natgillin/translations-raw huggingface dataset:
CE/BZA can be administered with or without food.
Kombinacijo CE/BZA se lahko daje s hrano ali brez nje.
• Increases in liver enzymes (identified in routine liver function testing)
• zvišanje jetrnih encimov (ugotovljeno pri rutinskem testiranju jetrne funkcije);
If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised.
Če se pojavi katerokoli od naslednjih bolezenskih stanj oziroma, če se je katerokoli od njih pojavilo že prej in/ali se je med nosečnostjo ali predhodnim hormonskim zdravljenjem poslabšalo, je treba bolnico skrbno nadzirati.
If more than one tablet has been forgotten, only the most recent tablet should be taken, the patient should not take double the usual dose to make up for missed tablets.
Če je pozabila vzeti več kot eno tableto, mora vzeti samo zadnjo in ne sme vzeti dvojnega običajnega odmerka, da nadomesti pozabljene tablete.
CE/BZA may be taken at any time of day, without regard to meals (see section 5.2).
CE/BZA se lahko jemlje kadarkoli čez dan, ne glede na obroke (glejte poglavje 5.2).
Following intravenous administration of a 3 mg dose of BZA alone, the volume of distribution is 14.7 3.9 l/kg.
Po intravenski uporabi 3-mg odmerka samega BZA je volumen porazdelitve 14,73,9 l/kg.
Oestrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs.
Estrogeni se obsežno porazdelijo po telesu, v večjih koncentracijah pa jih je na splošno mogoče najti v ciljnih organih za spolne hormone.
BZA is extensively metabolised in women.
BZA se pri ženskah obsežno presnavlja.
A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in women currently using HRT compared to women who have never used HRT (RR 1.43, 95% CI 1.31-1.56).
Pri metaanalizi 52 epidemioloških študij so poročali o povečanem tveganju za raka jajčnikov pri ženskah, ki trenutno uporabljajo HNZ, v primerjavi z ženskami, ki niso nikoli uporabljale HNZ (relativno tveganje 1,43, 95 % IZ 1,31-1,56).
• Memory loss (dementia)
• izguba spomina (demenca);
If you are having an operation
Če imate načrtovan kirurški poseg
Increases in blood pressure
zvišanje krvnega tlaka
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnicah.
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
- Preobčutljivost na učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1.
(thrombosis)'
(tromboza)«.
Results of the largest randomised placebo-controlled trial (WHI-study) and largest epidemiological study (MWS) are presented.
Prikazani so rezultati največjega randomiziranega, s placebom nadzorovanega preskušanja (študija WHI) in največje epidemiološke študije (MWS).
It should be taken into account that these conditions may recur or be aggravated during treatment with CE/BZA, in particular:
Treba je upoštevati, da se med zdravljenjem s CE/BZA ta bolezenska stanja lahko ponovijo ali poslabšajo, zlasti:
In addition, women taking CE/BZA should be advised to move about periodically during travel involving prolonged immobilisation.
Poleg tega je treba ženskam, ki jemljejo CE/BZA, svetovati, da se med potovanjem, pri katerem so dlje časa nepremične, občasno gibljejo.
However, if it is almost time to take your next tablet, skip the tablet you missed and only take your next scheduled tablet.
Če pa je skoraj čas za naslednjo tableto, izpustite pozabljeno tableto in vzemite samo naslednjo načrtovano tableto.
The European Medicines Agency has waived the obligation to submit the results of studies with CE/BZA in all subsets of the paediatric population in the ‘treatment of oestrogen deficiency symptoms in postmenopausal women' (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij s kombinacijo CE/BZA za vse podskupine pediatrične populacije za »zdravljenje simptomov pomanjkanja estrogena pri ženskah v postmenopavzi« (za informacije o uporabi pri pediatrični populaciji glejte poglavje 4.2).
In case of overdose it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
V primeru prevelikega odmerjanja je priporočljivo bolnico spremljati glede kakršnihkoli znakov ali simptomov neželenih učinkov in takoj uvesti ustrezno simptomatsko zdravljenje.
