FrancophonIA/ELRC3.0 huggingface dataset:
English: In its letter notifying the Agency of the withdrawal of application, the company stated that its decision was based on the CHMP's consideration that uncertainties remain due to the limited number of patients included in the main study, despite the data provided for Keytruda in the applied use.
Croatian: U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva tvrtka je navela da se odluka o povlačenju temelji na stajalištu CHMP-a da i dalje postoje nesigurnosti zbog ograničenog broja bolesnika uključenih u glavno ispitivanje, unatoč dostavljenim podatcima o primjeni lijeka Keytruda.
English: What is happening with Keytruda in its authorised uses?
Croatian: Što se događa s lijekom Keytruda kada je riječ o odobrenim primjenama?
English: What was Keytruda expected to be used for?
Croatian: Za što se lijek Keytruda trebao koristiti?
English: Keytruda was also expected to be used in combination with the chemotherapy medicines pemetrexed and carboplatin in NSCLC patients with metastatic ‘non-squamous' NSCLC, irrespective of whether their tumour produced the PD-L1 protein.
Croatian: Lijek Keytruda trebao se primjenjivati i u kombinaciji s kemoterapijskim lijekovima pemetreksedom i karboplatinom u bolesnika s metastatskim neskvamoznim NSCLC-om, neovisno o tome je li njihov tumor proizveo protein PD-L1.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Keytruda could not have been approved for the treatment of metastatic non-squamous NSCLC in combination with pemetrexed and carboplatin.
Croatian: Na temelju pregleda podataka i odgovora tvrtke na popise pitanja CHMP-a, u trenutku povlačenja CHMP je smatrao da postoje razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za liječenje metastatskog neskvamoznog NSCLC-a lijekom Keytruda u kombinaciji s pemetreksedom i karboplatinom.
English: Keytruda is a cancer medicine already authorised for use on its own to treat NSCLC.
Croatian: Keytruda je lijek za liječenje raka koji je već odobren za primjenu kao monoterapija za liječenje NSCLC-a.
English: The active substance in Keytruda, pembrolizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and block a receptor called PD-1.
Croatian: Djelatna tvar u lijeku Keytruda, pembrolizumab, monoklonsko je protutijelo (vrsta proteina) koje prepoznaje i inhibira djelovanje receptora PD-1.
English: How does Keytruda work?
Croatian: Kako djeluje lijek Keytruda?
English: Strength Pharmaceutical Form Route of Administration
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik
English: -- 1 Inactivated West Nile virus, strain VM-2: RP* 1.0-2.2/ml.
Croatian: -- 1 Inaktivirani virus zapadnog Nila, soj VM-2 RP* 1,0 - 2,2 *Relativna potentnost dobivena in vitro metodom u usporedbi s referentnim cjepivom koje se pokazalo učinkovitim kod konja.
English: Unopened: 3 years
Croatian: Neotvoren: 3 godine
English: Therefore, no interaction is expected.
Croatian: Stoga se ne očekuju interakcije.
English: Your doctor will know about this.
Croatian: Vaš liječnik je upoznat s time.
English: This leaflet was last revised in <date of Commission Decision>
Croatian: Ova uputa je zadnji puta revidirana u <datum odluke Komisije>
English: Component of a multipack, cannot be sold separately.
Croatian: Komponenta višestrukog pakiranja, ne može se prodavati zasebno.
English: Water for injection
Croatian: Voda za injekcije
English: See section 4.8 for further details regarding possible visual disturbances.
Croatian: Vidjeti dio 4.8. za više podataka u vezi s mogućim poremećajima vida.
English: No dose adjustment is required.
Croatian: Nisu potrebna prilagodba doze.
English: A significant reduction in ocular pain during the initial 10-12 hours postoperatively was also demonstrated.
Croatian: Pokazano je također značajno smanjenje boli u oku tijekom prvih 10-12 sati nakon operacije.
English: The following instructions must be adhered to:
Croatian: Potrebno je pridržavati se sljedećih uputa:
English: After dilution, chemical and physical in-use stability has been demonstrated for 6 hours at 25 ˚C.
Croatian: Nakon razrjeđivanja, utvrđena je kemijska i fizička stabilnost za primjenu tijekom 6 sati pri 25˚C.
English: Omidria should not be used in children and adolescents below the age of 18 as it has not been studied in these groups.
