natgillin/translations-raw huggingface dataset:
Jetrea works by separating the vitreous humour from the macula, and helping to close the macular hole if one is present, which may decrease the symptoms caused by VMT.
Zdravilo Jetrea deluje tako, da loči steklovino od makule in pomaga zapreti odprtino v makuli, če je ta prisotna.
• Patient information leaflet
• informativnim paketom za bolnike.
In this study, FTMH was present at baseline in 50/145 (34.5%) and 26/73 (35.6%) patients in the JETREA and sham groups, respectively.
V tej študiji je bil foramen makule, ki je segal čez vse plasti mrežnice (FTMH), navzoč ob izhodišču pri 50/145 (34,5 %) bolnikov, zdravljenih z zdravilom JETREA, in pri 26/73 (35,6 %) bolnikov z navideznim zdravljenjem.
If you get any side effects, talk to your doctor/ophthalmologist.
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom/oftalmologom.
In the integrated data, the VMA resolution rate at Day 28 was higher in patients treated with JETREA compared to placebo in both the subgroup with VMA ≤ 1500 microns at baseline (34.7% vs. 14.6%, p<0.001) and with VMA > 1500 microns at baseline (5.9% vs. 0%, p=0.113).
V integriranih podatkih je bil odstotek odprav VMA na 28. dan višji pri bolnikih, zdravljenih z zdravilom JETREA, v primerjavi s placebom v obeh podskupinah, z VMA ≤ 1500 mikronov v izhodišču (34,7 % v primerjavi s 14,6 %, p <0,001) in z VMA > 1500 mikronov v izhodišču (5,9 % v primerjavi z 0 %, p=0,113).
No formal studies have been conducted with JETREA in patients with renal impairment.
Formalnih študij z zdravilom JETREA pri bolnikih z okvaro ledvic niso izvedli.
JETREA treated patients were less likely to have had a vitrectomy by the end of the study (Month 6) compared with placebo treated patients (integrated data: 17.7% vs. 26.6%, respectively; p=0.016).
Pri bolnikih, zdravljenih z zdravilom JETREA, je bila potreba po vitrektomiji ob koncu študije (6. mesec) manjša v primerjavi z bolniki, zdravljenimi s placebom (integrirani podatki: 17,7 % v primerjavi s 26,6 %; p = 0,016).
Subretinal fluid and signs and symptoms of impaired photoreceptor function including decreased visual acuity (in some cases severe) were reported in association with these events.
V povezavi s temi dogodki so poročali o kopičenju tekočine pod mrežnico ter o znakih in simptomih slabšega delovanja fotoreceptorjev, vključno z zmanjšanjem ostrine vida (v nekaterih primerih hudo zmanjšanje).
The proportion of patients who achieved VMA resolution at Day 28 (primary endpoint) was 41.7% in the JETREA group compared with 6.2% in the sham group (p<0.001).
Delež bolnikov, pri katerih je bila na 28. dan dosežena odprava VMA (primarni cilj študije), je znašal 41,7 % v skupini, zdravljeni z zdravilom JETREA, v primerjavi s 6,2 % v skupini z navideznim zdravljenjem (p<0,001).
Using aseptic technique, dilute by adding 0.2 mL of sodium chloride 9 mg/mL (0.9%) solution for injection (sterile, preservative-free, non-buffered) into the Jetrea vial (Figure 3) and gently swirl the vial until the solutions are mixed (Figure 4).
Z aseptično tehniko vsebini viale z zdravilom Jetrea dodajte 0,2 ml 0,9-odstotne raztopine natrijevega klorida (9 mg/ml) za injiciranje (sterilno, brez konzervansov in pufrov), da jo razredčite (slika 3) in vialo nežno obračajte, dokler ni raztopina premešana (slika 4).
No formal studies have been conducted with JETREA in patients with hepatic impairment.
Formalnih študij z zdravilom JETREA pri bolnikih z okvaro jeter niso izvedli.
- The other ingredients are mannitol, citric acid, sodium hydroxide (NaOH) (for pH adjustment) and water for injections.
- Druge sestavine zdravila so manitol, citronska kislina, natrijev hidroksid (NaOH) (za uravnavanje pH) in voda za injekcije.
4) including subretinal fluid
4) vključno s kopičenjem tekočine pod mrežnico
The most clinically relevant adverse reactions included blindness transient, retinal tear, retinal detachment, lens subluxation and macular hole progression.