If you decide to stop taking this medicine before finishing the prescribed course of treatment, you should talk to your doctor first.
Če se odločite, da boste prenehali jemati to zdravilo, preden se konča predpisano zdravljenje, se morate najprej posvetovati z zdravnikom.
In a pharmacokinetic study (n=24) BMI appeared to have little impact on systemic exposure to CE and BZA.
V farmakokinetični študiji (n = 24) se je izkazalo, da ima ITM majhen vpliv na sistemsko izpostavljenost CE in BZA.
The occurrence of such an event is more likely in the first year of HRT than later (see section 4.8).
Pojav takega dogodka je verjetnejši v prvem letu hormonskega nadomestnega zdravljenja (HNZ) kot pozneje (glejte poglavje 4.8).
*study in women with no uterus
* Študija pri ženskah brez maternice
Based on available data no dosage adjustment is necessary based on age (see section 5.2).
Na podlagi razpoložljivih podatkov prilagajanje odmerka glede na starost ni potrebno (glejte poglavje 5.2).
Oestrogen therapy use does not improve cognitive function.
Zdravljenje z estrogeni ne izboljša kognitivne funkcije.
17β-estradiol is converted reversibly to estrone, and both can be converted to estriol, which is the major urinary metabolite.
17β-estradiol se reverzibilno pretvori v estron, oba pa se lahko pretvorita v estriol, ki je glavni presnovek v urinu.
In vitro and in vivo studies have shown that oestrogens are partially metabolised by cytochrome P450 enzymes, including CYP3A4.
Študije in vitro ter in vivo so pokazale, da se estrogeni delno presnavljajo preko encimov citokroma P450, vključno s CYP3A4.
Since you are more likely to get a blood clot in your veins as you get older and if any of the following applies to you, inform your doctor promptly:
Ker je verjetnost, da bo nastal krvni strdek v venah, z naraščanjem starosti večja, in če karkoli izmed navedenega velja za vas, nemudoma obvestite zdravnika:
• go for regular breast screening and cervical smear tests, as recommended by your doctor.
• opravite redni preventivni pregled dojk in bris materničnega vratu, kot to priporoča vaš zdravnik;
If you are going to have surgery, tell the surgeon you are taking DUAVIVE.
Če imate načrtovan kirurški poseg, povejte kirurgu, da jemljete zdravilo DUAVIVE.
Oestrogens circulate in the blood largely bound to SHBG and albumin.
V krvnem obtoku so estrogeni v veliki meri vezani na SHBG in albumin.
• Low levels of blood calcium (hypocalcaemia); frequently there will be no symptoms to suggest that your blood calcium is low, but when hypocalcaemia is severe you may feel tired, generally unwell, depressed and become dehydrated.
• nizke ravni kalcija v krvi (hipokalciemija); pogosto ni opaznih simptomov, ki kažejo na pomanjkanje kalcija v krvi, vendar se pri hudi hipokalciemiji lahko počutite utrujeno, na splošno slabo, ste depresivni ali dehidrirate.
The results of most epidemiological studies to date relevant to inadvertent foetal exposure to oestrogens indicate no teratogenic or foetotoxic effects.
Rezultati večine do sedaj opravljenih epidemioloških študij v zvezi z nenamernim izpostavljanjem zarodka estrogenom ne kažejo nobenih teratogenih ali fetotoksičnih učinkov.
Safety and efficacy have not been evaluated further in women with hepatic insufficiency.
Varnosti in učinkovitosti pri ženskah z jetrno insuficienco niso dodatno ocenjevali.
Some other studies, including the WHI trial, suggest that use of combined HRTs may be associated with a similar or slightly smaller risk (see section 4.8).
Nekatere druge študije, vključno s preskušanjem WHI, kažejo, da je uporaba kombiniranih HNZ lahko povezana s podobnim ali rahlo manjšim tveganjem (glejte poglavje 4.8).
