FrancophonIA/ELRC3.0 huggingface dataset:
English: Cardiac disorder atrioventricular block1, cardiac arrest1, arrhythmia1, cardiac failure1, congestive heart failure1, chest pain1, palpitations1, oedema1
Slovenian: srčna odpoved1, kongestivna srčna odpoved1, bolečine v prsnem košu1, palpitacije1, edem1
English: If you stop using GANFORT single-dose
Slovenian: Če ste prenehali uporabljati zdravilo GANFORT (enoodmerna oblika)
English: Choroidal detachment has been reported with administration of aqueous suppressant therapy (e.g. timolol, acetazolamide) after filtration procedures.
Slovenian: Pri zdravljenju z zdravili, ki zavirajo nastanek očesne vodke (npr. timololom, acetazolamidom), so po filtracijskih posegih poročali o odstopanju žilnice.
English: Increased brown iris pigmentation has also been observed during treatment with GANFORT (multi-dose formulation).
Slovenian: Pri zdravljenju z zdravilom GANFORT (večodmerna oblika) je bila opažena tudi povečana rjava pigmentacija šarenice.
English: Affecting the eye abnormal sensation in the eye, iris inflammation, swollen conjunctiva (see-through layer of the eye), painful eyelids, tired eyes, in-growing eyelashes, darkening of iris colour, eyes appear sunken, eyelid has moved away from the surface of the eye, darkening of eyelashes.
Slovenian: Učinki na oko nenormalen občutek v očesu, vnetje šarenice, otekla očesna veznica (prozorna plast očesa), boleče veke, utrujene oči, vraščene trepalnice, temnenje barve šarenice, oči so videti udrte, odstop veke od površine očesa, temnenje trepalnic.
English: Common punctuate keratitis, corneal erosion2, burning sensation2, conjunctival irritation1, eye pruritus, stinging sensation in the eye2, foreign body sensation, dry eye, erythema of eyelid, eye pain, photophobia, eye discharge2, visual disturbance2, eyelid pruritus, visual acuity worsened2, blepharitis2, eyelid oedema, eye irritation, lacrimation increased, growth of eyelashes.
Slovenian: boleče oko, fotofobija, izcedek iz očesa2, motnje vida2, pruritus očesne veke, poslabšana ostrina vida2, blefaritis2, edem očesne veke, draženje oči, povečano solzenje, rast trepalnic občasni iritis2, edem očesne veznice2, bolečina v očesni veki2, neobičajen občutek v očesu1,
English: Like other topically applied ophthalmic medicinal products, the active substances (timolol/ bimatoprost) in GANFORT may be absorbed systemically.
Slovenian: Kot pri drugih lokalnih očesnih zdravilih se tudi zdravilni učinkovini (timolol/bimatoprost) v zdravilu GANFORT lahko absorbirata sistemsko.
English: Before treatment is initiated, patients should be informed of the possibility of eyelash growth, and periorbital skin hyperpigmentation since these have been observed during treatment with GANFORT single-dose.
Slovenian: Pred zdravljenjem je treba bolnika obvestiti o možnih spremembah, ki so jih opazili med zdravljenjem z zdravilom GANFORT (enoodmerna oblika), to je o rasti trepalnic in hiperpigmentaciji kože okoli očesne votline.
English: - disturbances of heart rate such as slow heart beat - breathing problems, asthma or chronic obstructive pulmonary disease - poor blood circulation disease (such as Raynaud's disease or Raynaud's syndrome) - overactivity of the thyroid gland as timolol may mask signs and symptoms of thyroid disease - diabetes as timolol may mask signs and symptoms of low blood sugar - severe allergic reactions - liver or kidney problems - eye surface problems - separation of one of the layers within the eyeball after surgery to reduce the pressure in the eye - known risk factors for macular oedema (swelling of the retina within the eye leading to worsening vision), for example, cataract surgery
Slovenian: - bolezen z motnjami v prekrvavitvi (kot je Raynaudova bolezen ali Raynaudov sindrom); - povečano delovanje žleze ščitnice, ker lahko timolol prikrije znake in simptome bolezni ščitnice; - sladkorno bolezen, ker lahko timolol prikrije znake in simptome nizkega krvnega sladkorja; - hude alergijske reakcije; - težave z jetri ali ledvicami;
English: Bimatoprost is a potent ocular hypotensive active substance.
