natgillin/translations-raw huggingface dataset:
This medicine contains lactose (a type of sugar). 
To zdravilo vsebuje laktozo (vrsta sladkorja).
In addition, women taking CONBRIZA should be advised to move about periodically during prolonged travel. 
Poleg tega je treba ženskam, ki jemljejo zdravilo CONBRIZA, svetovati, naj se med daljšimi potovanji občasno sprehodijo.
If any of them apply to you, talk to your doctor before you take the medicine. 
Če katerikoli od njih velja za vas, se pogovorite z zdravnikom, preden zdravilo vzamete.
Manufacturer: PfizerIrelandPharmaceuticals, Little Connell,Newbridge, County Kildare, Ireland. 
Izdelovalec: Pfizer Ireland Pharmaceuticals, Little Connell, Newbridge, County Kildare, Irska.
However, if it is almost time to take your next dose of this medicine, skip the dose you missed and only take your next scheduled dose. 
Če pa je že skoraj čas za naslednji odmerek tega zdravila, pozabljenega izpustite in vzemite šele naslednji odmerek po razporedu.
No dose adjustment is necessary based on age. 
Prilagajanje odmerka na podlagi starosti ni potrebno.
if you are pre-menopausal. 
če še niste v menopavzi.
Total number of subjects n=1,724 n=1,741 
Celotno število oseb n = 1.724 n = 1.741
7 film-coated tablets 28 film-coated tablets 30 film-coated tablets 84 film-coated tablets 90 film-coated tablets 
7 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 84 filmsko obloženih tablet 90 filmsko obloženih tablet
Other venous thromboembolic events could also occur. 
Možni so tudi drugi venski trombembolični dogodki.
If you are traveling on long trips, you should walk around or exercise your legs and feet at regular intervals. 
Na dolgih potovanjih se morate sprehajati ali si v rednih presledkih razgibavati nogein stopala.
Patients with signs or symptoms of endometrial cancer; safety in this patient group has not been adequately studied. 
Bolnice z znaki ali simptomi raka endometrija; pri tej skupini bolnic varnosti niso dovolj proučili.
What CONBRIZA is and what it is used for 
Kaj je zdravilo CONBRIZA in za kaj ga uporabljamo
d p-value=0.035 
d vrednost p = 0,035
The safety data in the following table are derived from both clinical trials and spontaneous post-marketing reporting. 
Podatki o varnosti v spodnji preglednici izvirajo iz kliničnih preskušanj in tudi iz spontanih poročil v obdobja trženja zdravila.
EU/1/09/511/001 28 tablets EU/1/09/511/002 30 tablets EU/1/09/511/003 84 tablets EU/1/09/511/004 90 tablets EU/1/09/511/005 7 tablets 
EU/1/09/511/001 28 tablet EU/1/09/511/002 30 tablet EU/1/09/511/003 84 tablet EU/1/09/511/004 90 tablet EU/1/09/511/005 7 tablet
Not known (frequency cannot be estimated from the available data): 
Neznana (ni mogoče oceniti iz razpoložljivih podatkov):
The 3-year core study was extended twice, with two 2-year double-blind, placebocontrolled extensions, resulting in a total treatment duration of up to 7 years (7-year study). 
Triletna temeljna študija je bila dvakrat podaljšana z 2-letnimi, dvojno slepimi, s placebom nadzorovanimi podaljšanji, s čimer je skupen čas trajanja znašal do 7 let (7-letna študija).
Mean ± SD pharmacokinetic parameters of bazedoxifene (n=23) Cmax (ng/ml) 
Povprečje ± SD farmakokinetičnih parametrov bazedoksifena (n = 23) Cmax (ng/ml)
CONBRIZA should be discontinued prior to and during prolonged immobilisation (e.g., post-surgical recovery, prolonged bed rest), and therapy should be resumed only after the patient is fully ambulatory. 
Zdravilo CONBRIZA je treba ukiniti pred in med dolgotrajno imobilizacijo (npr. okrevanje po operaciji, dolgotrajno ležanje v postelji), zdravljenje pa se sme ponovno uvesti šele, ko je bolnica spet povsem pokretna.
Other medicines and CONBRIZA 
Druga zdravila in zdravilo CONBRIZA
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 taki simptomi pojavijo, se naj bolnice izogibajo vožnji ali upravljanju s stroji, ki zahtevajo natančno vidno zaznavo, dokler simptomi ne izzvenijo ali dokler jim zdravnik ne svetuje, da je tako početje varno.