Croatian: Omidria se ne smije koristiti u djece i adolescenata mlađih od 18 godina budući da nije ispitana u ovim skupinama.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 July 2015
Croatian: Datum prvog odobrenja: 28. srpnja 2015.
English: Analysis Set (n)
Croatian: Analitički set (n)
English: The safety and efficacy of Omidria in children below the age of 18 years has not been established.
Croatian: Sigurnost i djelotvornost lijeka Omidria u djece mlađe od 18 godina nije ustanovljena.
English: Do not use if the solution is cloudy, or if it contains particles.
Croatian: Ne koristiti ako je otopina zamućena ili ako sadrži čestice.
English: Other medicines and Omidria
Croatian: Drugi lijekovi i Omidria
English: From a microbiological point of view, the medicinal product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek se mora odmah primijeniti.
English: If you are able to become pregnant, you should be using suitable contraception before you are given Omidria.
Croatian: Ako možete zatrudniti, trebate koristiti odgovarajuću kontracepciju prije nego što primite lijek Omidria.
English: Anticipated systemic exposure is minimal and transient, however, caution should be used in treating patients with poorly controlled hypertension.
Croatian: Očekivano sistemsko izlaganje je minimalno i prolazno, no potreban je oprez pri liječenju bolesnika sa slabo kontroliranom hipertenzijom.
English: The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalost nuspojava definirana je kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: If your eye surgery will involve general anaesthesia, talk to your doctor about this.
Croatian: Ako će Vaš kirurški zahvat oka uključivati opću anesteziju, razgovarajte o ovome s Vašim liječnikom.
English: Prevention of miosis was confirmed in a categorical analysis.
Croatian: Prevencija mioze potvrđena je kategorijskom analizom.
English: Patients were randomised to either Omidria or placebo (1:1).
Croatian: Bolesnici su randomizirani za lijek Omidria ili placebo (1:1).
English: Pharmacotherapeutic group: {Not yet assigned}, ATC code: {Not yet assigned}
Croatian: Farmakoterapijska skupina: {Nije još dodijeljena}, ATK oznaka: {Nije još dodijeljena}
English: The risk of blood pressure elevations may be increased in patients requiring prolonged surgery.
Croatian: Rizik od povišenja krvnoga tlaka može biti povećan u bolesnika koji zahtijevaju produljeni kirurški zahvat.
English: Your doctor will monitor you for any signs or symptoms of side effects and will treat them if necessary.
Croatian: Vaš će Vas liječnik pratiti kako bi uočio sve znakove ili simptome nuspojava, te će ih liječiti ako to bude potrebno.
English: These episodes, some fatal, have usually occurred in patients with pre-existing cardiovascular diseases.
Croatian: Ove epizode, od kojih su pojedine smrtonosne, obično su nastupile u bolesnika s već postojećim kardiovaskularnim bolestima.
English: The population in the trials was 26 to 90 years of age (59% female, 41% male; 80% white, 12% black and 8% other race).
Croatian: Ispitivanjima je obuhvaćena populacija u dobi od 26 do 90 godina (59% žena, 41% muškaraca; 80% bijelaca, 12% crnaca i 8% drugih rasa).
English: Fifty-three percent of patients had brown irides, 28% had blue irides, and 19% had irides of other colours.
Croatian: 53% bolesnika imalo je smeđe šarenice, 28% je imalo plave, a 19% je imalo šarenice druge boje.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: PRILOG II. A. PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: OTHER SPECIAL WARNING(S), IF NECESSARY Use immediately after dilution.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Upotrijebiti odmah nakon razrjeđivanja.
English: Study 1 Analysis Set (n)
Croatian: Ispitivanje 1 Analitički set (n)
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Slijedom navedenog, nositelj odobrenja će ta izvješća podnositi u skladu s popisom referentnih datuma EU (EURD popis) predviđenim člankom 107 (c) stavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: What Omidria looks like and contents of the pack
Croatian: Kako Omidria izgleda i sadržaj pakiranja
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Croatian: SADRŽAJ PO TEŽINI, VOLUENU ILI DOZNOJ JEDINICI LIJEKA
English: Each of these same findings was reported at a similar frequency in patients receiving placebo.
Croatian: Svaki od ovih istih nalaza prijavljen je sa sličnom učestalošću u bolesnika koji su primali placebo.
English: Once opened the product should be diluted immediately.
Croatian: Nakon što se otvori lijek treba odmah razrijediti.
