natgillin/translations-raw huggingface dataset:
GANFORT single-dose has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure, congenital or narrow-angle glaucoma.
Jednodozni GANFORT nije ispitan kod bolesnika s upalnim stanjima oka, neovaskularnim, upalnim, kongenitalnim glaukomom te glaukomom zatvorenog ili uskog kuta.
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.
Manje često iritis2, edem konjunktive2, bol vjeđa2, abnormalni osjećaj u oku1, astenopija, trihijaza2, hiperpigmentacija šarenice2, produbljenje palpebralnog sulkusa, retrakcija vjeđe2, promjena boja trepavica (tamnjenje) 1.
Keep single-dose containers in the pouch in order to protect from light and moisture.
Jednodozne spremnike držite u vrećici kako biste ih zaštitili od svjetlosti i vlage.
There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral calcium channel blockers, guanethidine, beta-adrenergic blocking agents, parasympathomimetics, anti-arrhythmics (including amiodarone) and digitalis glycosides.
Postoji mogućnost aditivnih učinaka koji rezultiraju hipotenzijom, i/ili izrazitom bradikardijom kada se oftalmološki beta-blokator u otopini istovremeno primjenjuje s peroralnim blokatorima kalcijevih kanala, gvanetidinom, beta-adrenergičkim blokatorima, parasimpatomimeticima, antiaritmicima
GANFORT single-dose has not been studied in patients with hepatic or renal impairment.
Jednodozni GANFORT nije ispitivan u bolesnika s jetrenim ili bubrežnim oštećenjima.
GANFORT has not been studied in patients with hepatic or renal impairment.
GANFORT nije ispitivan u bolesnika s jetrenim ili bubrežnim oštećenjima.
If you forget to use GANFORT single-dose
Ako ste zaboravili primijeniti jednodozni GANFORT
Keep the singledose containers in the pouch and place the pouch back in carton in order to protect against light and moisture.
Jednodozne spremnike držite u vrećici, a vrećicu stavite natrag u kutiju kako biste ih zaštitili od svjetlosti i vlage.
Colourless to slightly yellow solution.
Bezbojna do blago žućkasta otopina.
Eye drops, solution, 3 x 3 ml
Kapi za oko, otopina, 3 x 3 ml
Fertility There are no data on the effects of GANFORT single-dose on human fertility.
Nema podataka o djelovanju jednodoznog GANFORT-a na ljudsku plodnost.
Absorption of timolol may cause similar undesirable effects as seen with systemic beta-blocking agents.
Apsorpcija timolola može prouzročiti slične nuspojave kao i kod sistemskih beta-blokatora.
GANFORT has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.
GANFORT nije ispitan kod bolesnika s upalnim stanjima oka, neovaskularnim, upalnim, kongenitalnim glaukomom te glaukomom zatvorenog ili uskog kuta.
Adverse reactions reported in phosphate containing eye drops
Nuspojave prijavljene pri primjeni kapi za oko koje sadrže fosfate
Once the container is removed from the pouch use within 7 days.
Nakon vađenja spremnika iz vrećice, iskoristiti unutar 7 dana.
Affecting the eye cystoid macular oedema (swelling of the retina within the eye leading to worsening vision), eye swelling, blurred vision.
Nuspojave kod kojih je učestalost nepoznata Zahvaćaju oko cistoidni makularni edem (oticanje mrežnice u oku što dovodi do pogoršanja vida), oticanje oka,
Clear, single-dose low density polyethylene (LDPE) containers with a twist-off tab.
Prozirni jednodozni spremnici od polietilena niske gustoće (LDPE) sa zatvaračem na navoj.
5 How to store GANFORT Contents of the pack and other information
Sadržaj pakiranja i druge informacije
Tel: +386 (0) 590 848 40
Ewopharma d.o.o. Tel: +386 (0) 590 848 40
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR POUCH CONTAINING STRIP OF 5 SINGLE-DOSE CONTAINERS
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA VREĆICU KOJA SADRŽI STRIP S 5 JEDNODOZNIH SPREMNIKA
Eye drops, solution, 3 ml
Kapi za oko, otopina, 3 ml
Not known cystoid macular oedema2, eye swelling, vision blurred2,
Nepoznato cistoidni makularni edem2, oticanje oka, zamućen vid2,
• The other ingredients are benzalkonium chloride (a preservative), sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate and purified water.
