FrancophonIA/ELRC3.0 huggingface dataset:
English: Carton 150 micrograms powder and solvent for solution for injection in pre-filled pen
Slovenian: PegIntron 150 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku
English: Discard the PegIntron pre-filled pen (CLEARCLICK) with any solution that is left in it after you give yourself the injection.
Slovenian: Morebitno raztopino, ki po injiciranju zdravila še ostane v PegIntron napolnjenem injekcijskem peresniku (CLEARCLICK), zavrzite.
English: PegIntron 80 micrograms powder for injection peginterferon alfa-2b
Slovenian: PegIntron 80 mikrogramov prašek za injekcijo peginterferon alfa-2b s.c.
English: EU/1/00/131/006 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/007 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)
Slovenian: EU/1/00/131/006 (1 viala praška, 1 ampula vehikla) EU/1/00/131/007 (1 viala praška, 1 ampula vehikla, 1 injekcijska brizga, 2 injekcijski igli, 1 čistilni tampon)
English: EU/1/00/131/047 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/048 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/050 (12 pens, 12 injection needles and 24 cleansing swabs)
Slovenian: EU/1/00/131/047 (1 peresnik, 1 injekcijska igla in 2 čistilna tampona) EU/1/00/131/048 (4 peresniki, 4 injekcijske igle in 8 čistilnih tamponov) EU/1/00/131/050 (12 peresnikov, 12 injekcijskih igel in 24 čistilnih tamponov)
English: The plasma half-life of PegIntron is prolonged compared with nonpegylated interferon alfa-2b.
Slovenian: V primerjavi z nepegiliranim interferonom alfa-2b je njegova razpolovna doba v plazmi daljša.
English: PegIntron 150 micrograms powder and solvent for solution for injection Each vial contains 150 micrograms of peginterferon alfa-2b measured on a protein basis.
Slovenian: PegIntron 150 mikrogramov prašek in vehikel za raztopino za injiciranje Ena viala vsebuje 150 mikrogramov peginterferona alfa-2b, merjeno na proteinski osnovi.
English: EU/1/00/131/016 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/017 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)
Slovenian: EU/1/00/131/016 (1 viala praška, 1 ampula vehikla) EU/1/00/131/017 (1 viala praška, 1 ampula vehikla, 1 injekcijska brizga, 2 injekcijski igli, 1 čistilni tampon)
English: PegIntron 150 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
Slovenian: PegIntron 150 mikrogramov prašek in vehikel za raztopino za injiciranje Eno vialo se rekonstituira z 0,7 ml vode za injekcije za dajanje do 0,5 ml raztopine.
English: PegIntron 120 micrograms powder and solvent for solution for injection Each vial contains 120 micrograms of peginterferon alfa-2b measured on a protein basis.
Slovenian: PegIntron 120 mikrogramov prašek in vehikel za raztopino za injiciranje Ena viala vsebuje 120 mikrogramov peginterferona alfa-2b, merjeno na proteinski osnovi.
English: PegIntron 80 micrograms powder and solvent for solution for injection Each vial contains 80 micrograms of peginterferon alfa-2b measured on a protein basis.
Slovenian: PegIntron 80 mikrogramov prašek in vehikel za raztopino za injiciranje Ena viala vsebuje 80 mikrogramov peginterferona alfa-2b, merjeno glede na beljakovine.
English: HCV/HIV Co-infected patients
Slovenian: Bolniki, sočasno okuženi s HCV / HIV
English: HCV/HIV co-infected patients
Slovenian: Bolniki, sočasno okuženi s HCV/HIV
English: PegIntron 120 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
Slovenian: PegIntron 120 mikrogramov prašek in vehikel za raztopino za injiciranje Eno vialo se rekonstituira z 0,7 ml vode za injekcije za dajanje do 0,5 ml raztopine.
English: EU/1/00/131/035 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/036 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/038 (12 pens, 12 injection needles and 24 cleansing swabs)
Slovenian: EU/1/00/131/035 (1 peresnik, 1 injekcijska igla in 2 čistilna tampona) EU/1/00/131/036 (4 peresniki, 4 injekcijske igle in 8 čistilnih tamponov) EU/1/00/131/038 (12 peresnikov, 12 injekcijskih igel in 24 čistilnih tamponov)
English: PegIntron 120 micrograms powder for injection peginterferon alfa-2b
Slovenian: PegIntron 120 mikrogramov prašek za injekcijo peginterferon alfa-2b s.c.
