natgillin/translations-raw huggingface dataset:
The following table summarises the adverse reactions reported in the treated eye in clinical studies and/or from post-marketing experience.
U sljedećoj tablici zbirno su prikazane nuspojave u liječenom oku zabilježene u kliničkim ispitivanjima i/ili nakon stavljanja lijeka u promet.
From a microbiological point of view, the medicinal product must be used immediately after opening.
S mikrobiološkog stajališta, lijek se mora primijeniti odmah nakon otvaranja.
A difference was maintained through the end of the studies (Month 6).
Razlika se zadržala do kraja ispitivanja (6. mjesec).
Oxurion NV Gaston Geenslaan 1 B-3001 Leuven Belgium
Oxurion NV Gaston Geenslaan 1 B-3001 Leuven Belgija
Oxurion NV Gaston Geenslaan 1 B-3001 Leuven BELGIUM
Oxurion NV Gaston Geenslaan 1 B-3001 Leuven BELGIJA
Your doctor/ophthalmologist will also give you a local anaesthetic to prevent any pain from the injection.
Liječnik/oftalmolog će Vam dati i lokalni anestetik da spriječi bol pri davanju injekcije.
One case of accidental overdose of 0.250 mg ocriplasmin (twice the recommended dose) has been reported.
Prijavljen je jedan slučaj slučajnog predoziranja dozom od 0,250 mg okriplazmina (dvaput više od preporučene doze).
The use of Jetrea is therefore not recommended in this patient group.
Stoga se primjena Jetree ne preporučuje za ovu dobnu skupinu bolesnika.
Patients should be monitored appropriately (see section 4.8).
Bolesnike treba prikladno motriti (vidjeti dio 4.8).
- The active substance is ocriplasmin.
- Djelatna tvar je okriplazmin.
The safety and efficacy of JETREA administered to both eyes concurrently has not been studied.
Sigurnost i djelotvornost primjene JETREE u oba oka istodobno nije ispitana.
The efficacy of JETREA was demonstrated in 2 pivotal multicentre, randomised, double-masked, placebo-controlled, 6-month studies in patients with VMT.
Djelotvornost JETREE dokazana je u dva pivotalna multicentrična, randomizirana, dvostruko maskirana, placebom kontrolirana, 6-mjesečna ispitivanja u bolesnika s VMT-om.
Lens subluxation/phacodonesis
Subluksacija leće/fakodoneza
Concentrate for solution for injection (sterile concentrate).
Koncentrat za otopinu za injekciju (sterilni koncentrat).
The potential for lens subluxation or phacodonesis cannot be ruled out.
Mogućnost subluksacije leće ili fakodoneze ne može se isključiti.
Days Post-Injection
Dani nakon injekcije
A single intravitreal injection of 0.175 mg (above the recommended dose), or placebo, was injected in the mid-vitreous of 24 eyes of children aged 0 to 16 years, 30 to 60 minutes prior to the planned start of vitrectomy.
Jednokratna intravitrealna injekcija od 0,175 mg (iznad preporučene doze), ili placebo, je injicirana u sredinu staklovine u 24 oka djece u dobi od 0 do 16 godina, 30 do 60 minuta prije planiranog početka vitrektomije.
The injection needle should be inserted 3.5-4.0 mm posterior to the limbus aiming towards the centre of the vitreous cavity avoiding the horizontal meridian.
Injekcijsku iglu treba uvesti 3,5-4,0 mm iza limbusa, usmjerivši ju prema središtu vitrealne šupljine i izbjegavajući horizontalni meridijan.
In study TG-MV-014, a sub-set of 40 patients receiving JETREA systematically underwent ERG testing; the ERG changes which had developed in 16 out of 40 patients resolved in the majority of patients (13 out of 16).
U ispitivanju TG-MV-014, podskupina od 40 bolesnika koji su primali JETREU, sistematično je bila podvrgnuta ERG testu; promjene ERG-a koje su se razvile kod 16 od 40 bolesnika povukle su se kod većine bolesnika (13 od 16).
The new in-use expiry date should be calculated and noted on the carton before it is placed in the refrigerator.
Novi rok valjanosti lijeka nakon odmrzavanja treba se izračunati i zapisati na kutiji prije stavljanja u hladnjak.
