FrancophonIA/ELRC3.0 huggingface dataset:
English: Can be used in PRRS virus-naïve gilts and sows pre-breeding or in the first half of gestation.
Slovenian: Lahko se uporablja pri na PRRS virus imunološko naivnih mladicah in plemenskih svinjah pred brejostjo ali v prvi polovici brejosti.
English: Newly introduced PRRS virus-naïve animals (e.g. replacement gilts from PRRS virus-negative herds) should be vaccinated prior to pregnancy.
Slovenian: Na novo vključene živali, ki še niso bile izpostavljene virusu PRRS (npr. nadomestne mladice iz čred, ki niso okužene z virusom PRRS), je treba cepiti pred brejostjo.
English: Local reactions in the form of swellings are very common and resolve spontaneously within 32 days.
Slovenian: Zelo pogoste so tudi lokalne reakcije v obliki oteklin, ki spontano izginejo v 32 dneh.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Glass vials (15 ml, containing 25, 50 or 125 doses)
Slovenian: Steklene viale (po 15 ml, ki vsebujejo 25, 50 ali 125 odmerkov)
English: A transient increase in rectal temperature (0.5 °C on average, and up to 1.4 °C individually) may very commonly occur within 4 days after vaccination.
Slovenian: Zelo pogosto se pojavi prehodno zvišanje rektalne temperature (povprečno 0,5 °C, v posameznih primerih tudi do 1,4 °C) v 4 dneh po cepljenju.
English: Gilts and sows: A single dose of 2 ml is given prior to introduction into the sow herd, approximately 4 weeks prior to breeding.
Slovenian: Mladice in plemenske svinje: Enkraten odmerek 2 ml se aplicira pred vključitvijo v čredo svinj,
English: Cardboard box of 1 vial of 15 ml (125 doses) and 1 vial of 250 ml of solvent.
Slovenian: Kartonska škatla z 1 vialo po 15 ml (125 odmerkov) in 1 vialo z 250 ml vehikla.
English: Modified live PRRSV*, strain 96V198: 102.2 - 105.2 CCID50**
Slovenian: Učinkovina: Modificirani živi virus PRRSV*, sev 96V198: 102,2- 105,2 CCID50**
English: Local reactions in the form of swellings are very common and resolve spontaneously within 9 days.
Slovenian: Zelo pogoste so tudi lokalne reakcije v obliki oteklin, ki spontano izginejo v 9 dneh.
English: Cardboard box of 1 vial of 15 ml (50 doses) and 1 vial of 100 ml of solvent.
Slovenian: Kartonska škatla z 1 vialo po 15 ml (50 odmerkov) in 1 vialo s 100 ml vehikla.
English: Can be used in non-PRRS virus-naive gilts and sows in the second half of gestation.
Slovenian: Lahko se uporablja pri na PRRS virus imunološko ne-naivnih mladicah in plemenskih svinjah v drugi polovici brejosti.
English: Modified live PRRSV, strain 96V198: 102.2 - 105.2 CCID50
Slovenian: Modificiran živi virus PRRSV, sev 96V198: 102,2 - 105,2 CCID50 FARMACEVTSKA OBLIKA
English: Each dose (2 ml) contains: Modified live PRRSV, strain 96V198: 102.2 - 105.2 CCID50
Slovenian: KOLIČINA UČINKOVIN(E) modificiran živi virus PRRSV, sev 96V198: 102,2 - 105,2 CCID50
English: Local reactions in the form of swellings are common and resolve spontaneously within 3 days.
Slovenian: Pogoste so tudi lokalne reakcije v obliki oteklin, ki spontano izginejo v 3 dneh.
English: Lactation:
Slovenian: Inkompatibilnosti:
English: Cardboard box of 1 vial of 15 ml (25 doses) and 1 vial of 50 ml of solvent.
Slovenian: Kartonska škatla z 1 vialo po 15 ml (25 odmerkov) in 1 vialo s 50 ml vehikla.
English: Dextran 40
Slovenian: 4.11 Karenca
English: The area of local tissue reaction is in general below 0.5 cm in diameter.
