natgillin/translations-raw huggingface dataset:
In clinical trials in mild to severe dementia, involving 1,784 patients treated with Axura and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Axura did not differ from those with placebo; the adverse reactions were usually mild to moderate in severity.
1595 ih je dobivalo placebo sveukupna stopa incidencije nuspojava u skupini liječenoj Axurom nije se razlikovala od stope incidencije nuspojava u skupini koja je primala placebo.
Week 4 (day 22-28): Take one 20 mg tablet per day (grey-red, oval-oblong) for 7 days.
4. tjedan (22.-28. dan): Uzimajte jednu tabletu od 20 mg dnevno (sivo-crvenu, duguljasto ovalnu) tijekom 7 dana.
From Week 4 on: The patient should take one 20 mg film-coated tablet per day.
Bolesnik treba uzimati jednu filmom obloženu tabletu od 20 mg dnevno.
EU/1/02/218/005 EU/1/02/218/006 EU/1/02/218/011
EU/1/02/218/005 EU/1/02/218/006
How to store Axura
Kako čuvati Axuru
one pump actuation week 2
1. tjedan jedan potisak pumpice
Very rare (may affect up to 1 in 10,000 users): • Seizures
Vrlo rijetke (mogu se javiti u do 1 na 10 000 osoba):
The other ingredients are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, and magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E 171) and iron oxide yellow (E 172) all in the tablet coating.
Drugi sastojci su: mikrokristalična celuloza,umrežena karmelozanatrij, koloidni bezvodni silicijev dioksid i magnezijev stearat, sve u jezgri tablete; te hipromeloza, makrogol 400, titanijev dioksid (E 171) i žuti željezov oksid (E 172), sve u ovojnici tablete.
The other ingredients are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E 171), iron oxide yellow and red (E 172), all in the tablet coating.
Drugi sastojci su: mikrokristalična celuloza, umrežena karmelozanatrij, koloidni bezvodni silicijev dioksid i magnezijev stearat, sve u jezgri tablete; te hipromeloza, makrogol 400, titanijev dioksid (E 171) i žuti željezov oksid, žuti i crveni (E 172), sve u ovojnici tablete.
The other ingredients for Axura 5/10/15 and 20 mg film-coated tablets are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E 171) and additional for Axura 10 mg film-coated tablets is iron oxide yellow (E 172) and for Axura 15 mg and Axura 20 mg film-coated tablets are iron oxide yellow and red (E 172), all in the tablet coating.
umrežena karmelozanatrij, koloidni bezvodni silicijev dioksid i magnezijev stearat sve u jezgri tablete; te hipromeloza, makrogol 400, titanijev dioksid (E 171) i dodatno za Axura 10 mg filmom obložene tablete žuti željezov oksid (E 172), a za Axura 15 mg i Axura 20 mg filmom obložene tablete žuti i crveni željezov oksid (E 172), sve u ovojnici tablete.
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer´s disease cooperative study - activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
U 6. mjesecu ispitivanja pokazani su povoljni učinci liječenja memantinom u usporedbi s placebom (analiza opaženih slučajeva za promjene bazirane na dojmu kliničara nakon intervjua (CIBIC-plus; engl. the clinician´s interview based impression of change): p=0,025; kooperativno ispitivanje
Axura should be administered orally once a day.
Axuru treba primjenjivati na usta jedanput na dan.
Package leaflet: Information for the user Axura 5 mg/pump actuation, oral solution
Uputa o lijeku: Informacija za korisnika Axura 5 mg/potisak, oralna otopina memantinklorid
Do not use Axura after the expiry date which is stated on the carton and the blister after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kartonskoj kutiji i blisteru nakon “Rok valjanosti”.
• There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is co-administered with HCT or any combination with HCT.
• Pri istodobnoj primjeni memantina i hidroklorotiazida (HCT-a) ili bilo koje od kombinacija s
Axura 5 mg/pump actuation, oral solution Memantine hydrochloride
Axura 5 mg/potisak, oralna otopina memantinklorid
Axura 15 mg 7 film-coated tablets.