Slovenian: Bimatoprost je močna zdravilna učinkovina za zmanjšanje očesnega tlaka.
English: From a microbiological point of view, the in-use storage times and conditions are the responsibility of the user and would normally not be longer than 28 days at 25°C.
Slovenian: Čas uporabe naj praviloma ne bi bil daljši od 28 dni pri temperaturi 25 °C.
English: The change may be more noticeable if you are only treating one eye. GANFORT may cause hair growth when in contact with the skin surface.
Slovenian: (enoodmerna oblika) lahko povzroči rast dlak, ko je v stiku s površino kože.
English: Do not use GANFORT single-dose if you are breast-feeding.
Slovenian: Zdravila GANFORT (enoodmerna oblika) ne uporabljajte, če dojite.
English: What GANFORT single-dose looks like and contents of the pack
Slovenian: Izgled zdravila GANFORT (enoodmerna oblika) in vsebina pakiranja
English: Keep single-dose containers in the pouch in order to protect from light and moisture.
Slovenian: Enoodmerne vsebnike hranite v verčici, za zagotovitev zaščite pred svetlobo in vlago.
English: Like other topically applied ophthalmic drugs, GANFORT (bimatoprost/timolol) is absorbed into the systemic circulation.
Slovenian: Kot pri drugih lokalnih očesnih zdravilih se tudi zdravilo GANFORT (bimatoprost/timolol) absorbira v sistemski krvni obtok.
English: Respiratory, thoracic and mediastinal disorders Asthma exacerbation2, COPD exacerbation2, cough1
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora poslabšanje astme2, poslabšanje KOPB2, kašelj1
English: Ophthalmic beta-blockers may induce dryness of eyes.
Slovenian: Očesni antagonisti adrenergičnih receptorjev beta lahko povzročijo suhost oči.
English: Vascular disorders
Slovenian: Odstopanje žilnice
English: GANFORT should not be used by breast-feeding women.
Slovenian: Doječe matere zdravila GANFORT ne smejo uporabljati.
English: Beta-blocking ophthalmological preparations may block systemic beta-agonist effects e.g. of adrenaline.
Slovenian: Kirurška anestezija Očesni antagonisti adrenergičnih receptorjev beta lahko zavirajo učinke sistemskih antagonistov adrenergičnih receptorjev beta, npr. adrenalina.
English: Each pack contains either 1 or 3 plastic bottles each with a screw-cap. Each bottle is about half full and contains 3 millilitres of solution.
Slovenian: Vsaka plastenka je napolnjena približno do polovice in vsebuje 3 ml raztopine.
English: Always use GANFORT single-dose exactly as your doctor or pharmacist has told you.
Slovenian: Pri uporabi zdravila GANFORT (enoodmerna oblika) natančno upoštevajte navodila zdravnika ali farmacevta.
English: In patients with a history of mild liver disease or abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin at baseline, bimatoprost had no adverse reactions on liver function over 24 months.
Slovenian: Pri bolnikih z anamnezo blage bolezni jeter ali nenormalnimi izhodiščnimi vrednosti alanin aminotransferaze (ALT), aspartat-aminotransferaze (AST) in/ali celokupnega bilirubina, bimatoprost v
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING 30 SINGLE-DOSE CONTAINERS (PROVIDED IN 3 POUCHES, EACH CONTAINING 10 SINGLE-DOSE CONTAINERS)
Slovenian: ŠKATLA S 30 ENOODMERNIMI VSEBNIKI, SHRANJENIMI V 3 VREČICAH S PO 10 ENOODMERNIMI VSEBNIKI
English: Always use GANFORT exactly as your doctor or pharmacist has told you.