For more information, see ‘Blood clots in a vein
Za dodatne informacije glejte »Krvni strdki v veni
This increase is most likely attributable to age-related changes in hepatic function.
To zvečanje je najverjetneje mogoče pripisati starostnim spremembam v delovanju jeter.
The pharmacokinetics of a 20 mg single dose of BZA were evaluated in a study in 26 healthy postmenopausal women.
Farmakokinetiko enkratnega 20 mg odmerka BZA so ocenili v študiji pri 26 zdravih ženskah v postmenopavzi.
The number of extra cases of stroke due to use of HRT will increase with age.
Število dodatnih primerov možganske kapi zaradi uporabe HNZ se veča s starostjo.
BZA is highly bound (98% - 99%) to plasma proteins in vitro, but does not bind to sex hormone binding globulin (SHBG).
BZA se in vitro v veliki meri (98 %-99 %) veže na beljakovine v plazmi, vendar se ne veže na globulin, ki veže spolne hormone (SHBG).
T3 resin uptake is decreased, reflecting the elevated TBG.
Vezava T3 na smolo je zmanjšana, kar odraža zvečanje TBG.
What DUAVIVE is and what it is used for
Kaj je zdravilo DUAVIVE in za kaj ga uporabljamo
Before initiating or reinstituting treatment with CE/BZA, a complete personal and family medical history should be taken.
Pred začetkom prvega ali ponovnega zdravljenja s CE/BZA je treba raziskati celotno osebno in družinsko anamnezo.
Stop taking DUAVIVE and see a doctor immediately if you get any of the following serious side effects:
Prenehajte jemati zdravilo DUAVIVE in nemudoma obiščite zdravnika, če opazite kateregakoli izmed spodaj navedenih resnih neželenih učinkov:
Coronary artery disease (CAD)
Koronarna arterijska bolezen (KAB)
Women 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, dyspnoea).
Ženske je treba opozoriti, naj nemudoma obiščejo svojega zdravnika, če se pojavijo morebitni simptomi trombembolije (npr. boleče otekanje noge, nenadna bolečina v prsnem košu, dispneja).
The most commonly reported adverse reaction is abdominal pain, occurring in more than 10% of patients in clinical trials.
Neželeni učinek, o katerem so najpogosteje poročali, je bila bolečina v trebuhu, ki se je med kliničnimi preskušanji pojavila pri več kot 10 % bolnic.
The expiry date refers to the last date of that month.
Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Pharmacotherapeutic group: Sex hormones and modulators of the genital system; estrogens, combinations with other drugs; ATC code: G03CC07
Farmakoterapevtska skupina: spolni hormoni in zdravila za uravnavanje delovanja spolovil; estrogeni v kombinaciji z drugimi učinkovinami; oznaka ATC: G03CC07.
This can cause symptoms such as hot face, neck and chest ("hot flushes").
To lahko povzroči simptome, kot je občutek vročine v obrazu, vratu in prsih (»vročinski oblivi«).
This medicine is for use only by postmenopausal women.
To zdravilo je namenjeno uporabi samo pri ženskah po menopavzi.
CE/BZA has not been studied in women with baseline triglyceride levels >300 mg/dL (>3.4 mmol/L).
Kombinacije CE/BZA pri ženskah z izhodiščnimi vrednostmi trigliceridov > 300 mg/dl (> 3,4 mmol/l) niso raziskovali.
Talk to your doctor before taking this medicine if you have ever had any of the following problems, as these may return or become worse during treatment with DUAVIVE.
Pred začetkom jemanja tega zdravila se posvetujte z zdravnikom, če ste kadarkoli imeli ali imate katerokoli izmed naštetih bolezni, saj se te med zdravljenjem z zdravilom DUAVIVE lahko ponovijo ali poslabšajo.
Women already on chronic anticoagulant treatment require careful consideration of the benefit risk of use of hormone therapy.