Axura 15 mg 7 filmom obloženih tableta.
Axura 5 mg film-coated tablets Axura 10 mg film-coated tablets Axura 15 mg film-coated tablets Axura 20 mg film-coated tablets Memantine hydrochloride
Axura 5 mg filmom obložene tablete Axura 10 mg filmom obložene tablete Axura 15 mg filmom obložene tablete Axura 20 mg filmom obložene tablete memantinklorid
Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets
Axura 5 mg+10 mg+15 mg+20 mg filmom obložene tablete
One treatment initiation pack contains 28 tablets in 4 blisters with 7 tablets of Axura 5 mg, 7 tablets of Axura 10 mg, 7 tablets of Axura 15 mg and 7 tablets of Axura 20 mg.
7 Axura tableta od 10 mg, 7 Axura tableta od 15 mg i 7 Axura tableta od 20 mg.
Do not use Axura after the expiry date which is stated on the carton and the bottle label after the EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kartonskoj kutiji i naljepnici boce nakon “Rok valjanosti”.
Axura 20 mg film-coated tablets Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Axura 20 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 20 mg memantinklorida, što odgovara 16,62 mg memantina.
In patients with moderate renal impairment (creatinine clearance 30-49 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations).
30-49 ml/min), dnevna doza bi trebala biti 10 mg (1 ml otopine, što odgovara dva potiska pumpice).
Axura 10 mg 7 film-coated tablets.
Axura 10 mg 7 filmom obloženih tableta.
From Week 4 on: The patient should take 2 ml solution (20 mg) equivalent to four pump actuations once a day.
Bolesnik treba uzimati 2 ml otopine (20 mg) što odgovara četiri potiska pumpice dnevno.
Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets Axura 20 mg film-coated tablets
Axura 5 mg+10 mg+15 mg+20 mg filmom obložene tablete Axura 20 mg filmom obložene tablete
Axura 5 mg 7 film-coated tablets.
Axura 5 mg 7 filmom obloženih tableta.
Axura 20 mg film-coated tablets
Axura 20 mg filmom obložene tablete
Axura 10 mg film-coated tablets Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Axura 10 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 10 mg memantinklorida, što odgovara 8,31 mg memantina.
Axura 5 mg, 10 mg, 15 mg, 20 mg film-coated tablets Memantine hydrochloride
Axura 5 mg, 10 mg, 15 mg, 20 mg filmom obložene tablete memantinklorid
Memantine-treated patients showed a statistically significantly better effect than placebo-treated patients on the primary endpoints: Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 last observation carried forward (LOCF).
Alzheimer´s disease assessment scale) (p=0,003) i CIBIC-plus (p=0,004) u 24. tjednu liječenja (zadnje opažanje preneseno dalje (LOCF; engl. last observation carried forward)).
Axura 10 mg film-coated tablets
Axura 10 mg filmom obložene tablete
- if you are allergic (hypersensitive) to memantine hydrochloride or any of the other ingredients of Axura oral solution (listed in section 6).
- ako ste alergični (preosjetljivi) na memantinklorid ili neki drugi sastojak Axura oralne otopine
Axura 10 mg film-coated tablets Memantine hydrochloride
Axura 10 mg filmom obložene tablete memantinklorid
Axura 20 mg film-coated tablets Memantine hydrochloride
Axura 20 mg filmom obložene tablete memantinklorid
Axura 5 mg/pump actuation, oral solution
Axura 5 mg/potisak, oralna otopina
• Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)
Manje česte (mogu se javiti u do 1 na 100 osoba): • umor, gljivične infekcije, smetenost, halucinacije, povraćanje, poremećaj hoda, zatajenje srca i zgrušavanje venske krvi (tromboza/tromboembolija)
Axura 5 mg film-coated tablets are presented as white to off-white, oval-oblong with imprint ‘5' on one side and imprint ‘MEM' on the other side.
Axura 5 mg filmom obložene tablete su bijele do gotovo bijele, ovalno duguljaste s utisnutom oznakom ‘5' na jednoj strani i ‘MEM' na drugoj strani.