English: Pen label - PegIntron 80 micrograms powder and solvent for solution for injection in pre-filled pen
Slovenian: Nalepka na peresniku - PegIntron 80 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku
English: EU/1/00/131/043 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/044 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/046 (12 pens, 12 injection needles and 24 cleansing swabs)
Slovenian: EU/1/00/131/043 (1 peresnik, 1 injekcijska igla in 2 čistilna tampona) EU/1/00/131/044 (4 peresniki, 4 injekcijske igle in 8 čistilnih tamponov) EU/1/00/131/046 (12 peresnikov, 12 injekcijskih igel in 24 čistilnih tamponov)
English: EU/1/00/131/021 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/022 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)
Slovenian: EU/1/00/131/021 (1 viala praška, 1 ampula vehikla) EU/1/00/131/022 (1 viala praška, 1 ampula vehikla, 1 injekcijska brizga, 2 injekcijski igli, 1 čistilni tampon)
English: nd dose reduction of PegIntron is to 0.5 µg/kg/week.
Slovenian: Če je potrebno, lahko še drugič zmanjšate odmerek zdravila PegIntron, in sicer na 0,5 µg/kg/teden.
English: EU/1/00/131/039 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/040 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/042 (12 pens, 12 injection needles and 24 cleansing swabs)
Slovenian: EU/1/00/131/039 (1 peresnik, 1 injekcijska igla in 2 čistilna tampona) EU/1/00/131/040 (4 peresniki, 4 injekcijske igle in 8 čistilnih tamponov) EU/1/00/131/042 (12 peresnikov, 12 injekcijskih igel in 24 čistilnih tamponov)
English: PegIntron 50 micrograms powder for injection peginterferon alfa-2b
Slovenian: PegIntron 50 mikrogramov prašek za injekcijo peginterferon alfa-2b s.c.
English: PegIntron 100 micrograms powder and solvent for solution for injection Each vial contains 100 micrograms of peginterferon alfa-2b measured on a protein basis.
Slovenian: PegIntron 100 mikrogramov prašek in vehikel za raztopino za injiciranje Ena viala vsebuje 100 mikrogramov peginterferona alfa-2b, merjeno na proteinski osnovi.
English: Pen label - PegIntron 100 micrograms powder and solvent for solution for injection in pre-filled pen
Slovenian: Nalepka na peresniku - PegIntron 100 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku
English: EU/1/00/131/001 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/002 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)
Slovenian: EU/1/00/131/001 (1 viala praška, 1 ampula vehikla) EU/1/00/131/002 (1 viala praška, 1 ampula vehikla, 1 injekcijska brizga, 2 injekcijski igli, 1 čistilni tampon)
English: PegIntron 150 micrograms powder for injection peginterferon alfa-2b
Slovenian: PegIntron 150 mikrogramov prašek za injekcijo peginterferon alfa-2b s.c.
English: PegIntron 100 micrograms powder for injection peginterferon alfa-2b
Slovenian: PegIntron 100 mikrogramov prašek za injekcijo peginterferon alfa-2b s.c.
English: PegIntron 150 micrograms powder and solvent for solution for injection Each vial contains 150 micrograms of peginterferon alfa-2b as measured on a protein basis.
Slovenian: PegIntron 150 mikrogramov prašek in vehikel za raztopino za injiciranje Ena viala vsebuje 150 mikrogramov peginterferona alfa-2b, merjeno glede na beljakovine.
English: PegIntron 50 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
Slovenian: PegIntron 50 mikrogramov prašek in vehikel za raztopino za injiciranje Eno vialo se rekonstituira z 0,7 ml vode za injekcije za dajanje do 0,5 ml raztopine.
English: PegIntron 50 micrograms powder and solvent for solution for injection Each vial contains 50 micrograms of peginterferon alfa-2b measured on a protein basis.