English: Ketorolac plasma concentrations were detected in 11 of 14 patients.
Croatian: Koncentracije ketorolaka u plazmi uočene su u 11 od 14 bolesnika.
English: Omidria must not be used:
Croatian: Omidria se ne smije primijeniti:
English: What Omidria is and what it is used for
Croatian: Što je Omidria i za što se koristi
English: Your doctor will decide if Omidria is suitable for you.
Croatian: Vaš će liječnik odlučiti je li primjena lijeka Omidria primjerena za vas.
English: The safety profile of Omidria is based on data from 459 adult patients collected during clinical development obtained in randomised controlled trials.
Croatian: Sigurnosni profil lijeka Omidria temelji se na podacima prikupljenima od 459 odraslih bolesnika tijekom kliničkog razvoja u randomiziranim kontroliranim ispitivanjima.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Omidria in one or more subsets of the paediatric population in lens therapeutic procedures (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka Omidria u jednoj ili više podskupina pedijatrijske populacije u terapijskim postupcima za leće (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The elderly population has been studied in clinical studies.
Croatian: Starija populacija ispitivana je u kliničkim ispitivanjima.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u .
English: For any information about this medicine, please contact the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom lijeku obratite se nositelju odobrenja za stavljanje gotovog lijeka u promet:
English: Hyperthyroidism and unstable cardiovascular disease should be addressed prior to surgery.
Croatian: Hipertireoza i nestabilna kardiovaskularna bolest trebaju se liječiti prije kirurškog zahvata.
English: Side effects listed below are typically mild to moderate in intensity and usually resolve on their own without any long-term effects.
Croatian: Niže navedene nuspojave u pravilu su blage do umjerene u intenzitetu i obično nestaju same od sebe bez dugotrajnih učinaka.
English: Non-clinical data reported in the literature for the individual components in Omidria revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenic potential, or toxicity to reproduction and development.
Croatian: Neklinički podaci prijavljeni u literaturi za pojedinačne komponente lijeka Omidria ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti, reproduktivne i razvojne toksičnosti.
English: As your vision may be affected, you should not drive or use machines until your vision has cleared.
Croatian: Budući da lijek može utjecati na Vaš vid, ne smijete upravljati vozilima ili raditi sa strojevima sve dok Vam se vid ne razbistri.
English: Postoperative pain was evaluated by a self-administered 0-100 mm visual analogue scale (VAS).
Croatian: Postoperativna bol je bila ocjenjena samoprimjenjenom vizualnom analognom skalom (VAS) od 0-100 mm.
English: Therefore, use Omidria with caution in individuals who have previously exhibited sensitivities to these active substances.
Croatian: Stoga, lijek Omidria treba primjenjivati pažljivo u pojedinaca koji su prethodno bili preosjetljivi na ove djelatne tvari.
English: 4.7 Effects on ability to drive and use machines Omidria can have a major influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Omidria može značajno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Endothelial cell counts were not conducted during the clinical studies.
Croatian: Nije provedeno brojanje endotelnih stanica tijekom kliničkih ispitivanja.
English: For dilution instructions, see section 6.6.
Croatian: Za uputu o razrjeđivanju vidjeti dio 6.6.
English: Uncommon side effects: - nausea - pain - headache
Croatian: Manje česte nuspojave: - mučnina - bol - glavobolja
English: Do not store above 25 ˚C.
Croatian: Ne čuvati na temperaturi iznad 25 ˚C.
English: The most frequently reported adverse reactions were, eye pain (4.8%), anterior chamber inflammation (3.9%), conjunctival hyperaemia (2.2%), photophobia (1.7%), corneal oedema (1.3%) and inflammation (1.3%).
Croatian: Najčešće prijavljene nuspojave bile su bol u oku (4,8%), upala prednje komore (3,9%), konjuktivalna hiperemija (2,2%), fotofobija (1,7%), edem rožnice (1,3%) i upala (1,3%).
English: As vision may be temporarily affected following intraocular lens replacement in patients who receive Omidria, patients should be advised not to drive or use machines until vision is clear.
Croatian: Budući da vid može biti privremeno narušen nakon zamjene intraokularne leće u bolesnika koji primaju lijek Omidria, bolesnicima treba savjetovati da ne upravljaju vozilima i ne rade sa strojevima dok im se vid ne razbistri.
