natgillin/translations-raw huggingface dataset:
The unopened vial in the original carton protected from light may be stored in a refrigerator (2 °C to 8 °C) for up to 1 week.
Neotvorena bočica u originalnoj kutiji, zaštićena od svjetlosti, može se čuvati u hladnjaku (2 °C do
- Symptoms such as eye pain, worsening eye redness, severely blurred or decreased vision, increased sensitivity to light or increased number of dark floating spots in the field of vision (floaters) are also seen in up to 1 in 10 patients and may be the signs of an infection, bleeding, separation or tear of the retina or an increase in the pressure inside the treated eye.
- Simptomi kao što su bol, crvenilo oka koje se pogoršava, jako zamućen vid ili slabiji vid, pojačana osjetljivost na svjetlo ili veći broj tamnih lebdećih mrlja u vidnom polju („mušice“) također su primjećeni u do 1 na 10 bolesnika i mogu biti znaci infekcije, krvarenja, razderotine mrežnice ili porasta tlaka u liječenom oku.
The proportion of patients who underwent vitrectomy for an event of VMA/VMT was 8.3% in the JETREA group compared to 19.2% in the sham group.
Udio bolesnika koji su imali vitrektomiju zbog VMA/VMT bio je 8,3 % u JETREA skupini u odnosu na 19,2 % u placebo skupini.
Lens subluxation was observed in the 3 species at ocriplasmin concentrations at or above 41 µg/mL vitreous, a concentration above the intended clinical concentration of 29 µg/mL.
životinjske vrste pri koncentracijama okriplazmina od 41 µg/ml staklovine i većima, što je više od predviđene kliničke koncentracije od 29 µg/ml.
Mannitol, citric acid, sodium hydroxide, water for injections.
Manitol, citratna kiselina, natrijev hidroksid, voda za injekcije.
In the JETREA group, 1 patient (0.7%) developed retinal tear and retinal detachment between Day 0 and Day 7 post-injection.
JETREOM, 1 bolesnik (0,7%) razvio je rupturu mrežnice i odignuće mrežnice u periodu između 0. i 7. dana nakon injekcije.
Treatment with JETREA in the other eye is not recommended concurrently or within 7 days of the initial injection in order to monitor the post-injection course including the potential for decreased vision in the injected eye.
Ne preporučuje se istodobna primjena JETREE u drugo oko, a ni unutar 7 dana od prve injekcije, kako bi se mogao pratiti tijek nakon davanja injekcije, uključujući mogućnost slabijeg vida na oko u koje je injekcija primijenjena.
How Jetrea is given
Kako se Jetrea daje
Vials are for single use only.
Bočice su samo za jednokratnu primjenu.
The proportion of patients who gained ≥ 2 or ≥ 3 lines in BCVA at Month 6, irrespective of vitrectomy, was slightly higher in the JETREA group (36.2%, 18.6%) than in the sham group (28.6%, 13.1%).
Udio bolesnika koji su dobili ≥ 2 ili ≥ 3 reda BCVA u 6. mjesecu, neovisno o vitrektomiji, bio je malo veći u JETREA skupini (36,2%, 18,6%) u odnosu na placebo skupinu (28,6%, 13,1%).
It is unknown whether JETREA is excreted in human milk.
Nije poznato izlučuje li se JETREA u majčino mlijeko.
The patient had a decrease in BCVA of 21 ETDRS letters from baseline that returned to within 9 letters of baseline at the end of the study.
BCVA se u bolesnika smanjila za 21 slovo na ETDRS tabelici u usporedbi s početnom, no do kraja ispitivanja vratila se na 9 slova u odnosu na onu početnu.
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).
JETREA je indicirana u odraslih za liječenje vitreomakularne trakcije (VMT), uključujući kada je povezana s makularnom rupom promjera manjeg ili jednakog 400 mikrona (vidjeti dio 5.1).
