natgillin/translations-raw huggingface dataset:
• Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency, see section 4.4);
• znane trombofilne bolezni (npr. pomanjkanje beljakovine C, beljakovine S ali antitrombina, glejte poglavje 4.4.)
Table 2 shows the percentage of subjects who reported a change from baseline in their MBS dyspareunia at week 12.
V preglednici 2 je prikazan odstotek oseb, ki so v 12. tednu poročale o spremembi MBS disparevnije glede na izhodiščno vrednost.
Taking oestrogen-only HRT tablets for a long time can increase the risk of developing cancer of the womb lining (the endometrium).
Dolgotrajno jemanje tablet za HNZ, ki vsebujejo samo estrogen, lahko poveča tveganje za nastanek raka maternične sluznice (endometrija).
Intrarosa is used to treat postmenopausal women having moderate to severe symptoms of vulvar and vaginal atrophy.
Zdravilo Intrarosa se uporablja pri ženskah po menopavzi z zmernimi do hudimi simptomi atrofije vulve in vagine.
Pessary 28 pessaries and 6 applicators.
vaginalne globule 28 vaginalnih globul in šest aplikatorjev.
• increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”);
• povečano tveganje za nastanek krvnih strdkov (glejte razdelek „Krvni strdki v veni
Age range (years) Incidence per 1000 women in placebo arm over 5 years
Starost (v letih) Incidenca na 1.000 žensk v skupini, ki je jemala placebo, v 5 letih
• Leave your index (pointer) finger free to press the applicator plunger after the applicator is inserted into your vagina.
• Kazalec pustite prost, da potisnete bat aplikatorja, potem ko ste aplikator vstavili v vagino.
• Undiagnosed genital bleeding;
• nepojasnjena genitalna krvavitev
What Intrarosa is and what it is used for
Kaj je zdravilo Intrarosa in za kaj ga uporabljamo
It is not required to stop Intrarosa if vaginal discharge occurs (see section 4.4).
Če se pojavi vaginalni izcedek, zdravljenja z zdravilom Intrarosa ni treba prekiniti (glejte poglavje 4.4).
Other binding proteins may be elevated in serum, i.e. corticoid binding globulin (CBG), sex-hormone-binding globulin (SHBG) leading to increased circulating corticosteroids and sex steroids, respectively.
npr. kortikoide vezoči globulin (CBG- corticoid binding globulin) ali spolne hormone vežoči globulin (SHBG- sex-hormone-binding globulin), kar vodi v zvišanje kortikosteroidov oz. spolnih steroidov v obtoku.
Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.
Zdravilo Intrarosa je indicirano za zdravljenje atrofije vulve in vagine pri ženskah po menopavzi, ki imajo zmerne do hude simptome.
• If you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina;
• Če imate ali ste nedavno imeli bolezen, ki so jo povzročili krvni strdki v arterijah, npr.
None of these conditions has been observed with Intrarosa during the clinical trials.
Pri zdravilu Intrarosa med kliničnimi preskušanji ni bilo ugotovljeno nobeno od teh stanj.
Elderly No dose adjustment is considered necessary in elderly women.
Pri starejših bolnicah odmerka ni treba prilagajati.
Risk ratio and 95%CI
Razmerje tveganj in 95-% IZ
Concomitant use with systemic hormone replacement therapy (oestrogen-only or oestrogenprogestagen combination or androgen treatment) or vaginal oestrogens has not been investigated and is therefore not recommended.
Hkratne uporabe s sistemskim hormonskim nadomestnim zdravljenjem (samo z estrogenom ali kombinacijo estrogena in progestagena ali androgena) ali vaginalnimi estrogeni niso proučevali, zato se je ne priporoča.
WHI studies combined - Additional risk of ischaemic stroke*4 over 5 years' use
Študije WHI skupaj - dodatno tveganje za ishemično kap*4 več kot 5 let uporabe
Efficacy data were obtained from two US and Canadian randomised, double-blind, placebo-controlled, multicentre, pivotal phase III trials (ERC-231/Trial 1 and ERC-238/Trial 2) performed in postmenopausal women aged 40 to 80 years (mean age = 58.6 years in Trial 1 and 59.5 years in Trial 2) with vulvar and vaginal atrophy (VVA ).
