FrancophonIA/ELRC3.0 huggingface dataset:
English: How to take Senshio
Slovenian: Kako jemati zdravilo Senshio
English: The incidence of endometrial hyperplasia was 0.3% (1 case out of 317 biopsies) after 1 year of treatment with an upper 95% confidence limit of 1.74% (see section 5.1).
Slovenian: 1 letu zdravljenja z zgornjo 95-odstotno mejo zaupanja 1,74% (glejte poglavje 5.1).
English: Any of the following medicines, as their concentrations may be increased while taking Senshio: Metformin used to treat Type II diabetes.
Slovenian: Senshio povečajo: o Metformin, ki se uporablja za zdravljenje sladkorne bolezni tipa II.
English: Hypromellose (E 464) Lactose monohydrate Titanium dioxide (E 171) Triacetin (E 1518) Macrogols (E 1521)
Slovenian: laktoza monohidrat titanov dioksid (E 171) triacetin (E 1518)
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Zdravilo Senshio vsebuje laktozo Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte z zdravnikom.
English: Common side effects (may affect up to 1 in 10 people): - An infection of the genitals caused by a fungus (thrush) - Hot flushes - Muscle cramps - Vaginal or genital discharge - Rash
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnic): - glivična okužba spolovil (gobice) - vročinski oblivi - mišični krči - izcedek iz nožnice ali spolovil - izpuščaj
English: Trial 1 Dryness
Slovenian: Preskušanje 1 Suhost
English: Ospemifene and its major metabolite, 4-hydroxyospemifene, inhibited organic cation transporter (OCT)1 in vitro at clinically relevant concentrations.
Slovenian: Ospemifen in njegov glavni presnovek, 4-hidroksiospemifen, sta in vitro zavrla prenašalec organskih kationov (OCT, organic cation transporter)1 v klinično pomembnih koncentracijah.
English: In total, there were 317 subjects on ospemifene and 64 subjects on placebo who had a baseline as well as a week 52 biopsy.
Slovenian: Skupaj je bila biopsija ob izhodišču in v 52. tednu opravljena pri 317 osebah, ki so dobivale ospemifen in pri 64 osebah, ki so dobivale placebo.
English: The incidence of abnormal, but not clinically significant, findings on breast palpation and mammography decreased in the ospemifene 60 mg population during the 1-year study (trial 3) from 1.6% to 0.6% and from 11.8% to 8.1% respectively.
Slovenian: Incidenca nenormalnih, a klinično nepomembnih izsledkov pri palpaciji dojk in na mamografiji se je v 1-letni študiji pri populaciji z ospemifenom 60 mg zmanjšala (preskušanje 3) z
English: It is recommended that ospemifene should be taken with food at the same time each day.
Slovenian: Jemanje ospemifena se priporoča skupaj s hrano in vsaj dan ob istem času.
English: Symptoms of an allergic reaction may include rash, itchy skin, raised patches on your skin (urticaria), swelling of the tongue and throat that may cause difficulty in breathing or swallowing.
Slovenian: izbočene predele kože (koprivnica), otekanje jezika in žrela, ki lahko oteži dihanje ali požiranje.
English: Senshio 60 mg film-coated tablets
Slovenian: IME ZDRAVILA Senshio 60 mg filmsko obložene tablete
English: In vitro, ospemifene and 4-hydroxyospemifene inhibited glucuronidation mainly via UGT1A3 and UGT1A9 at clinically relevant concentrations.
Slovenian: Ospemifen in 4-hidroksiospemifen sta in vitro zavrla glukoronidacijo v glavnem prek UGT1A3 in UGT1A9 v klinično pomembnih koncentracijah.
English: Senshio 60 mg film-coated tablets ospemifene
Slovenian: IME ZDRAVILA Senshio 60 mg filmsko obložene tablete ospemifen
English: The pharmacokinetics of ospemifene is only mildly affected by mild and moderate hepatic impairment (Child Pugh scores 5-9) when compared to healthy matched controls.