Klinično najpomembnejši neželeni učinki so bili prehodna slepota, raztrganje mrežnice, odstop mrežnice, subluksacija očesne leče in povečevanje foramna makule.
Sodium chloride, mannitol, citric acid, sodium hydroxide, hydrochloric acid, water for injections.
natrijev klorid, manitol, citronska kislina, natrijev hidroksid, klorovodikova kislina, voda za injekcije
The recommended dose is 0.125 mg in 0.1 mL of the solution administered by intravitreal injection to the affected eye once as a single dose.
Priporočeni odmerek je 0,125 mg v 0,1 ml raztopine, uporabljen v obliki intravitrealne injekcije v prizadeto oko kot enkratni odmerek.
The recommended dose is 0.125 mg (0.1 mL of the diluted solution) administered by intravitreal injection to the affected eye once as a single dose.
Priporočeni odmerek je 0,125 mg (0,1 ml razredčene raztopine), uporabljen v obliki intravitrealne injekcije v prizadeto oko kot enkratni odmerek.
In the sham group, no events occurred prior to vitrectomy.
V skupini z navideznim zdravljenjem pred vitrektomijo ni bilo nobenih dogodkov.
Blindness transient, lens subluxation*, retinal tear*5), retinal detachment*5), night blindness, pupillary reflex impaired, diplopia, hyphaema, miosis, pupils unequal, corneal abrasion, anterior chamber inflammation, eye inflammation, conjunctival irritation
Občasni prehodna slepota, subluksacija leče*, raztrganje mrežnice*5), odstop mrežnice*5), nočna slepota, zmanjšan pupilarni refleks, diplopija, hifema, mioza, neenakomerni zenici, abrazija roženice, vnetje sprednjega očesnega prekata, vnetje očesa, draženje očesne veznice
2) including scotoma
1) vključno z zamegljenim vidom2) vključno s skotomi
Jetrea is a concentrate for solution for injection in a vial.
Zdravilo Jetrea je koncentrat za raztopino za injiciranje v viali.
In 3 clinical studies with follow-up from 6 months (TG-MV-006 and TG-MV-007) to 24 months (TG-MV-014), the most commonly reported adverse reactions were vitreous floaters, eye pain, photopsia and chromatopsia as well as conjunctival haemorrhage resulting from the injection procedure.
(TG-MV-006 in TG-MV-007) do 24 mesecev (TG-MV-014) so bili najpogostejši neželeni učinki, o katerih so poročali, delci v steklovini, bolečina v očesu, fotopsija in kromatopsija ter krvavitev očesne veznice zaradi postopka injiciranja.
JETREA is indicated in adults for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns (see section 5.1).
Zdravilo JETREA je indicirano pri odraslih za zdravljenje vitreomakularne trakcije (VMT), tudi v primeru, ko je povezana s foramnom makule premera 400 mikronov ali manj (glejte poglavje 5.1).
Jetrea is given as an injection into the eye.
Zdravilo Jetrea se injicira v oko.
If this event occurs, it should be treated according to standard medical practice.
Če se tak dogodek pojavi, je potrebno zdravljenje skladno s standardno zdravstveno prakso.
A total of 220 patients (JETREA 146, sham 74) were randomised in this study.
V tej študiji so naključno razvrstili skupaj 220 bolnikov (146 za zdravilo JETREA in 74 za navidezno zdravljenje).
- The other ingredients are sodium chloride (NaCl), mannitol, citric acid, sodium hydroxide (NaOH) (for pH adjustment), hydrochloric acid (HCl) (for pH adjustment) and water for injections.
- Druge sestavine zdravila so natrijev klorid (NaCl), manitol, citronska kislina, natrijev hidroksid (NaOH) (za uravnavanje pH), klorovodikova kislina (HCl) (za uravnavanje pH) in voda za injekcije.
In the integrated analysis of the National Eye Institute Visual Function Questionnaire-25 (VFQ-25), a numerical difference in favour of JETREA over placebo was shown in each sub-scale score, as well as the composite score.
Visual Function Questionnaire-25) se je za vsak podseštevek in za skupni seštevek pokazala številčna razlika v korist skupine z zdravilom JETREA pred skupino s placebom.
in integrated data
KLINIČNI PODATKI
1 vial contains 0.5 mg ocriplasmin.
1 viala vsebuje 0,5 mg okriplazmina.