Slovenian: Pri uporabi zdravila GANFORT natančno upoštevajte navodila zdravnika ali farmacevta.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING 90 SINGLE-DOSE CONTAINERS (PROVIDED IN 9 POUCHES, EACH CONTAINING 10 SINGLE-DOSE CONTAINERS)
Slovenian: ŠKATLA Z 90 ENOODMERNIMI VSEBNIKI, SHRANJENIMI V 9 VREČICAH S PO 10 ENOODMERNIMI VSEBNIKI
English: • The other ingredients are benzalkonium chloride (a preservative), sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate and purified water.
Slovenian: • Pomožne snovi: benzalkonijev klorid (konzervans), natrijev klorid, natrijev dihidrogenfosfat heptahidrat, citronska kislina monohidrat in prečiščena voda.
English: If you use GANFORT single-dose with another eye medicine, leave at least 5 minutes between putting in GANFORT single-dose and the other medicine.
Slovenian: Če poleg zdravila GANFORT uporabljate še kakšno drugo očesno zdravilo, je treba različna zdravila vkapati v razmiku najmanj 5 minut.
English: White opaque low-density polyethylene bottles with polystyrene screw cap. Each bottle has a fill volume of 3 ml.
Slovenian: Plastenka iz belega polietilena z majhno gostoto, z navojno zaporko iz polistirena.
English: GANFORT single-dose has not been studied in patients with hepatic or renal impairment.
Slovenian: Zdravilo GANFORT (enoodmerna oblika) ni bilo preizkušeno pri bolnikih z očesnimi vnetji,
English: The incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration.
Slovenian: Incidenca sistemskih neželenih učinkov ob lokalni uporabi v očesu je nižja kot pri sistemski uporabi.
English: Uncommon iritis2, conjunctival oedema2, eyelid pain2, abnormal sensation in the eye1, asthenopia, trichiasis2, iris hyperpigmentation2, deepening of eyelid sulcus, eyelid retraction2, eyelash discolouration (darkening)1.
Slovenian: astenopija, trihiaza2, hiperpigmentacija šarenice2, poglobitev sulkusa veke, retrakcija veke2, razbarvanje trepalnic (potemnitev)1
English: GANFORT has not been studied in patients with hepatic or renal impairment.
Slovenian: Varnosti in učinkovitosti zdravila GANFORT pri bolnikih z okvaro jeter ali ledvic niso preučevali.
English: Pharmacotherapeutic group: Ophthalmological,- beta-blocking agents - ATC code: S01ED51
Slovenian: Oznaka ATC: S01ED51 Mehanizem delovanja
English: Skin and subcutaneous tissue disorders psoriasiform rash1 or exacerbation of psoriasis1, skin rash1 Musculoskeletal and connective tissue disorders myalgia1 Reproductive system and breast disorders sexual dysfunction1, decreased libido1
Slovenian: Bolezni kože in podkožja psoriaziformni izpuščaj1 ali poslabšanje psoriaze1, kožni izpuščaji1
English: Surgical anaesthesia β-blocking ophthalmological preparations may block systemic β-agonist effects e.g. of adrenaline.
Slovenian: Kirurška anestezija Očesni antagonisti adrenergičnih receptorjev beta lahko zavirajo učinke sistemskih antagonistov adrenergičnih receptorjev beta npr. adrenalina.
English: Bimatoprost/timolol
Slovenian: Dojenje Timolol
English: - if you are allergic to bimatoprost, timolol, beta-blockers or any of the other ingredients of GANFORT (listed in section 6) - if you have now or have had in past respiratory problems such as asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/ or long-standing cough) - if you have heart problems such as low heart rate, heart block, or heart failure
Slovenian: - če imate ali ste v preteklosti imeli bolezen dihal, kot je astma, hud kronični obstruktivni bronhitis (huda pljučna bolezen, ki lahko povzroči sopihanje, težave z dihanjem in/ali dolgotrajni kašelj);
English: Eye drops, solution, in single-dose container.
Slovenian: kapljice za oko, raztopina, v enoodmernem vsebniku brezbarvna do rahlo rumenkasta raztopina
English: • The other ingredients are sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate and purified water.
Slovenian: • Pomožne snovi: natrijev klorid, natrijev dihidrogenfosfat heptahidrat, citronska kislina monohidrat in prečiščena voda.