Slovenian: V primerjavi s kontrolno skupino zdravih oseb so ugotovili, da na farmakokinetiko ospemifena le malo vpliva blaga ali zmerna okvara jeter (razred po Child-Pughu 5-9).
English: Effects of ospemifene on other medicinal products
Slovenian: Učinki ospemifena na druga zdravila
English: Talk to your doctor or pharmacist before taking Senshio if any of the following apply to you.
Slovenian: Če kar koli od navedenega velja za vas, se pred začetkom jemanja zdravila Senshio posvetujte z zdravnikom ali farmacevtom.
English: Colloidal silicon dioxide (E 551) Magnesium stearate (E 578) Mannitol (E 421) Microcrystalline cellulose (E 460) Povidone (E 1201) Pregelatinised starch (maize) Sodium starch glycolate (type A)
Slovenian: Jedro tablete: koloidni silicijev dioksid (E 551) magnezijev stearat (E 578) manitol (E 421) mikrokristalna celuloza (E 460) povidon (E 1201)
English: 5.0% superficial cells in the vaginal smear, a vaginal pH >5.0 and were required to have at least one moderate or severe VVA symptom, where patients had to choose the symptom that was the most bothersome (MBS).
Slovenian: Študijska populacija je bila sestavljena iz pretežno zdravih žensk po menopavzi, starih med 41 in 80 leti (povprečna starost = 59 let), ki so imele ob izhodišču ≤ 5,0% površinskih celic v brisu nožnice, pH nožnice > 5,0 in ki so imele vsaj en zmeren ali hud simptom VVA, pri čemer so bolnice izbrale simptom, ki je bil najbolj moteč (MBS, most bothersome symptom).
English: Therefore, caution is recommended when co-administering ospemifene with fluconazole.
Slovenian: Zato se pri sočasni uporabi ospemifena s flukonazolom priporoča previdnost.
English: Tell your doctor immediately if you become pregnant while taking Senshio; treatment should be stopped immediately.
Slovenian: Če med jemanjem zdravila Senshio zanosite, o tem takoj obvestite zdravnika; takoj prenehajte z zdravljenjem.
English: The major metabolite, 4-hydroxyospemifene, was seen to undergo formation rate-limited elimination (with t1/2 similar to the parent compound) in a human mass balance study.
Slovenian: V študiji utežnega razmerja pri ljudeh so opazili, da je glavni presnovek, 4-hidroksiospemifen, predmet izločanja, omejenega s hitrostjo nastajanja (s podobnim t1/2 kot izhodišča spojina).
English: Senshio is for use only in postmenopausal women.
Slovenian: Zdravilo Senshio se uporablja samo pri ženskah po menopavzi.
English: In healthy subjects, the absorption of ospemifene is not affected by co-administration of oral omeprazole, a medicinal product that increases gastric pH.
Slovenian: Pri zdravih osebah sočasna uporaba peroralnega omeprazola, zdravila, ki povečuje pH v želodcu, ne vpliva na absorpcijo ospemifena
English: CYP2C9 poor metabolisers
Slovenian: Bolnice s slabo presnovo s CYP2C9
English: Hepatic impairment
Slovenian: - glavobol
English: In vitro, ospemifene and 4-hydroxyospemifene inhibited glucuronidation via UGT1A3 and UGT1A9 at clinically relevant concentrations.
Slovenian: Ospemifen in 4-hidroksiospemifen sta in vitro zavrla glukoronidacijo prek UGT1A3 in UGT1A9 v klinično pomembnih koncentracijah.
English: Dyspareunia 60 mg OSP Placebo p-value 60 mg OSP Placebo p-value
Slovenian: 60 mg OSP Placebo vrednost p 60 mg OSP Placebo vrednost p Preskušanje 1 -1,26
English: Therefore care should be taken if ospemifene is administered with a BCRP inhibitor.
Slovenian: Zato je pri sočasni uporabi ospemifena z zaviralcem BCRP potrebna previdnost.