Visual acuity reduced*, visual impairment1), visual field defect2), vision blurred, retinal haemorrhage, vitreous haemorrhage, macular hole*, macular degeneration, retinal degeneration, macular oedema3), retinal oedema4), retinal pigment epitheliopathy, metamorphopsia, conjunctival oedema, eyelid oedema, vitritis, anterior chamber cell, anterior chamber flare, iritis, photopsia, conjunctival hyperaemia, ocular hyperaemia, vitreous detachment, eye irritation, dry eye, foreign body sensation in eyes, eye pruritus, ocular discomfort, photophobia, lacrimation increased
krvavitev v mrežnico, krvavitev v steklovino, foramen makule*, degeneracija makule, degeneracija mrežnice, makularni edem3), edem mrežnice4), pigmentna epiteliopatija mrežnice, metamorfopsija, edem veznice, edem veke, vitritis, celice v sprednjem očesnem prekatu, motnjave v sprednjem očesnem prekatu, iritis, fotopsija, hiperemija veznice, očesna hiperemija, odstop steklovine, draženje očesa, suho oko, občutek tujka v očeh, očesni pruritus, neprijeten občutek v očesu, fotofobija, povečano solzenje
In the placebo-controlled pivotal phase III studies (TG-MV-006 and TG-MV-007), 7.7% of JETREA patients and 1.6% of placebo patients had acute ≥ 2-line (≥ 10 ETDRS letters) loss in best-corrected visual acuity (BCVA) during the first week after injection with no alternative explanation for the change.
V osrednjih, s placebom kontroliranih študijah faze III (TG-MV-006 in TG-MV-007), je imelo 7,7 % bolnikov, zdravljenih z zdravilom JETREA, in 1,6 % bolnikov, ki so dobili placebo, akutno izgubo najboljše korigirane vidne ostrine (BCVA) za ≥ 2 vrstici (≥ 10 ETDRS črk) v prvem tednu po injiciranju.
Jetrea is a solution for injection in a vial.
Zdravilo Jetrea je raztopina za injiciranje v viali.
The European Medicines Agency has waived the obligation to submit the results of studies with JETREA in all subsets of the paediatric population in the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns (see section 4.2 for information on paediatric use).
JETREA za vse podskupine pediatrične populacije za zdravljenje vitreomakularne trakcije, vključno v povezavi s foramnom makule premera 400 mikronov ali manj (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
In study TG-MV-014, events of macular hole (including both progression and new onset) were reported in 15.8% JETREA vs. 13.5% sham recipients at Month 24.
V študiji TG-MV-014 so v 24. mesecu poročali o dogodkih v zvezi s foramnom makule (vključno z napredovanjem in novim pojavom) pri 15,8 % bolnikov, ki so bili zdravljeni z zdravilom JETREA, v primerjavi s 13,5 % prejemnikov navideznega zdravljenja.
In a paediatric study evaluating JETREA as an adjunct to vitrectomy, one case of subluxation was reported in a premature infant who received a single intravitreal injection of JETREA 0.175 mg.
V pediatrični študiji, v kateri so ocenili zdravilo JETREA kot dodatno zdravljenje poleg vitrektomije, so poročali o enem primeru subluksacije pri nedonošenčku, ki je prejel eno samo intravitrealno injekcijo zdravila JETREA 0,175 mg. Subluksacijo leče so opazili pri 3 živalskih vrstah s koncentracijami okriplazmina nad predvidenimi kliničnimi koncentracijami (glejte poglavje 5.3).
No systemic toxicity was observed after intravitreal administration of ocriplasmin.
Po intravitrealnem dajanju okriplazmina niso opazili sistemske toksičnosti.
In study TG-MV-014, incomplete Inner Segment/Outer Segment (IS/OS) band, also referred to as Ellipsoid Zone, in the central area was very common at baseline (65.8% in the JETREA group and 62.2% in the sham group).
Nenormalen izvid optične koherentne tomografije V študiji TG-MV-014 je bil v izhodišču v centralnem delu zelo pogosto navzoč nepopoln trak notranjega segmenta/zunanjega segmenta (IS - Inner Segment/OS - Outer Segment), imenovan tudi elipsoidna cona (65,8 % bolnikov iz skupine, ki je prejemala zdravilo JETREA, in 62,2 % iz skupine,
If an adverse reaction occurs, it should be treated according to standard medical practice.
Če pride do neželenega učinka, ga zdravite v skladu s standardno zdravstveno prakso.
