natgillin/translations-raw huggingface dataset:
In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.
Pri vsaki bolnici je treba tveganja in koristi natančno oceniti vsaj enkrat na leto; HNZ se sme nadaljevati le, dokler koristi odtehtajo tveganja.
As well as regular check-ups with your doctor, be sure to:
Poleg rednih pregledov pri zdravniku ne pozabite:
However, a majority of CHMP members endorsed the applicant/MAH's approach to provide a very low dose alternative of combined continuous HRT.
Vendar pa je večina članov CHMP podprla pristop predlagatelja/imetnika dovoljenja za promet, ki je želel priskrbeti alternativen zelo nizek odmerek zdravila za kontinuirano kombinirano HNZ.
Before you start treatment and regularly during treatment, your doctor will evaluate whether Activelle is a suitable treatment for you.
Pred začetkom zdravljenja in redno med zdravljenjem bo ocenil, ali je zdravilo Activelle (še) primerno za vas.
Therapy should be discontinued in case a contra-indication (see section 4.3) is discovered and in the following situations:
Zdravljenje je treba prekiniti, če odkrijete kakšno kontraindikacijo (glejte poglavje 4.3) in v primeru:
The number of additional cases of breast cancer in women who use HRT is broadly similar for women who start HRT irrespective of age at start of use (between the ages of 45-65) (see section 4.4).
Število dodatnih primerov raka na dojki pri ženskah, ki uporabljajo HNZ, je na splošno podobno pri ženskah, ki začnejo HNZ, ne glede na starost na začetku uporabe (v starosti od 45 do 65 let) (glejte poglavje 4.4).
How to take the first tablet Break the plastic tab and tip out the first tablet.
Uporaba prve tablete Odlomite plastično zaporo in iztresite prvo tableto.
- The proportion of proliferative endometrium (71%) was higher, on the contrary the proportion of atrophic endometrium was lower (19%) than expected for a continuous combination.
- Delež proliferacijskega endometrija (71 %) je bil večji, v nasprotju s tem pa je bil delež atropičnega endometrija nižji (19 %) od vrednosti, pričakovane za kombinacijo za kontinuirano uporabo.
Post marketing experience:
Pomarketinške izkušnje
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV / IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
• If bleeding continues after stopping HRT.
• se krvavitve nadaljujejo po prenehanju uporabe HNZ.
Your doctor should aim to prescribe the lowest dose for the shortest time that gives you relief from your symptoms.
Zdravnik si mora prizadevati, da vam predpiše najnižji odmerek, ki zagotavlja ublažitev simptomov, za najkrajši čas.
The most important metabolites are isomers of 5α-dihydro-NET and of tetrahydro-NET, which are excreted mainly in the urine as sulfate or glucuronide conjugates.
Najpomembnejši presnovki so izomeri 5α-dihidro-NET in tetrahidro-NET, ki se v glavnem izločijo v urinu kot sulfatni ali glukuronidni konjugati.
Using Activelle with food and drink The tablets can be taken with or without food and drink.
Jemanje zdravila Activelle skupaj s hrano in pijačo Tableto lahko vzamete ne glede na obroke ali pijačo.
If you get breakthrough bleeding or spotting, it is usually nothing to worry about, especially during the first few months of taking HRT.
Če se vam pojavi vmesna krvavitev ali krvavkast izcedek, to ponavadi ni razlog za skrb, še posebej ne v prvih mesecih uporabe HNZ.
Patients should be told to contact their doctors immediately when they are aware of a potential thromboembolic symptom (e.g. painful swelling of a leg, sudden pain in the chest, dyspnea).
Bolnicam je treba naročiti, da se morajo takoj posvetovati z zdravnikom, če opazijo možne simptome trombembolije (npr. bolečo oteklost noge, nenadno bolečino v prsih, dispnejo).
Blood clots in the deep veins
Krvni strdki v globokih venah
Stop taking HRT until your doctor says you can.
Prenehajte jemati HNZ in ga ne uporabljajte, dokler vam zdravnik ne pove, da ga lahko.
For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used.