English: In patients with moderate hepatic impairment the exposure of ospemifene and 4-hydroxyospemifene was approximately 30% and 70% higher.
Slovenian: 4-hidroksiospemifenu približno 30% oz. 70% višja.
English: - If you are allergic to ospemifene or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Senshio Ne jemljite zdravila Senshio - če ste alergični na ospemifen ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Contains lactose.
Slovenian: povezanih z dojkami.
English: Trial 1 Trial 2
Slovenian: Preskušanje 1
English: Fri.
Slovenian: Disparevnija
English: Across all placebo-controlled clinical trials of ospemifene, deep vein thrombosis occurred at a frequency of approximately 3.65 cases per 1,000 patient years on 60 mg ospemifene (95% confidence interval of 0.44 to 13.19) versus 3.66 cases per 1,000 patient years for placebo (95% confidence interval of 0.09 to 20.41; relative risk is 1.0).
Slovenian: (95-% interval zaupanja 0,44 do 13,19) v primerjavi s 3,66 primerov na 1.000 bolnic-let za placebo
English: Coadministration of ospemifene with strong/moderate CYP3A4 inhibitors should be avoided in patients who are known or suspected to be CYP2C9 poor metabolizers based on genotyping or previous history/experience with other CYP2C9 substrates.
Slovenian: pri bolnicah, za katere je znano ali pri se sumi, da imajo slabo presnovo s CYP2C9 na podlagi genotipiziranja ali z obstoječo anamnezo/izkušnjami z drugimi substrati CYP2C9, izogniti.
English: Any other medicine belonging to the group called SERMs, such as tamoxifen, toremifene, bazedoxifene and raloxifene.
Slovenian: • Vsa druga zdravila, ki sodijo v skupino zdravil, imenovanih SERM, kot so tamoksifen,
English: Co-administration of ketoconazole, a strong CYP3A4 inhibitor, increased the AUC of ospemifene by 1.4-fold.
Slovenian: močnega zaviralca CYP3A4, je povečala AUC ospemifena za 1,4-krat.
English: It must not be taken by women who are pregnant, who could still have a baby or are breast-feeding.
Slovenian: Nosečnice, ženske v rodni dobi ali ženske, ki dojijo, ga ne smejo uporabljati.
English: No clinically meaningful differences in ospemifene pharmacokinetics have been observed over the age range studied (40-80) years of age.
Slovenian: V razponu preučevane starosti (40-80) niso opazili klinično pomembnih razlik v farmakokinetiki ospemifena.
English: Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women who are not candidates for local vaginal oestrogen therapy.
Slovenian: (VVA, vulvar and vaginal atrophy) pri ženskah po menopavzi, ki niso primerne za lokalno vaginalno zdravljenje z estrogenom.
English: Oudehaske
Slovenian: Oudehaske Nizozemska
English: The MAH shall complete, within the stated timeframe, the below measures:
Slovenian: Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe:
English: Gender Senshio is indicated for use only in postmenopausal women.
Slovenian: Zdravilo Senshio je indicirano samo pri ženskah po menopavzi.
English: No dose adjustment is necessary in patients with mild or moderate hepatic impairment.
Slovenian: Pri bolnicah z blago ali zmerno okvaro jeter odmerka ni treba prilagajati.
English: Patients with liver disease
Slovenian: Žilne bolezni vročinski oblivi
English: Dryness
Slovenian: Suhost
English: How to store Senshio
Slovenian: Shranjevanje zdravila Senshio
English: Both CYP2C9 and CYP3A4 are involved in the metabolism of ospemifene.
Slovenian: Pri presnovi ospemifena sodelujeta tako CYP2C9 kot CYP3A4.
English: Ospemifene was not mutagenic or clastogenic when evaluated in a standard battery of in vitro and in vivo tests.
Slovenian: V standardnem nizu testov in vitro in in vivo ospemifen ni bil mutagen ali klastogen.