Pri ženskah, ki se že kronično zdravijo z antikoagulansi, je treba skrbno pretehtati razmerje koristi in tveganja hormonskega zdravljenja.
• Worsening of porphyria, a rare blood disorder which is passed down in families (inherited).
• poslabšanje porfirije, redke bolezni krvi, ki se prenaša v družini (je dedna).
• An effect on the way in which your blood sugar (glucose) levels are controlled including increased glucose levels in the blood
• vpliv na način, na katerega telo nadzira ravni sladkorja v krvi (glukozo), vključno z zvišanimi ravnmi glukoze v krvi;
Depending on the duration of oestrogen-only use and oestrogen dose, the increase in risk of endometrial cancer in epidemiology studies varied from 5 to 55 extra cases diagnosed in every 1,000 women between the ages of 50 and 65 years.
Glede na trajanje zdravljenja samo z estrogenom in odmerke estrogena je znašalo zvečanje tveganja za raka endometrija v epidemioloških študijah med 5 in 55 dodatnih diagnosticiranih primerov na vsakih 1.000 žensk, starih od 50 do 65 let.
Before you start taking this medicine, your doctor will ask you about your own and your family's medical history.
Preden začnete uporabljati to zdravilo, vas bo zdravnik vprašal o vaši osebni in družinski anamnezi (pretekle bolezni in zdravstvena stanja vas in vaših družinskih članov).
Breast cancer risk associated with the use of oestrogens alone is represented by several studies.
Tveganje za raka dojke, povezano z uporabo samo estrogena, so predstavili v več študijah.
If any of the above conditions appear for the first time while taking this medicine, stop taking it at once and consult your doctor immediately.
Če se katerakoli izmed zgoraj navedenih bolezni prvič pojavi med tem, ko jemljete to zdravilo, ga nemudoma prenehajte jemati in se posvetujte z zdravnikom.
In women with no personal history of VTE but with a first-degree relative with a history of thrombosis at young age, screening may be offered after careful counselling regarding its limitations (only a proportion of thrombophilic defects are identified by screening).
Ženskam, ki nimajo VTE v osebni anamnezi, vendar imajo sorodnika v prvem kolenu z anamnezo tromboze v mladosti, se lahko predlaga presejalni pregled po temeljitem svetovanju o omejitvah takšnega testiranja (pri presejalnih pregledih se odkrije le del trombofiličnih okvar).
This medicine contains 0.0088 mg sorbitol in each tablet.
To zdravilo vsebuje 0,0088 mg sorbitola na tableto.
In postmenopausal women, a significant proportion of the circulating oestrogens exists as sulfate conjugates, especially estrone sulfate, which serves as a circulating reservoir for the formation of more active oestrogens.
Pri ženskah v postmenopavzi velik delež estrogenov v obtoku obstaja v obliki sulfatnih konjugatov, zlasti estronsulfata, ki deluje kot skladišče za tvorbo aktivnejših estrogenov.
For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used (see section 4.4).
Za začetek in nadaljevanje zdravljenja simptomov postmenopavze je treba uporabiti najmanjši učinkoviti odmerek, trajanje uporabe pa mora biti čim krajše (glejte poglavje 4.4).
Pharmacokinetic studies for CE/BZA were conducted in healthy postmenopausal women who were naturally postmenopausal or who had undergone bilateral oophorectomy.
Farmakokinetične študije kombinacije CE/BZA so izvedli pri zdravih ženskah v postmenopavzi, ki so bile naravno v postmenopavzi ali pa so imele bilateralno ooforektomijo.
The following data are based on the findings in studies with bazedoxifene.
Podatki v nadaljevanju temeljijo na ugotovitvah študij z bazedoksifenom.
Other medicines and DUAVIVE
Druga zdravila in zdravilo DUAVIVE
These substitute for the loss of oestrogen production in menopausal women, and alleviate menopausal symptoms.
Ti nadomeščajo nezmožnost tvorbe estrogena pri ženskah v menopavzi in lajšajo menopavzalne simptome.