Slovenian: Premer območja reakcije lokalnega tkiva je običajno manjši od 0,5 cm.
English: Dosage:
Slovenian: Vehikel:
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov proizvajalca (proizvajalcev) zdravila, odgovornega (odgovornih) za sproščanje zadevne serije
English: Vaccinate healthy animals only.
Slovenian: Posebna opozorila za vsako ciljno živalsko vrsto Cepite samo zdrave živali.
English: A minor and transient increase in rectal temperature (0.4 °C on average, and up to 0.6 °C individually) may very commonly occur 4 hours post vaccination in non-PRRS virus-naïve gilts and sows in the second half of gestation.
Slovenian: Zelo pogosto se lahko pojavi manjše in prehodno zvišanje rektalne temperature (povprečno 0,4 °C, v posameznih primerih tudi do 0,6 °C) v 4 urah po cepljenju pri na PRRS virus imuološko ne-naivnih mladicah in plemenskih svinjah v drugi polovici brejosti.
English: The area of local tissue reaction is in general below 5 cm in diameter.
Slovenian: Premer območja reakcije lokalnega tkiva je običajno manjši od 5 cm.
English: Suvaxyn PRRS MLV lyophilisate for suspension for injection for pigs
Slovenian: Suvaxyn PRRS MLV liofilizat in vehikel za suspenzijo za injiciranje za prašiče
English: The area of local tissue reaction is in general below 2 cm in diameter.
Slovenian: Premer območja reakcije lokalnega tkiva je običajno manjši od 2 cm.
English: Anaphylactic-type reactions (vomiting, tremors and/or mild depression) may uncommonly occur in piglets shortly after vaccination.
Slovenian: Takoj po cepljenju se lahko pri pujskih občasno pojavijo reakcije anafilaktičnega tipa (bruhanje, tresavica in/ali blažja depresija).
English: A minor and transient increase in rectal temperature (0.8 °C on average, and up to 1.0 °C individually) may very commonly occur 4 hours post vaccination in PRRS virus-naïve gilts and sows in the first half of gestation.
Slovenian: Zelo pogosto se lahko pojavi manjše in prehodno zvišanje rektalne temperature (povprečno 0,8 °C, v posameznih primerih tudi do 1,0 °C) v 4 urah po cepljenju pri na PRRS virus imunološko naivnih mladicah in plemenskih svinjah v prvi polovici brejosti.
English: PACKAGE LEAFLET: Suvaxyn PRRS MLV lyophilisate and solvent for suspension for injection for pigs
Slovenian: NAVODILO ZA UPORABO: Suvaxyn PRRS MLV liofilizat in vehikel za suspenzijo za injiciranje za prašiče
English: A minor and transient increase in rectal temperature (0.2 °C on average, and up to 1.0 °C individually) may very commonly occur 4 hours post vaccination in pre-breeding PRRS virus-naïve gilts and sows.
Slovenian: Zelo pogosto se lahko pojavi manjše in prehodno zvišanje rektalne temperature (povprečno 0,2 °C, v posameznih primerih tudi do 1,0 °C) v 4 urah po cepljenju pri na PRRS virus imunološko naivnih mladicah in plemenskih svinjah pred brejostjo.
English: Marketing authorization holder and manufacturer responsible for batch release:
Slovenian: Imetnik dovoljenja za promet z zdravilom in proizvajalec odgovoren za sproščanje serij: Zoetis Belgium SA
English: After the administration of a 10-fold overdose to non-PRRS virus-naïve gilts and sows in the second half of pregnancy a transient increase in rectal temperature (0.3 °C on average, and up to 0.6 °C individually) occurred 4 hours post vaccination.
Slovenian: Pri na PRRS virus imunološko ne-naivnih mladicah in plemenskih svinjah v drugi polovici brejosti se je po aplikaciji 10-kratnega prekomernega odmerka pojavilo prehodno zvišanje rektalne temperature
English: A transient increase in rectal temperature (0.3 ºC on average, and up to 1.2 °C individually) very commonly occurred 24 hours post vaccination.