Uncommon (may affect up to 1 in 100 users):
Česte(mogu se javiti u do 1 na 10 osoba):
The 10 mg film-coated tablets are pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings "1-0" on one side and "M M" on the other side.
Filmom obložene tablete od 10 mg su blijedožute do žute, filmom obložene tablete ovalnog oblika, s razdjelnom crtom i utisnutom oznakom “1-0” na jednoj strani i “M M” na drugoj strani.
Axura 15 mg film-coated tablets are presented as orange to grey-orange, oval-oblong with imprint ‘15' on one side and imprint ‘MEM' on the other side.
Axura 15 mg filmom obložene tablete su narančaste do sivo-narančaste, ovalno duguljaste s utisnutom oznakom ‘15' na jednoj strani i ‘MEM' na drugoj strani.
Week 1 (day 1-7): The patient should take half a 10 mg film-coated tablet (5 mg) per day for 7 days.
Bolesnik treba uzimati jednu i pol filmom obloženu tabletu od 10 mg (15 mg) dnevno tijekom 7 dana.
Axura 20 mg film-coated tablets are presented as are pale red to grey-red, oval-oblong with imprint ‘20' on one side and imprint ‘MEM' on the other side.
Axura 20 mg filmom obložene tablete su blijedocrvene do sivo-crvene, ovalno duguljaste s utisnutom oznakom ‘20' na jednoj strani i ‘MEM' na drugoj strani.
Axura film-coated tablets are presented as pale red to grey-red, oval-oblong film-coated tablets with imprint ‘20' on one side and imprint ‘MEM' on the other side.
Axura filmom obložene tablete su blijedocrvene do sivo-crvene, ovalno duguljaste filmom obložene tablete s utisnutom oznakom ‘20' na jednoj strani i ‘MEM' na drugoj strani.
Gastrointestinal disorders
- oralnih antikoagulansa
Tél: +352 45 07 07-1
HANFF Global Health Solutions s.à r.l. Tél: +352 45 07 07-1
Axura film-coated tablets are presented as pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings "1-0" on one side and "M M" on the other side.
Axura filmom obložene tablete su blijedožute do žute boje, filmom obložene tablete ovalnog oblika s razdjelom crtom i utisnutim oznakama “1-0” na jednoj strani te “M M” na drugoj strani.
In patients with moderate renal impairment (creatinine clearance 30-49 ml/min) daily dose should be 10 mg per day.
30-49 ml/min), dnevna doza bi trebala biti 10 mg na dan.
Additional for 15 mg and 20 mg film-coated tablets: Iron oxide yellow and red (E 172)
željezov oksid, žuti i crveni (E 172) Axura 20 mg filmom obložene tablete
Each pack of 28 film- coated tablets for a 4 week treatment schedule contains: 7 x Axura 5 mg
Svako pakiranje s 28 filmom obloženih tableta za plan liječenja za 4 tjedna sadrži:
Week 3 (day 15-21): The patient should take one 15 mg film-coated tablet per day (grey-orange, oval-oblong) for 7 days.
Bolesnik treba uzimati jednu filmom obloženu tabletu od 15 mg (sivo-narančastu, duguljasto ovalnu) dnevno tijekom 7 dana.
If the pump does not function properly, consult your doctor or a pharmacist.Lock the dosing pump after using Axura.
Obratite se svom liječniku ili ljekarniku prije nego uzmete Axura
Tablet coating for 5/10/15/20 mg film-coated tablets Hypromellose
Drugi sastojci Axura 5/ 10/ 15 i 20 mg filmom obloženih tableta su mikrokristalična celuloza,
Tablet coating
Često omaglica
List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration and marketing authorisation holders in the Member States
Popis naziva, farmaceutskih oblika, jačina lijekova, putova primjene i nositelja odobrenja u državama članicama
Radnička cesta 80 10000 Zagreb Croatia
AstraZeneca d.o.o. Radnička cesta 80 10000 Zagreb Croatia
C/ Serrano Galvache 56, 28033 Madrid,
C/ Serrano Galvache 56,
Palazzo Galileo, Via F. Sforza, 20080 Basiglio (MI), Italy
Sforza, 20080 Basiglio (MI), Italy
AstraZeneca BV Louis Pasteurlaan 5 2719 EE Zoetermeer The Netherlands
Nizozemska AstraZeneca BV Louis Pasteurlaan 5
AstraZeneca Farmacéutica Spain, S.A. Parque Norte.Edificio Roble.