Za uvedbo in nadaljevanje zdravljenja pomenopavznih simptomov je treba uporabiti najmanjši učinkoviti odmerek in ga uporabljati najkrajši možni čas (glejte tudi poglavje 4.4).
There was evidence of a higher incidence of hyperplasia when the progestogen was given every three months compared to when the progestogen was given sequentially every month.
Prisotni so bili dokazi večje pojavnosti hiperplazije, če so progestogen dajali vsake tri mesece, v primerjavi z dajanjem progestogena sekvenčno vsak mesec.
The Cochrane review (Lethaby et al 2004) and analysis of available observational data (Anderson 2003, Beresford 97, Jain 2000, Hill 2000, Hully 98, MWS 2005, Newcomb 2003, Pike 97, Pukkala 2001, Weiderpass 99) suggest that addition of progestogen for at least 12 days per cycle reduces, but may not completely eliminate, the increased incidence of endometrial cancer caused by unopposed oestrogens; and that combined continuous HRT does not increase the risk of endometrial cancer.
Pregled, ki ga je izvedel Cochrane (Lethaby et al 2004) in analiza razpoložljivih podatkov o opazovanjih (Anderson 2003, Beresford 97, Jain 2000, Hill 2000, Hully 98, MWS 2005, Newcomb 2003, Pike 97, Pukkala 2001, Weiderpass 99) nakazujejo, da dajanje progestogena vsaj 12 dni na cikel zmanjša, vendar ne odpravi v popolnosti povečane pojavnosti raka endometrija, ki ga povzročajo estrogeni, ki niso modificirani z učinki progestogena, in da kombinirano kontinuirano HNZ ne poveča tveganja raka endometrija.
You may start treatment with Activelle on any convenient day.
Zdravljenje z zdravilom Activelle lahko začnete kateri koli dan, ki vam ustreza.
Activelle is prescribed for women who have not had their womb removed, and whose periods stopped more than a year ago.
Zdravilo Activelle je namenjeno ženskam, ki jim maternica ni bila odstranjena in menstruacij nimajo že več kot eno leto.
• If you are allergic (hypersensitive) to estradiol, norethisterone acetate or any of the other ingredients of Activelle (listed in section 6,“Further information”).
• ste alergični na (preobčutljivi za) estradiol, noretisteronacetat ali katero koli drugo sestavino zdravila Activelle (sestavine so naštete v poglavju 6, "Dodatne informacije"),
Conjugated oestrogens are excreted with the bile, where they are hydrolysed and reabsorbed (enterohepatic circulation), and mainly in urine in biologically inactive form.
Konjugirani estrogeni se deloma izločijo v žolču, pri čemer se hidrolizirajo in reabsorbirajo (enterohepatični obtok), v glavnem pa v urinu v biološko neaktivni obliki.
On the next day simply move the transparent dial clockwise one space as indicated by the arrow.
Naslednji dan preprosto premaknite prozorno kazalno ploščico v smeri urnega kazalca za en predalček, kot kaže puščica.
Given that there are studies demonstrating negative effects of combined HRT on the risk of breast cancer and cardiovascular complications, the general recommendation for HRT is to only treat women with severe symptoms, negatively affecting their quality of life.
Ker obstajajo študije, v katerih so uspeli dokazati negativne učinke kombiniranega HNZ na tveganje za pojav raka dojk in kardiovaskularnih zapletov, je splošno priporočilo za HNZ, da je treba zdraviti le ženske s hudimi simptomi, ki negativno vplivajo na kakovost življenja.
Effects on the skin
Vpliv na kožo
During treatment periodic check-ups are recommended of a frequency and nature adapted to the individual woman.
Med zdravljenjem so priporočljivi redni pregledi; njihovo pogostnost in naravo je treba prilagoditi posameznici.
There is a small increase in this risk for women who have been using HRT for more than 5 years compared with women of the same age who have never used HRT.
Tveganje je malenkost večje pri ženskah, ki so HNZ uporabljale več kot 5 let, kakor pri ženskah enake starosti, ki nikoli niso uporabljale HNZ.
Other medicines may increase the effects of Activelle: • Medicines containing ketoconazole (a fungicide).