Slovenian: PegIntron 50 mikrogramov prašek in vehikel za raztopino za injiciranje Ena viala vsebuje 50 mikrogramov peginterferona alfa-2b, merjeno glede na beljakovine.
English: PegIntron 100 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
Slovenian: PegIntron 100 mikrogramov prašek in vehikel za raztopino za injiciranje Eno vialo se rekonstituira z 0,7 ml vode za injekcije za dajanje do 0,5 ml raztopine.
English: st dose reduction of PegIntron is to 1 µg/kg/week.
Slovenian: Opomba 2: Pri odraslih bolnikih je prvo zmanjšanje odmerka zdravila PegIntron na 1 µg/kg/teden.
English: - Break off the top of the ampoule of solvent.
Slovenian: - Odlomite vrh ampule z vehiklom.
English: EU/1/00/131/031 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/032 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/034 (12 pens, 12 injection needles and 24 cleansing swabs)
Slovenian: EU/1/00/131/031 (1 peresnik, 1 injekcijska igla in 2 čistilna tampona) EU/1/00/131/032 (4 peresniki, 4 injekcijske igle in 8 čistilnih tamponov) EU/1/00/131/034 (12 peresnikov, 12 injekcijskih igel in 24 čistilnih tamponov)
English: PegIntron 120 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
Slovenian: PegIntron 120 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku peginterferon alfa-2b
English: PegIntron 80 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
Slovenian: PegIntron 80 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku peginterferon alfa-2b
English: PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
Slovenian: PegIntron 50 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku peginterferon alfa-2b
English: PegIntron 150 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
Slovenian: PegIntron 150 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku peginterferon alfa-2b
English: Common side effects (may affect up to 1 in 10 people): - fungal infection, common cold, cold sores, pharyngitis (sore throat), sinusitis, ear infection, coughing, throat pain, feeling cold, eye pain, - decrease in blood clotting cells called platelets, that may result in easy bruising and spontaneous bleeding, swollen glands (swollen lymph nodes), blood thyroid tests abnormalities, decrease in thyroid gland activity, which may make you feel tired, depressed, increase your sensitivity to cold and other symptoms, - wanting or attempting to harm yourself aggressive behaviour, agitation, anger, mood changes, nervousness or restlessness, depression, feeling anxious, trouble falling asleep or staying asleep, emotional instability, poor quality sleep, feeling sleepy, disturbance in attention.
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): - glivične okužbe, navaden prehlad, herpesni izpuščaji, faringitis (vnetje grla), sinusitis, okužba ušes, kašelj, bolečine v grlu, občutek mrazenja, očesne bolečine, - zmanjšanje števila celic za strjevanje krvi, ki jim pravimo trombociti, kar lahko vodi do nagnjenosti k nastanku podplutb in spontanih krvavitev, otekle žleze (otekle bezgavke), nenormalni izvidi krvnih preiskav delovanja žleze ščitnice, zmanjšanje delovanja žleze ščitnice, ki lahko povzroči utrujenost, depresijo, povečanje občutljivosti na mraz in druge simptome,
English: PegIntron 150 micrograms powder and solvent for injection peginterferon alfa-2b
Slovenian: PegIntron 150 mikrogramov prašek in vehikel za raztopino za injiciranje peginterferon alfa-2b
English: PegIntron 100 micrograms powder and solvent for injection peginterferon alfa-2b
Slovenian: PegIntron 100 mikrogramov prašek in vehikel za raztopino za injiciranje peginterferon alfa-2b
English: PegIntron 50 micrograms powder and solvent for injection peginterferon alfa-2b
Slovenian: PegIntron 50 mikrogramov prašek in vehikel za raztopino za injiciranje peginterferon alfa-2b
English: Please refer to the ribavirin SmPC for capsules or oral solution when PegIntron is to be used in combination with ribavirin.
Slovenian: Če bo bolnik zdravilo PegIntron uporabljal sočasno z ribavirinom, prosimo, glejte SmPC za ribavirin trde kapsule ali peroralno raztopino.