Parque Norte.Edificio Roble.
AstraZeneca UK Ltd. 2 Kingdom Street, London W2 6BD, United Kingdom
2 Kingdom Street, London W2 6BD, United Kingdom
Crestor 20 mg 20 mg
CRESTOR 20 mg
CRESTOR 40 mg 40mg
CRESTOR 40 mg
• Some medicine may be present in your tears.
• Nešto bi lijeka moglo biti prisutno u Vašim suzama.
4 days (including the day of administration)
4 dana (uključujući dan primjene)
Followed by 5 days
Nakon čega slijedi 5 dana
This will be repeated on your other eye at least 6 days afterwards.
Ovo će se ponoviti na Vašem drugom oku nakon barem 6 dana.
31 subjects were enrolled, 13 males and 18 females.
Bio je uključen 31 ispitanik, 13 muških i 18 ženskih.
Your doctor will talk to you about the anaesthesia and how it will be given to you.
Liječnik će razgovarati s Vama o anesteziji i o tome kako ćete je dobiti.
If it does occur, your doctor will treat the symptoms as necessary.
Ako dođe do toga, liječnik će liječiti Vaše simptome prema potrebi.
Control, N = 10
Kontrolna skupina, N = 10
• Change of the electrical activity of the heart
• Promjena električne aktivnosti srca
Do not stop taking the medicine without first talking to your doctor.
Nemojte prestati uzimati lijek a da prije toga ne razgovarate s liječnikom.
Vertical dotted lines represent additional 25% above and below the box.
Okomite isprekidane linije predstavljaju dodatnih 25% iznad i ispod pravokutnika.
Followed by 5 days of one dose every other day
Nakon čega slijedi 5 dana primjene jedne doze svaki drugi dan
Study 301 was an open-label, randomised, controlled study.
Ispitivanje 301 bilo je otvoreno, randomizirano, kontrolirano ispitivanje.
The virus used to deliver the gene does not cause disease in humans.
Virus koji se koristi za isporuku gena ne uzrokuje bolest u ljudi.
22 November 2018
22. studenog 2018.
What Luxturna is and what it is used for
Što je Luxturna i za što se koristi
There are no known clinically significant interactions.
Nema poznatih klinički značajnih interakcija.
Your doctor may be able to help reduce any discomfort caused by these temporary disturbances.
Liječnik bi Vam mogao pomoći smanjiti moguću nelagodu uzrokovanu tim privremenim smetnjama.
Patients may resume swimming and strenuous activity, after a minimum of one to two weeks, on the advice of their healthcare professional.
Bolesnici mogu nastaviti s plivanjem i napornim aktivnostima nakon najmanje jednog do dva tjedna, prema savjetu svog zdravstvenog radnika.
The interval between injection to the eyes for each subject was from 6 to 18 days.
Interval između injekcija u pojedino oko za svakog ispitanika bio je od 6 do 18 dana.
The effects of this medicine on pregnancy and the unborn child are not known.
Učinci ovog lijeka na trudnoću i nerođeno dijete nisu poznati.
10 subjects were randomised to the control (non-intervention) group.
Deset ispitanika bilo je randomizirano u kontrolnu (neintervencijsku) skupinu.
Luxturna is given under anaesthesia.
Luxturna se daje pod anestezijom.
Please talk to your doctor before travelling.
Razgovarajte sa svojim liječnikom prije putovanja.
After receiving Luxturna:
Nakon što primite Luxturnu:
The average age was 15 years (range 4 to 44 years), including 64% paediatric subjects (n=20, age from 4 to 17 years) and 36% adults (n=11).