Intraocular pressure increased, macular reflex abnormal, optical coherence tomography (OCT) abnormal* * see section ‘Description of selected adverse reactions' 1) including dim vision
Povišeni intraokularni tlak, abnormalni makularni refleks, abnormalni nalaz optičke koherentne tomografije (OCT)*.
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.
Populacije o kojima nema podataka ili su podaci ograničeni JETREA nije ispitana u bolesnika s makularnom rupom velikog promjera (> 400 mikrona), visokom miopijom (> 8 dioptrija sferne korekcije ili aksijalne dužine > 28 mm), afakijom, regmatogenom ablacijom mrežnice u anamnezi, zonularnom nestabilnošću, nedavnom operacijom oka ili intraokularnom injekcijom (uključujući liječenje laserom), proliferativnom dijabetičkom retinopatijom, ishemijskim retinopatijama, okluzijama mrežnične vene, eksudativnom senilnom makularnom degeneracijom (SMD) i vitrealnim krvarenjem.
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.
Nakon razrjeđivanja s 0,2 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekciju, 0,1 ml razrijeđene otopine sadržava 0,125 mg okriplazmina.
• How to prepare for Jetrea treatment
• Kako se pripremiti za liječenje s Jetreom • Kako se provodi liječenje Jetreom
To prepare JETREA for intravitreal injection, adhere to the following instructions: Remove the vial from the freezer and allow to thaw at room temperature (takes about 2 minutes).
Za pripravu Jetree za intravitrealnu injekciju pridržavajte se niže navedenih uputa: 1. Izvadite bočicu iz zamrzivača i ostavite da se sadržaj odmrzne pri sobnoj temperaturi (traje oko 2
Ophthalmological examinations may be abnormal following the administration of JETREA.
Nalazi oftalmoloških pretraga nakon primjene JETREE mogu biti abnormalni.
Intravitreal use after dilution.
Intravitrealna primjena nakon razrjeđivanja.
The proportion of patients with ≥3 lines improvement from baseline was only greater in the JETREA group (23.4% vs. 12.8%, respectively) in the subgroup who had no FTMH at baseline.
Udio bolesnika sa ≥ 3 reda poboljšanja u odnosu na početno mjerenje bio je veći samo u JETREA skupini (23,4% naspram 12,8%), u podskupini koja nije imala FTMH na početku ispitivanja.
Patients with a smaller VMA diameter at baseline (≤ 1500 microns) were more likely to achieve VMA resolution at Day 28 compared with those who had a diameter > 1500 microns.
U bolesnika s manjim promjerom VMA na početku ispitivanja (≤ 1500 mikrona) postojala je veća sklonost povlačenja VMA do 28. dana nego u onih s promjerom VMA > 1500 mikrona.
The injection volume of 0.1 mL is then delivered into the mid-vitreous.
Injekcijski volumen od 0,1 ml potom se aplicira u sredinu staklovine.
No studies have been conducted to examine the pharmacokinetics of ocriplasmin in patients with renal impairment since the systemic exposure is expected to be very low after intravitreal administration.
Ispitivanja farmakokinetike okriplazmina u bolesnika s oštećenjem funkcije bubrega nisu provedena jer se očekuje da sistemska izloženost bude vrlo mala nakon intravitrealne primjene.
Jetrea must be given by a qualified ophthalmologist (eye specialist) who has experience in giving injections into the eye.
Jetreu smije davati samo kvalificirani oftalmolog (specijalist za oko) koji ima iskustvo u davanju injekcija u oko.
Ethnicity Experience is limited in groups other than Caucasians.
Etnička pripadnost Iskustvo s ostalim rasama, osim bijele, je ograničeno.
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).
JETREOM vitrektomija je do kraja ispitivanja (6. mjesec) bila rjeđe indicirana nego u onih koji su primili placebo (integrirani podaci: 17,7% nasuprot 26,6%; p=0,016).