JETREA has not been studied in patients with large diameter macular holes (> 400 microns), high myopia (> 8 dioptre spherical correction or axial length > 28 mm), aphakia, history of rhegmatogenous retinal detachment, lens zonule instability, recent ocular surgery or intraocular injection (including laser therapy), proliferative diabetic retinopathy, ischaemic retinopathies, retinal vein occlusions, exudative age-related macular degeneration (AMD) and vitreous haemorrhage.
močno kratkovidnostjo (>8 dioptrij sferične korekcije ali osne dolžine >28 mm), afakijo, regmatogenim odstopom mrežnice v anamnezi, nestabilnostjo zonule leče, nedavno operacijo na očesu ali intraokularno injekcijo (vključno z lasersko terapijo), proliferativno diabetično retinopatijo, ishemičnimi retinopatijami, okluzijo mrežnične vene, eksudativno starostno makularno degeneracijo in krvavitvijo v steklovino.
In the integrated data, the VMA resolution rate at Day 28 was higher in patients treated with JETREA compared to placebo in both the subgroup without ERM (37.4% vs. 14.3%, p<0.001) and with ERM (8.7% vs. 1.5%, p=0.046).
28. dan višji pri bolnikih, zdravljenih z zdravilom JETREA, v primerjavi s placebom v obeh podskupinah, brez ERM (37,4 % v primerjavi s 14,3 %, p <0,001) in z ERM (8,7 % v primerjavi z 1,5 %, p=0,046).
In study TG-MV-014, 2.8% of JETREA patients and 1.4% of sham patients had acute ≥ 2-line loss in BCVA during the first week after injection.
V študiji TG-MV-014 je imelo v prvem tednu po injiciranju 2,8 % bolnikov, zdravljenih z zdravilom JETREA, in 1,4 % bolnikov, ki so dobili navidezno zdravljenje, akutno izgubo najboljše korigirane ostrine vida (BCVA) za ≥ 2 vrstici.
In the integrated data, full-thickness macular hole (FTMH) was present at baseline in 106/464 (22.8%) patients and 47/188 (25%) patients in the JETREA and placebo groups, respectively.
V integriranih podatkih je bil pri 106/464 (22,8 %) bolnikih v skupini z zdravilom JETREA oz.
TG-MV-007 Placebo
TG-MV-007 placebo kombinirano placebo
Eye disorders
- vnetje očesa
In the placebo-controlled pivotal phase III studies (TG-MV-006 and TG-MV-007), retinal breaks (tears and detachment) were reported in 1.9% of patients injected with JETREA vs. 4.3% injected with placebo.
V osrednjih, s placebom kontroliranih študijah faze III (TG-MV-006 in TG-MV-007), so o razpoki mrežnice (raztrganje in odstop) poročali pri 1,9 % bolnikov, ki so jim injicirali zdravilo JETREA, v primerjavi s 4,3 %, ki so jim injicirali placebo.
Jetrea is given as a single injection into the affected eye.
Zdravilo Jetrea boste prejeli v obliki injekcije v prizadeto oko.
Over 1400 patients have been treated with the recommended dose of 0.125 mg of JETREA in interventional clinical studies.
V intervencijskih kliničnih študijah so več kot 1400 bolnikov zdravili s priporočenim odmerkom
In the placebo-controlled pivotal phase III studies (TG-MV-006 and TG-MV-007), events of macular hole (including both progression and new onset) were reported for 6.7% of all patients injected with JETREA vs. 9.6% injected with placebo at Month 6.
V osrednjih, s placebom kontroliranih študijah faze III (TG-MV-006 in TG-MV-007), so poročali o dogodkih v zvezi s foramnom makule (vključno z napredovanjem in novim pojavom) pri 6,7 % vseh bolnikov, ki so jim injicirali zdravilo JETREA, v primerjavi z 9,6 % bolnikov, ki so jim injicirali placebo v 6. mesecu.
There is a risk for a significant decrease in visual acuity during the first week after the injection.
V prvem tednu po injiciranju obstaja tveganje za pomembno zmanjšanje ostrine vida.
Each vial contains 0.5 mg of ocriplasmin* in 0.2 mL solution.
Ena viala vsebuje 0,5 mg okriplazmina* v 0,2 ml raztopine.
Intraocular pressure increased, macular reflex abnormal, optical coherence tomography (OCT) abnormal* * see section ‘Description of selected adverse reactions' 1) including dim vision
Pogosti zvišan očesni tlak, nenormalen makularni refleks, nenormalen izvid optične koherentne tomografije (OCT)*
Using aseptic technique, dilute by adding 0.2 mL of sodium chloride 9 mg/mL (0.9%) solution for injection (sterile, preservative-free, non-buffered) into the JETREA vial and gently swirl the vial until the solutions are mixed.
dodajte 0,2 ml 0,9-odstotne raztopine natrijevega klorida (9 mg/ml) za injiciranje (sterilno, brez konzervansov in pufrov), da jo razredčite in vialo nežno obračajte, dokler ni raztopina premešana.