Nekatera druga zdravila lahko povečajo učinke zdravila Activelle: • zdravila, ki vsebujejo ketokonazol (učinkovina proti glivicam).
After administration of two Activelle tablets, the average peak plasma concentration was 24 pg/ml (CV 38 %).
Po uporabi dveh tablet Activelle je bila povprečna plazemska koncentracija 24 pg/ml (KV 38 %).
It is not known whether these results also applies to women younger than 65 years when starting the treatment or to women taking other HRT preparations.
Ni znano, ali ti izsledki veljajo tudi za ženske, ki so na začetku zdravljenja mlajše od 65 let, oz. za ženske, ki jemljejo druga zdravila za HNZ.
It corresponds to abnormal endometrium and distinction from hyperplasia is not so clear.
Ustreza nenormalnemu endometriju, razlika med njim in hiperplazijo pa ni tako jasna.
Pregnancy and breast-feeding Do not take Activelle if you are pregnant or breast-feeding.
Nosečnost in dojenje Ne jemljite zdravila Activelle, če ste noseči ali dojite.
• If you have had a blood clot before, or have had any blood clotting problem that needed treatment with a medicine such as Warfarin
• ste imeli krvni strdek kdaj prej ali ste imeli kakršno koli težavo s strjevanjem krvi, ki je zahtevala zdravljenje z zdravili, kakršno je varfarin,
If you ever have had angina or heart attack, you should talk to your doctor about the risks and benefits of HRT.
Če ste kdaj imeli angino pektoris ali srčni infarkt, se morate z zdravnikom pogovoriti o tveganjih in koristih HNZ.
Move the dial every day
Vsak dan zavrtite kazalno ploščico
Oestrogens may cause fluid retention, and therefore patients with cardiac or renal dysfunction should be carefully observed.
Estrogeni lahko povzročijo zastajanje tekočine, zato je treba bolnice z motenim delovanjem srca ali ledvic skrbno spremljati.
Like all medicines, Activelle can have side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Activelle neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
If you have an intolerance to some sugars, contact your doctor before taking Activelle.
Če imate intoleranco za nekatere sladkorje, se pred začetkom jemanja zdravila Activelle posvetujte z zdravnikom.
• If you are very overweight
• ste pretežki,
If breakthrough bleeding or spotting appears after some time on therapy, or continues after treatment has been discontinued, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.
Če se vmesna krvavitev ali krvavkast izcedek pojavi po določenem času zdravljenja oz. se nadaljuje po prekinitvi zdravljenja, je treba ugotoviti razlog; takšno ugotavljanje lahko vključuje biopsijo endometrija za izključitev endometrijskega malignoma.
• For 1000 current or recent users of HRT, the number of additional cases during the corresponding period will be o For users of oestrogen-only replacement therapy
• Na 1.000 žensk, ki trenutno uporabljajo HNZ ali so ga uporabljale nedavno, bo število dodatnih primerov v ustreznem obdobju Za uporabnice zgolj estrogenskega nadomestnega zdravljenja
In the present study, 7 samples had insufficient tissue and endometrial thickness > 4mm (the cut-off point for endometrial thickness was 4 mm).
V trenutni študiji sedem vzorcev tkiva ni bilo ustreznih, saj so bili debeli manj kot 4 mm (točka reza za endometrijsko debelino je bila 4 mm).
Where prolonged immobilisation is liable to follow elective surgery, particularly abdominal or orthopaedic surgery to the lower limbs, consideration should be given to temporarily stopping HRT four to six weeks earlier, if possible.
Če je verjetno, da bo elektivni operaciji, zlasti trebušni operaciji ali ortopedski operaciji spodnjih udov, sledila dolgotrajna imobilizacija, je treba razmisliti o prehodni prekinitvi HNZ od štiri do šest tednov prej, če je mogoče.
Those women already on anticoagulant treatment require careful consideration of the benefit-risk of use of HRT.
Pri ženskah, ki že prejemajo antikoagulantno zdravljenje, je treba natančno pretehtati koristi in tveganja HNZ.