Visual symptoms perceived in the contralateral eye or bilaterally have also been reported.
Prijavljeni su i simptomi koji zahvaćaju vid, primjećeni u kontralateralnom oku ili bilateralno.
Visual acuity reduced
Smanjena vidna oštrina
Information on resolution of specific events such as chromatopsia and ERG changes can be found in the relevant paragraph of the ‘description of selected adverse reactions' section.
Informacije o povlačenju posebnih događaja poput kromatopsije i promjena ERG-a mogu se pronaći u poglavlju „opis odabranih nuspojava“.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, other than sterile, preservative-free, non-buffered diluent sodium chloride 9 mg/mL (0.9%) solution for injection.
Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima, osim sa sterilnom, bez konzervansa, nepuferiranom 0,9%-tnom (9 mg/ml) otopinom natrijeva klorida za injekcije.
The difference for improvement in the general vision sub-scale score was statistically significant (6.1 JETREA vs. 2.1 placebo, p=0.024).
Razlika u poboljšanju rezultata dobivenog podljestvicom za ocjenu općeg vida bila je statistički značajna. (6,1 JETREA nasuprot 2,1 placebo, p=0,024).
JETREA should be used during pregnancy only if the clinical benefit outweighs the potential risks.
JETREA se smije davati u trudnoći samo ako se ocijeni da klinička korist nadmašuje moguće rizike.
A total of 652 patients (JETREA 464, placebo 188) were randomised in these 2 studies.
Ukupno 652 bolesnika (JETREA 464, placebo 188) su randomizirana u ta 2 ispitivanja.
Inform your doctor/ophthalmologist if you have had an injection of a medicine into the eye recently.
Obavijestite liječnika/oftalmologa ako ste nedavno dobili injekciju u oko.
Information about storage
Informacije o čuvanju
Repeated administration in the same eye is not recommended.
Ponovljena primjena u isto oko se ne preporučuje.
Some effects (such as flashes, floaters) can also be perceived from the untreated eye in some cases.
Neke nuspojave (poput bljeskova, lebdećih mrlja u vidnom polju) mogu se u nekim slučajevima opaziti na drugom oku.
In monkeys, after administration of 125 µg/eye (68 µg/mL vitreous) the ERG was fully recovered by Day 55.
U majmuna se, nakon primjene 125 µg po oku (68 µg/ml staklovine) ERG posve normalizirao do 55. dana.
Only a clear, colourless solution without visible particles should be used.
Smije se primijeniti samo bistra, bezbojna otopina bez vidljivih čestica.
Very common Retinogram abnormal*, colour vision test abnormal†
Abnormalni retinogram*, abnormalni nalaz testa kolornog vida†
VMT is caused by traction resulting from a persistent attachment of the vitreous humour (jelly-like material in the back of the eye) to the macula.
VMT uzrokuje trakcija koja je posljedica stalne pripijenosti staklovine (materijal u stražnjem dijelu oka, nalik na želatinu) uz makulu.
The majority of these reactions were non-serious, mild to moderate in intensity and resolved within 2 to 3 weeks.
Nuspojave većinom nisu bile ozbiljne, po svojoj naravi bile su blage do umjerene i prolazile su unutar 2 do 3 tjedna.
Intravitreal injections have been associated with intraocular inflammation/infection, intraocular haemorrhage and increased intraocular pressure (IOP).
Intravitrealne su injekcije povezane s intraokularnom upalom/infekcijom, intraokularnim krvarenjem i povišenim intraokularnim tlakom IOT).
Pack containing 1 vial.
Pakiranje sadržava 1 bočicu.
Ocriplasmin induced an inflammatory response and transient ERG changes in rabbits and monkeys, while no inflammation or ERG changes were observed in minipigs.
Okriplazmin je izazvao upalni odgovor i prolazne promjene ERG-a u kunića i majmuna, no u patuljastih svinja nisu zamijećene ni upala ni promjene ERG-a.
At Month 24, 51.4% of JETREA patients had a ≥ 5 points improvement in VFQ-25 composite score compared to 30.1% in the sham group.
U 24. mjesecu, 51,4% bolesnika u JETREA skupini imalo je poboljšanje ≥ 5 bodova u VFQ-25 kompozitnom rezultatu u odnosu na 30,1% u placebo skupini.