In a clinical study in patients scheduled for vitrectomy receiving 0.125 mg JETREA (corresponding to a theoretical start concentration of 29 µg/mL vitreous), mean ocriplasmin activity was 9% of theoretical start concentration 2-4 hours after injection and below the lower level of quantification at 7 days.
U kliničkom ispitivanju bolesnika predviđenih za vitrektomiju koji su primili 0,125 mg JETREE (što odgovara teoretskoj početnoj koncentraciji 29 µg/ml staklovine), srednja vrijednost aktivnosti okriplazmina 2-4
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.
U integriranim podacima, makularna rupa pune debljine (engl. full-thickness macular hole, FTMH) bila je prisutna na početku ispitivanja kod 106/464 (22,8%) bolesnika u JETREA skupini i 47/188 (25%) bolesnika u placebo skupini.
A significantly higher percentage of JETREA treated patients experienced total PVD at Day 28 compared to placebo treated patients (integrated data: 13.4% vs. 3.7%, respectively; p<0.001).
Značajno veći postotak bolesnika liječenih JETREOM iskusili su potpuno stražnje odvajanje staklovine 28. dana u usporedbi s placebom liječenim bolesnicima (integrirani podaci: 13,4% nasuprot 3,7%, p<0,001).
All adverse reactions were ocular.
Sve nuspojave bile su okularne.
For storage conditions after thawing/opening of the medicinal product, see section 6.3.
Za uvjete čuvanja nakon odmrzavanja/otvaranja lijeka vidjeti dio 6.3.
In both pivotal studies, the proportion of patients who achieved VMA resolution at Day 28 (primary endpoint) was significantly (p≤0.003) higher in the JETREA group compared with the placebo group.
U oba pivotalna ispitivanja udio bolesnika u kojih se VMA povukla 28. dana (primarni ishod) bio je značajno veći (p≤0,003) u JETREA skupini u usporedbi s placebo skupinom.
The intravitreal injection procedure should be carried out under controlled aseptic conditions, which include the use of surgical hand disinfection, sterile gloves, a sterile drape, a sterile eyelid speculum (or equivalent) and the availability of sterile paracentesis (if required).
Postupak davanja intravitrealne injekcije mora se obaviti u nadziranim aseptičnim uvjetima, koji uključuju kiruršku dezinfekciju ruku, sterilne rukavice, sterilni ogrtač, sterilni spekulum za vjeđe (ili ekvivalent) i dostupnost sterilne paracenteze (u slučaju potrebe).
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)
- oslabljeni vid noću ili kod slabijeg osvjetljenja - poremećaj u reakciji Vašeg oka na svjetlost koji može pojačati osjetljivost na svjetlo (oštećenje refleksa zjenice) - dvostruki vid - nakupljanje krvi u prednjem dijelu oka - abnormalno sužavanje zjenice (crni dio u središtu oka)
Only 0.1 mL of the total 0.3 mL solution in the vial should be administered.
Potrebno je primijeniti samo 0,1 ml od ukupno 0,3 ml otopine u bočici.
The efficacy of JETREA has been further confirmed in a randomised, double-masked, shamcontrolled, 24-month study in patients with VMT finalised since the initial marketing authorisation approval.
Ispitivanje TG-MV-014 Djelotvornost JETREE dalje je potvrđena u randomiziranom, dvostruko maskiranom, placebom kontroliranom ispitivanju u trajanju od 24 mjeseca u bolesnika sa VMT, završenom nakon inicijalnog odobrenja za stavljanje lijeka u promet.
In study TG-MV-014, retinal tear was reported in 1.4% of patients injected with JETREA and 6.8% of sham recipients; the incidence of retinal detachment was 1.4% in both arms.
U ispitivanju TG-MV-014, ruptura mrežnice bila je prijavljena u 1,4 % bolesnika koji su primali injekciju JETREE i 6,8 % bolesnika koji su primali placebo, incidencija odignuća mrežnice bila je 1,4 % u obje skupine.
Following the intravitreal injection, patients should be monitored for any side effects such as (but not limited to) intraocular inflammation/infection and elevation in IOP.