Each film-coated tablet contains 142.8 mg lactose (as monohydrate). 
Ena filmsko obložena tableta vsebuje 142,8 mg laktoze (v obliki monohidrata).
The median T-score ranged from -0.6 to -1.4, depending on the skeletal site. 
Mediana ocena T je segala od -0,6 do -1,4, odvisno od lokacije v skeletu.
if you have had increased levels of triglycerides (a type of fat found in your blood) in the past. 
če ste kdaj prej imeli zvišano raven trigliceridov (vrsta maščob v vaši krvi).
In subjects treated with bazedoxifene, the incidence of fractures was related to the baseline fracture risk: the higher the fracture risk, the greater the benefit with bazedoxifene treatment. 
Pri osebah, zdravljenih z bazedoksifenom, je bila pojavnost zlomov povezana s tveganjem izhodiščnega zloma: čim večja je bila nevarnost zloma, tem večja je bila korist zdravljenja z bazedoksifenom.
Because these changes are not considered clinically relevant, bazedoxifene can be administered without regard to meals. 
Ker te spremembe ne veljajo za klinično pomembne, lahko dajemo bazedoksifen ne glede na obroke.
In long-term studies renal tumours (adenomas and carcinomas) were observed at all doses tested, most likely as a consequence of this chronic renal damage. 
V dolgoročnih študijah so pri vseh preskušanih odmerkih opazili ledvične tumorje (adenome in karcinome), ki so najverjetneje nastali zaradi teh kroničnih ledvičnih okvar.
The major route of excretion of radio-labelled bazedoxifene is the faeces, and less than 1% of the dose is eliminated in urine. 
Poglavitna pot odstranjevanja radioaktivno označenega bazedoksifena iz telesa je z blatom, z urinom se izloči manj kot 1 % odmerka.
Bazedoxifene does not induce or inhibit the activities of major CYP isoenzymes. 
Bazedoksifen niti ne inducira niti ne inhibira aktivnosti poglavitnih izoencimov CYP.
c p-value=0.22 
c vrednost p = 0,22
In clinical trials, somnolence was reported as an adverse reaction, and patients should be advised on the potential effect on driving and using machines. 
V kliničnih preskušanjih so poročali o zaspanosti kot neželenem učinku, zato je treba bolnice opozoriti na možne učinke na sposobnost vožnje in upravljanja s stroji.
Uncommon Frequency not known (cannot be estimated from available data) 
Neznana (ni mogoče oceniti iz razpoložljivih podatkov)
They are packed in PVC/Aclar blisters and are available in packs of 7, 28, 30, 84 or 90 tablets. 
Pakirane so v pretisnih omotih iz PVC/Aclar, na voljo pa so v pakiranjih po 7, 28, 30, 84 ali 90 tablet.
You should continue taking this medicine as long as your doctor tells you to. 
To zdravilo morate jemati toliko časa, kot vam je naročil zdravnik.
CONBRIZA is only indicated for use in postmenopausal women (see section 4.3) and should not be used during breast-feeding. 
Zdravilo CONBRIZA je indicirano le za uporabo pri ženskah v postmenopavzi (glejte poglavje 4.3) in se ga med dojenjem ne sme uporabljati.
This pharmacological effect of bazedoxifene can also be expected in pre-menopausal women, but is considered clinically irrelevant in post-menopausal women. 
Ta farmakološki učinek bazedoksifena lahko pričakujemo tudi pri ženskah pred menopavzo, vendar velja pri ženskah po menopavzi za klinično nepomembnega.
Table 1: Effect of bazedoxifene on risk of vertebral fractures after 3 years of treatment Number of subjects 
Preglednica 1: Učinek bazedoksifena na tveganje za zlome vretenc po 3 letih zdravljenja Število oseb
Its safety in premenopausal women has not been established, and its use is not recommended in this population. 
Njegove varnosti za ženske pred menopavzo niso dokazali in uporaba tega zdravila pri tej populaciji ni priporočljiva.
If you feel drowsy after taking this medicine, you should avoid driving or operating machines. 
Če ste po jemanju tega zdravila zaspani, ne upravljajte vozil ali strojev.