238/preskušanje 2) pri ženskah po menopavzi, starih od 40 do 80 let (povprečna starost = 58,6 let v preskušanju 1 in 59,5 leta v preskušanju 2), z atrofijo vulve in vagine (VVA- vulvar and vaginal atrophy).
Each pessary contains 6.5 mg of prasterone.
Ena globula vsebuje 6,5 mg prasterona.
• Insert one prasterone pessary in your vagina once a day at bedtime with an applicator or your finger.
• V vagino enkrat na dan pred spanjem z aplikatorjem ali prstom vstavite eno globulo s prasteronom.
The applicator should be inserted into the vagina as far as it can comfortably go without force.
Aplikator vstavite tako daleč v vagino, kolikor gre brez sile.
• you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots;
• imate izrazito čezmerno telesno maso (ITM > 30 kg/m2); • imate težave s strjevanjem krvi, ki jih je treba dolgo časa zdraviti z zdravilom za preprečevanje nastanka krvnih strdkov;
How to use Insert the pessary into the vagina with your finger or with an applicator provided in the pack.
Način uporabe vaginalna uporaba Zdravilo Intrarosa se lahko vstavi v vagino s prstom ali z aplikatorjem, ki je v pakiranju.
This is due to melting of the hard fat used as vehicle, added to the expected increase in vaginal secretions due to treatment.
ki služi kot vehikel, ob pričakovanem povečanju količine vaginalnih izločkov zaradi zdravljenja.
Intrarosa has not been studied in women with history of thromboembolic diseases, uncontrolled hypertension or heart disease.
Učinek HNZ na srce in obtočila Zdravila Intrarosa niso proučevali pri ženskah z anamnezo trombemboličnih bolezni, nenadzorovane hipertenzije ali bolezni srca.
It should be taken into account that these conditions may recur or be aggravated during treatment with Intrarosa, in particular: - Leiomyoma (uterine fibroids) or endometriosis - Risk factors for thromboembolic disorders (see below) - Risk factors for oestrogen dependent tumours, e.g. 1st degree heredity for breast cancer - Hypertension - Liver disorders (e.g. liver adenoma) - Diabetes mellitus with or without vascular involvement - Cholelithiasis - Migraine or (severe) headache - Systemic lupus erythematosus.
- dejavniki tveganja za od estrogena odvisne tumorje, npr. dedovanje v prvem kolenu pri raku dojk, - hipertenzija, - bolezni jeter (npr. adenom jeter), - sladkorna bolezen s prizadetostjo ožilja ali brez nje, - holelitiaza, - migrena ali (hud) glavobol, - sistemski eritematozni lupus, - hiperplazija endometrija v anamnezi (glejte spodaj), - epilepsija, - astma, - otoskleroza.
• An up to 2-fold increased risk of having breast cancer diagnosed is reported in women taking combined oestrogen-progestagen therapy for more than 5 years.
• Pri ženskah, ki so se zdravile z estrogensko-progestagenskim zdravljenjem več kot 5 let, so poročali o 2-krat povečanem tveganju za diagnozo raka dojk.
Intrarosa is for use in postmenopausal women only.
Zdravilo Intrarosa je namenjeno za uporabo samo pri ženskah po menopavzi.
Cases of breast and ovarian cancer have been reported in women treated with 6.5 mg of prasterone for 52 weeks (see section 4.4).
Pri ženskah, ki so bile 52 tednov zdravljene s 6,5 mg prasterona, so poročali o primerih raka dojk in jajčnikov (glejte poglavje 4.4).
No case of coronary artery disease has been reported during clinical trials.
Med kliničnim preskušanjem niso poročali o nobenem primeru bolezni koronarnih arterij.
The European Medicines Agency has waived the obligation to submit the results of studies with Intrarosa in all subsets of the paediatric population.
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom
One case of breast cancer at week 52 has been reported on 1196 women who have been exposed with the 6.5 mg dose which is below the incidence rate observed in the normal population of the same age.
1 196 ženskah, ki so bile izpostavljene 6,5-miligramskemu odmerku, so po 52 tednih poročali o enem primeru raka dojk, kar je pod stopnjo pojavnosti, opazovano pri normalni populaciji iste starosti.