English: PegIntron 80 micrograms powder and solvent for injection peginterferon alfa-2b
Slovenian: PegIntron 80 mikrogramov prašek in vehikel za raztopino za injiciranje peginterferon alfa-2b
English: PegIntron 100 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
Slovenian: PegIntron 100 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku peginterferon alfa-2b
English: PegIntron 120 micrograms powder and solvent for injection peginterferon alfa-2b
Slovenian: PegIntron 120 mikrogramov prašek in vehikel za raztopino za injiciranje peginterferon alfa-2b
English: EU/1/00/131/015 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/028 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Slovenian: EU/1/00/131/028 (12 vial praška, 12 ampul vehikla, 12 injekcijskih brizg, 24 injekcijskih igel, 12 čistilnih tamponov)
English: EU/1/00/131/025 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/030 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Slovenian: EU/1/00/131/030 (12 vial praška, 12 ampul vehikla, 12 injekcijskih brizg, 24 injekcijskih igel, 12 čistilnih tamponov)
English: EU/1/00/131/010 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/027 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Slovenian: EU/1/00/131/027 (12 vial praška, 12 ampul vehikla, 12 injekcijskih brizg, 24 injekcijskih igel, 12 čistilnih tamponov)
English: EU/1/00/131/023 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/024 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
Slovenian: EU/1/00/131/024 (4 viale praška, 4 ampule vehikla, 4 injekcijske brizge, 8 injekcijskih igel, 4 čistilni tamponi)
English: EU/1/00/131/020 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/029 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Slovenian: EU/1/00/131/029 (12 vial praška, 12 ampul vehikla, 12 injekcijskih brizg, 24 injekcijskih igel, 12 čistilnih tamponov)
English: Dose reduction of PegIntron in children and adolescents is accomplished by modifying the recommended dose in a two-step process from the original starting dose of 60 g/m 2/week, to 40 g/m 2/week, then to 20 g/m 2/week, if needed.
Slovenian: Pri otrocih in mladostnikih je prvo zmanjšanje odmerka zdravila PegIntron na 40 µg/m2/teden in drugo zmanjšanje odmerka zdravila PegIntron na 20 µg/m2/teden.
English: Both active substances have been available in the European Union (EU) as separate preparations for a number of years.
Slovenian: Obe zdravilni učinkovini sta v Evropski uniji (EU) v obliki ločenih pripravkov na voljo že vrsto let.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Omidria on 28 July 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Omidria, veljavno po vsej Evropski uniji, izdala 28. julija 2015.
English: Other information about Omidria
Slovenian: Druge informacije o zdravilu Omidria
English: What measures are being taken to ensure the safe and effective use of Omidria?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Omidria?
English: The full EPAR and risk management plan summary for Omidria can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Omidria sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Omidria.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Omidria.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Omidria are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Omidria večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Ketorolac is a non-steroidal anti-inflammatory drug (NSAID).
Slovenian: Ketorolak je nesteroidno protivnetno zdravilo (NSAID).
English: With regard to the safety of Omidria, the medicine was generally well tolerated.
Slovenian: Z vidika varnosti zdravila Omidria so ga bolniki na splošno dobro prenašali.
English: What benefits of Omidria have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Omidria izkazalo v študijah?
English: Although the effect of Omidria on pain was modest, it was considered clinically important.
Slovenian: Čeprav je bil učinek zdravila Omidria na bolečino zmeren, je bil klinično pomemben.
English: A risk management plan has been developed to ensure that Omidria is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Omidria je bil pripravljen načrt obvladovanja tveganj.
English: Phenylephrine is a ‘selective alpha-1 adrenergic receptor agonist', which attaches to and activates alpha-1 adrenergic receptors that are found on smooth muscle cells, causing these muscles to contract.
Slovenian: Fenilefrin je „selektivni agonist alfa-1-adrenergičnih receptorjev“, ki se veže na alfa-1-adrenergične receptorje v celicah gladkih mišic in jih aktivira, kar povzroči skrčenje mišic.
English: What is Omidria and what is it used for?
Slovenian: Kaj je zdravilo Omidria in za kaj se uporablja?