English: Tel: +353 (1) 526 6789 Fax: +353 (1) 526 6888 eMail: regulatory@omeros.ie
Croatian: Tel: +353 (1) 526 6789 Faks: +353 (1) 526 6888 E-mail: regulatory@omeros.ie
English: Histologic examination in non-clinical toxicology studies demonstrated no treatment-related effects on the cornea and, in clinical trials with Omidria, no detrimental effects were observed on best-corrected visual acuity (BCVA).
Croatian: Histološka pretraga u nekliničkim toksikološkim ispitivanjima nije pokazala učinke na rožnicu povezane s liječenjem i, u kliničkim ispitivanjima s lijekom Omidria, nisu uočeni štetni učinci na najbolju korigiranu oštrinu vida (eng. best-corrected visual acuity, BVCA).
English: Talk to your doctor or nurse before Omidria is used if you: - have heart disease - have raised blood pressure - have overactive thyroid glands (hyperthyroidism) - are allergic to acetylsalicylic acid or other painkillers called non-steroidal anti-inflammatory drugs (NSAIDs) - have asthma.
Croatian: Obratite se svom liječnikom ili medicinskoj sestri prije primjene lijeka Omidria ako: - imate bolest srca - imate povišeni krvni tlak - imate prekomjerno aktivnu štitnjaču (hipertireoza) - ste alergični na acetilsalicilatnu kiselinu ili druge lijekove za ublažavanje boli zvane nesteroidni prouupalni lijekovi (NSAIL-i) - imate astmu.
English: The efficacy and safety of Omidria was evaluated in two Phase 3, randomised, multicentre, doublemasked, placebo-controlled clinical trials in 808 adult patients undergoing intraocular lens replacement.
Croatian: Djelotvornost i sigurnost lijeka Omidria ocijenjeni su u dva randomizirana, multicentrična, dvostruko maskirana, placebom kontrolirana klinička ispitivanja Faze 3 provedena u 808 odraslih bolesnika podvrgnutih zamjeni intraokularne leće.
English: This product must be diluted before intraocular use.
Croatian: Ovaj lijek se mora razrijediti prije intraokularne primjene.
English: Omidria is a medicine used during surgery on the eye.
Croatian: Omidria je lijek koji se koristi tijekom kirurškog zahvata na oku.
English: Patients with narrow-angle glaucoma.
Croatian: Bolesnici s glaukomom uskog kuta.
English: It may also cause headache, anxiety, nausea, vomiting, and abnormal rapid heart rhythm.
Croatian: Može uzrokovati i glavobolju, tjeskobu, mučninu, povraćanje i abnormalno brzi srčani ritam.
English: − No other medicinal products should be added to the prepared irrigation solution.
Croatian: Drugi lijekovi ne smiju se dodavati u pripremljenu otopinu irigata.
English: If you are given more Omidria than you should have been Phenylephrine, one of the active substances of Omidria, may cause a rapid rise in blood pressure if too much is given and enough passes into the blood to affect other parts of the body.
Croatian: Ako primite više lijeka Omidria nego što ste trebali Fenilefrin, jedna od djelatnih tvari lijeka Omidria, može uzrokovati brzo povećanje krvnoga tlaka ako se primijeni prevelika količina, te dovoljno uđe u krv za učinak u drugim dijelovima tijela.
English: Ketorolac is an NSAID that inhibits both cyclooxygenase enzymes (COX1 and COX2), reducing pain and inflammation by decreasing tissue concentrations of prostaglandins resulting from surgical trauma.
Croatian: Ketorolak je NSAIL koji inhibira oba enzima ciklooksigenaza (COX1 i COX2), smanjujući bol i upalu tako što snižava koncentracije prostaglandina u tkivu nastale kirurškom traumom.
English: Clear, colourless to slightly yellow, solution with a pH: 6.3 ±0.3.
Croatian: Bistra, bezbojna do blago žućkasta otopina sa pH: 6,3 ± 0,3.
English: Adverse reactions reported in patients receiving Omidria were typical postoperative findings and most were mild to moderate in intensity and resolved without intervention or any residual effects.
Croatian: Nuspojave prijavljene u bolesnika koji primaju lijek Omidria su bili obično postoperativni nalazi, te je većina bila blagog do umjerenog intenziteta i povukle su se bez intervencije ili ikakvoga rezidualnog učinka.