Slovenian: (povprečno 0,3 °C, v posameznih primerih tudi do 1,2 °C) v 24 urah po cepljenju.
English: Ph. Eur.
Slovenian: Rp-Vet.
English: The administration of a 10-fold overdose to PRRS virus-naïve pre-breeding or pregnant gilts and sows in the first or second half of pregnancy induced similar adverse reactions as those described under section 6.
Slovenian: kratnega odmerka pri na PRRS virus imunološko naivnih mladicah in plemenskih svinjah pred brejostjo ali v prvi ali drugi polovici brejosti.
English: Suvaxyn PRRS MLV solvent for suspension for injection for pigs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Suvaxyn PRRS MLV liofilizat za suspenzijo za injiciranje za prašiče
English: The educational materials should be submitted at the same time as the variation of product information application.
Slovenian: Izobraževalna gradiva je treba predložiti sočasno z vlogo za spremembo informacij o zdravilu.
English: 16 December 2014
Slovenian: 16. decembra 2014
English: 12 January 2015
Slovenian: 12. januarja 2015
English: Implementation of the agreement by the Member States (submission of the variation to implement the changes to the product information by the Marketing Authorisation Holder):
Slovenian: Izvajanje sporazuma s strani držav članic (predložitev vloge za spremembo za vključitev sprememb v informacije o zdravilu s strani imetnika dovoljenja za promet z zdravilom):
English: November 2014 CMDh meeting
Slovenian: zasedanje skupine CMDh novembra 2014
English: Use in adults, including the elderly
Slovenian: Uporaba pri odraslih, vključno s starejšimi
English: Continue with the next dose as planned.
Slovenian: Nadaljujte z naslednjim odmerkom, kot je predvideno.
English: • Wash your hands before you start.
Slovenian: • Preden začnete, si umijte roke.
English: Use the medicine at around the same time each day.
Slovenian: Zdravilo uporabljajte vsak dan ob približno istem času.
English: Over half were aged ≥ 65 years.
Slovenian: Več kot polovica je bila stara ≥ 65 let.
English: The median age of study participants was 65.5 years (range 18 to 91 years).
Slovenian: Mediana starost udeležencev študije je bila 65,5 leta (razpon od 18 do 91 let).
English: Do not put in any more drops until it is time for your next regular dose.
Slovenian: Kapljic ne uporabljajte več, dokler ni čas za vaš naslednji redni odmerek.
English: Netarsudil 0.02% Once daily
Slovenian: Netarsudil 0,02 % enkrat na dan
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1400/001
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/1/19/1400/001
English: Clear solution, pH 5 (approximately).
Slovenian: Bistra raztopina, pH 5 (približno).
English: Studies in animal and man suggest that the main mechanism of action is increased trabecular outflow.
Slovenian: Študije pri živalih in ljudeh kažejo, da je glavni mehanizem delovanja povečan trabekularni odtok.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator until opened.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku do odprtja.
English: If the pressure in the eye is too high, it can damage your sight.
Slovenian: Če je tlak v očeh previsok, lahko okvari vaš vid.
English: Patients should be monitored in case of prolonged use.
Slovenian: V primeru dolgotrajne uporabe je treba bolnike spremljati.
English: Treatment of an overdose would include supportive and symptomatic therapy.
Slovenian: Zdravljenje prevelikega odmerjanja bi vključevalo podporno in simptomatsko zdravljenje.
English: Cornea verticillata occurred in approximately 20% of the patients in controlled Phase 3 clinical studies.
Slovenian: Cornea verticillata se je pojavila pri približno 20 % bolnikov v nadzorovanih kliničnih študijah 3. faze.
English: This reaction did not result in any apparent visual functional changes in patients.
Slovenian: Ta učinek pri bolnikih ni povzročil opaznih funkcionalnih sprememb vida.
English: It could infect the drops.
Slovenian: Tako bi lahko okužili kapljice.
English: Long-term studies in animals have not been performed to evaluate the carcinogenic potential of netarsudil.
Slovenian: Dolgoročnih študij pri živalih za ovrednotenje kancerogenega potenciala netarsudila niso izvedli.
