natgillin/translations-raw huggingface dataset:
As with any topical ocular treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machines. 
Tako kot pri drugih topičnih zdravilih za oči, lahko tudi zdravilo GANFORT povzroči prehodno zamegljen vid. Bolniki morajo pred vožnjo ali upravljanjem s stroji počakati, da simptomi minejo.
Benzalkonium chloride is known to discolour soft contact lenses. 
Znano je, da benzalkonijev klorid spremeni barvo kontaktnih leč.
- If you have any further questions, please ask your doctor, pharmacist, or nurse. 
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Timolol is partially metabolised by the liver with timolol and its metabolites excreted by the kidney. 
Timolol se delno presnovi v jetrih, izloča pa se preko ledvic skupaj s svojimi presnovki.
• The active substances are bimatoprost 0.3 mg/ml and timolol 5 mg/ml corresponding to timolol maleate 6.8 mg/ml. 
• Zdravilni učinkovini sta bimatoprost 0,3 mg/ml in timolol 5 mg/ml, v obliki 6,8 mg/ml timololijevega maleata.
Eye drops, solution, 3 ml 
kapljice za oko, raztopina, 3 ml
Choroidal detachment 
Jetrne okvare
Epidemiological studies have not revealed malformative effects but have shown a risk for intra uterine growth retardation when beta-blockers are administered by the oral route. 
Epidemiološke študije niso pokazale škodljivih učinkov na razvoj ploda, vendar pa je bilo ob oralni uporabi antagonistovvadrenergičnih receptorjev beta ugotovljeno tveganje za upočasnitev intrauterine rasti.
These two components decrease elevated intraocular pressure (IOP) by complementary mechanisms of action and the combined effect results in additional IOP reduction compared to either compound administered alone. 
Obe sestavini znižujeta povišan očesni tlak (IOT) s komplementarnim delovanjem.
GANFORT single-dose has a rapid onset of action. 
Zdravilo GANFORT (enoodmerna oblika) začne delovati hitro.
Other medicines and GANFORT single-dose 
Druga zdravila in zdravilo GANFORT (enoodmerna oblika)
5 How to store GANFORT Contents of the pack and other information 
Shranjevanje zdravila GANFORT Vsebina pakiranja in dodatne informacije
If GANFORT is administered until delivery, the neonate should be carefully monitored during the first days of life. 
uporabljalo pred porodom, je treba novorojenca prve dni po rojstvu skrbno opazovati.
Sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water. 
Natrijev klorid, natrijev dihidrogenfosfat heptahidrat, citronska kislina monohidrat, klorovodikova kislina ali natrijev hidroksid (za uravnavanje pH) in prečiščena voda.
GANFORT medicinal product 
Shranjevanje zdravila GANFORT
What GANFORT looks like and contents of the pack 
Izgled zdravila GANFORT in vsebina pakiranja
Alopecia2 
neznana pogostnost alopecija2
Like other topically applied ophthalmic medicinal products, the active substances (timolol/ bimatoprost) in GANFORT single-dose may be absorbed systemically. 
Kot pri drugih lokalnih očesnih zdravilih se tudi zdravilni učinkovini (timolol/bimatoprost) v zdravilu GANFORT (enoodmerna oblika) lahko absorbirata sistemsko.
If you are worried, talk to your doctor or pharmacist. 
Če ste zaradi tega zaskrbljeni, se posvetujte z zdravnikom ali farmacevtom
Benzalkonium chloride, sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water. 
Benzalkonijev klorid, natrijev klorid, natrijev dihidrogenfosfat heptahidrat, citronska kislina monohidrat, klorovodikova kislina ali natrijev hidroksid (za uravnavanje pH) in prečiščena voda.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR SINGLE BOTTLE 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA ENO PLASTENKO
These may affect more than 1 user in 10 Affecting the eye redness. 
Pojavijo se lahko pri več kot 1 od 10 bolnikov
Keep the singledose containers in the pouch and place the pouch back in carton in order to protect against light and moisture. 