English: The most common side effects with Omidria (which may affect up to 1 in 10 people) are eye pain, anterior chamber inflammation (inflammation of the fluid-filled space inside the eye between the iris and the cornea), conjunctival hyperaemia (redness of the membrane that lies over the white part of the eye), photophobia (increased sensitivity of the eyes to light), corneal oedema (swelling of the transparent layer in front of the eye that covers the pupil and iris) and inflammation.
Slovenian: Najpogostejši neželeni učinki zdravila Omidria (ki lahko prizadenejo največ 1 osebo od 10) bolečina v očesu, vnetje sprednjega očesnega prekata (vnetje s tekočino napolnjenega prostora v očesu med šarenico in roženico), hiperemija očesne veznice (pordelost membrane, ki prekriva beločnico), fotofobija (povečana občutljivost očesa za svetlobo), edem roženice (otekanje prozorne plasti sprednjega dela očesa, ki prekriva zenico in šarenico) in vnetje.
English: It works by blocking certain enzymes called cyclo-oxygenases, which produce prostaglandins, substances that are involved in pain and inflammation processes.
Slovenian: Deluje tako, da zavira encime, imenovane ciklooksigenaze, ki proizvajajo prostaglandine, tj. snovi, ki sodelujejo pri bolečini in vnetnih procesih.
English: What are the risks associated with Omidria?
Slovenian: Kakšna tveganja so povezana z zdravilom Omidria?
English: For more information about treatment with Omidria, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Omidria preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: This is a type of surgery in which a new lens is implanted into the eye.
Slovenian: To je vrsta kirurškega posega, pri katerem se v oko vsadi nova leča.
English: In both studies, the main measures of effectiveness were the change in diameter of the pupil by the end of the surgery, and how much eye pain patients felt soon after surgery, as indicated by the patient using a standard pain scale from 1 to 100.
Slovenian: V obeh študijah sta bili glavni merili učinkovitosti sprememba premera zenice na koncu kirurškega posega in bolečina, ki so jo bolniki občutili takoj po kirurškem posegu in se je merila s standardno bolečinsko lestvico z rezultatom od 1 do 100.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Omidria, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: For practical information about using Omidria, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Omidria naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The recommended dose is 4 ml of Omidria diluted in 500 ml of irrigation solution, to be used during the surgery to replace the lens.
Slovenian: Priporočeni odmerek je 4 ml zdravila Omidria, razredčenega v 500 ml raztopine za izpiranje, ki se uporablja med kirurškim posegom za zamenjavo leče.
English: For the full list of all side effects reported with Omidria, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Omidria, glejte navodilo za uporabo.
English: It is not intended to provide practical advice on how to use Omidria.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The incidence of side effects with Omidria was similar to that reported in patients receiving placebo.
Slovenian: Pogostnost neželenih učinkov zdravila Omidria je bila podobna pogostnosti, o kateri so poročali pri bolnikih, ki so prejemali placebo.
English: Both studies showed that the pupil remained dilated during surgery in patients given Omidria (+0.1 mm), while it contracted in those given placebo (-0.5 mm).
Slovenian: V obeh študijah so pokazali, da je zenica med kirurškim posegom z zdravilom Omidria ostala razširjena (+0,1 mm), medtem ko se je pri placebu zožila (-0,5 mm).
English: It can only be obtained with a prescription and must be given by a qualified ophthalmological surgeon (eye surgery specialist) experienced in lens replacement.
Slovenian: Izdaja zdravila je le na recept, uporabljati pa ga mora usposobljeni oftalmološki kirurg (specialist za očesne kirurške posege) z izkušnjami z zamenjavo leče.
English: Omidria must not be used in patients who have narrow-angle glaucoma, a serious condition of the eye in which the pressure inside the eye rises rapidly because fluid cannot drain out.
Slovenian: Zdravilo Omidria se ne sme uporabljati pri bolnikih z glavkomom z zaprtim zakotjem, kar je resno očesno stanje, pri katerem se tlak v očesu hitro poviša zaradi nezmožnosti odtekanja tekočine.
English: This makes lens replacement surgery easier.
Slovenian: To olajša kirurški poseg za zamenjavo leče.
English: Why is Omidria approved?
Slovenian: Zakaj je bilo zdravilo Omidria odobreno?