Estradiol: The active ingredient, synthetic 17β-estradiol, is chemically and biologically identical to endogenous human estradiol.
Estradiol: zdravilna učinkovina, sintezni 17β-estradiol, je kemično in biološko identična endogenemu človeškemu estradiolu.
Activelle is not indicated during pregnancy.
Zdravilo Activelle ni indicirano med nosečnostjo.
• Pain in back or neck
• bolečine v hrbtu ali vratu
After oral administration of an Activelle tablet, norethisterone acetate is rapidly absorbed and transformed to norethisterone (NET).
Po peroralni uporabi zdravila Activelle se noretisteronacetat hitro absorbira in spremeni v noretisteron (NET).
Due to the large differences between animal species and between animals and humans preclinical results are of limited value for predicting the effect on humans.
Zaradi izrazitih razlik med živalskimi vrstami ter med živalmi in človekom je napovedna vrednost predkliničnih rezultatov glede uporabe estrogenov pri človeku omejena.
• If you have a history of blood clots (thrombosis) or have risk factors for blood clots (these risk factors and symptoms for a blood clot are listed in section 4,“Other side effects of combined
• če ste kdaj imeli krvne strdke (trombozo) ali imate dejavnike tveganja za krvne strdke (ti dejavniki tveganja in simptomi krvnih strdkov so navedeni v poglavju 4,"Drugi neželeni učinki kombiniranega HNZ"),
Activelle will not cause regular monthly bleeding, but when first starting the tablets, many women experience slight vaginal bleeding or spotting.
Zdravilo Activelle ne povzroča rednih mesečnih krvavitev, toda na začetku jemanja se pri številnih ženskah pojavi rahla krvavitev iz nožnice ali krvavkast izcedek.
Novo Nordisk Pharma Ltd Broadfield Park Brighton Road UK- RH11 9RT Crawley West Sussex
Broadfield Park Brighton Road UK- RH11 9RT Crawley West Sussex Velika Britanija
Generally recognised risk factors for VTE include a personal history or family history, severe obesity (Body Mass Index > 30 kg/m2) and systemic lupus erythematosus (SLE).
Med splošno priznanimi dejavniki tveganja za VTE so osebna ali družinska anamneza, huda debelost (indeks telesne mase > 30 kg/m2) in sistemski eritematozni lupus.
• If you have high blood pressure
• če imate visok krvni tlak,
SPECIAL STORAGE CONDITIONS Do not store above 25°C
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 25 °C.
Turn the inner disc to set the day of the week opposite the little plastic tab.
Obrnite notranjo ploščico tako, da bo dan v tednu nastavljen ob malo plastično zaporo.
If you are anxious for the risk of breast cancer, you should talk to your doctor about the risks and benefits of HRT.
Če vas skrbi zaradi tveganja za raka na dojki, se z zdravnikom pogovorite o tveganjih in koristih HNZ.
In this review, progestogen addition as continuous therapy was more effective than sequential therapy in reducing the risk of endometrial hyperplasia at longer duration of treatment.
V tem pregledu je bil dodatek progestogena kot kontinuirano zdravljenje bolj učinkovit kot sekvenčno zdravljenje pri zmanjševanju tveganja hiperplazije endometrija pri dolgoročnejšem zdravljenju.
Do not start taking Activelle:
Ne začnite jemati zdravila Activelle, če:
The objective of this study was to determine the endometrial safety of 2 years of treatment with low CEE doses (0.3, 0.45 and 0.625 mg).
Cilj te študije je bil določiti endometrijsko varnost dve leti trajajočega zdravljenja z majhnimi odmerki konjugiranih konjskih estrogenov (0,3; 0,45 in 0,625 mg).
It is not yet known whether other types of HRT increase the risk in the same way.
Ni še znano, ali tveganje na enak način povečujejo tudi druge vrste HNZ.
In the already licensed dose of Activelle, the ratio between NETA and E2 is 1:2, while this ratio is 1:5 in the new strength of Activelle.
V že odobrenem odmerku zdravila Activelle je razmerje med NETA in E2 enako 1:2, medtem ko je to razmerje v zdravilu Activelle z novo jakostjo spremenjeno v 1:5.