Prosječna dob bila je 15 godina (raspon od 4 do 44 godine), uključujući 64% pedijatrijskih ispitanika (n=20, dob od 4 do 17 godina) i 36% odraslih (n=11).
Immunomodulatory regimen
Imunomodulacijski režim
No dose adjustment is required in these patients (see section 5.2).
Nije potrebna prilagodba doze u tih bolesnika (vidjeti dio 5.2).
Accidental exposure must be avoided.
Mora se izbjegavati slučajno izlaganje.
It is important that you take this medicine according to the instructions given.
Važno je da uzimate lijek prema uputama koje dobijete.
o Inform healthcare professionals that the patient has received gene therapy, and the importance of reporting adverse events.
o Obavještava zdravstvene radnike da je bolesnik primio gensku terapiju i o važnosti prijavljivanja štetnih događaja.
As a precaution, you should not receive Luxturna while you are pregnant.
Kao predostrožnost, ne smijete primiti Luxturnu tijekom trudnoće.
Your doctor may delay your treatment until your infection is gone because this medicine may make it more difficult for you to fight an infection.
Liječnik bi mogao odgoditi Vaše liječenje dok se infekcija ne povuče zato što bi ovaj lijek mogao otežati borbu protiv infekcije.
You will need to stay for post-operative observation for a few hours after each procedure to monitor your recovery and watch for any side effects from the surgery or the anaesthesia.
Morat ćete ostati radi postoperativnog promatranja nekoliko sati nakon svakog zahvata kako bi se pratio Vaš oporavak i nuspojave operacije ili anestezije.
Repeat the same procedure to prepare a backup syringe.
Ponovite isti postupak za pripremu rezervne štrcaljke.
• Tell your doctor if you have an active infection of any sort.
• Obavijestite liječnika ako imate bilo kakvu aktivnu infekciju.
Each box represents the middle 50% of distribution of MLMT score change.
Svaki pravokutnik predstavlja srednjih 50% distribucije promjene rezultata za MLMT.
Children and adolescents Luxturna has not been studied in children under four years of age.
Djeca i adolescenti Luxturna nije bila ispitivana u djece ispod četiri godine starosti.
Do not drive or use heavy machines until your vision has recovered.
Nemojte upravljati vozilima ili teškim strojevima dok Vam se vid ne oporavi.
What you need to know before you are given Luxturna
Što morate znati prije nego dobijete Luxturnu
Nonclinical biodistribution
Neklinička biodistribucija
This enables the retina to produce the proteins needed for vision.
To omogućuje mrežnici da proizvede proteine koji su potrebni za vid.
If you are pregnant or breast-feeding, think you might be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before being treated with Luxturna.
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili medicinskoj sestri za savjet prije liječenja Luxturnom.
If any of the above applies to you, or if you are unsure of any of the above, please talk to your doctor before you receive Luxturna.
Ako se bilo što od navedenog odnosi na Vas ili ako niste sigurni oko nečega od navedenog, obratite se svom liječniku prije nego primite Luxturnu.
Tell your doctor or nurse if you have any visual problems.
Obavijestite svog liječnika ili medicinsku sestru ako imate bilo kakve probleme s vidom.
Information on how to obtain the special formats will be provided in the patient card.
Informacija kako doći do posebnih formata bit će navedena u kartici za bolesnika.
This leaflet is available as an audio file and in a large print from the web site: http://www.voretigeneneparvovec.support
Ova je uputa dostupna kao audio datoteka i s većim slovima na internetskoj stranici: http://www.voretigeneneparvovec.support
The adverse reactions are listed by system organ class and frequency using the following convention: very common (≥1/10), common ≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Nuspojave su navedene prema klasifikaciji organskih sustava i učestalosti prema sljedećoj konvenciji: vrlo često (≥1/10), često ≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Patients and their caregivers should be provided with the patient information pack, including:
Bolesnike i njihove skrbnike je potrebno opskrbiti paketom informacija za bolesnika, koji uključuje:
The development or worsening of cataracts is a known complication of the eye surgery that will be required before you receive Luxturna.