Enoodmerne vsebnike hranite v vrečici in vrečico vrnite v škatlo, da zagotovite zaščito pred svetlobo in vlago.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING THREE BOTTLES 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA VSEBUJE TRI PLASTENKE
How to use GANFORT single-dose 
Kako uporabljati zdravilo GANFORT (enoodmerna oblika)
Adverse reactions reported in phosphate containing eye drops 
Drugi neželeni učinki kapljic za oko, ki vsebujejo fosfat
Cardiac disorder atrioventricular block1, cardiac arrest1, arrhythmia1, cardiac failure1, congestive heart failure1, chest pain1, palpitations1, oedema1 
srčna odpoved1, kongestivna srčna odpoved1, bolečine v prsnem košu1, palpitacije1, edem1
If you stop using GANFORT single-dose 
Če ste prenehali uporabljati zdravilo GANFORT (enoodmerna oblika)
Choroidal detachment has been reported with administration of aqueous suppressant therapy (e.g. timolol, acetazolamide) after filtration procedures. 
Pri zdravljenju z zdravili, ki zavirajo nastanek očesne vodke (npr. timololom, acetazolamidom), so po filtracijskih posegih poročali o odstopanju žilnice.
Increased brown iris pigmentation has also been observed during treatment with GANFORT (multi-dose formulation). 
Pri zdravljenju z zdravilom GANFORT (večodmerna oblika) je bila opažena tudi povečana rjava pigmentacija šarenice.
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. 
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.
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. 
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,
Like other topically applied ophthalmic medicinal products, the active substances (timolol/ bimatoprost) in GANFORT may be absorbed systemically. 
Kot pri drugih lokalnih očesnih zdravilih se tudi zdravilni učinkovini (timolol/bimatoprost) v zdravilu GANFORT lahko absorbirata sistemsko.
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. 
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.
- 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 
- 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;
Bimatoprost is a potent ocular hypotensive active substance. 
Bimatoprost je močna zdravilna učinkovina za zmanjšanje očesnega tlaka.
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. 
Čas uporabe naj praviloma ne bi bil daljši od 28 dni pri temperaturi 25 °C.
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. 
(enoodmerna oblika) lahko povzroči rast dlak, ko je v stiku s površino kože.
Do not use GANFORT single-dose if you are breast-feeding. 
Zdravila GANFORT (enoodmerna oblika) ne uporabljajte, če dojite.
What GANFORT single-dose looks like and contents of the pack 
Izgled zdravila GANFORT (enoodmerna oblika) in vsebina pakiranja
Keep single-dose containers in the pouch in order to protect from light and moisture. 
Enoodmerne vsebnike hranite v verčici, za zagotovitev zaščite pred svetlobo in vlago.
Like other topically applied ophthalmic drugs, GANFORT (bimatoprost/timolol) is absorbed into the systemic circulation. 
Kot pri drugih lokalnih očesnih zdravilih se tudi zdravilo GANFORT (bimatoprost/timolol) absorbira v sistemski krvni obtok.
Respiratory, thoracic and mediastinal disorders Asthma exacerbation2, COPD exacerbation2, cough1 
Bolezni dihal, prsnega koša in mediastinalnega prostora poslabšanje astme2, poslabšanje KOPB2, kašelj1
Ophthalmic beta-blockers may induce dryness of eyes. 
Očesni antagonisti adrenergičnih receptorjev beta lahko povzročijo suhost oči.
Vascular disorders 
Odstopanje žilnice
GANFORT should not be used by breast-feeding women. 
Doječe matere zdravila GANFORT ne smejo uporabljati.
Beta-blocking ophthalmological preparations may block systemic beta-agonist effects e.g. of adrenaline. 
Kirurška anestezija Očesni antagonisti adrenergičnih receptorjev beta lahko zavirajo učinke sistemskih antagonistov adrenergičnih receptorjev beta, npr. adrenalina.
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. 