English: - Headache - Vaginal bleeding
Slovenian: izcedek iz spolovil, vaginalna krvavitev hipertrofija endometrijaa
English: Ospemifene and its major metabolite, 4-hydroxyospemifene, are metabolised by multiple metabolic pathways, the main enzymes involved are UGT1A3, UGT2B7, UGT1A1 and UGT1A8, and CYP2C9,
Slovenian: pri čemer so glavni encimi, ki so vključeni v presnovo UGT1A3, UGT2B7, UGT1A1 in UGT1A8 ter CYP2C9, CYP3A4 in CYP2C19.
English: C.
Slovenian: PC
English: No dose adjustment is necessary for patients with mild to moderate hepatic impairment.
Slovenian: Jetrna okvara Pri bolnicah z blago do zmerno jetrno okvaro odmerka ni treba prilagajati.
English: Contents of the pack and other information What Senshio contains
Slovenian: Kaj vsebuje navodilo Kaj je zdravilo Senshio in za kaj ga uporabljamo
English: No changes in blood biochemical parameters such as ALT or ALP were determined in postmenopausal women treated with Ospemifene in clinical studies.
Slovenian: Pri ženskah po menopavzi, ki so se v kliničnih študijah zdravile z ospemifenom, niso opazili sprememb biokemičnih parametrov v krvi, kot sta vrednost ALT
English: The PL is updated in accordance.
Slovenian: V skladu s tem se posodobi tudi navodilo za uporabo zdravila.
English: Talk to your doctor before taking Senshio with:
Slovenian: Pred začetkom jemanja zdravila Senshio s katerim od naslednjih zdravil se posvetujte z zdravnikom:
English: Close monitoring is required with frequent or prolonged use.
Slovenian: Skrbno spremljanje je potrebno pri pogosti ali daljši uporabi.
English: Date of first Authorisation: 25 November 2008 Date of latest renewal: 26 August 2013
Slovenian: Datum prve odobritve: 25. november 2008 Datum zadnjega podaljšanja: 26. avgust 2013
English: 2, cold hands and feet
Slovenian: 2, hladne dlani in stopala
English: However, a risk to the suckling child cannot be excluded.
Slovenian: Vendar pa tveganja za dojenčka ne moremo izključiti.
English: It may harm them even if their signs of illnesses are the same as yours.
Slovenian: Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.
English: These could be the signs of an allergic reaction (frequency is not known).
Slovenian: To so lahko znaki alergijske reakcije (pogostnost ni znana).
English: How to use
Slovenian: Kako uporabljati
English: B-2870 Puurs Belgium or
Slovenian: B-2870 Puurs Belgija ali
English: Do not put in any more drops until it is time for your next regular dose.
Slovenian: Kapljic ne vkapajte ponovno, dokler ne bo čas za naslednji redni odmerek.
English: 4 weeks after first opening.
Slovenian: 4 tedne po prvem odprtju
English: They are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), or not known (cannot be estimated from the available data).
Slovenian: Razvrščeni so v skladu z naslednjim dogovorom: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1000), zelo redki (<1/10.000) ali pogostnost neznana (je ni mogoče oceniti iz razpoložljivih podatkov).
English: Not known (frequency cannot be estimated from the available data)
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
English: Contact with soft contact lenses should be avoided.
Slovenian: Stiku z mehkimi kontaktnimi lečami se je treba izogibati.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določenie v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: (see section 4.4 Special warnings and precautions for use), keratopathy
Slovenian: (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi), keratopatija
English: Cartons containing 1 or 3 bottles.
Slovenian: Škatle z 1 ali 3 kapalnimi vsebniki.
English: You can usually carry on taking the drops, unless the effects are serious.
Slovenian: Običajno lahko nadaljujete z uporabo kapljic kljub neželenim učinkom, razen če so resni.
English: Throw away the bottle 4 weeks after first opening to prevent infections, and use a new bottle.
Slovenian: Kapalni vsebnik zavrzite 4 tedne po prvem odprtju, da boste preprečili okužbe, in potem uporabite nov vsebnik.