Razvoj ili pogoršanje mrena poznata je komplikacija operacije oka koja će biti potrebna prije nego primite Luxturnu.
This medicinal product must not be administered by intravitreal injection.
Ovaj se lijek ne smije primjenjivati intravitrealnom injekcijom.
Temporary visual disturbances, such as blurred vision and photophobia, may occur during the weeks that follow the treatment.
Privremene vidne smetnje, kao što su zamućeni vid i fotofobija, mogu nastupiti tijekom tjedana koji uslijede nakon liječenja.
You should follow these precautions for 14 days.
Tih mjera opreza trebate se pridržavati 14 dana.
In the Phase 3 study, the MLMT used seven levels of illumination ranging from 400 lux to 1 lux (corresponding to, for example, a brightly lit office down to a moonless summer night).
U ispitivanju faze 3, MLMT je koristio sedam razina osvjetljenja u rasponu od 400 luksa do 1 luksa (što odgovara, primjerice, rasponu od dobro osvijetljenog ureda do ljetne večeri bez mjesečine).
You will not be given Luxturna if you are allergic to voretigene neparvovec or any of the other ingredients of this medicine (listed in section 6) if you have an eye infection if you have eye inflammation
Nećete dobiti Luxturnu ako ste alergični na voretigen neparvovek ili neki drugi sastojak ovog lijeka (naveden u dijelu 6) ako imate infekciju oka ako imate upalu oka
What Luxturna is and what it is used for What you need to know before you are given Luxturna How Luxturna is given to you Possible side effects
Što je Luxturna i za što se koristi Što morate znati prije nego dobijete Luxturnu Kako se Luxturna primjenjuje Moguće nuspojave
Ocular or periocular infection.
Okularna ili periokularna infekcija.
During treatment with this medicine, the doctor inserts an air bubble in the eye, which is slowly absorbed by your body.
Tijekom liječenja ovim lijekom, liječnik uvodi mjehurić zraka u oko, koji Vaše tijelo polako apsorbira.
Results of full-field light sensitivity testing at the first study year: white light [Log10(cd.s/m2)] are shown in Table 5 below.
Rezultati testiranja fotoosjetljivosti u punom vidnom polju u prvoj godini ispitivanja: bijela svjetlost [Log10(cd.s/m2)] prikazani su u Tablici 5 u nastavku.
One subject in the control group withdrew consent and was discontinued from the study.
Jedan je ispitanik u kontrolnoj skupini povukao pristanak i prekinuo sudjelovanje u ispitivanju.
Effects on male and female fertility have not been evaluated in animal studies.
Učinci na mušku i žensku plodnost nisu bili procjenjivani u ispitivanjima na životinjama.
Serious adverse reactions related to the administration procedure were reported in three subjects during the clinical programme.
Ozbiljne nuspojave povezane s postupkom primjene bile su zabilježene u tri ispitanika tijekom kliničkog programa.
Tell your doctor about any visual disturbances that you experience.
Obavijestite svoga liječnika o vidnim smetnjama koje primijetite.
D30, D90, D180: 30, 90 and 180 days after start of study;
D30, D90, D180: 30, 90 i 180 dana nakon početka ispitivanja;
Follow these precautions for 14 days after the treatment.
Slijedite ove mjere opreza tijekom 14 dana nakon liječenja.
There is no information on the effect of Luxturna on male or female fertility.
Nema informacija o učinku Luxturne na mušku i žensku plodnost.
30 June 2030
30. lipanj 2030.
The qualified staff (i.e. vitreoretinal surgeons and pharmacists) at the treatment centres should be provided with educational materials including:
Kvalificiranom osoblju (tj. vitreoretinalnom kirurgu i ljekarniku) u centru za liječenje potrebno je osigurati edukacijske materijale koji uključuju:
Initiation of the immunomodulatory regimen for the second eye should follow the same schedule and supersede completion of the immunomodulatory regimen of the first eye.
Započinjanje imunomodulacijskog režima za drugo oko treba pratiti isti raspored i zamijeniti dovršetak imunomodulacijskog režima za prvo oko.