Adverse reactions were categorised as very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000), very rare (< 1/10,000) or not known (cannot be estimated from available data).
Neželeni učinki so bili razvrščeni kot 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) ali neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Medical examination/follow-up
Zdravstveni pregled/kontrolni pregled
Venous thromboembolism (VTE)
Venska trombembolija (VTE)
What you need to know before you take DUAVIVE
Kaj morate vedeti, preden boste vzeli zdravilo DUAVIVE
The distribution of exogenous oestrogens is similar to that of endogenous oestrogens.
Porazdelitev eksogenih estrogenov je podobna porazdelitvi endogenih estrogenov.
- Acute liver disease or a history of liver disease as long as liver function tests have failed to return to normal.
- Akutna bolezen jeter ali bolezen jeter v anamnezi, dokler se vrednosti testov funkcije jeter ne vrnejo na normalne.
• regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel.
• si redno pregledujete dojke in ste pozorni na vse spremembe, kot so nastanek jamic na koži, spremembe na bradavicah ali kakršnekoli zatrdline, ki jih lahko vidite ali otipate.
The following data are based on the findings in studies with BZA.
Podatki v nadaljevanju temeljijo na ugotovitvah študij z BZA.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
There are no data from the use of CE/BZA in pregnant women.
Podatkov o uporabi CE/BZA pri nosečnicah ni.
The risk of ovarian cancer varies with age.
Tveganje za raka jajčnikov se spreminja s starostjo.
Swallow tablet whole.
Tableto pogoltnite celo.
CE components, 17β-estradiol, estrone, and estriol are excreted in the urine, along with glucuronide and sulfate conjugates.
Komponente CE, 17β-estradiol, estron in estriol, se izločijo z urinom, skupaj z glukuronidom in sulfatnimi konjugati.
There were no significant pharmacokinetic interactions between bazedoxifene and the following medicinal products: ibuprofen, atorvastatin and azithromycin or an antacid containing aluminium and magnesium hydroxide.
Med bazedoksifenom in naslednjimi zdravili ni bilo pomembnih farmakokinetičnih interakcij: ibuprofen, atorvastatin, azitromicin ali antacid, ki vsebuje aluminijev in magnezijev hidroksid.
Patients treated with CE/BZA should be monitored carefully for signs of development of gallbladder disease.
Bolnice, ki se zdravijo s CE/BZA, je treba skrbno spremljati glede znakov pojava bolezni žolčnika.
Red Iron oxide (E172)
Črnilo črni železov oksid (E172)
Among these, 1,585 women were treated with CE 0.45 mg/BZA 20 mg and 1,241 received placebo.
Med njimi je 1.585 žensk prejemalo 0,45 mg CE /20 mg BZA, 1.241 žensk pa je prejemalo placebo.
BZA is eliminated with a half-life of approximately 30 hours.
Razpolovna doba izločanja BZA je približno 30 ur.
Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1 antitrypsin, ceruloplasmin).
Koncentracije drugih beljakovin v plazmi se lahko zvečajo (angiotenzinogen/substrat renina, alfa-1-antitripsin, ceruloplazmin).
Heart disease (heart attack)
Bolezen srca (srčna kap)
Conditions which need supervision
Bolezenska stanja, pri katerih je potreben nadzor
If prolonged immobilisation is to follow elective surgery temporarily stopping CE/BZA 4 to 6 weeks earlier is recommended.
Če elektivnemu kirurškemu posegu sledi daljša imobilizacija, je priporočljivo zdravljenje s CE/BZA začasno prekiniti 4 do 6 tednov pred posegom.
The bazedoxifene component of this medicine has been reported to cause problems with eyesight such as blurred vision.
Poročali so, da bazedoksifenska komponenta tega zdravila povzroča težave z vidom, npr. zamegljen vid.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake Uporabno do.
DUAVIVE is indicated for the treatment of oestrogen deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom treatment with progestin-containing therapy is not appropriate.