The diagnosis of vitreomacular traction (VMT) should comprise of a complete clinical picture including patient history, clinical examination and investigation using currently accepted diagnostic tools, such as optical coherence tomography (OCT).
Dijagnoza vitreokmakularne trakcije (VMT) se mora sastojati od kompletne kliničke slike, uključujući bolesnikovu anamnezu, klinički pregled i ispitivanje korištenjem trenutno prihvaćenih dijegnostičkih sredstava, kao što je optička koherentna tomografija (OCT).
Pathological changes related to intraocular haemorrhage were observed in rabbits and monkeys.
Patološke promjene povezane s intraokularnim krvarenjem zamijećene su u kunića i majmuna.
The visual acuity decrease had resolved by the end of the studies for the majority of JETREA patients (80.6%) but there were some patients who had not recovered despite vitrectomy.
Smanjenje vidne oštrine povuklo se do kraja ispitivanja kod većine bolesnika koji su primali JETREU (80,6%) , ali je bilo i nekih bolesnika koji se nisu oporavili unatoč vitrektomiji.
If you have any further questions on the use of this medicine, ask your doctor/ophthalmologist.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku/oftalmologu.
The effect of ocriplasmin (particularly in inducing resolution of vitreomacular adhesion or causing total posterior vitreous detachment [PVD]) is reduced in subjects with an epiretinal membrane (ERM) or a diameter of VMA > 1500 microns (see section 5.1).
Učinak okriplazmina (osobito u indukciji uklanjanja vitreomakularne adhezije ili uzrokovanju potpunog stražnjeg odvajanja staklovine smanjen je u osoba s epiretinalnom membranom (ERM) ili s VMA promjera > 1500 mikrona (vidjeti dio 5.1).
Information about storage and the time to use Jetrea once it has been thawed and diluted are described in the section intended for healthcare professionals only.
Informacije o čuvanju i vremenu u kojem se Jetrea treba primijeniti nakon odmrzavanja i razrjeđivanja opisane su u poglavlju namijenjenom samo za zdravstvene radnike.
The systemic toxicity of ocriplasmin has been evaluated in both rat and dog.
Sistemska toksičnost okriplazmina ispitana je u štakora i pasa.
What you need to know before you are given Jetrea 3.
Što morate znati prije nego primite Jetreu
The systemic exposure of JETREA is expected to be very low after intravitreal injection.
Očekuje se da je sistemska izloženost JETREI nakon intravitrealne injekcije vrlo niska.
The main reasons for vitrectomy were retinal detachment and retinopathy of prematurity.
Osnovni razlozi za vitrektomiju bili su ablacija mrežnice i retinopatija nedonoščadi.
The patient also developed mild conjunctival hyperaemia, eye inflammation and miosis which resolved with corticosteroid eye drops.
Bolesnik je razvio i blagu hiperemiju konjunktive, upalu oka i miozu koje su prošle nakon primjene kortikosteroidnih kapi za oči.
See section 4.4 for instructions on post-injection monitoring.
Vidjeti dio 4.4 za upute o praćenju nakon davanja injekcije.
Talk to your doctor/ophthalmologist before you are given Jetrea.
Posavjetujte se s liječnikom/oftalmologom prije nego što primite Jetreu.
Repeated administration of JETREA in the same eye has not been adequately studied and is therefore not recommended.
Ponovna primjena JETREE u isto oko nije primjereno ispitana te se stoga ne preporučuje.
There is no relevant use of JETREA in children aged under 18 years for the indication of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.
Nema relevantne primjene JETREE u u djece u dobi ispod 18 godina za indikaciju vitreomakularne trakcije (VMT), uključujući kada je povezana s makularnom rupom promjera manjeg ili jednakog 400 mikrona.
- Symptoms such as fluctuation of vision, double vision, headache, halos around light, nausea and vomiting have been reported in up to 1 in 100 patients and may be the signs of a displacement or wobbling of the lens in the eye from its normal position.
- Simptomi poput promjenjivog vida, dvoslike, glavobolje, krugova oko svjetla u vidnom polju, mučnine i povraćanja prijavljivani su u do 1 na 100 bolesnika i mogu biti znaci pomaka ili nestabilnosti leće u oku s njena normalnog položaja.