Nakon intravitrealne injekcije bolesnike treba pratiti radi mogućih nuspojava, uključujući (ali ne ograničeno na)
Chromatopsia (including dyschromatopsia and colour vision test abnormal) Colour vision alterations (including yellowish vision and abnormal Roth 28-hue colour vision test) have been reported as a very common adverse reaction in patients injected with JETREA.
Alteracije kolornog vida (uključujući žućkasti vid i abnormalan rezultat testa kolornog vida Roth 28nijansi) su prijavljene kao vrlo česte nuspojave u bolesnika koji su primili injekciju JETREE.
See section 4.4 for monitoring recommendations.
Vidjeti dio 4.4. za preporuke o praćenju bolesnika.
4) including subretinal fluid
3uključujući cistoidni edem makule 4) uključujući subretinalnu tekućinu
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).
VMA do 28. dana bila veća u bolesnika liječenih JETREOM nego u onih koji su primili placebo, i to i u podskupini bez ERM-a (37,4% nasuprot 14,3%, p<0,001) i u podskupini s ERM-om (8,7% nasuprot 1,5%, p=0,046).
Inject 0.1 mL of the diluted solution immediately into the mid-vitreous as it contains no preservatives.
8. Odmah injicirajte 0,1 ml razrijeđene otopine u središte staklovine jer otopina ne sadrži nikakve konzervanse.
Jetrea contains the active substance ocriplasmin.
Jetrea sadržava djelatnu tvar okriplazmin.
Of these, the proportion of patients who achieved FTMH closure without vitrectomy at Day 28 was higher in the JETREA group than the placebo group (40.6% vs. 10.6%, respectively; p<0.001).
Od njih, udio bolesnika u kojih je do 28. dana postignuto zatvaranje FTMH-a bez vitrektomije bio je veći u skupini koja je primila JETREU nego u onoj koja je primila placebo (40,6% nasuprot 10,6%, p<0,001).
Progression rates after Month 6, however, were higher in sham or placebo than in those treated with JETREA.
Stope progresije nakon 6. mjeseca bile su veće kod bolesnika liječenih placebom nego u onih liječenih JETREOM.
No formal studies have been conducted with JETREA in patients with hepatic impairment.
Formalna ispitivanja JETREE u bolesnika s oštećenjem bubrega nisu provedena.
The median time to resolution was 6 months.
Medijan vremena do povlačenja simptoma iznosio je 6 mjeseci.
Sodium chloride, mannitol, citric acid, sodium hydroxide, hydrochloric acid, water for injections.
Natrijev klorid, manitol, citratna kiselina, natrijev hidroksid, kloridna kiselina, voda za injekcije.
After dilution, 0.1 mL contains 0.125 mg ocriplasmin.
Nakon razrjeđivanja, 0,1 ml sadržava 0,125 mg okriplazmina.
For handling of the medicinal product, see section 6.6.
Za upute o rukovanju lijekom, vidjeti dio 6.6.
Very common Vitreous floaters, eye pain, conjunctival haemorrhage, chromatopsia*
Zamućenja u vidnom polju, bol u oku, krvarenje u spojnicu, kromatopsija*
0.3 mL solution in a vial (type I glass) closed with a chlorobutyl rubber stopper and a blue polypropylene flip-off cap.
0,3 ml otopine u bočici (staklo tipa I) zatvorenoj čepom od klorbutilne gume i sa plavom polipropilenskom flip-off kapicom . Pakiranje sadržava 1 bočicu.
No systemic toxicity was observed after intravitreal administration of ocriplasmin.
Nakon intravitrealne primjene okriplazmina nije primijećena sistemska toksičnost.
No studies have been conducted to examine the pharmacokinetics of ocriplasmin in patients with hepatic impairment since the systemic exposure is expected to be very low after intravitreal administration.