Figure 1: Serum Concentrations of Prasterone (A), Testosterone (B), and Estradiol (C) Measured Over a 24h Period on Day 7 Following Daily Administration of Placebo or Intrarosa (mean ± S.D.)
Slika 1: Serumske koncentracije prasterona (A), testosterona (B) in estradiola (C), merjene v 24
Additional cases per 1000 HRT users over 5 years
Dodatnih primerov na 1.000 uporabnic HNZ v 5 letih
• Known or suspected oestrogen-dependent malignant tumours (e.g endometrial cancer);
• znani od estrogena odvisni maligni tumorji (npr. rak endometrija) ali sum nanje
Do not take Intrarosa if any of the following applies to you.
če za vas velja kar koli od naslednjega.
WHI Studies - Additional risk of VTE over 5 years' use
Študije WHI - dodatno tveganje za VTE po 5 letih uporabe
• If you have cancer which is sensitive to oestrogens, such as cancer of the womb lining
• Če imate raka, ki je občutljiv na estrogene, npr. raka maternične sluznice (endometrija), ali če obstaja sum, da bi ga lahko imeli.
• blood clots in the veins of the legs or lungs (venous thromboembolism);
• rak jajčnikov; • krvni strdki v venah nog ali pljučih (venska trombembolija)
The most frequently observed adverse reaction was vaginal discharge.
Povzetek varnostnega profila Najpogosteje opaženi neželeni učinek je bil vaginalni izcedek.
Additional cases per 1000 HRT users over 5 years (95%CI)
Dodatnih primerov na 1.000 uporabnic HNZ v 5 letih (95-% IZ)
Incidence per 1000 women in placebo arm over 5 years
Incidenca na 1.000 žensk v skupini, ki je jemala placebo, v 5 letih
The use of Intraorsa in combination with hormone replacement therapy (oestrogen-only or oestrogenprogestagen combination or androgen treatment) or vaginal oestrogens is not recommended.
Uporaba zdravila Intrarosa v kombinaciji s hormonskim nadomestnim zdravljenjem (samo z estrogenom ali kombinacijo estrogena in progestagena ali androgena) ali vaginalnimi estrogeni ni priporočljiva.
The following diseases are reported more often in women using HRT medicines which circulate in the blood compared to women not using HRT.
Pri ženskah, ki jemljejo zdravila za HNZ, ki vstopajo v kri, so v primerjavi z ženskami, ki ne uporabljajo HNZ, pogosteje poročali o naslednjih boleznih: Ta tveganja so manjša pri estrogenskih zdravilih, ki se dajejo v vagino.
In a study conducted in postmenopausal women, administration of the Intrarosa pessary once daily for 7 days resulted in a mean prasterone Cmax and area under the curve from 0 to 24 hours (AUC0-24) at day 7 of 4.4 ng/mL and 56.2 ng h/mL, respectively, which were significantly higher than those in the group treated with placebo (Table 3; Figure 1).
V študiji, opravljeni pri ženskah po menopavzi, je uporaba globul zdravila Intrarosa enkrat na dan 7 dni privedla do povprečnega Cmax in površine pod krivuljo od 0 do 24 ur (AUC0-24) 4,4 ng/ml in
For example, in women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.
Na primer pri ženskah, starih od 50 do 54 let, bodo v 5-letnem obdobju diagnosticirali raka jajčnikov pri približno dveh ženskah od 2.000.
Speak to your doctor for advice.
Posvetujte se z zdravnikom.
Breast-feeding Intrarosa is not indicated during breast-feeding.
Dojenje Zdravilo Intrarosa ni indicirano med dojenjem.
Intrarosa contains the active substance prasterone.
Zdravilo Intrarosa vsebuje učinkovino prasteron.
Ischaemic stroke
Ishemična kap
Patients with renal and/or hepatic impairment
Bolnice z okvaro ledvic in/ali jeter
Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.
Pojav krvnega strdka v veni bi v petletnem obdobju v povprečju pričakovali pri 4 do 7 ženskah od 1.000 v 50. letih, ki ne jemljejo HNZ.
Cases of abnormal Pap smears either Atypical Squamous Cells of Undetermined Significance (ASCUS) or Low Grade Squamous Intraepithelial Lesion (LSIL) have been reported with a common frequency in women treated with Intrarosa for 52 weeks (see section 4.4).