JETREA should be used during breast-feeding only if the clinical benefit outweighs the potential risks.
JETREA se smije davati tijekom dojenja samo ako se ocijeni da klinička korist nadmašuje moguće rizike.
Ocriplasmin levels in the vitreous decrease rapidly after intravitreal administration.
Razine okriplazmina u staklovini naglo se snižavaju nakon intravitrealne primjene.
Early progression rates of full-thickness macular hole (until Day 7 post-injection) at RPE (retinal pigment epithelium) level were higher in the JETREA treated patients compared to sham or placebo.
Stope rane progresije makularne rupe pune debljine (do 7. dana nakon injekcije) na razini retinalnog pigmentnog epitela (RPE) bile su veće kod bolesnika liječenih JETREOM nego u bolesnika koji su primali placebo.
Fertility There are no data on the effect of JETREA on fertility.
Nema podataka o učinku JETREE na plodnost.
Tell your doctor/ophthalmologist if you have or have had any eye conditions or eye treatments.
Obavijestite liječnika/oftalmologa ako imate ili ste imali bilo koji poremećaj oka ili ako ste liječili oko.
In rabbits and monkeys, the incidence of vitreous cell infiltrates tended to resolve over time.
U kunića i majmuna je stanični infiltrat u staklovini pokazivao tendenciju povlačenja s vremenom.
ERG changes were not predictive of negative outcomes in terms of visual acuity; visual acuity improved or was maintained in 15 out of 16 patients compared to baseline.
Promjene ERG-a nisu bile prediktivne za negativni ishod s obzirom na vidnu oštrinu; vidna oštrina poboljšala se ili je zadržana kod 15 od 16 bolesnika u usporedbi sa početnom.
Do not use this medicine after the expiry date which is stated on the label and on the carton after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji nakon oznake EXP ili „Rok valjanosti“.
FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED Belasis Avenue
UK LIMITED Belasis Avenue
Therefore administration to both eyes concurrently is not recommended.
Stoga se za sada primjena u oba oka istodobno ne preporučuje.
JETREA 0.375 mg/0.3 mL solution for injection is a ‘ready-diluted' formulation, no further dilution is required.
JETREA 0,375 mg/0,3 ml otopina za injekciju je pripremljena razrijeđena formulacija; nije potrebno daljnje razrijeđivanje.
The most common reason for performing vitrectomy was FTMH (in 24.8% JETREA treated patients and 23.3 % sham patients).
Najčešći razlog za obavljanje vitrektomije bila je FTMH (u 24,8 % bolesnika liječenih JETREOM i 23,3 % onih koji su primali placebo).
Because of the small dose administered (0.125 mg), detectable levels of ocriplasmin in systemic circulation are not expected after intravitreal injection.
Zbog male primijenjene doze (0,125 mg), ne očekuju se mjerljive razine okriplazmina u sistemskoj cirkulaciji nakon intravitrealne injekcije.
After thawing, unopened vial may be stored for up to 1 week in a refrigerator.
Neotvorena bočica može se čuvati u hladnjaku najviše tjedan dana nakon odmrzavanja.
3 years when stored in a freezer (-20 °C ± 5 °C).
3 godine kada se čuva u zamrzivaču (-20 °C ± 5°C)
Some tests and imaging of the back of the eye (retina) have been found to be abnormal after Jetrea administration.
Neki testovi i snimke stražnjeg dijela oka (mrežnice) bili su neoubičajeni nakon primjene Jetree.
Figure 1: Proportion of patients with VMA resolution up to Day 180 (Month 6) (TG-MV-006, TG-MV-007 and integrated data)
Udio bolesnika u kojih se VMA povukla do 180. dana (6 mjeseci) (TG-MV-006, TG-MV-007 i integrirani podaci)
The remaining sodium chloride 9 mg/mL (0.9%) solution for injection should be discarded.
Preostalu 0,9 %-tnu (9 mg/ml) otopinu natrijeva kloridna za injekciju treba baciti.