English: Fax: +353 (1) 526 6888
Croatian: Faks: +353 (1) 526 6888
English: The maximum ketorolac concentration seen was 4.2 ng/mL.
Croatian: Maksimalna uočena koncentracija ketorolaka iznosila je 4,2 ng/mL.
English: There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other non-steroidal anti-inflammatory drugs (NSAIDs).
Croatian: Prisutna je mogućnost ukrižene osjetljivosti na acetilsalicilatnu kiselinu, derivate fenilacetatne kiseline i druge nestereoidne protuupalne lijekove (NSAIL-ove).
English: − The bag should be gently inverted in order to mix the solution.
Croatian: Vrećicu treba pažljivo okrenuti kako bi se otopina izmiješala.
English: Omidria is used in adults to rinse the eye during surgery to implant a new lens (part of the eye that focuses light passing through the pupil to allow you to see clearly).
Croatian: Omidria se koristi u odraslih osoba za ispiranje oka tijekom kirurškog zahvata ugradnje nove leće (dijela oka koji fokusira svijetlo koje prolazi kroz zjenicu kako bi se omogućila jasnija slika).
English: Sodium citrate dihydrate
Croatian: Natrijev citrat dihidrat
English: All patients were treated with standardised preoperative topical mydriatic and anaesthetic agents.
Croatian: Svi su bolesnici liječeni standardiziranim preoperativnim topikalnim midriatičkim i anesteziološkim lijekovima.
English: The magnitude of the mydriatic effect of Omidria may be altered in patients who concurrently receive medicinal products that can affect pupil size, such as opioids (miotics) or non-sedating antihistamines (mydriatics).
Croatian: Razmjer midrijatičkog učinka lijeka Omidria može se promijeniti u bolesnika koji istovremeno primaju lijekove koji utječu na veličinu zjenice, poput opioida (miotika) ili nesedatirajućih antihistaminika (midrijatika).
English: The diluted solution is to be used within 6 hours after dilution.
Croatian: Razrijeđena otopina se koristi unutar 6 sati nakon razrjeđivanja.
English: If any of the above applies to you, please inform your doctor.
Croatian: Ako se bilo što prethodno navedenog odnosi na Vas, molimo o istom obavijestite liječnika.
English: Phenylephrine may potentiate the cardiovascular depressant effects of some inhalation anesthetic medicinal products.
Croatian: Fenilefrin može potencirati depresivne učinke na kardiovaskularni sustav pojedinih inhalacijskih anestezioloških lijekova.
English: Side effects affecting the eye:
Croatian: Nuspojave koje zahvaćaju oko:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1018/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1018/001
English: The medicine is used to keep the pupil dilated (widened) during surgery and to reduce eye pain after the procedure.
Croatian: Lijek se koristi za održavanje zjenice dilatiranom (proširenom) tijekom kirurškog zahvata i za smanjivanje boli u oku nakon zahvata.
English: Mydriasis was maintained in the Omidria -treated groups, while the placebo-treated groups experienced progressive constriction of the pupil (see figure).
Croatian: Midrijaza je održana u skupinama koje su liječene lijekom Omidria, dok su grupe koje su primale placebo imale progresivnu konstrikciju zjenice (vidjeti sliku).
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for intraocular irrigation Multipack: 10 (1 pack of 10) vials
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za irigat za oko Višestruko pakiranje: 10 (1 pakiranje od 10) bočica
English: - One of the active substances in Omidria can react with several types of anaesthetics.
Croatian: - Jedna od djelatnih tvari lijeka Omidria može stupiti u interkaciju s nekoliko vrsta anestetika.
English: Omidria has not been evaluated in the the absence of standard preoperative mydriatic and anesthetic agents.
Croatian: Omidria nije ocijenjena u odsutnosti standardnih preoperativnih midrijatičkih i anestezijskih lijekova.
English: Systemic overdose of phenylephrine may cause a rapid rise in blood pressure.
Croatian: Sistemsko predoziranje fenilefrinom može uzrokovati brzo povišenje krvnoga tlaka.
English: Significant elevations in blood pressure have been reported following instillation of topical ocular phenylephrine.
Croatian: Značajna povišenja krvnog tlaka prijavljena su nakon ukapavanja topikalnog okularnog fenilefrina.
English: What Omidria is and what it is used for What you need to know before Omidria is used How Omidria is used
Croatian: Što je Omidria i za što se koristi Što morate znati prije nego počnete primjenjivati lijek Omidria