After dilution, 0.1 mL contains 0.125 mg ocriplasmin.
Po redčenju 0,1 ml raztopine vsebuje 0,125 mg okriplazmina.
In the integrated data, 26.5% in the JETREA group compared with 10.1% in the placebo group achieved VMA resolution at Day 28 (p<0.001).
10,1 % bolnikov v skupini s placebom 28. dan doseglo odpravo VMA (p <0,001).
See section 4.4 of the Summary of Product Characteristics for instructions on post-injection monitoring.
Za navodila za spremljanje po injiciranju glejte poglavje 4.4 Povzetka glavnih značilnosti zdravila.
Macular hole
OVOJNINAH VIALA
After dilution with 0.2 mL of sodium chloride solution, 0.1 mL of the diluted solution contains 0.125 mg of ocriplasmin.
Po redčenju z 0,2 ml raztopine natrijevega klorida vsebuje 0,1 ml razredčene raztopine 0,125 mg okriplazmina.
Common
Skupaj
Once completely thawed, remove the protective orange polypropylene flip-off cap from the vial.
S povsem odmrznjene viale odstranite zaščitno oranžno polipropilensko odmično zaporko.
Transient increases in IOP including transient blindness and non-perfusion of the optic nerve have been seen within 60 minutes of injection of JETREA.
V roku 60 minut po injiciranju zdravila JETREA so opazili prehodno zvišanje očesnega tlaka, vključno s prehodno slepoto in ne-perfundiranostjo vidnega živca.
Replace the needle with an appropriate sterile needle, carefully expel the excess volume from the syringe by slowly depressing the plunger so that the plunger tip aligns with the 0.1 mL line on the syringe (corresponding to 0.125 mg ocriplasmin) (Figure 6).
Iglo zamenjajte z ustrezno sterilno iglo, previdno iztisnite presežek volumna iz injekcijske brizge s počasnim pritiskanjem bata tako, da vrh bata poravnate s črto, ki označuje 0,1 ml na injekcijski brizgi (ustreza 0,125 mg okriplazmina) (slika 6).
Progression rates after Month 6, however, were higher in sham or placebo than in those treated with JETREA.
Vendar so bile pogostnosti napredovanja po 6 mesecih višje pri bolnikih, zdravljenih navidezno ali s placebom,
Replace the needle with an appropriate sterile needle, carefully expel the excess volume from the syringe by slowly depressing the plunger so that the plunger tip aligns with the 0.1 mL line on the syringe (corresponding to 0.125 mg ocriplasmin) (Figure 4).
Iglo zamenjajte z ustrezno sterilno iglo, previdno iztisnite presežek volumna iz injekcijske brizge s počasnim pritiskanjem bata tako, da vrh bata poravnate s črto, ki označuje 0,1 ml na injekcijski brizgi (ustreza 0,125 mg okriplazmina) (slika 4).
How Jetrea is given
Kako se daje zdravilo Jetrea
Retinal breaks (tears and detachment)
Razpoka mrežnice (raztrganje in odstop)
Replace the needle with an appropriate sterile needle, carefully expel the excess volume from the syringe by slowly depressing the plunger so that the plunger tip aligns with the 0.1 mL line on the syringe (corresponding to 0.125 mg ocriplasmin).
Iglo zamenjajte z ustrezno sterilno iglo, previdno iztisnite presežek volumna iz injekcijske brizge s počasnim pritiskanjen bata tako, da vrh bata poravnate s črto, ki označuje 0,1 ml na injekcijski brizgi (ustreza 0,125 mg okriplazmina).
Description of selected adverse reactions
Opis izbranih neželenih učinkov Zmanjšana ostrina vida
Once completely thawed, remove the protective blue polypropylene flip-off cap from the vial.
S povsem odmrznjene viale odstranite zaščitno modro polipropilensko odmično zaporko.
