjem estrogenov ali hormonskim nadomestnim zdravljenjem skrbno spremljati, ker so pri tej motnji med estrogenskim zdravljenjem opisani redki primeri velikega zvišanja trigliceridov v plazmi s posledičnim pankreatitisom.
English: • If you have systemic lupus erythematosus (SLE, autoimmune collagen disease, which may affect many organ systems)
Slovenian: • imate sistemski eritematozni lupus (avtoimunsko bolezen veziva, ki lahko prizadene številne organe).
English: The pharmacokinetics of estradiol is not influenced by norethisterone acetate.
Slovenian: Noretisteronacetat ne vpliva na farmakokinetiko estradiola.