Zdravilo DUAVIVE je indicirano za zdravljenje simptomov pomanjkanja estrogena pri ženskah v postmenopavzi z maternico (vsaj 12 mesecev od zadnje menstruacije), pri katerih zdravljenje s progestini ni primerno.
On average, compared to women 51 to 64 years of age (n=8), women 65 to 74 years of age (n=8) showed a 1.5-fold increase in AUC, and women 75 years of age (n=8) showed a 2.6-fold increase in AUC.
V primerjavi z ženskami, starimi od 51 do 64 let (n = 8), so pri ženskah, starih od 65 do 74 let (n = 8), opazili povprečno 1,5-kratno zvečanje vrednosti AUC, pri ženskah, starih 75 let (n = 8), pa 2,6-kratno zvečanje vrednosti AUC.
For women with a history of cholestatic jaundice associated with past oestrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, CE/BZA should be discontinued.
Pri ženskah s holestatskim ikterusom, povezanim s preteklo uporabo estrogenov ali z nosečnostjo, je potrebna previdnost, pri ponovitvi bolezni pa je treba zdravljenje s CE/BZA prekiniti.
*WHI study in women with no uterus, which did not show an increase in risk of breast cancer
* Študija WHI pri ženskah brez maternice, pri katerih niso ugotovili zvečanega tveganja za raka dojke.
These may be signs of a liver disease
To sta lahko znaka bolezni jeter;
• Changes in mood
• spremembe razpoloženja;
• Cervical erosion found on medical examination
• erozija materničnega vratu, ugotovljena pri zdravniškem pregledu;
If you forget to take DUAVIVE
Če ste pozabili vzeti zdravilo DUAVIVE
• high blood pressure
• visok krvni tlak;
DUAVIVE is a medicine that contains two active substances called conjugated oestrogens and bazedoxifene.
DUAVIVE je zdravilo, ki vsebuje dve učinkovini, imenovani konjugirani estrogeni in bazedoksifen.
Of the total number of women in phase 3 clinical trials who received CE/BZA 20 mg, 2.4% (n=77) were aged ≥65 years.
Od skupnega števila žensk v kliničnih preskušanjih 3. faze, ki so prejemale CE/BZA, jih je bilo 2,4 % (n = 77) starih ≥ 65 let.
If you have any unexpected vaginal bleeding, you must contact your doctor as soon as possible.
Če se vam pojavijo nepričakovane krvavitve iz nožnice, morate čimprej obvestiti zdravnika.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Bolnice z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze, intoleranco za fruktozo, malabsorpcijo glukoze/galaktoze ali pomanjkanjem saharaze-izomaltaze ne smejo jemati tega zdravila.
This medicine contains conjugated oestrogens and bazedoxifene and is used to treat women with a uterus (womb).
To zdravilo vsebuje konjugirane estrogene in bazedoksifen, uporablja pa se za zdravljenje žensk, ki imajo maternico.
If you take more DUAVIVE than you should
Če ste vzeli večji odmerek zdravila DUAVIVE, kot bi smeli
Relief of oestrogen-deficiency symptoms and bleeding patterns
Lajšanje simptomov pomanjkanja estrogena in vzorci krvavitve
Adverse reactions were categorised as very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100) or rare ( 1/10,000 to < 1/1,000).
Neželeni učinki so bili razvrščeni kot zelo pogosti ( 1/10), pogosti ( 1/100 do < 1/10), občasni ( 1/1.000 do < 1/100) ali redki ( 1/10.000 do
If such symptoms occur, patients should avoid driving or use of machines that requires accurate visual perception until symptoms have resolved, or until they have received medical advice that it is safe to do so.
Če se pojavijo taki simptomi, se morajo bolnice izogibati vožnji ali upravljanju strojev, ki zahtevajo natančno vidno zaznavo, dokler simptomi ne izzvenijo ali dokler jim zdravnik ne svetuje, da so te dejavnosti varne.
It may harm them,
ki je imela raka dojke);