But contact your doctor as soon as possible:
Z zdravnikom se posvetujte čim prej, če:
Pharmacotherapeutic group: Progestogens and estrogens, fixed combinations, ATC code: G03FA01
Farmakoterapevtska skupina: gestageni in estrogeni, kombinacije, oznaka ATC: G03FA01.
You may find it helpful to make a note of any bleedings in a diary.
Koristilo vam bo, če si morebitne krvavitve zabeležite v poseben dnevnik.
After you have used all 28 tablets in a calendar pack, go straight to using the next pack.
Ko porabite vseh 28 tablet v koledarskem pakiranju, nadaljujte z naslednjim pakiranjem brez prekinitve.
One tablet should be taken orally once a day without interruption, preferably at the same time every day.
Tablete je treba jemati peroralno, po eno tableto enkrat na dan, brez prekinitve in po možnosti vsak dan ob istem času.
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in women more than one year after menopause.
Hormonsko nadomestno zdravljenje (HNZ) simptomov pomanjkanja estrogenov pri ženskah, ki so več kot eno leto po menopavzi.
However, some CHMP members were of the opinion that the data provided are insufficient to support that it is not the case with 0.5 mg E2.
Vendar pa so bili nekateri člani CHMP mnenja, da predloženi podatki niso zadostni za podporo trditvi, da tako ne bo tudi pri odmerku 0,5 mg E2.
One randomised controlled trial and epidemiological studies found a two- to threefold higher risk for users compared with non-users.
Eno randomizirano kontrolirano preskušanje in epidemiološke študije so pri uporabnicah ugotovile dva- do trikrat večje tveganje kot pri neuporabnicah.
Dementia
Demenca
Medical examination/follow-up
Zdravniški pregled in spremljanje
If any of the following applies to you, talk to your doctor.
Če kaj od naštetega velja za vas, se posvetujte z zdravnikom.
According to the European guideline, the endometrial biopsies should be classified, according to standardized criteria into the general classes of atrophic, proliferative, secretory, hyperplasia without atypia, hyperplasia with atypia, cancer and others.
V skladu z evropskimi smernicami bi bilo treba endometrijske biopsije razvrstiti na podlagi standardiziranih meril v splošne razrede, kot so atrofični, proliferativni, sekretorni, hiperplazijski brez atipičnosti, hiperplazijski z atipijo, rakasti in drugi.
Heart disease
Bolezen srca
If you have taken more Activelle than you should, or if for example a child has taken Activelle accidentally, talk to your doctor or hospital to assess the risk and for advice.
Če ste vzeli večji odmerek zdravila Activelle, kot bi smeli Če ste vzeli večji odmerek zdravila Activelle, kot bi smeli, ali če je zdravilo po naključju zaužil otrok, se obrnite na zdravnika ali bolnišnico, da boste izvedeli, kolikšno je tveganje, in da boste dobili nasvet.
Like other progestogens norethisterone causes virilization of female fetuses in rats and monkeys.
Tako kot drugi progestageni je tudi noretisteron pri podganah in opicah povzročil virilizacijo ženskih plodov.
The risk of VTE may be temporarily increased with prolonged immobilisation, major trauma or major surgery.
Tveganje za VTE se lahko prehodno poveča zaradi dolgotrajne imobilizacije, hujše poškodbe ali večje operacije.
• Smoking
• kajenje,
According to this recommendation, the applicant provided data from a trial (KLIM/PD/7/USA) which studied endometrial safety of the combination of E2 1 mg and NETA 0.1 mg.
Skladno s tem priporočilom je predlagatelj priskrbel podatke iz preskušanja (KLIM/PD/7/USA), v katerem so raziskovali endometrijsko varnost kombinacije E2 1 mg in NETA 0,1 mg.
On the basis of all these data, the majority of the CHMP was of the opinion that Activelle 0.5 mg estradiol/0.1 mg NETA is safe in terms of endometrial hyperplasia and neoplasia risk and that it offers a needed low-dose hormone replacement alternative with a positive benefit-risk.