Treatment with ocriplasmin did not demonstrate an effect on posterior vitreous detachment rate, vitreous liquefaction grade, immediate postoperative retinal reattachment rate, development of proliferative vitreoretinopathy, or stage of retinopathy of prematurity.
Liječenje okriplazminom nije pokazalo utjecaj na stopu ablacije stražnje staklovine, stupanj likvefakcije staklovine, stopu prilijeganja mrežnice neposredno nakon operacije, razvoj proliferativne vitreoretinopatije ili stadij retinopatije kod nedonoščadi.
Transient increases in IOP including transient blindness and non-perfusion of the optic nerve have been seen within 60 minutes of injection of JETREA.
Prolazna povišenja IOT-a, uključujući prolaznu sljepoću i izostanak perfuzije vidnog živca, zamijećeni su unutar 60 minuta nakon injekcije JETREE.
However, after treatment, a higher proportion of patients in the JETREA group had a change from an intact IS/OS band at baseline to an incomplete IS/OS band in the central area at a later time point compared with the sham group (7.7% and 2.8%, respectively at Day 28).
Ipak, nakon liječenja, veći udio bolesnika u JETREA skupini imao je promjenu od netaknutog IS/OS sloja na početku mjerenja do nepotpunog IS/OS sloja u središnjem području u kasnijoj vremenskoj točki u odnosu na placebo skupinu (7,7% odnosno 2,8% u 28. danu).
Remove the vial from the freezer and allow to thaw at room temperature (takes about 2 minutes).
Izvadite bočicu iz zamrzivača i ostavite da se sadržaj odmrzne pri sobnoj temperaturi (potrebno je oko 2 minute).
Of these, 30% of JETREA treated patients and 15.4% of patients in the sham group experienced non-surgical FTMH closure at Month 24.
Od njih, 30 % bolesnika liječenih JETREOM i 15,4 % bolesnika u placebo skupini imali su nekirurško zatvaranje FTMH-a u 24. mjesecu.
For storage conditions after thawing and opening/dilution of the medicinal product, see section 6.3.
Za uvjete čuvanja nakon odmrzavanja i otvaranja/razrjeđivanja lijeka vidjeti dio 6.3.
• Patient information leaflet
• Informativna pakiranja za bolesnike
A total of 220 patients (JETREA 146, sham 74) were randomised in this study.
Ukupno 220 bolesnika (JETREA 146, placebo 74) randomizirano je u ovom ispitivanju.
The proportion of patients who underwent vitrectomy was smaller in the JETREA group than in the sham group at all visits.
Udio bolesnika koji su imali vitrektomiju bio je manji u JETREA skupini u odnosu na placebo skupinu kod svih posjeta.
Intravitreal use after dilution
Intravitrealna primjena nakon razrjeđivanja
Intravenous administration of 10 mg/kg was generally well tolerated in both rat and dog whether administered as single dose or as repeated dose.
Dozu od 10 mg/ml, primijenjenu intravenski, općenito su dobro podnosili i štakori i psi, bez obzira je li primijenjena jednokratno ili opetovano.
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).
Pedijatrijska populacija Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja JETREE u svim podskupinama pedijatrijske populacije pri liječenju vitreomakularne trakcije (VMT), uključujući kada je ona povezana s makularnom rupom promjera manjeg ili jednakog 400 mikrona (vidjeti dio 4.2 informacije o pedijatrijskoj primjeni).
The difference continued to be statistically significant through Month 6 in each study (p≤0.024).
Razlika je u oba ispitivanja ostala statistički značajna do kraja 6. mjeseca (p≤0,024).
There are no data for the use of JETREA in pregnant women.
Nema podataka o primjeni JETREE trudnicama.
To prepare Jetrea for intravitreal injection, adhere to the following instructions: 1.
Za pripravu JETREE za intravitrealnu injekciju pridržavajte se niže navedenih uputa:
JETREA is administered by intravitreal injection only.
JETREA se primjenjuje samo intravitrealnom injekcijom.
0.2 mL solution in a vial (type I glass) closed with a chlorobutyl rubber stopper and an orange polypropylene flip-off cap.
0,2 ml otopine u bočici (staklo tipa I) zatvorenoj čepom od klorbutilne gume i sa narančastom polipropilenskom flip-off kapicom.