Pri ženskah, ki so bile 52 tednov zdravljene z zdravilom Intrarosa, so poročali o primerih nenormalnih brisov PAP, bodisi z atipičnimi ploščatimi celicami nedoločenega pomena (ASCUS) ali s ploščatocelično intraepitelijsko lezijo nizke stopnje (LSIL) (glejte poglavje 4.4).
If vaginal discharge occurs, it is not required to stop Intrarosa.
Če se pojavi izcedek iz vagine, zdravljenja z zdravilom Intrarosa ni treba prekiniti.
No cases of arterial thromboembolic disease have been reported during clinical trials.
Med kliničnim preskušanjem niso poročali o nobenem primeru arterijske trombembolične bolezni.
In women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.
Pri ženskah, starih od 50 do 54 let, bodo v 5-letnem obdobju diagnosticirali raka jajčnikov pri približno dveh ženskah od 2.000.
Additional cases per 1000 never-users of HRT over a 5 year period*1
Dodatnih primerov na 1.000 žensk, ki nikoli niso uporabljale HNZ, v obdobju petih let *1
The occurrence of such an event is more likely in the first year of using HT (see section 4.4).
Pojav takega dogodka je verjetnejši v prvem letu HNZ
The following side effects have been reported with HRT containing estrogens but not with Intrarosa during clinical trials:
Pri HNZ, ki vsebuje estrogene, ne pa tudi pri zdravilu Intrarosa v času trajanja kliničnih preskušanj, so poročali o naslednjih neželenih učinkih:
• gallstones;
• žolčni kamni;
Speak to your doctor if you think this dose is too strong or not strong enough.
Če menite, da je odmerek premočen ali ni dovolj močen, se pogovorite z zdravnikom.
Looking at women in their 50s who are not taking HRT, on average, 8 in 1000 would be expected to have a stroke over a 5-year period.
Možgansko kap bi v petletnem obdobju pričakovali v povprečju pri 8 ženskah od 1.000 v 50. letih, ki ne jemljejo HNZ.
• Tear off one wrapped pessary from the 7-pessary strip.
• S traka s sedmimi globulami odtrgajte ovito globulo.
• Oestrogens increase thyroid binding globulin (TBG), leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels (by radio-immunoassay).
• Estrogeni povečujejo tiroksin-vezoči globulin (TBG- thyroid binding globulin), kar vodi v porast celokupnega ščitničnega hormona, merjeno z na beljakovine vezanim jodom (PBI),
This is likely due to melting of the hard fat added to an expected increase in vaginal secretions due to treatment.
Do tega pride zaradi topljenja trde masti, ki med zdravljenjem pričakovano poveča količino vaginalnih izločkov.
Prasterone corrects the symptoms and signs of vulvar and vaginal atrophy by replacing the oestrogens which are normally produced before menopause by the ovaries of women.
Prasteron z nadomeščanjem estrogenov, ki jih pri ženskah pred menopavzo normalno tvorijo jajčniki,
If a thrombophilic defect is identified which segregates with thrombosis in family members or if the defect is ‘severe' (e.g, antithrombin, protein S, or protein C deficiencies or a combination of defects) HRT is contraindicated.
„huda“ (npr. pomanjkanje antitrombina, beljakovine S ali beljakovine C ali kombinacija okvar), je HNZ kontraindiciran.
• breast cancer;
• rak dojke;
If you become pregnant, stop taking Intrarosa and contact your doctor.
Intrarosa prenehajte jemati in se posvetujte z zdravnikom.
However, as the baseline risk of stroke is strongly age-dependent, the overall risk of stroke in women who use HRT will increase with age (see section 4.8).
Ker pa je izhodiščno tveganje za kap zelo odvisno od starosti, se bo splošno tveganje za kap pri ženskah, ki uporabljajo
One case of pulmonary embolism has been reported in the 6.5 mg group and one in the placebo group during clinical trials.
6,5-miligramski odmerek, o enem pa pri bolnicah, ki so jemale placebo.
Cervical/ uterine polyps Breast mass (benign)
Polipi na materničnem vratu/maternici Tvorba v dojki (benigna)
Intrarosa has not been studied in women with current or previous arterial thromboembolic disease.