• Drugi sastojci su benzalkonijev klorid (kao konzervans), natrijev klorid, natrijev hidrogenfosfat heptahidrat, citratna kiselina hidrat i pročišćena voda.
This may cause similar side effects as seen with ”intravenous” and /or “oral” beta-blocking agents.
To može prouzročiti slične nuspojave kao i kod beta-blokatora koji se primjenjuju u venu i/ili kroz usta.
Remove contact lenses before use.
Prije primjene izvaditi kontaktne leće.
No new adverse reactions specific for GANFORT have been observed in clinical studies.
U kliničkim ispitivanjima nisu zabilježene nove nuspojave specifične za GANFORT.
GANFORT may cause blurred vision in some patients.
Kod nekih bolesnika GANFORT može prouzročiti zamagljen vid.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING POUCH CONTAINING STRIP OF 5 SINGLE-DOSE CONTAINERS
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VREĆICA KOJA SADRŽI STRIP S 5 JEDNODOZNIH SPREMNIKA
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 hidrogenfosfat heptahidrat, citratna kiselina hidrat, kloridna kiselina ili natrijev hidroksid (za podešavanje pH) i pročišćena voda.
Sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.
Natrijev klorid, natrijev hidrogenfosfat heptahidrat, citratna kiselina hidrat, kloridna kiselina ili natrijev hidroksid (za podešavanje pH) i pročišćena voda.
Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
U nekih bolesnika sa značajno oštećenom rožnicom prijavljeni su vrlo rijetki slučajevi kalcifikacije rožnice povezani s primjenom kapi za oko koje sadrže fosfate.
Respiratory disorders
Poremećaji jetre
Once the single-dose container is removed from the pouch use within 7 days.
Nakon vađenja jednodoznog spremnika iz vrećice, iskoristite unutar 7 dana.
Keep GANFORT single-dose out of the sight and reach of children.
Kako čuvati jednodozni GANFORT Jednodozni GANFORT čuvajte izvan pogleda i dohvata djece.
Like other topically applied ophthalmic medicinal products, the active substances (timolol/ bimatoprost) in GANFORT may be absorbed systemically.
Kao i kod ostalih topikalno primijenjenih oftalmoloških lijekova, djelatne tvari (timolol/bimatoprost) sadržane u kapima GANFORT mogu se sistemski apsorbirati.
• The other ingredients are sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate and purified water.
• Drugi sastojci su natrijev klorid, natrijev hidrogenfosfat heptahidrat, citratna kiselina hidrat i pročišćena voda.
Neither nevi nor freckles of the iris appear to be affected by treatment.
Čini se da liječenje ne utječe na nevuse i pjege šarenice.
Recommended dosage in adults (including older people) The recommended dose is one drop of GANFORT single-dose in the affected eye(s) once daily, administered either in the morning or in the evening.
Preporučena doza je jedna kap jednodoznog GANFORT-a jedanput dnevno u zahvaćeno oko (oči), ukapana ujutro ili uvečer.
How to store GANFORT single-dose
Kako primjenjivati jednodozni GANFORT
Do not use GANFORT single-dose if you are breast-feeding.
Nemojte primjenjivati jednodozni GANFORT ako dojite.
All containers should be kept in the pouch and carton to protect from light and moisture and discarded 10 days after first opening the pouch.
Spremnike držite u vrećici, a vrećicu vratite natrag u kutiju kako biste ih zaštitili od svjetlosti i vlage i bacite 10 dana od prvog otvaranja vrećice.
Like other topically applied ophthalmic medicinal products, the active substances (timolol/ bimatoprost) in GANFORT single-dose may be absorbed systemically.
Kao i kod ostalih topikalno primijenjenih oftalmoloških lijekova, djelatne tvari (timolol/bimatoprost) sadržane u kapima jednodoznog GANFORT-a mogu se sistemski apsorbirati.
GANFORT single-dose may cause blurred vision in some patients.
Kod nekih bolesnika jednodozni GANFORT može prouzročiti zamagljen vid.
Therefore, GANFORT single-dose should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular oedema (e.g. intraocular surgery, retinal vein occlusions, ocular inflammatory disease and diabetic retinopathy).