English: Investigations liver function tests (LFT) abnormal2
Slovenian: Splošne težave in spremembe na mestu aplikacije astenija1,2 Preiskave nenormalni testi jetrne funkcije2
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti rinitis2
English: No new adverse reactions specific for GANFORT have been observed in clinical studies.
Slovenian: V kliničnih študijah niso opazili nobenih novih neželenih učinkov, ki bi bili značilni samo za zdravilo GANFORT.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH PLASTENKA
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR POUCH CONTAINING STRIP OF 5 SINGLE-DOSE CONTAINERS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA VREČICO S 5 ENOODMERNIMI VSEBNIKI
English: GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container.
Slovenian: GANFORT 0,3 mg/ml + 5 mg/ml kapljice za oko, raztopina, v enoodmernem vsebniku.
English: GANFORT single-dose should not be used by breast-feeding women.
Slovenian: Doječe matere zdravila GANFORT (enoodmerna oblika) ne smejo uporabljati.
English: One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate).
Slovenian: En ml raztopine vsebuje 0,3 mg bimatoprosta in 5 mg timolola (v obliki 6,8 mg timololijevega maleata).
English: GANFORT single-dose contains two different active substances (bimatoprost and timolol) that both reduce pressure in the eye. Bimatoprost belongs to a group of medicines called prostamides, a prostaglandin analogue.
Slovenian: Zdravilo GANFORT vsebuje dve različni zdravilni učinkovini (bimatoprost in timolol), ki obe znižujeta očesni tlak.
English: This helps to stop GANFORT getting into the rest of the body.
Slovenian: Tako zdravilo GANFORT ne pride drugam v telo.
English: Mean changes from baseline worse eye IOP ranged from -9.16 to -7.98 mm Hg for GANFORT (single-dose) group, and from -9.03 to -7.72 mm Hg for the GANFORT (multi-dose formulation) group across the 12-week study.
Slovenian: -7,98 mm Hg pri skupini, ki je prejemala enoodmerno obliko zdravila GANFORT, in od -9,03 do
English: If you're worried, talk to a doctor or pharmacist.
Slovenian: V primeru zaskrbljenosti se posvetujte z zdravnikom ali farmacevtom.
English: Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g. quinidine, fluoxetine, paroxetine) and timolol.
Slovenian: Pri sočasnem zdravljenju z zaviralci CYP2D6 (npr. kinidinom, fluoksetinom in paroksetinom) in timololom so poročali o potenciranem sistemskem antagonističnem učinku na adrenergične receptorje beta (npr. zmanjšanem srčnem utripu, depresiji).
English: Based on studies of GANFORT (multi-dose formulation), the IOP-lowering effect of GANFORT is non-inferior to that achieved by adjunctive therapy of bimatoprost (once daily) and timolol (twice daily).
Slovenian: Študije večodmerne oblike zdravila GANFORT so pokazale, da učinek zdravila GANFORT za zniževanje IOT ni nič manjši od tistega, ki ga dosežemo s kombinirano terapijo z bimatoprostom
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING POUCH CONTAINING STRIP OF 5 SINGLE-DOSE CONTAINERS
Slovenian: PODATKI NA ZUNANJI OVOJNINI VREČICA S 5 ENOODMERNIMI VSEBNIKI
English: GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container bimatoprost/timolol
Slovenian: GANFORT 0,3 mg/ml + 5 mg/ml kapljice za oko, raztopina, v enoodmernem vsebniku bimatoprost/timolol
English: There was no accumulation of bimatoprost in the blood over time and the safety profile was similar in elderly and young patients.
Slovenian: Varnostni profil je bil podoben pri obeh starostnih skupinah.
English: GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution
Slovenian: GANFORT 0,3 mg/ml + 5 mg/ml kapljice za oko, raztopina
English: There is a potential for hair growth to occur in areas where GANFORT solution comes repeatedly in contact with the skin surface.
Slovenian: Zdravilo GANFORT lahko povzroči rast dlak, ko je v stiku s površino kože.