Ispitivanja farmakokinetike okriplazmina u bolesnika s oštećenjem funkcije jetre nisu provedena jer se očekuje da sistemska izloženost bude vrlo mala nakon intravitrealne primjene.
This provides a usable amount to deliver a single dose of 0.1 mL containing 0.125 mg ocriplasmin.
To osigurava iskoristivu količinu za primjenu jedne doze od 0,1 ml koja sadržava 0,125 mg okriplazmina.
Any excess volume should be expelled prior to injection in order to deliver a single dose of 0.1 mL containing 0.125 mg ocriplasmin.
Suvišni volumen treba istisnuti prije davanja injekcije kako bi se primijenila jedna doza od 0,1 ml koja sadrži 0,125 mg okriplazmina.
- 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.
- Ostali sastojci su natrijev klorid (NaCl), manitol, citratna kiselina, natrijev hidroksid (NaOH) (za podešavanje pH), kloridna kiselina (HCl) (za podešavanje pH) i voda za injekcije.
Electroretinographic (ERG) changes (a- and b-wave amplitude decrease) have been reported as a very common adverse reaction in patients injected with JETREA; in the majority of cases visual impairment and chromatopsia were also reported.
Elektroretinografske (ERG) promjene (smanjenje amplituda a- i b-valova) prijavljene su kao vrlo česta nuspojava u bolesnika koji su primili injekciju JETREE.
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-007) do 24 mjeseca (TG-MV-014) najčešće prijavljivane nuspojave bile su zamućenja u vidnom polju, bol u oku, fotopsija i kromatopsija, kao i krvarenje u spojnicu uzrokovano postupkom davanja injekcije.
5) events occurring pre-vitrectomy † using the Roth 28-hue colour vision test. See also section 4.4.
† koristeći test kolornog vida Roth 28-nijansi.
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).
Udio bolesnika kod kojih je do 28. dana (primarna mjera ishoda) postignuto povlačenje VMA bio je 41,7% u JETREA skupini u odnosu na 6,2% u skupini liječenoj placebom (p<0,001).
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.
U ispitivanju TG-MV-014, 2,8% bolesnika koji su primali JETREU i 1,4 % bolesnika koji su primali placebo imalo je akutno smanjenje BCVA ≥ 2 reda tijekom prvog tjedna nakon injekcije.
If you get any side effects, talk to your doctor/ophthalmologist.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika/oftalmologa.
1 vial contains 0.375 mg ocriplasmin in 0.3 mL solution (1.25 mg/mL).
1 bočica sadržava 0,375 mg okriplazmina u 0,3 ml otopine (1,25 mg/ml).
The median time to resolution was 3 months.
Medijan vremena do povlačenja simptoma iznosio je 3 mjeseca.
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
Prolazna sljepoća, subluksacija leće*, ruptura mrežnice *5), odignuće mrežnice *5), noćno sljepilo, oštećenje refleksa zjenice, diplopija, hifema, mioza, nejednake zjenice, abrazija rožnice, upala u prednjoj očnoj sobici, upala oka, nadražaj konjunktive.
- The other ingredients are mannitol, citric acid, sodium hydroxide (NaOH) (for pH adjustment) and water for injections.
- Ostali sastojci su manitol, citratna kiselina, natrijev hidroksid (NaOH) (za podešavanje pH) i voda za injekcije.
Concentrate for solution for injection 1 vial
Koncentrat za otopinu za injekciju
• Summary of Product Characteristics (SmPC) • Information packs for the patients
• Uputa o lijeku: Informacija za bolesnika
You should contact your doctor/ophthalmologist immediately if you develop any of the eye symptoms described in section 4, after an injection of Jetrea.
Morate se odmah javiti liječniku/oftalmologu ako nakon injekcije Jetree razvijete bilo koji simptom oka opisan u dijelu 4.
How Jetrea is stored
Kako čuvati Jetreu
Mannitol
JETREE
Each vial contains 0.375 mg of ocriplasmin* in 0.3 mL solution (1.25 mg/mL).