(višedozni pripravak) Stoga jednodozni GANFORT treba koristiti s oprezom kod bolesnika s afakijom, u bolesnika s pseudoafakijom s pokidanom stražnjom kapsulom leće, ili kod bolesnika s poznatim faktorom rizika za nastanak edema makule (npr. nakon intraokularnog kirurškog zahvata,
Rhinitis2
Često rinitis2
Gastrointestinal disorders nausea1,2, diarrhoea1, dyspepsia1, dry mouth1, abdominal pain1, vomiting1
Poremećaji probavnog sustava mučnina1,2, dijareja1, dispepsija1, suhoća usta1, bol u abdomenu1, povraćanje1
Respiratory, thoracic and mediastinal disorders Asthma exacerbation2, COPD exacerbation2, cough1
Poremećaji dišnog sustava, prsišta i sredoprsja egzacerbacija astme2, egzacerbacija KOPB-a2,
Recommended dosage in adults (including older people) The recommended dose is one drop of GANFORT in the affected eye(s) once daily, administered either in the morning or in the evening.
Preporučena doza je jedna kap GANFORT-a jedanput dnevno u zahvaćeno oko (oči), ukapana ujutro ili uvečer.
No new adverse reactions specific for GANFORT single-dose have been observed in clinical studies.
U kliničkim ispitivanjima nisu zabilježene nove nuspojave specifične za jednodozni GANFORT.
The change may be more noticeable if you are only treating one eye. GANFORT singledose may cause hair growth when in contact with the skin surface.
Primjena jednodoznog GANFORT-a može uzrokovati rast dlake ako dođe u kontakt s površinom kože.
Eye drops, solution 90 x 0.4 ml
Kapi za oko, otopina 90 x 0,4 ml
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.
Abnormalni osjećaj u oku, upala šarenice, otečena očna spojnica (prozirna sluznica oka), bolne vjeđe, umorne oči, rast trepavica prema unutra, tamnjenje šarenice, oči koje se doimaju upalo, odvajanje vjeđe od površine oka, tamnjenje trepavica.
Eye drops, solution 5 x 0.4 ml
Kapi za oko, otopina 5 x 0,4 ml
Do not use GANFORT single-dose after the expiry date which is stated on the single-dose container and the carton.
Jednodozni GANFORT se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na jednodoznom spremniku i kutiji iza oznake „EXP/Rok valjanosti”.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING THREE BOTTLES
KUTIJA KOJA SADRŽI TRI BOČICE
Common blepharal pigmentation2, hirsutism2, skin hyperpigmentation (periocular).
trihijaza2, hiperpigmentacija šarenice2, produbljenje palpebralnog sulkusa,
Eye drops, solution 30 x 0.4 ml
Kapi za oko, otopina 30 x 0,4 ml
Not known
Nepoznato umor
One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate).
1 ml otopine sadrži 0,3 mg bimatoprosta i 5 mg timolola (u obliku 6,8 mg timololmaleata).
One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate)
1 ml otopine sadrži 0,3 mg bimatoprosta i 5 mg timolola (u obliku 6,8 mg timololmaleata)
Package leaflet: Information for the user GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container
Uputa o lijeku: Informacije za korisnika GANFORT 0,3 mg/ml + 5 mg/ml kapi za oko, otopina, u jednodoznom spremniku bimatoprost/timolol
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.
Jedno pakiranje sadrži 1 ili 3 plastične bočice sa zatvaračem s navojem.
Timolol lowers IOP by reducing aqueous humour formation.
Timolol snižava intraokularni tlak smanjivanjem stvaranja očne vodice.
Choroidal detachment has been reported with administration of aqueous suppressant therapy (e.g. timolol, acetazolamide) after filtration procedures.
Ablacija žilnice prijavljena je kod primjene supresivne terapije očne vodice (npr. timolol,
2017;26(9):e214-e216, four strong cases of hallucinations with ophthalmic timolol (single-substance) were reported, all in elderly patients with coexisting CNS pathology.
zabilježena su četiri pouzdana slučaja halucinacija uslijed uzimanja timolola za oftalmološku primjenu (kao pojedinačne tvari), sva četiri u bolesnika starije životne dobi s postojećom patologijom SŽS-a.