English: Do not use this medicine after the expiry date which is stated on the bottle and the carton after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli poleg oznake „EXP“.
English: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: If you stop using Rhokiinsa the pressure in your eye will not be controlled which could lead to loss of sight.
Slovenian: Če prenehate uporabljati zdravilo Rhokiinsa, tlak v vašem očesu ne bo nadzorovan, kar lahko privede do izgube vida.
English: • If you need to use the drops in both eyes, repeat the steps for your other eye while you have the bottle open.
Slovenian: • Če morate kapljice uporabljati v obeh očesih, zgornje korake ponovite še za drugo oko, plastenka pa naj pri tem ostane odprta.
English: If one dose is missed, treatment should continue with the next dose in the evening.
Slovenian: Če bolnik izpusti en odmerek, naj zdravljenje nadaljuje z naslednjim večernim odmerkom.
English: If you are using other eye drops, wait at least five minutes after using them and then use Rhokiinsa.
Slovenian: Če uporabljate še druge kapljice za oko, po njihovi uporabi počakajte vsaj pet minut, nato pa uporabite zdravilo Rhokiinsa.
English: The drop will go in here (Picture 1).
Slovenian: To je mesto, kamor je treba dati kapljico (slika 1).
English: If netarsudil is to be used concomitantly with other topical ophthalmic medicinal products, each medicinal product should be administered at least five (5) minutes apart.
Slovenian: Če se netarsudil uporablja sočasno z drugimi topičnimi oftalmičnimi zdravili, je treba posamezna zdravila uporabiti s presledkom vsaj pet (5) minut.
English: The efficacy of netarsudil has not been studied beyond 12 months.
Slovenian: Učinkovitosti netarsudila niso preučevali za obdobje, daljše od 12 mesecev.
English: Store in a refrigerator (2°C - 8°C) until opened.
Slovenian: Shranjujte v hladilniku (2 °C-8 °C) do odprtja.
English: Day 15
Slovenian: 15. dan
English: Do not use a double dose to make up for a forgotten dose.
Slovenian: Ne uporabite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: • Pull down your lower eyelid with a clean finger to form a ‘pocket' between the eyelid and your eye.
Slovenian: • S čistim prstom povlecite spodnjo veko, tako da ustvarite „žepek“ med veko in očesom.
English: However, there was a relatively small proportion of subjects with moderate or severe hyperaemia who discontinued treatment because of this adverse reaction (6.0% in Phase 3 clinical studies).
Slovenian: Vendar pa je razmeroma majhen delež preskušancev z zmerno ali hudo hiperemijo zaradi tega neželenega učinka prekinil zdravljenje (6,0 % v kliničnih študijah 3. faze).
English: If you are using eye ointments, these should be used last.
Slovenian: Če uporabljate mazila za oko, jih uporabite nazadnje.
English: Twice a day dosing is not well tolerated and is not recommended.
Slovenian: Učinki na očeh Odmerjanja dvakrat dnevno bolniki ne prenašajo dobro in ga ne priporočamo.
English: Subjects with known contraindications or hypersensitivity to timolol were excluded from the studies.
Slovenian: Preskušanci z znanimi kontraindikacijami ali preobčutljivostjo za timolol so bili iz študij izključeni.
English: Day 90
Slovenian: 90. dan
English: Do not use Rhokiinsa if you are pregnant unless your doctor still recommends it.
Slovenian: Zdravila Rhokiinsa ne uporabljajte, če ste noseči, razen če vam ga zdravnik vseeno priporoči.
English: If transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machines.
Slovenian: Če ima po vkapanju kapljic bolnik začasno zamegljen vid, mora počakati, da se mu vid zbistri, preden sme voziti ali upravljati stroje.
English: Rhokiinsa should not be used in children and teenagers under 18 years of age as it has only been studied in adults.
Slovenian: Zdravilo Rhokiinsa se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let, ker ga v teh starostnih skupinah niso preučevali.
English: There are no data on the effects of netarsudil on male or female fertility.
Slovenian: Ni podatkov o učinkih netarsudila na plodnost moških ali žensk.