Jedna bočica sadržava 0,375 mg okriplazmina* u 0,3 ml otopine (1,25 mg/ml).
Jetrea is given as a single injection into the affected eye.
Jetrea se daje u jednoj injekciji u zahvaćeno oko.
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.
U placebom kontroliranim pivotalnim ispitivanjima faze III (TG-MV-006 i TG-MV-007), slučajevi makularne rupe (uključujući progresiju i nove slučajeve) prijavljeni su u 6,7% svih ispitanika koji su primili injekciju JETREE i u 9,6% onih koji su primili injekciju placeba u 6. mjesecu.
If this event occurs, it should be treated according to standard medical practice.
Dogodi li se taj slučaj, treba provesti liječenje u skladu sa standardnom medicinskom praksom.
Jetrea is a concentrate for solution for injection in a vial.
Jetrea je koncentrat za otopinu za injekciju u bočici.
If an adverse reaction occurs, it should be treated according to standard medical practice.
Pojavi li se nuspojava, treba ju liječiti u skladu sa standardnom medicinskom praksom.
Contact your doctor/ophthalmologist immediately if you develop any of the following symptoms after injection of Jetrea.
Odmah se javite svom liječniku/oftalmologu ako nakon injekcije Jetree razvijete bilo koji od niže navedenih simptoma.
The vial and any unused portion of the diluted solution must be discarded after single use.
Bočica i sva neiskorištena razrijeđena otopina moraju se baciti nakon jednokratne primjene.
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.
ispitanika koji su primali JETREU i 1,6% onih koji su primali placebo zamijećeno je akutno smanjenje najbolje korigirane vidne oštrine (BCVA) za ≥ 2 reda (≥ 10 slova na EDTRS tablici) tijekom prvog tjedna nakon injekcije, bez alternativnog objašnjenja te promjene.
Over 1400 patients have been treated with the recommended dose of 0.125 mg of JETREA in interventional clinical studies.
U intervencijskim kliničkim ispitivanjima preporučenu dozu od 0,125 mg JETREE primilo je više od 1400 bolesnika.
Jetrea is a solution for injection in a vial.
Jetrea je otopina za injekciju u bočici.
Package leaflet: Information for the patient JETREA 0.375 mg/0.3 mL solution for injection
Uputa o lijeku: Informacije za bolesnika JETREA 0,375 mg/0,3 ml otopina za injekciju okriplazmin
Ocriplasmin has a proteolytic activity against protein components of the vitreous body and the vitreoretinal interface (VRI) (e.g. laminin, fibronectin and collagen) and aims to dissolve the protein matrix responsible for the abnormal vitreomacular adhesion (VMA).
(npr. laminin, fibronektin, kolagen) s ciljem da otopi proteinski matriks odgovoran za nenormalnu vitreomakularnu adheziju (VMA).
One vial of Jetrea contains 0.375 mg of ocriplasmin in 0.3 mL solution.
Jedna bočica Jetree sadržava 0,375 mg okriplazmina u 0,3 ml otopine.
in integrated data
KLINIČKI PODACI
(17.1% and 6.4%) (p=0.003 and p=0.024, respectively).
u 6. mjesecu ( 28,0% i 12,3% redom) u usporedbi s bolesnicima liječenim placebom (17,1% i 6,4%) (redom, p=0,003 i p=0,024).
Package leaflet: Information for the patient JETREA 0.5 mg/0.2 mL concentrate for solution for injection
Uputa o lijeku: Informacije za bolesnika JETREA 0,5 mg/0,2 ml koncentrat za otopinu za injekciju okriplazmin
JETREA 0.5 mg/0.2 mL sterile concentrate ocriplasmin
JETREA 0,5 mg/0,2 ml sterilni koncentrat okriplazmin
Method of administration Single use vial for intravitreal use only.
Bočica za jednokratnu primjenu, samo za intravitrealnu primjenu.
Post-injection monitoring
Praćenje nakon injekcije