English: One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate)
Slovenian: 1 ml raztopine vsebuje 0,3 mg bimatoprosta in 5 mg timolola (v obliki 6,8 mg timololijevega maleata)
English: The following side effects may be seen with GANFORT (multi-dose and/or single-dose):
Slovenian: Pri zdravilu GANFORT (pri večodmerni in/ali enoodmerni obliki) lahko opazite naslednje neželene učinke: Zelo pogosti neželeni učinki
English: After 12 months of treatment with GANFORT (multi-dose formulation), the incidence of iris pigmentation was 0.2%.
Slovenian: (večodmerna oblika) je bila incidenca pigmentacije šarenice 0,2 %.
English: Gastrointestinal disorders nausea1,2, diarrhoea1, dyspepsia1, dry mouth1, abdominal pain1, vomiting1
Slovenian: Bolezni prebavil navzea1,2, diareja1, dispepsija1, suha usta1,
English: GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution bimatoprost/timolol
Slovenian: GANFORT 0,3 mg/ml + 5 mg/ml kapljice za oko, raztopina bimatoprost/timolol
English: Hepatic
Slovenian: astma
English: Macular oedema, including cystoid macular oedema, has been reported with GANFORT.
Slovenian: Pri uporabi zdravila GANFORT so opazili pojav makularnega edema, vključno s cistoidnim makularnim edemom.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS POUCH CONTAINING STRIP OF 10 SINGLE-DOSE CONTAINERS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: Do not use GANFORT if you are breast-feeding.
Slovenian: Zdravila GANFORT ne uporabljajte, če dojite.
English: GANFORT single-dose
Slovenian: GANFORT (enoodmerna oblika)
English: See leaflet for further information.
Slovenian: Opozorila so navedena v navodilu za uporabo.
English: Respiratory reactions, including death due to bronchospasm in patients with asthma, have been reported following administration of some ophthalmic beta-blockers.
Slovenian: Po uporabi nekaterih očesnih antagonistov adrenergičnih receptorjev beta so opazili neželene učinke na dihala, vključno s smrtjo zaradi bronhospazma pri bolnikih z astmo.
English: Macular oedema, including cystoid macular oedema has been reported with GANFORT (multi-dose formulation).
Slovenian: Pri uporabi zdravila GANFORT (večodmerna oblika) so opazili pojav makularnega edema, vključno s cistoidnim makularnim edemom.
English: Package leaflet: Information for the user GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container
Slovenian: Navodilo za uporabo GANFORT 0,3 mg/ml + 5 mg/ml kapljice za oko, raztopina, v enoodmernem vsebniku bimatoprost/timolol
English: No new adverse reactions specific for GANFORT single-dose have been observed in clinical studies.
Slovenian: V klinični študiji niso opazili nobenih novih neželenih učinkov, ki bi bili značilni samo za zdravilo GANFORT(enoodmerna oblika).
English: Common headache, dizziness2
Slovenian: otekanje oči, zamegljen vid2
English: Put the cap back on and close the bottle straight after you have used it.
Slovenian: Po uporabi plastenko dobro zaprite.
English: Insomnia2, nightmare2
Slovenian: Psihiatrične motnje neznana pogostnost nespečnost2, nočne more2
English: Common side effects
Slovenian: ENOODMERNI VSEBNIK
English: Not known cystoid macular oedema2, eye swelling, vision blurred2,
Slovenian: neznana pogostnost cistoidni makularni edem2,
English: June 2023
Slovenian: junij 2023
English: While the overall number of events was small, the difference between the two arms was sufficiently large to reach statistical significance.
Slovenian: Medtem, ko je bilo celokupno število dogodkov majhno, je bila razlika med obema skupinama zadostno velika, da je dosegla statistično značilnost.
English: Ethnicity and race
Slovenian: Narodnost in rasa
English: Children and adolescents This medicine is not for use in children and adolescents under 18 years of age.
Slovenian: Otroci in mladostniki Zdravilo ni namenjeno za uporabo pri otrocih in mladostnikih, ki so mlajši od 18 let.
English: Pregnancy and contraception information for men and women
Slovenian: Nosečnost in informacije o kontracepciji za moške in ženske
English: Take extra care to reduce your risk of a fall.