Vsaka plastenka je napolnjena približno do polovice in vsebuje 3 ml raztopine.
Always use GANFORT single-dose exactly as your doctor or pharmacist has told you. 
Pri uporabi zdravila GANFORT (enoodmerna oblika) natančno upoštevajte navodila zdravnika ali farmacevta.
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. 
Pri bolnikih z anamnezo blage bolezni jeter ali nenormalnimi izhodiščnimi vrednosti alanin aminotransferaze (ALT), aspartat-aminotransferaze (AST) in/ali celokupnega bilirubina, bimatoprost v
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING 30 SINGLE-DOSE CONTAINERS (PROVIDED IN 3 POUCHES, EACH CONTAINING 10 SINGLE-DOSE CONTAINERS) 
ŠKATLA S 30 ENOODMERNIMI VSEBNIKI, SHRANJENIMI V 3 VREČICAH S PO 10 ENOODMERNIMI VSEBNIKI
Always use GANFORT exactly as your doctor or pharmacist has told you. 
Pri uporabi zdravila GANFORT natančno upoštevajte navodila zdravnika ali farmacevta.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING 90 SINGLE-DOSE CONTAINERS (PROVIDED IN 9 POUCHES, EACH CONTAINING 10 SINGLE-DOSE CONTAINERS) 
ŠKATLA Z 90 ENOODMERNIMI VSEBNIKI, SHRANJENIMI V 9 VREČICAH S PO 10 ENOODMERNIMI VSEBNIKI
• The other ingredients are benzalkonium chloride (a preservative), sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate and purified water. 
• Pomožne snovi: benzalkonijev klorid (konzervans), natrijev klorid, natrijev dihidrogenfosfat heptahidrat, citronska kislina monohidrat in prečiščena voda.
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. 
Če poleg zdravila GANFORT uporabljate še kakšno drugo očesno zdravilo, je treba različna zdravila vkapati v razmiku najmanj 5 minut.
White opaque low-density polyethylene bottles with polystyrene screw cap. Each bottle has a fill volume of 3 ml. 
Plastenka iz belega polietilena z majhno gostoto, z navojno zaporko iz polistirena.
GANFORT single-dose has not been studied in patients with hepatic or renal impairment. 
Zdravilo GANFORT (enoodmerna oblika) ni bilo preizkušeno pri bolnikih z očesnimi vnetji,
The incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. 
Incidenca sistemskih neželenih učinkov ob lokalni uporabi v očesu je nižja kot pri sistemski uporabi.
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. 
astenopija, trihiaza2, hiperpigmentacija šarenice2, poglobitev sulkusa veke, retrakcija veke2, razbarvanje trepalnic (potemnitev)1
GANFORT has not been studied in patients with hepatic or renal impairment. 
Varnosti in učinkovitosti zdravila GANFORT pri bolnikih z okvaro jeter ali ledvic niso preučevali.
Pharmacotherapeutic group: Ophthalmological,- beta-blocking agents - ATC code: S01ED51 
Oznaka ATC: S01ED51 Mehanizem delovanja
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 
Bolezni kože in podkožja psoriaziformni izpuščaj1 ali poslabšanje psoriaze1, kožni izpuščaji1
Surgical anaesthesia β-blocking ophthalmological preparations may block systemic β-agonist effects e.g. of adrenaline. 
Kirurška anestezija Očesni antagonisti adrenergičnih receptorjev beta lahko zavirajo učinke sistemskih antagonistov adrenergičnih receptorjev beta npr. adrenalina.
- 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 
- 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);
Eye drops, solution, in single-dose container. 
kapljice za oko, raztopina, v enoodmernem vsebniku brezbarvna do rahlo rumenkasta raztopina
• The other ingredients are sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate and purified water. 
• Pomožne snovi: natrijev klorid, natrijev dihidrogenfosfat heptahidrat, citronska kislina monohidrat in prečiščena voda.