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
Poremećaji kože i potkožnog tkiva osip koji nalikuje psorijazi1 ili egzacerbacija psorijaze1, osip kože1
Package leaflet: Information for the user GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution
Uputa o lijeku: Informacije za korisnika GANFORT 0,3 mg/ml + 5 mg/ml kapi za oko, otopina bimatoprost/timolol
Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation following ocular dosing.
Nakon primjene u oko, kada dostigne sistemsku cirkulaciju, bimatoprost je glavna tvar koja cirkulira u tijelu.
Hold the single-dose container upright (with the cap pointing upwards) and twist off the cap. Gently pull down the lower eyelid to form a pocket.
Pridržavajte jednodozni spremnik uspravno (sa zatvaračem okrenutim prema gore) i odvrnite zatvarač.
Nervous system disorders
Poremećaji dišnog sustava
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING 90 SINGLE-DOSE CONTAINERS (PROVIDED IN 9 POUCHES, EACH CONTAINING 10 SINGLE-DOSE CONTAINERS)
KUTIJA KOJA SADRŽI 90 JEDNODOZNIH SPREMNIKA (ISPORUČENIH
GANFORT single-dose should not be used by breast-feeding women.
Jednodozni GANFORT se ne smije primjenjivati tijekom dojenja.
2 years.
godine liječenja.
GANFORT 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.
GANFORT sadrži dvije različite djelatne tvari (bimatoprost i timolol), obje snižavaju očni tlak.
Do not use GANFORT if you are breast-feeding.
Nemojte primjenjivati GANFORT ako dojite.
GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container.
GANFORT 0,3 mg/ml + 5 mg/ml kapi za oko, otopina, u jednodoznom spremniku.
Bimatoprost/timolol
Dojenje Timolol
GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution
GANFORT 0,3 mg/ml + 5 mg/ml kapi za oko, otopina
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.
svrbež oka, osjećaj bockanja u oku2, osjećaj stranog tijela, suho oko, eritem vjeđe, bol u oku, fotofobija, iscjedak iz oka2, smetnje vida2, svrbež vjeđe,
These may affect more than 1 user in 10 Affecting the eye redness.
Mogu se javiti kod više od 1 na 10 korisnika
Common
Jednodozni
GANFORT 0.3 mg /ml + 5 mg/ml eye drops, solution bimatoprost/timolol
GANFORT 0,3 mg/ml + 5 mg/ml kapi za oko, otopina bimatoprost/timolol
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 istodobnoj primjeni inhibitora CYP2D6 (npr. kinidin, fluoksetin, paroksetin)i timolola.
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.
Jednodozni GANFORT sadrži dvije različite djelatne tvari (bimatoprost i timolol), obje snižavaju očni tlak.
The following side effects may be seen with GANFORT (single-dose and/or multi-dose):
Pri primjeni GANFORT-a (u obliku jednodoznog i/ili u obliku višedoznog pripravka), mogu se pojaviti sljedeće nuspojave:
Before you use this medicine, tell your doctor if you have now or have had in the past - coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure, low blood pressure,
Obavijestite svog liječnika ako primjenjujete ili namjeravate primijeniti lijekove za snižavanje krvnog tlaka, lijekove za srce,
Respiratory, thoracic and mediastinal disorders
- dišnih problema, astme ili kronične opstruktivne bolesti pluća
Vascular disorders
Ablacija žilnice
- 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
(naveden u dijelu 6.) - ako trenutno bolujete ili ste u prošlosti bolovali od respiratornih problema poput astme, teškog kroničnog opstruktivnog bronhitisa (teške plućne bolesti koja može prouzročiti piskanje,
GANFORT should not be used by breast-feeding women.
GANFORT se ne smije primjenjivati tijekom dojenja.
- coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking),
- koronarne bolesti srca (simptomi mogu uključivati bol ili stezanje u prsnom košu, nedostatak zraka ili gušenje), srčanog zatajenja, niskog krvnog tlaka, - poremećaja otkucaja srca kao što su spori otkucaji srca,
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.
Promjena može biti uočljivija ako liječite samo jedno oko.
Bradycardia
Nepoznato bradikardija
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 kapi za oko, otopina, u jednodoznom spremniku bimatoprost/timolol
In addition, signs and symptoms of beta-blockade (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery.
Osim toga, kada su beta-blokatori davani do poroda, kod novorođenčadi su zabilježeni znakovi i simptomi beta-blokade (npr.