Since chronic progressive nephropathy and corticomedullar nephrocalcinosis are most likely rat-specific nephropathies, these findings are presumably not relevant for humans. 
Ker sta kronična progresivna nefropatija in kortikomedularna nefrokalcinoza najverjetneje za podgane specifični nefropatiji, te ugotovitve za ljudi verjetno niso relevantne.
All subjects received calcium supplementation daily; most received 600 mg calcium (e.g., Caltrate) daily, while some received up to 1,200 mg daily. 
Vse osebe so vsak dan prejemale dodatke kalcija; večina jih je prejemala po 600 mg kalcija (npr. Caltrate) na dan, nekatere pa do 1.200 mg na dan.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. 
Bolnice z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze-galaktoze ne smejo jemati tega zdravila.
This increase was most likely attributed to age-related changes in hepatic function. 
Ta porast lahko najverjetneje pripišemo starostnim spremembam delovanja jeter.
What you need to know before you take CONBRIZA 
Kaj morate vedeti, preden boste vzeli zdravilo CONBRIZA
These tumours are considered as spontaneous renal cell carcinomas that are known to occur in nonhuman primates and are unlikely to be relevant to humans. 
Ti tumorji veljajo za spontane karcinome ledvičnih celic, za katere je znano, da se pojavljajo pri primatih, razen pri človeku, in ni verjetno, da bi bili relevantni za ljudi.
Following intravenous administration of a 3 mg dose of bazedoxifene, the volume of distribution is 14.7 ± 3.9 l/kg. 
Po intravenski aplikaciji 3 mg odmerka bazedoksifena je volumen porazdelitve 14,7 ± 3,9 l/kg.
Pharmacotherapeutic group: Selective estrogen receptor modulator, ATC code: G03XC02. 
Farmakoterapevtska skupina: selektivni modulator estrogenskih receptorjev (SERM); oznaka ATC: G03XC02.
A significant reduction in the incidence of vertebral fractures has been demonstrated; efficacy on hip fractures has not been established. 
Dokazali so pomembno zmanjšanje incidence zlomov vretenc; učinkovitosti za zlome kolka niso dokazali.
If this happens, you should avoid driving or operating machines until your doctor tells you that it is safe to do so. 
Če se pojavijo, ne vozite in upravljajte s stroji, dokler vam zdravnik ne pove, da je tako početje varno.
Histological assessment of bone biopsies from all treatment groups revealed formation of normal lamellar bone in all treated subjects. 
Histološki pregled kostnih biopsij iz vseh zdravljenih skupin je pri vseh zdravljenih osebah pokazal oblikovanje normalne lamelarne kosti.
The concentrations of this glucuronide are approximately 10-fold higher than those of unchanged active substance in plasma. 
Koncentracija tega glukuronida v plazmi je približno 10-krat višja od koncentracije nespremenjene zdravilne učinkovine.
CONBRIZA has minor influence on the ability to drive and use machines. 
Zdravilo CONBRIZA ima blag vpliv na sposobnost vožnje in upravljanja s stroji.
In subjects with 10-year fracture probabilities at or above 16%, bazedoxifene was associated with a significant decrease in the risk of all clinical fractures. 
Pri osebah z 10-letno verjetnostjo zloma 16 % ali več je bil bazedoksifen povezan s pomembnim zmanjšanjem tveganja vseh kliničnih zlomov.
All subjects were to receive 1,200 mg of elemental calcium and 400 IU of vitamin D daily. 
Vse osebe v raziskavi so prejemale po 1.200 mg elementarnega kalcija in po 400 i.e. vitamina D na dan.
Bazedoxifene is highly bound (98% - 99%) to plasma proteins in vitro. 
Bazedoksifen se in vitro v veliki meri (98 % - 99 %) veže na plazemske beljakovine.
Any uterine bleeding during CONBRIZA therapy is unexpected and should be fully investigated. 
Morebitna maternična krvavitev med zdravljenjem z zdravilom CONBRIZA ni pričakovana in jo je treba podrobno raziskati.
This is because sitting for a long time in the same position may prevent good blood circulation and may increase your risk of blood clots. 
Dolgotrajno sedenje v istem položaju lahko namreč poslabša krvni obtok in zveča nevarnost krvnih strdkov.
The rate of VTE was highest in the first year with a relative risk of 2.69. 