Investigations liver function tests (LFT) abnormal2 
Splošne težave in spremembe na mestu aplikacije astenija1,2 Preiskave nenormalni testi jetrne funkcije2
Respiratory, thoracic and mediastinal disorders 
Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti rinitis2
No new adverse reactions specific for GANFORT have been observed in clinical studies. 
V kliničnih študijah niso opazili nobenih novih neželenih učinkov, ki bi bili značilni samo za zdravilo GANFORT.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH PLASTENKA
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR POUCH CONTAINING STRIP OF 5 SINGLE-DOSE CONTAINERS 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA VREČICO S 5 ENOODMERNIMI VSEBNIKI
GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container. 
GANFORT 0,3 mg/ml + 5 mg/ml kapljice za oko, raztopina, v enoodmernem vsebniku.
GANFORT single-dose should not be used by breast-feeding women. 
Doječe matere zdravila GANFORT (enoodmerna oblika) ne smejo uporabljati.
One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate). 
En ml raztopine vsebuje 0,3 mg bimatoprosta in 5 mg timolola (v obliki 6,8 mg timololijevega maleata).
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. 
Zdravilo GANFORT vsebuje dve različni zdravilni učinkovini (bimatoprost in timolol), ki obe znižujeta očesni tlak.
This helps to stop GANFORT getting into the rest of the body. 
Tako zdravilo GANFORT ne pride drugam v telo.
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. 
-7,98 mm Hg pri skupini, ki je prejemala enoodmerno obliko zdravila GANFORT, in od -9,03 do
If you're worried, talk to a doctor or pharmacist. 
V primeru zaskrbljenosti se posvetujte z zdravnikom ali farmacevtom.
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. 
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).
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). 
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
PARTICULARS TO APPEAR ON THE OUTER PACKAGING POUCH CONTAINING STRIP OF 5 SINGLE-DOSE CONTAINERS 
PODATKI NA ZUNANJI OVOJNINI VREČICA S 5 ENOODMERNIMI VSEBNIKI
GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container bimatoprost/timolol 
GANFORT 0,3 mg/ml + 5 mg/ml kapljice za oko, raztopina, v enoodmernem vsebniku bimatoprost/timolol
There was no accumulation of bimatoprost in the blood over time and the safety profile was similar in elderly and young patients. 
Varnostni profil je bil podoben pri obeh starostnih skupinah.
GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution 
GANFORT 0,3 mg/ml + 5 mg/ml kapljice za oko, raztopina
There is a potential for hair growth to occur in areas where GANFORT solution comes repeatedly in contact with the skin surface. 
Zdravilo GANFORT lahko povzroči rast dlak, ko je v stiku s površino kože.
One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate) 
1 ml raztopine vsebuje 0,3 mg bimatoprosta in 5 mg timolola (v obliki 6,8 mg timololijevega maleata)
The following side effects may be seen with GANFORT (multi-dose and/or single-dose): 
Pri zdravilu GANFORT (pri večodmerni in/ali enoodmerni obliki) lahko opazite naslednje neželene učinke: Zelo pogosti neželeni učinki
After 12 months of treatment with GANFORT (multi-dose formulation), the incidence of iris pigmentation was 0.2%. 
(večodmerna oblika) je bila incidenca pigmentacije šarenice 0,2 %.
Gastrointestinal disorders nausea1,2, diarrhoea1, dyspepsia1, dry mouth1, abdominal pain1, vomiting1 
Bolezni prebavil navzea1,2, diareja1, dispepsija1, suha usta1,
GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution bimatoprost/timolol 
GANFORT 0,3 mg/ml + 5 mg/ml kapljice za oko, raztopina bimatoprost/timolol
Hepatic 
astma
Macular oedema, including cystoid macular oedema, has been reported with GANFORT. 
Pri uporabi zdravila GANFORT so opazili pojav makularnega edema, vključno s cistoidnim makularnim edemom.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS POUCH CONTAINING STRIP OF 10 SINGLE-DOSE CONTAINERS 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Do not use GANFORT if you are breast-feeding. 