Slovenian: Bodite posebej pozorni, da zmanjšate tveganje za padce.
English: 10 people).
Slovenian: 10 bolnikov).
English: The median time to symptomatic progression was not reached in either treatment group.
Slovenian: Mediani čas do simptomatskega napredovanja ni bil dosežen v nobeni zdravljeni skupini.
English: The tablets should be swallowed whole and can be taken with or without food.
Slovenian: Tablete je treba pogoltniti cele in se jih lahko jemlje s hrano ali brez nje.
English: Therefore, the safety of apalutamide in these patients has not been established.
Slovenian: Zato varnost uporabe apalutamida pri teh bolnikih ni bila ugotovljena.
English: All subjects who were not surgically castrated received ADT continuously throughout the study.
Slovenian: Vsi preiskovanci, ki niso bili kirurško kastrirani, so prejemali ADT neprekinjeno ves čas študije.
English: Table 1: Adverse reactions identified in clinical studies
Slovenian: Preglednica 1: Neželeni učinki, ugotovljeni v kliničnih študijah
English: If you forget to take Erleada, take your usual dose as soon as you remember.
Slovenian: Če ste pozabili vzeti zdravilo Erleada, vzemite svoj običajni odmerek, čim se spomnite.
English: Not known (frequency cannot be estimated from the available data): • abnormal heart tracing on an ECG (electrocardiogram)
Slovenian: Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov): • nepravilnosti na posnetku delovanja srca (na EKG - elektrokardiogramu)
English: Information for men - follow this advice during treatment and for 3 months after stopping
Slovenian: Informacije za moške - naslednje nasvete upoštevajte med zdravljenjem in še 3 mesece po prekinitvi
English: Frequency categories are defined as follows: 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) and not known (frequency cannot be estimated from the available data).
Slovenian: Kategorije pogostnosti so opredeljene takole: 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); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: The median days to onset of skin rash was 82 days with a range of 1 to 994 days.
Slovenian: Mediani čas do nastopa kožnega izpuščaja je bil 82 dni, v razponu od 1 do 994 dni.
English: There were no grade 3 or 4 adverse events.
Slovenian: Do neželenih učinkov 3. oziroma 4. stopnje ni prišlo.
English: Not all pack sizes may be marketed.
Slovenian: Na trgu morda ni vseh navedenih velikosti pakiranj.
English: Patients should be advised of this risk in regards to driving or operating machines.
Slovenian: Bolnike je treba opozoriti na to tveganje pri vožnji in upravljanju strojev.
English: If you are at higher risk of seizures (see Section 2), talk to your doctor.
Slovenian: Če pri vas obstaja večje tveganje za pojav krčev (glejte poglavje 2), se posvetujte z zdravnikom.
English: Adverse reactions observed during clinical studies are listed below by frequency category.
Slovenian: Neželeni učinki, ki so jih opazili v kliničnih študijah, so navedeni spodaj po kategorijah pogostnosti.
English: Falls and fractures
Slovenian: Padci in zlomi
English: There is also a risk of increased formation of active metabolites.
Slovenian: Obstaja tudi tveganje za povečano tvorbo aktivnih presnovkov.
English: Other important adverse reactions include fractures (12%) and hypothyroidism (8%).
Slovenian: Druga pomembna neželena učinka sta zlomi (12%) in hipotiroidizem (8%).
English: Figure 1: Kaplan-Meier metastasis-free survival (MFS) curve in Study ARN-509-003
Slovenian: Slika 1: Kaplan-Meierjevi krivulji preživetja brez metastaz (MFS) v študiji ARN-509-003
English: (2) Pull out
Slovenian: (2) Izvlecite.
English: The median age was 74 years (range 48-97) and 26% of subjects were 80 years of age or older.
Slovenian: Mediana starost je bila 74 let (od 48 do 97 let) in 26% preiskovancev je bilo starih najmanj 80 let.
English: Pharmacotherapeutic group: Endocrine therapy, anti-androgens, ATC code: L02BB05
Slovenian: Farmakoterapevtska skupina: endokrino zdravljenje, antiandrogeni, oznaka ATC: L02BB05