Zdravilo Intrarosa pri ženskah s trenutno ali preteklo arterijsko trombembolično boleznijo ni bilo proučevano.
How to store Intrarosa
Kako uporabljati zdravilo Intrarosa
• Press the applicator plunger with your index (pointer) finger to release the pessary.
• S kazalcem pritisnite na bat aplikatorja, da sprostite globulo.
Intrarosa 6,5 mg pessary prasterone
Intrarosa 6,5 mg vaginalne globule prasteron
No data on efficacy and safety are available in women currently treated with hormonal therapy such as: androgens, hormone replacement therapy (oestrogen alone or combined with progestogens).
Za ženske, ki se trenutno zdravijo s hormonsko terapijo, kot so: androgeni ali nadomestno hormonsko zdravljenje (samo estrogeni ali kombinacija s progestogeni), ni na voljo nobenih podatkov o učinkovitosti in varnosti.
Cases of abnormal Pap smears corresponding to ASCUS or Low Grade Squamous Intraepithelial Lesion (LSIL) have been reported in women treated with the 6.5 mg dose (common frequency).
Pri ženskah, ki so bile zdravljene s 6,5-miligramskim odmerkom (običajna pogostnost) so poročali o primerih nenormalnih brisov PAP, ki so ustrezali ASCUS ali ploščati intraepitelijski leziji nizke stopnje (LSIL-Low Grade Squamous Intraepithelial Lesion).
Weight fluctuation
Nihanje telesne mase
The occurrence of such an event is more likely in the first year of HRT than later (see section 4.8).
HNZ kot pozneje (glejte poglavje 4.8).
Intrarosa has not been studied in women with a current hormonal treatment: hormone replacement therapy (oestrogens alone or combined with progestogens) or androgens treatment.
Zdravilo Intrarosa pri ženskah, zdravljenih s hormonskim nadomestnim zdravljenjem (samo z estrogeni ali kombinacijo s progestogeni) ali androgeni ni bilo proučevano.
Instructions on how to use Intrarosa How should I use Intrarosa
Kako jemati zdravilo Intrarosa Kako naj jemljem zdravilo Intrarosa
Oestrogen only HRT
Samo estrogensko HNZ
• You may have vaginal discharge due to melting of the ‘hard fat base' which adds to increased vaginal secretions due to treatment.
• Zaradi topljenja „trde maščobne podlage“, ki med zdravljenjem poveča količino vaginalnih izločkov, se lahko pojavi izcedek iz vagine.
• Known, past or suspected breast cancer;
• znan ali pretekli rak dojk ali sum na raka dojk
Intrarosa is not meant for women with child-bearing potential.
Zdravilo Intrarosa ni namenjeno za uporabo pri ženskah v rodni dobi.
Intrarosa has not been studied in women with current or previous venous thromboembolic disease.
Zdravilo Intrarosa pri ženskah s trenutno ali preteklo vensko trombembolično boleznijo ni bilo proučevano.
No cases of endometrial hyperplasia have been reported in women treated for 52 weeks during the clinical studies.
v katerih so ženske zdravili 52 tednov, niso poročali o nobenem primeru hiperplazije endometrija.
There is no relevant use of Intrarosa in female children of any age group for the indication of vulvar and vaginal atrophy due to menopause.
Uporaba zdravila Intrarosa za indikacijo atrofije vulve in vagine zaradi menopavze ne pride v poštev pri deklicah katere koli starosti.
• Systemic HRT is associated with a 1.3-3 fold risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism.
• Sistemski HNZ je povezan z 1,3-3-krat večjim tveganjem nastanka venske trombembolije (VTE),
− with a uncommon frequency (may affect up to 1 in 100 people): benign cervical or uterine polyps, benign breast mass.
LGSIL), nihanja telesne mase (bodisi povečanja ali zmanjšanja); - občasnih (ki se lahko pojavijo pri največ 1 od 100 bolnic): benigni polipi na materničnem vratu ali maternici, benigna tvorba v dojki.
Package leaflet: Information for the user Intrarosa 6.5 mg pessary prasterone This medicine is subject to additional monitoring.
Navodilo za uporabo: informacije za uporabnika Intrarosa 6,5 mg vaginalne globule prasteron (prasteron.)