Delež VTE je bil največji v prvem letu, pri čemer je relativno tveganje znašalo 2,69.
as it may increase your risk of getting blood clots. 
ker lahko zveča nevarnost nastanka krvnih strdkov.
Histomorphometric assessment revealed normal mineralisation, as evidenced by the presence of normal osteoid thickness, normal mineralisation lag time, and mineral apposition rate. 
Histomorfometrični pregled je pokazal normalno mineralizacijo, na katero so kazali prisotnost normalne debeline osteoida, normalnega časa zaostajanja mineralizacije in hitrosti nalaganja mineralov.
The bazedoxifene 40 mg dose was decreased to a 20 mg dose after approximately 4 years. 
Odmerek bazedoksifena se je zmanjšal iz 40 mg na 20 mg po približno 4 letih.
These effects on bone remodeling lead to an increase in bone mineral density (BMD), which in turn contributes to a reduction in the risk of fractures. 
Ti učinki na preoblikovanje kosti zvečajo mineralno kostno gostoto (MKG), ki nato prispeva k zmanjšanju nevarnosti kostnih zlomov.
There are no data from the use of bazedoxifene in pregnant women. 
Podatkov o uporabi bazedoksifena pri nosečnicah ni na voljo.
a of subjects with ≥1 new vertebral fracture Kaplan-Meier rate estimates p-value=0.015 
a oseb z ≥ 1 novim zlomom vretenc Ocene pogostnosti po Kaplan-Meierju vrednost p = 0,015
The pharmacokinetics of a 20 mg single-dose of bazedoxifene were evaluated in a study in 26 healthy postmenopausal women. 
Farmakokinetiko 20 mg enkratnega odmerka bazedoksifena so ovrednotili v študiji pri 26 zdravih ženskah v postmenopavzi.
What CONBRIZA is and what it is used for What you need to know before you take CONBRIZA How to take CONBRIZA 
Kaj je zdravilo CONBRIZA in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo CONBRIZA Kako jemati zdravilo CONBRIZA Možni neželeni učinki
if you have or have had a blood clot (for example, in the blood vessels in your legs, lungs, or eyes). 
če imate ali ste kdaj imeli krvni strdek (na primer v krvnih žilah nog, pljuč ali oči).
In rats, treatment with bazedoxifene for approximately one year partially prevented the effects of ovariectomy on numerous skeletal parameters (bone mineral content, bone mineral density, and architecture). 
Pri podganah je približno enoletno dajanje bazedoksifena delno preprečilo učinke ovariektomije na številne parametre skeleta (vsebnost mineralov v kosteh, mineralna kostna gostota in arhitektura kosti).
The treatment effect was similar among those with and without prevalent vertebral fractures (Table 1). 
Učinek zdravljenja je bil pri bolnicah s prisotnimi zlomi vretenc in pri tistih brez njih podoben (preglednica 1).
The efficacy of bazedoxifene was established in two multicentre, double-blind, randomised, placeboand active-control, Phase 3 trials: 3-year osteoporosis treatment trial and a 2-year osteoporosis prevention trial. 
Učinkovitost bazedoksifena so dokazali v dveh multicentričnih, dvojno slepih, randomiziranih, s placebom in drugo zdravilno učinkovino nadzorovanih preskušanjih 3. faze: 3-letno preskušanje zdravljenja osteoporoze in 2-letno preskušanje preprečevanja osteoporoze.
if you are immobile (unable to move) for some time, such as being wheel-chair bound, sitting for a prolonged period of timeor having to stay in bed while recovering from an operation or illness. 
če ste daljši čas nepokretni (se ne morete premikati), na primer vezani na invalidski voziček, dolgo časa sedite ali morate med okrevanjem po operaciji ali bolezni ostati v postelji.
The majority of adverse reactions occurring during the clinical trials were mild to moderate in severity and did not lead to discontinuation of therapy. 
Neželeni učinki, ki so se pojavili med kliničnimi preskušanji, so bili po izraženosti večinoma blagi do zmerni in niso zahtevali prekinitve zdravljenja.
The most frequent drug-related adverse reactions in double-blind, randomised studies were hot flushes and muscle spasms (includes leg cramps). 
Najpogostejši neželeni učinki, povezani z zdravilom, v dvojno slepih randomiziranih študijah so bili vročinski oblivi in mišični krči (vključno s krči v nogah).