Zdravila GANFORT ne uporabljajte, če dojite.
GANFORT single-dose 
GANFORT (enoodmerna oblika)
See leaflet for further information. 
Opozorila so navedena v navodilu za uporabo.
Respiratory reactions, including death due to bronchospasm in patients with asthma, have been reported following administration of some ophthalmic beta-blockers. 
Po uporabi nekaterih očesnih antagonistov adrenergičnih receptorjev beta so opazili neželene učinke na dihala, vključno s smrtjo zaradi bronhospazma pri bolnikih z astmo.
Macular oedema, including cystoid macular oedema has been reported with GANFORT (multi-dose formulation). 
Pri uporabi zdravila GANFORT (večodmerna oblika) so opazili pojav makularnega edema, vključno s cistoidnim makularnim edemom.
Package leaflet: Information for the user GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container 
Navodilo za uporabo GANFORT 0,3 mg/ml + 5 mg/ml kapljice za oko, raztopina, v enoodmernem vsebniku bimatoprost/timolol
No new adverse reactions specific for GANFORT single-dose have been observed in clinical studies. 
V klinični študiji niso opazili nobenih novih neželenih učinkov, ki bi bili značilni samo za zdravilo GANFORT(enoodmerna oblika).
Common headache, dizziness2 
otekanje oči, zamegljen vid2
Put the cap back on and close the bottle straight after you have used it. 
Po uporabi plastenko dobro zaprite.
Insomnia2, nightmare2 
Psihiatrične motnje neznana pogostnost nespečnost2, nočne more2
Common side effects 
ENOODMERNI VSEBNIK
Not known cystoid macular oedema2, eye swelling, vision blurred2, 
neznana pogostnost cistoidni makularni edem2,
June 2023 
junij 2023
While the overall number of events was small, the difference between the two arms was sufficiently large to reach statistical significance. 
Medtem, ko je bilo celokupno število dogodkov majhno, je bila razlika med obema skupinama zadostno velika, da je dosegla statistično značilnost.
Ethnicity and race 
Narodnost in rasa
Children and adolescents This medicine is not for use in children and adolescents under 18 years of age. 
Otroci in mladostniki Zdravilo ni namenjeno za uporabo pri otrocih in mladostnikih, ki so mlajši od 18 let.
Pregnancy and contraception information for men and women 
Nosečnost in informacije o kontracepciji za moške in ženske
Take extra care to reduce your risk of a fall. 
Bodite posebej pozorni, da zmanjšate tveganje za padce.
10 people). 
10 bolnikov).
The median time to symptomatic progression was not reached in either treatment group. 
Mediani čas do simptomatskega napredovanja ni bil dosežen v nobeni zdravljeni skupini.
The tablets should be swallowed whole and can be taken with or without food. 
Tablete je treba pogoltniti cele in se jih lahko jemlje s hrano ali brez nje.
Therefore, the safety of apalutamide in these patients has not been established. 
Zato varnost uporabe apalutamida pri teh bolnikih ni bila ugotovljena.
All subjects who were not surgically castrated received ADT continuously throughout the study. 
Vsi preiskovanci, ki niso bili kirurško kastrirani, so prejemali ADT neprekinjeno ves čas študije.
Table 1: Adverse reactions identified in clinical studies 
Preglednica 1: Neželeni učinki, ugotovljeni v kliničnih študijah
If you forget to take Erleada, take your usual dose as soon as you remember. 
Če ste pozabili vzeti zdravilo Erleada, vzemite svoj običajni odmerek, čim se spomnite.
Not known (frequency cannot be estimated from the available data): • abnormal heart tracing on an ECG (electrocardiogram) 
Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov): • nepravilnosti na posnetku delovanja srca (na EKG - elektrokardiogramu)
Information for men - follow this advice during treatment and for 3 months after stopping 
Informacije za moške - naslednje nasvete upoštevajte med zdravljenjem in še 3 mesece po prekinitvi