Cases of hypertension have been reported in clinical trials with an uncommon frequency and similar incidence rates were observed in both groups (6.5 mg prasterone and placebo).
pri obeh skupinah (prasteron 6,5 mg in placebo) pa so poročali o podobni pojavnosti.
Intrarosa has not been studied in women with active or past breast cancer.
Zdravilo Intrarosa pri ženskah z aktivnim ali preteklim rakom ni bilo proučevano.
• changes in the nipple;
• vdolbinice v koži; • spremembe bradavice;
• ovarian cancer;
• sladkorna bolezen;
Abnormal Pap smear (mostly ASCUS or LGSIL)
ASCUS ali LGSIL)
How to use Intrarosa
Kako uporabljati zdravilo
For women who have been taking HRT for 5 years, there will be about 3 cases per 2000 users (i.e. about 1 extra case).
2.000 uporabnicami (tj. približno en dodaten primer).
Breast cancer
- Bolezni žolčnika
• Estrogen is a metabolite of prasterone.
Hiperplazija in rak endometrija • Estrogen je presnovek prasterona.
• The use of oestrogen-only and oestrogen + progestagen therapy is associated with an up to 1.5 fold increased relative risk of ischaemic stroke.
• Uporaba samo estrogenskega in estrogensko-progestagenskega zdravljenja je povezana z do
The plunger of the applicator should be pressed to release the pessary.
Pritisnite na bat aplikatorja, da sprostite globulo.
How Intrarosa works
placeba Intrarosa
Stroke
KORAK
Intrarosa 6.5 mg pessary.
Intrarosa 6,5 mg vaginalne globule
Dyspareunia
A- prasterona
28 pessaries.
vaginalne globule 28 vaginalnih globul.
The additional risk becomes clear within a few years.
Pojav takega dogodka je verjetnejši v prvem letu
Other adverse reactions have been reported in association with oestrogen/progestagen treatment: - Gall bladder disease.
V zvezi z zdravljenjem z estrogenom in kombinacijo estrogena in progestagena so poročali tudi o drugih neželenih učinkih:
The CHMP agrees with the scientific conclusions made by the PRAC.
Odbor CHMP soglaša z znanstvenimi zaključki, ki jih je sprejel odbor PRAC.
, headache (especially at the beginning of treatment)
, glavobol (zlasti na začetku zdravljenja)
The AUC is 50% higher in elderly (>65 years) than in young subjects.
AUC je pri starejših (>65 let) 50 % večja kot pri mladih osebah.
The safety of Rasilamlo has been evaluated in studies of up to one year duration.
Varnost zdravila Rasilamlo so ocenjevali v študijah, ki so trajale do eno leto.
Clinical monitoring and dose adjustment may thus be required.
Morda bo potrebno klinično spremljanje in prilagajanje
, exfoliative dermatitis
, eksfoliativni dermatitis
The cumulative review retrieved 187 cases out of which 57 were sufficiently documented, in 8 of these cases a causal relationship could not be ruled out.
V kumulativni pregled so zajeli 187 primerov, od katerih je bilo 57 ustrezno dokumentiranih, v 8 od teh primerov pa niso mogli izključiti vzročne povezanosti z zdravilom.
Use in pregnancy is only recommended when there is no safer alternative and when the disease itself carries greater risk for the mother and foetus.
Pri nosečnicah je uporaba priporočena samo v primeru, da ni na voljo nobene varnejše možnosti, bolezen sama pa pomeni večje tveganje tako za mater kot za plod.
Aliskiren has been studied in 1,864 patients aged 65 years or older, and in
Aliskiren so proučevali pri 1.864 bolnikih, starih 65 let ali več, in pri
The blood pressure reductions with the combination were maintained throughout the entire 24-hour dose interval.
Znižanje krvnega tlaka pri uporabi kombinacije se je ohranilo skozi celoten 24-urni interval odmerjanja.
The adverse reactions are ranked by frequency, the most frequent first, using the following convention: 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); very rare (<1/10,000), not known (cannot be estimated from the available data).
Neželeni učinki so razvrščeni po pogostnosti, najpogostejši najprej, pri čemer je uporabljen naslednji dogovor: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).