This medicine should be taken with an adequate amount of calcium and vitamin D. Consult your doctor to see if your dietary calcium and vitamin D intake is adequate and whether you need calcium and vitamin D supplementation. 
To zdravilo jemljite z ustrezno količino kalcija in vitamina D. Posvetujte se z zdravnikom, ali uživate hrano z dovolj kalcija in vitamina D in ali potrebujete dodatke kalcija in vitamina D. Če jemljete dodatke kalcija in/ali vitamina D, jihlahko jemljete sočasno s tem zdravilom.
The mean pharmacokinetic parameters of bazedoxifene after multiple doses in healthy postmenopausal ambulatory women who were naturally postmenopausal or who had undergone bilateral oophorectomy are summarized in Table 2. 
Povprečni farmakokinetični parametri bazedoksifena po večkratnih odmerkih pri zdravih pokretnih ženskah v postmenopavzi, ki so imele bodisi naravno menopavzo bodisi bilateralno ooforektomijo, so povzeti v preglednici 2.
There were no significant pharmacokinetic interactions between bazedoxifene and the following medicinal products: ibuprofen, atorvastatin, azithromycin, or an antacid containing aluminium and magnesium hydroxide. 
Med bazedoksifenom in naslednjimi zdravili ni bilo pomembnih farmakokinetičnih interakcij: ibuprofen, atorvastatin, azitromicin in antacid, ki je vseboval aluminijev in magnezijev hidroksid.
The mean LS and FN T-scores at baseline were -2.4 and -1.7, respectively. 
Povprečni oceni T LS in FN v izhodišču sta bili -2,4 oziroma -1,7.
Elderly patients 
Starejše bolnice
Elderly patients No dose adjustment is necessary based on age (see section 5.2). 
Starejše bolnice Prilagajanje odmerka na podlagi starosti ni potrebno (glejte poglavje 5.2).
Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium. 
Imetnik dovoljenja za promet z zdravilom: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgija.
Importantly, in both species, the administration of bazedoxifene had no deleterious effects on bone quality. 
Pomembno je, da pri nobeni od teh dveh živalskih vrst dajanje bazedoksifena ni škodljivo vplivalo na kakovost kosti.
Bazedoxifene is eliminated with a half-life of approximately 30 hours. 
Bazedoksifen se odstranjuje iz telesa z razpolovnim časom približno 30 ur.
In a post-hoc analysis, the 10-year fracture probability as an index of baseline fracture risk was determined. 
V naknadni (post-hoc) analizi so ugotovili 10-letno verjetnost zloma kot indeks tveganja izhodiščnega zloma.
After 3 years the relative risk was 1.63 and after a 5 year study period the relative risk was 1.50. 
Po 3 letih je relativno tveganje znašalo 1,63, po petih letih izvajanja študije pa je relativno tveganje znašalo 1,50.
In a post-hoc analysis, the relative risk of non-vertebral fractures in bazedoxifene-treated subjects decreased with increased fracture probability. 
V naknadni analizi se je relativno tveganje za nevretenčne zlome pri osebah, zdravljenih z bazedoksifenom, zmanjševalo z rastočo verjetnostjo zlomov.
It is used for the treatment of osteoporosis in women after they have reached menopause, when they are at an increased risk of fractures. 
Uporablja se za zdravljenje osteoporoze pri ženskah po doseženi menopavzi, ko jih bolj ogrožajo zlomi kosti.
After 7 year study period the relative risk was 1.51 (see section 5.1). 
Po 7 letih izvajanja študije je relativno tveganje znašalo 1,51 (glejte poglavje 5.1).
if you have any unexplained vaginal bleeding. 
če imate nepojasnjeno krvavitev iz nožnice.
Bazedoxifene undergoes metabolism by uridine diphosphate glucuronosyltransferase (UGT) enzymes in the intestinal tract and liver (see section 5.2). 
Bazedoksifen se presnavlja preko encimov uridin difosfat glukuroniltransferaz (UGT) v črevesju in jetrih (glejte poglavje 5.2).
Similar reductions in the rate of bone turnover have been observed in the osteoporosis prevention study. 
Podobno zmanjšanje hitrosti premene kostnine so opazili v študiji preprečevanja osteoporoze.
CONBRIZA contains the active substance bazedoxifene, and is a medicine that belongs to a group of non-hormonal medicines called Selective Estrogen Receptor Modulators (SERMs). 