Na osnovi vseh teh podatkov je bila večina članov CHMP mnenja, da je zdravilo Activelle 0,5 mg estradiol/0,1 mg NETA varno, kar se tiče nevarnosti hiperplazije in neoplazije endometrija, in da nudi potrebno alternativo hormonskega nadomeščanja s pozitivnim razmerjem med koristnimi učinki in tveganji.
Oestrogen and progestagen for continuous combined hormone replacement therapy (HRT).
Estrogen in progestagen za stalno kombinirano hormonsko nadomestno zdravljenje (HNZ).
In this study, the upper limit of the two-sided 95% CI of the incidence of endometrial hyperplasia was higher than the upper limit of 2%, and is therefore not considered acceptable.
V tej študiji je bila zgornja omejitev dvostranskega 95 % intervala zaupanja za pojavnost endometrijske hiperplazije višja kot zgornja meja 2 %, zaradi česar ni sprejemljiva.
This systematic review therefore supports that a continuous combined low dose regimen, as in Activelle 0,5mg/0,1mg, would provide sufficient endometrial protection.
Ta sistematični pregled torej podpira mnenje, da kontinuirano zdravljenje s kombinacijo nizkih odmerkov, kot v primeru zdravila Activelle 0,5 mg/0,1 mg, zagotavlja zadostno zaščito endometrija.
Activelle is prescribed to relieve unpleasant symptoms like hot flushes, night sweats and vaginal dryness, which occur when the oestrogen levels decline and the periods stop (menopause).
Zdravilo Activelle uporabljamo za ublažitev neprijetnih simptomov - npr. vročinskih valov, nočnega znojenja in suhosti nožnice - ki se pojavijo, ko se raven estrogenov zmanjša in menstruacije izginejo (menopavza).
Non-clinical data based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential reveal no special hazard for humans apart from those already discussed in other sections of the summary of product characteristics.
Predklinični podatki na osnovi običajnih študij toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in kancerogenega potenciala ne kažejo posebnih tveganj za človeka razen tistih, ki jih obravnavajo druga poglavja tega povzetka glavnih značilnosti zdravila.
Therefore, this new product contains a known progestogen at a lower dose than the known marketed dose, and a new ratio oestrogen/progestogen (1:5 instead of 1:2).
Zaradi tega vsebuje to novo zdravilo znani progestogen v odmerku, ki je nižji od odmerka, ki je že na trgu, in novo razmerje med estrogenom ter progestogenom (1:5 namesto
• If you get migraines or severe headaches
• če se vam pojavijo migrene ali hudi glavoboli,
The results of most epidemiological studies to date relevant to inadvertent foetal exposure to combinations of oestrogens and progestagens indicate no teratogenic or foetotoxic effect.
Izsledki večine dosedanjih epidemioloških študij, relevantnih glede naključne izpostavljenosti ploda kombinacijam estrogenov in progestagenov, ne kažejo teratogenih ali fetotoksičnih učinkov.
• If you have further questions, ask your doctor or pharmacist
• Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
In Pickar J.H.
V dokumentaciji Pickar J.H.
• If you have porphyria (a liver enzyme disease)
• imate porfirijo (posebno bolezen jetrnih encimov).
Rarely, these conditions may come back or get worse during treatment with Activelle:
V redkih primerih se lahko ta stanja med zdravljenjem z zdravilom Activelle znova pojavijo ali se poslabšajo:
If you forget to take your tablet at the usual time, take it within the next 12 hours.
Če ste pozabili pravočasno vzeti tableto, jo vzemite v naslednjih 12 urah.
The only trial that studied the 0.1 mg NETA dose was the Novo Nordisk study KLIM/PD/7/USA , which some CHMP members considered to be inconclusive.
Edino preskušanje, v katerem so preučevali 0,1 mg NETA, je bila študija KLIM/PD/7/USA družbe Novo Nordisk, ki so jo nekateri člani CHMP obravnavali kot neprepričljivo.
• If any of the conditions listed in section 2,“Do not take Activelle”, occur.
• se vam pojavi katero koli stanje, navedeno v poglavju 2, "Ne jemljite zdravila Activelle".