GANFORT single-dose can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma.
Na jednodozni GANFORT mogu utjecati drugi primijenjeni lijekovi, ili on može utjecati na njih,
Hepatic
adrenalina.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING 30 SINGLE-DOSE CONTAINERS (PROVIDED IN 3 POUCHES, EACH CONTAINING 10 SINGLE-DOSE CONTAINERS)
KUTIJA KOJA SADRŽI 30 JEDNODOZNIH SPREMNIKA (ISPORUČENIH
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS POUCH CONTAINING STRIP OF 10 SINGLE-DOSE CONTAINERS
VREĆICA KOJA SADRŽI STRIP S 10 JEDNODOZNIH SPREMNIKA
Use any eye ointment or eye gel last.
Ako trebate primijeniti mast za oko ili gel za oko, učinite to na kraju.
- 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
- slabe cirkulacije (bolesti perifernih krvnih žila kao što je Raynaudova bolest ili Raynaudov sindrom), - pojačane aktivnosti štitne žlijezde, jer timolol može zamaskirati znakove i simptome bolesti štitne žlijezde,
- if you are allergic to bimatoprost, timolol, beta-blockers or any of the other ingredients of GANFORT single-dose (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
- koronarne bolesti srca (simptomi mogu uključivati bol ili stezanje u prsnom košu, nedostatak zraka ili gušenje), srčanog zatajenja, niskog krvnog tlaka, - poremećaja otkucaja srca kao što su spori otkucaji srca, - dišnih problema, astme ili kronične opstruktivne bolesti pluća
However, consideration should be given to the likelihood of compliance when considering either morning or evening dosing.
Ipak prilikom propisivanja treba uzeti u obzir odgovara li bolesniku vrijeme primjene, odnosno kada je vjerojatnije da će bolesnik propisani lijek primijeniti.
• go to the hospital straight away
• odmah otiđite u bolnicu
June 2023
Lipanj 2023
• Take this medicine by mouth.
• Uzmite ovaj lijek kroz usta.
There were no grade 3 or 4 adverse events.
Nije bilo događaja 3. ni 4. stupnja.
While the overall number of events was small, the difference between the two arms was sufficiently large to reach statistical significance.
Dok je ukupni broj događaja bio mali, razlika između dvije skupine je bila dovoljno velika za dostizanje statističkog značaja.
• has not metastasised to other parts of the body and
• koji se nije proširio (metastazirao) u druge dijelove tijela i
Children and adolescents This medicine is not for use in children and adolescents under 18 years of age.
Ovaj se lijek ne smije primjenjivati u djece i adolescenata mlađih od 18 godina.
Talk to your doctor if you have any questions about contraception.
Obratite se svom liječniku ako imate bilo kakvih pitanja o kontracepciji.
What Erleada is and what it is used for
Što je Erleada i za što se koristi
Each carton contains one bottle.
Jedno pakiranje sadrži jednu bocu.
Androgens can cause the cancer to grow.
Androgeni mogu uzrokovati rast raka.
• You can take Erleada with food or between meals.
• Lijek Erleada možete uzeti s hranom ili između obroka.
Do not take this medicine if any of the above apply to you.
Nemojte uzimati ovaj lijek ako se bilo što od gore navedenoga odnosi na Vas.
If a child or young person accidentally takes Erleada:
Ako dijete ili mlada osoba slučajno uzmu lijek Erleada:
The median time to symptomatic progression was not reached in either treatment group.
Medijan vremena do simptomatske progresije nije dostignut ni u jednoj liječenoj skupini.
The tablets should be swallowed whole and can be taken with or without food.
Tablete treba progutati cijele, a mogu se uzimati s hranom ili bez nje.
Pregnancy and contraception information for men and women
Informacije o trudnoći i kontracepciji za muškarce i žene
Ethnicity and race
Etnička pripadnost i rasa
Therefore, the safety of apalutamide in these patients has not been established.
Stoga nije utvrđena sigurnost apalutamida u tih bolesnika.
(2) Pull out
(2) Izvucite
If you are at higher risk of seizures (see Section 2), talk to your doctor.
Ako kod Vas postoji povećan rizik od napadaja (pogledajte dio 2.), razgovarajte sa svojim liječnikom.
OTHER Fold over to close
Preklopite da biste zatvorili