Zdravilo CONBRIZA vsebuje zdravilno učinkovino bazedoksifen in je zdravilo, ki spada v skupino nehormonskih zdravil z imenom selektivni modulatorji estrogenskih receptorjev (SERM).
Studies in rats have shown adverse effects on fertility (see section 5.3). 
Študije na podganah so pokazale škodljive vplive na plodnost (glejte poglavje 5.3).
Supplemental calcium and/or vitamin D should be added to the diet if daily intake is inadequate. 
Če je dnevni vnos kalcija in/ali vitamina D nezadosten, ju je k redni prehrani treba dodajati.
Impaired renal function showed little or no influence on bazedoxifene pharmacokinetics, and no dosing adjustment is required. 
Zmanjšano delovanje ledvic je malo ali nič vplivalo na farmakokinetiko bazedoksifena, prilagajanje odmerjanja torej ni potrebno.
If you forget to take CONBRIZA 
Če ste pozabili vzeti zdravilo CONBRIZA
CONBRIZA 20 mg film-coated tablets 
CONBRIZA 20 mg filmsko obložene tablete
Osteoporosis treatment trial 
Preskušanje zdravljenja osteoporoze
The risk factors associated with VTE cases in clinical trials included: advanced age, obesity, immobilisation, surgery, major trauma and malignancy. 
Dejavniki tveganja, povezani s primeri VTE v kliničnih preskušanjih bazedoksifena, so obsegali: višjo starost, debelost, imobilizacijo, operacijo, večje poškodbe in raka.
Based on in vitro bazedoxifene plasma protein binding characteristics, drug interactions with warfarin, digoxin and diazepam are unlikely. 
Na podlagi in vitro značilnosti vezave bazedoksifena na plazemske beljakovine je medsebojno delovanje z varfarinom, digoksinom in diazepamom malo verjetno.
An additional study evaluating the effects of a standardized medium-fat meal on the pharmacokinetics of bazedoxifene at steady-state showed a 42% and 35% increase in Cmax and AUC, respectively, when 20 mg bazedoxifene was administered with food. 
Dodatna študija, v kateri so ocenjevali učinke standardiziranega srednje mastnega obroka na farmakokinetiko bazedoksifena v stanju dinamičnega ravnovesja, je pokazala 42 % porast Cmax in 35 % porast AUC, če so 20 mg bazedoksifena dajali s hrano.
Do not take CONBRIZA 
Ne jemljite zdravila CONBRIZA
When single doses of 20 mg bazedoxifene were administered with a high-fat meal, Cmax and AUC increased by 28% and 22%, respectively. 
Ko so dajali enkratne 20 mg odmerke bazedoksifena z obrokom z visoko vsebnostjo maščob, je Cmax porasla za 28 % in AUC za 22 %.
Race No pharmacokinetic differences based on ethnic group were observed. 
Rasa Opazili niso nikakršnih farmakokinetičnih razlik med pripadnicami različnih etničnih skupin.
This medicine may cause harm to your unborn child if taken during pregnancy. 
Če bi to zdravilo jemali v nosečnosti, bi lahko škodovalo vašemu nerojenemu otroku.
Osteoporosis prevention trial 
Preskušanje preprečevanja osteoporoze
PVC/Aclar blister packs of 7, 28, 30, 84, and 90 film-coated tablets. 
Pretisni omoti iz PVC/Aclar, ki vsebujejo po 7, 28, 30, 84 ali 90 filmsko obloženih tablet.
It must not be taken by women who are pregnant or who could still have a baby. 
Nosečnice ali ženske, ki bi še vedno lahko zanosile, ga ne smejo jemati.
If you have other events affecting the eye and/or vision (seeing sparks or flashes of light, narrowing of visual field, and swelling of eye or eyelid) 
če imate druge neželene učinke, ki vplivajo na oko in/ali vid (videnje isker ali bliskov svetlobe, zoženje vidnega polja in otekanje očesa ali očesne veke)
After 3 years the relative risk was 1.63 and after a 5 year study period the relative risk was 1.50; after 7 years the relative risk was 1.51 (see sections 4.8 and 5.1). 
Po treh letih je relativno tveganje znašalo 1,63, po petih letih izvajanja študije pa je relativno tveganje znašalo 1,50; po 7 letih je relativno tveganje znašalo 1,51 (glejte poglavji 4.8 in 5.1).