Uncommon side effects (may affect up to 1 in 100 patients): - transient severe decreased vision - difficulty in seeing well at night or in dim light - disturbance in your eye's reaction to the light that may increase your sensitivity to light (pupillary reflex impaired) - double vision - accumulation of blood in the front part of the eye - abnormal constriction of the pupil (black part in the centre of the eye) - different sized pupils - a scratch or scrape of the cornea (transparent layer that covers the front of the eye)
- težave z vidom ponoči ali pri zatemnitvi - motnja v odzivu vaših oči na svetlobo, ki lahko poveča občutljivost na svetlobo (zmanjšan refleks zenice) - dvojni vid
(17.1% and 6.4%) (p=0.003 and p=0.024, respectively).
(neodvisno od vitrektomije) v 6. mesecu (28,0 oz. 12,3 %) v primerjavi z bolniki, zdravljenimi s placebom (17,1 % oz. 6,4 %) (p = 0,003 oz. p = 0,024).
The difference continued to be statistically significant through Month 6 in each study (p≤0.024).
Razlika je bila še naprej v obeh študijah statistično pomembna do 6. meseca
One vial of Jetrea contains 0.375 mg of ocriplasmin in 0.3 mL solution.
Ena viala zdravila Jetrea vsebuje 0,375 mg okriplazmina v
Inject 0.1 mL of the solution immediately into the mid-vitreous.
Takoj injicirajte 0,1 ml raztopine v sredino steklovine.
No reproductive toxicology studies have been performed.
Študij toksičnosti o vplivu zdravila na sposobnost razmnoževanja niso izvedli.
A greater proportion of patients in the JETREA group had a ≥ 5 points improvement in VFQ-25
Višji delež bolnikov, zdravljenih z zdravilom JETREA, je pridobil ≥ 2 ali ≥ 3 vrstice pri BCVA
JETREA 0.5 mg/0.2 mL sterile concentrate ocriplasmin
JETREA 0,5 mg/0,2 ml sterilni koncentrat okriplazmin intravitrealna uporaba po razredčenju
After dilution with 0.2 mL of sodium chloride 9 mg/mL (0.9%) solution for injection, 0.1 mL of the diluted solution contains 0.125 mg ocriplasmin.
Po redčenju z 0,2 ml raztopine 0,9-odstotnega natrijevega klorida (9 mg/ml) za injiciranje vsebuje
Jetrea must be prepared and administered by a qualified ophthalmologist experienced in intravitreal injections.
Zdravilo JETREA mora pripraviti in dati usposobljen oftalmolog, ki ima izkušnje z dajanjem intravitrealnih injekcij.
JETREA is administered by intravitreal injection only.
Spremljanje po injiciranju Zdravilo JETREA se daje samo v obliki intravitrealne injekcije.
Inject 0.1 mL of the diluted solution immediately into the mid-vitreous.
Takoj injicirajte 0,1 ml razredčene raztopine v sredino steklovine.
JETREA must be administered by a qualified ophthalmologist experienced in intravitreal injections.
Zdravilo JETREA mora dati usposobljen oftalmolog, ki ima izkušnje z dajanjem intravitrealnih injekcij.
JETREA 0.5 mg/0.2 mL concentrate for solution for injection
JETREA 0,5 mg/0,2 ml koncentrat za raztopino za injiciranje
JETREA 0.5 mg/0.2 mL concentrate for solution for injection ocriplasmin
JETREA 0,5 mg/0,2 ml koncentrat za raztopino za injiciranje okriplazmin
Visually inspect the vial for particulate matter.
Vsebino viale preglejte in se prepričajte, da v njej ni delcev.
1 vial contains 0.375 mg ocriplasmin in 0.3 mL solution (1.25 mg/mL).
1 viala vsebuje 0,375 mg okriplazmina v 0,3 ml raztopine (1,25 mg/ml), kar zagotavlja uporabno količino za dajanje enkratnega odmerka 0,1 ml, ki vsebuje 0,125 mg okriplazmina.
Jetrea contains the active substance ocriplasmin.
Zdravilo Jetrea vsebuje zdravilno učinkovino okriplazmin.
Ophthalmological examinations may be abnormal following the administration of JETREA.
Po dajanju zdravila JETREA lahko izvidi nekaterih oftalmoloških preiskav postanejo nenormalni.
Sodium hydroxide (NaOH) (for pH adjustment) Hydrochloric acid (HCl) (for pH adjustment) Water for injections
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev klorid (NaCl) manitol citronska kislina natrijev hidroksid (NaOH) (za uravnavanje pH) klorovodikova kislina (HCl) (za uravnavanje pH) voda za injekcije
Discard the vial and any unused portion of the diluted solution after single use.
Vialo in vso količino neporabljene raztopine po enkratni uporabi zavrzite.