English: Approximately 75% of subjects included in the netarsudil treatment groups of Phase 3 studies were Caucasian and 24% Black or African American.
Slovenian: Približno 75 % preskušancev, vključenih v skupine, zdravljene z netarsudilom, v študijah 3. faze je bilo belcev, 24 % pa črne rase oz. Afroameričanov.
English: Each bottle contains 2.5 ml of the medicine and each pack contains one bottle with a screw-cap.
Slovenian: Ena plastenka vsebuje 2,5 ml zdravila in vsako pakiranje vsebuje eno plastenko z navojnim pokrovčkom.
English: The incidence of cornea verticillata was higher in certain subpopulations: elderly (≥65 years) versus non-elderly (24.8 vs. 15.9%); males versus females (24.4 vs. 18.4%) and in white versus other races (25.6 vs. 7.0%).
Slovenian: Pojavnost cornee verticillate je bila večja v določenih podpopulacijah: pri starejših (≥ 65 let) v primerjavi z mlajšimi (24,8 v primerjavi s 15,9 %); pri moških v primerjavi z ženskami (24,4 v primerjavi z 18,4 %) in pri belcih v primerjavi z drugimi rasami (25,6 v primerjavi s 7,0 %).
English: • Only put one drop into your eye each time.
Slovenian: • V posamezno oko vsakič kapnite samo eno kapljico.
English: • General side effects: Headache
Slovenian: • Splošni neželeni učinki: glavobol
English: The majority of cornea verticillata resolved upon discontinuation of treatment.
Slovenian: Večina primerov cornee verticillate je izzvenela po prekinitvi zdravljenja.
English: It is therefore recommended to dose netarsudil once daily.
Slovenian: Zato se priporoča odmerjanje netarsudila enkrat na dan.
English: Carton containing 1 bottle.
Slovenian: Škatla vsebuje eno plastenko.
English: decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Rhokiinsa therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja ali prenehanjem/prekinitvijo zdravljenja z zdravilom Rhokiinsa, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Timolol 0.5% twice daily Difference (95% CI) Netarsudil - Timolol
Slovenian: Razlika (95-odstotni IZ) netarsudil - timolol
English: With the exception of the incidence of cornea verticillata, no other difference in safety profile was observed between races or age groups (see section 4.8).
Slovenian: Z izjemo pojavnosti cornee verticillate med skupinami različnih ras ali starostnimi skupinami niso opazili drugih razlik v varnostnem profilu (glejte poglavje 4.8).
English: The safety of netarsudil has been evaluated in clinical studies, including four well-controlled Phase 3 studies.
Slovenian: Varnost netarsudila so ocenili v kliničnih študijah, vključno s štirimi dobro nadzorovanimi študijami
English: Reactions are classified according to the convention: 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) or not known (cannot be estimated from the available data).
Slovenian: < 1/100), redki (od ≥ 1/10 000 do < 1/1 000), zelo redki (< 1/10 000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Marketing Authorisation Holder and Manufacturer Aerie Pharmaceuticals Ireland, Limited Athlone Business and Technology Park, Dublin Road,
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Aerie Pharmaceuticals Ireland, Limited Athlone Business and Technology Park, Dublin Road,
English: The most common ocular adverse reaction observed is conjunctival hyperemia which was reported in 51% of patients.
Slovenian: Najpogostejši opaženi neželeni učinek je hiperemija veznice, o kateri so poročali pri 51 % bolnikov.
English: The safety and efficacy of Rhokiinsa in children below the age of 18 years have not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila Rhokiinsa pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
English: Only use Rhokiinsa for your eyes (ocular use).
Slovenian: Zdravilo Rhokiinsa uporabljajte samo za oči (okularna uporaba).
English: • Hold the bottle, pointing down, between your thumb and fingers.
Slovenian: • Plastenko držite obrnjeno navzdol med palcem in ostalimi prsti.
English: Twice a day dosing was also associated with a higher discontinuation rate due to adverse reactions (53.8%) during a 12-month study.