English: (predominantly in patients with preexisting bronchospastic disease), dyspnoea
Slovenian: (predvsem pri bolnikih z obstoječo bronhospastično boleznijo), dispneja
English: The following measure is useful to limit the amount of medicine that will come into the blood after application of eye drops: - Keep the eyelid closed, while simultaneously applying gentle pressure to the corner of the eye next to the nose with a finger for at least 2 minutes.
Slovenian: Naslednji ukrepi pomagajo zmanjšati količino zdravila, ki bo prišla v kri po uporabi kapljic za oko: - Držite očesno veko zaprto, medtem ko sočasno s prstom nežno pritiskate na očesni kot ob nosu vsaj 2 minuti.
English: This medicine contains 3.34 µg benzalkonium chloride per drop (= 1 dose) which is equivalent to 0.01% or 0.1 mg/ml.
Slovenian: To zdravilo vsebuje 3,34 µg benzalkonijevega klorida na kapljico (= 1 odmerek), kar je enako 0,01 % ali 0,1 mg/ml.
English: White to off-white uniform suspension, pH 7.2 (approximately).
Slovenian: Bela do belkasta, enakomerna suspenzija, pH 7,2 (približno).
English: Clinical effects:
Slovenian: Klinični učinki:
English: The response of these patients should be closely observed.
Slovenian: Odziv teh bolnikov na zdravljenje je torej treba skrbno spremljati.
English: 3, nightmare
Slovenian: 3, nočne more
English: Caution is recommended in the concomitant use of this medicinal product with clonidine.
Slovenian: Previdnost je potrebna pri sočasni uporabi tega zdravila s klonidinom.
English: Stop using this medicine and contact your doctor immediately if you develop skin rash, severe skin reaction, or severe redness and itching of the eye.
Slovenian: Prenehajte z uporabo tega zdravila in se nemudoma posvetujte s svojim zdravnikom, če se razvijejo kožni izpuščaj, huda kožna reakcija ali huda rdečina in srbenje oči.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2. dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Do not use a double dose to make up for the forgotten dose.
Slovenian: Ne uporabite dvojnega odmerka, da bi nadomestili izpuščenega.
English: Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines.
Slovenian: Začasno zamegljen vid ali druge motnje vida lahko vplivajo na sposobnost vožnje ali upravljanja s stroji.
English: If you are taking another carbonic anhydrase inhibitor (acetazolamide or dorzolamide), talk to your doctor.
Slovenian: Če sočasno jemljete še drug zaviralec karboanhidraze (acetazolamid ali dorzolamid), se posvetujte s svojim zdravnikom.
English: Patients with corneal diseases should be treated with caution.
Slovenian: Bolnike z boleznimi roženice je treba zdraviti previdno.
English: 1, asthma
Slovenian: 1, astma
English: Timolol is metabolised by two pathways.
Slovenian: Timolol se presnavlja po dveh poteh.
English: If you stop using AZARGA without speaking to your doctor, the pressure in your eye will not be controlled which could lead to loss of sight.
Slovenian: Če ste prenehali uporabljati zdravilo AZARGA, ne da bi se posvetovali s svojim zdravnikom, vaš očesni tlak ne bo nadzorovan in lahko pride do izgube vida.
English: You should not use AZARGA if you are pregnant or might get pregnant, unless your doctor considers it necessary.
Slovenian: Zdravila AZARGA ne smete uporabljati, če ste noseči ali bi lahko zanosili, razen če vaš zdravnik meni, da je to nujno potrebno.
English: The safety and efficacy of AZARGA in children and adolescents aged 0 to 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila AZARGA pri otrocih in mladostnikih, starih 0 do 18 let, še nista bili dokazani.
English: • If you have too much acidity in your blood (a condition called hyperchloraemic acidosis).
Slovenian: • Če je vaša kri preveč kisla (motnja, ki ji pravimo hiperkloremična acidoza).
English: To reduce the systemic absorption, see section 4.2.
Slovenian: Glede zmanjšanja sistemske absorpcije glejte poglavje 4.2.
English: Studies have shown that timolol does not dialyse readily.