The ≥ 2 or ≥ 3 lines gain in BCVA without vitrectomy favoured JETREA over sham both at Month 6 (26.8%, 14.0%, vs. 15.62%, 6.2%, respectively) and Month 24 (31.9%, 16.8%, vs. 11,7%, 4.1%, respectively).
Poboljšanje ≥ 2 ili ≥ 3 reda BCVA bez vitrektomije bilo je veće u JETREA skupini nego u placebo skupini i u 6. mjesecu (26,8%, 14,0%, naspram 15,62%, 6,2%) i u 24. mjesecu (31,9%, 16,8%, naspram 11,7%, 4,1%).
At all post-injection days, p≤0.024 in TG-MV-006, p≤0.009 in TG-MV-007, p<0.001
U sv im danima nakon injekcije p≤0.024 u TG-MV-006, p≤0.009 u TG-MV-007, p<0.001 u integriranim podacima
Store in a freezer (-20 °C ± 5 °C).
Čuvati u zamrzivaču (-20 °C ± 5 °C).
Lens subluxation was observed in 3 animal species at ocriplasmin concentrations above the intended clinical concentration (see section 5.3).
Subluksacija leće zamijećena je u tri životinjske vrste pri koncentracijama okriplazmina većima od one za kliničku primjenu (vidjeti dio
If any of the above events occur the patient should be treated according to standard medical practice.
Dogodi li se bilo što od gore navedenog, bolesnika treba liječiti u skladu sa standardnom medicinskom praksom.
The incidence of retinal detachment that occurred pre-vitrectomy was 0.4% in the JETREA group and none in the placebo group, while the incidence of retinal tears (without detachment) that occurred pre-vitrectomy was 0.2% in the JETREA group and 0.5% in the placebo group.
Incidencija odignuća mrežnice, koje su se dogodile prije vitrektomije, iznosila je 0,4% u skupini koja je primila injekciju JETREE i nula u onoj koja je primila injekciju placeba, dok je incidencija ruptura mrežnice (bez odignuća), koje su se dogodile prije vitrektomije, iznosila 0,2% u skupini koja je primila injekciju JETREE i 0,5% u onoj koja je primila placebo.
Jetrea is given as an injection into the eye.
Jetrea se daje injekcijom u oko.
This effect was maintained over time and VMA resolution was consistently greater in the JETREA group at each post-injection study visit compared with the sham group.
Ovaj se učinak održao tijekom vremena i povlačenje VMA bilo je dosljedno veće u JETREA skupini kod svakog posjeta nakon injekcije u ispitivanju, u usporedbi sa placebo skupinom.
2) including scotoma
1) uključujući zamagljeni vid 2) uključujući skotome
Preoperative antibiotic drops may be administered at the discretion of the treating ophthalmologist.
Preoperativno se mogu primjeniti antibiotske kapi prema odluci oftalmologa zaduženog za liječenje.
The periocular skin, eyelid and ocular surface should be disinfected and adequate anaesthesia and a broad spectrum topical microbiocide should be administered prior to the injection according to standard medical practice.
Površinu kože oko oka kao i površinu vjeđe i oka treba prije injekcije dezinficirati, te dati prikladnu anesteziju i površinski mikrobicid širokog spektra u skladu sa standardnom medicinskom praksom.
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.
U ovom ispitivanju, FTMH je bio prisutan na početku ispitivanja kod 50/145 (34,5%) bolesnika u JETREA skupini i 26/73 (35,6%) u placebo skupini.
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).
Primjenom aseptičke tehnike, razrijedite dodavanjem 0,2 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekciju (sterilna, bez konzervansa, nepuferirana) u bočicu s Jetreom (Slika 3) i pažljivo vrtite bočicu dok se tekućine ne izmiješaju (Slika 4).
The difference was maintained from Day 7 through Month 6
Razlika se održavala od 7. dana do kraja 6. mjeseca (Slika 1).
Studies TG-MV-006 and TG MV-007
Ispitivanja TG-MV-006 i TG MV-007
No dose adjustment or special considerations are anticipated for patients with hepatic impairment (see section 5.2).
Ne predviđaju se prilagođavanje doze ni posebna upozorenja za bolesnike s oštećenjem funkcije jetre (vidjeti dio 5.2).