Slovenian: Dvakrat dnevno odmerjanje je bilo v 12-mesečni študiji povezano tudi z večjo stopnjo prekinitve zdravljenja zaradi neželenih učinkov (53,8 %).
English: What Rhokiinsa is and what it is used for What you need to know before you use Rhokiinsa How to use Rhokiinsa
Slovenian: Kaj je zdravilo Rhokiinsa in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Rhokiinsa Kako uporabljati zdravilo Rhokiinsa
English: INFORMATION IN BRAILLE Rhokiinsa
Slovenian: PODATKI V BRAILLOVI PISAVI Rhokiinsa
English: Unopened bottles: Store in a refrigerator (2°C - 8°C).
Slovenian: Neodprte plastenke: shranjujte v hladilniku (2 °C-8 °C).
English: If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
Slovenian: Če imate po uporabi tega zdravila nenormalen občutek v očesu, vas zbada ali imate bolečine v očesu, se pogovorite z zdravnikom.
English: • Do not touch the dropper with your fingers when opening or closing the bottle.
Slovenian: • Pri odpiranju ali zapiranju plastenke se kapalne konice ne dotikajte s prsti.
English: The efficacy and safety of netarsudil in subjects with compromised corneal epithelium or co-existing ocular pathologies e.g. pseudoexfoliation and dispersion pigment syndrome has not been established.
Slovenian: Učinkovitost in varnost netarsudila pri preskušancih s prizadetim roženičnim epitelijem ali sočasnimi očesnimi patologijami, npr. psevdoeksfoliacijo in pigmentnim disperzijskim sindromom, nista bili dokazani.
English: Benzalkonium chloride, boric acid, mannitol, sodium hydroxide, water for injections.
Slovenian: Benzalkonijev klorid, borova kislina, manitol, natrijev hidroksid, voda za injekcije.
English: Intravenous administration of netarsudil mesylate to pregnant rats and rabbits during organogenesis did not produce adverse embryofetal effects at clinically relevant systemic exposures.
Slovenian: Intravensko dajanje netarsudilijevega mesilata brejim podganam in kuncem med organogenezo pri klinično pomembnih sistemskih izpostavljenostih ni povzročila neželenih embriofetalnih učinkov.
English: What Rhokiinsa is and what it is used for
Slovenian: Kaj je zdravilo Rhokiinsa in za kaj ga uporabljamo
English: Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye).
Slovenian: Benzalkonijev klorid lahko povzroči tudi draženje oči, zlasti če imate suhe oči ali težave z roženico (prosojni, sprednji del očesa).
English: Efficacy was also investigated in patients with baseline IOP ≥25 mmHg and <30 mmHg.
Slovenian: Učinkovitost so preučevali tudi pri bolnikih z izhodiščnim IOP ≥ 25 mmHg in < 30 mmHg.
English: No data on potential interactions specific to netarsudil is currently available (see section 4.5).
Slovenian: Trenutno ni na voljo podatkov o morebitnem medsebojnem delovanju, specifičnem za netarsudil (glejte poglavje 4.5).
English: Throw away the bottle 4 weeks after first opening to prevent infections and use a new bottle.
Slovenian: Da preprečite okužbe, plastenko zavrzite 4 tedne po prvem odprtju in uporabite novo.
English: - The other excipients are benzalkonium chloride (see section 2 under ‘Rhokiinsa contains benzalkonium chloride'), mannitol, boric acid, sodium hydroxide and water for injections.
Slovenian: - Druge sestavine zdravila so benzalkonijev klorid (glejte poglavje 2 „Zdravilo Rhokiinsa vsebuje benzalkonijev klorid“), manitol, borova kislina, natrijev hidroksid in voda za injekcije.
English: These studies also suggest that netarsudil lowers IOP by reducing episcleral venous pressure.
Slovenian: Te študije kažejo tudi, da netarsudil znižuje IOP z zniževanjem episkleralnega venskega tlaka.
English: Animal studies with intravenous administration do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant exposures (see section 5.3).
Slovenian: Študije na živalih pri intravenski uporabi in klinično pomembnih izpostavljenostih ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja (glejte poglavje 5.3).