Slovenian: Študije so pokazale, da se timolol ne odstranjuje zlahka z dializo.
English: • Brinzolamide and timolol are absorbed systemically.
Slovenian: • Brinzolamid in timolol se absorbirata sistemsko.
English: Summary of the safety profile
Slovenian: Povzetek profila varnosti zdravila
English: , nervousness
Slovenian: , živčnost
English: Warnings and precautions Only use AZARGA for dropping in your eye(s).
Slovenian: Opozorila in previdnostni ukrepi Zdravilo AZARGA uporabljajte samo za vkapanje v svoje oko (oči).
English: • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Slovenian: • Preobčutljivost na učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1,
English: This may lead to a corneal decompensation and oedema and wearing contact lenses might increase the risk for the cornea.
Slovenian: To lahko vodi v dekompenzacijo ter edem roženice in bi nošenje kontaktnih leč lahko povečalo tveganje za okvaro roženice.
English: Alcon Cusí, S.A. Camil Fabra 58 08320 El Masnou Barcelona Spain
Slovenian: Alcon Cusí, S.A. Camil Fabra 58 08320 El Masnou Barcelona Španija
English: Children and adolescents AZARGA is not recommended for children and adolescents under 18 years.
Slovenian: Otroci in mladostniki Zdravilo AZARGA ni priporočljivo za otroke in mladostnike, mlajše od 18 let.
English: Dysgeusia (bitter or unusual taste in the mouth following instillation) was a frequently reported systemic adverse reaction associated with the use of AZARGA during clinical trials.
Slovenian: Disgevzija (grenek ali nenavaden okus v ustih po vkapanju zdravila) je bila pogosto prijavljen sistemski neželeni učinek, povezan z uporabo zdravila AZARGA v kliničnih preskušanjih.
English: AZARGA is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Slovenian: Zdravilo AZARGA ni priporočljivo za uporabo pri otrocih in mladostnikih, mlajših od 18 let, zaradi pomanjkanja podatkov o njegovi varnosti in učinkovitosti.
English: If you use more AZARGA than you should, rinse your eye with warm water.
Slovenian: Če ste uporabili večji odmerek zdravila AZARGA, kot bi smeli, sperite oko s toplo vodo.
English: One route yields an ethanolamine side chain on the thiadiazole ring and the other giving an ethanolic side chain on the morpholine nitrogen and a second similar side chain with a carbonyl group adjacent to the nitrogen.
Slovenian: Ena vodi do nastanka etanolaminske stranske verige na tiadiazolnem obroču, druga pa do nastanka etanolne stranske verige na morfolinskem dušiku in druge podobne stranske verige s karbonilno skupino sosedno od dušika.
English: Additional adverse reactions associated with the use of the individual components that may potentially occur with AZARGA are included in the table above.
Slovenian: Dodatni neželeni učinki, povezani z uporabo posameznih sestavin zdravila, ki bi se lahko pojavili tudi pri uporabi zdravila AZARGA, so vključeni v zgornjo tabelo.
English: Caution is recommended.
Slovenian: Potrebna je previdnost.
English: During lactation, the no adverse effect level in the offspring was 5 mg/kg/day.
Slovenian: Med dojenjem je odmerek brez neželenih učinkov pri mladičih znašal 5 mg/kg/dan.
English: If you are using other eye drop or eye ointment medicines leave at least 5 minutes between each medicine.
Slovenian: Če uporabljate tudi druge kapljice za oko ali mazila za oko, počakajte najmanj 5 minut med uporabo vsakega zdravila.
English: Do not drive or use machines until your vision is clear.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ne vozite in ne upravljajte strojev, dokler se vam vid ne zbistri.
English: Use in adults, including the elderly The dose is one drop of AZARGA in the conjunctival sac of the affected eye(s) twice daily.
Slovenian: Uporaba pri odraslih, vključno s starostniki Odmerek je ena kapljica zdravila AZARGA v veznično vrečko prizadetega očesa (oči) dvakrat na dan.