natgillin/translations-raw huggingface dataset:
Marketing Authorisation Holder and Manufacturer
84 Imetnik dovoljenja za promet z zdravilom in izdelovalec
1 D-79639 Grenzach-Wyhlen
1 D- 79639 Grenzach- Wyhlen Nemčija
Slovenská republika Roche Slovensko, s.r.o.
85 Slovenská republika Ísland Roche Slovensko, s. r. o.
81
86
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
POGOJI ALI OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABE ZDRAVILA, KI JIH MORAJO UVESTI DRŽAVE ČLANICE
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 POGOJI ALI OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABE ZDRAVILA, KI JIH MORAKO UVESTI DRŽAVE ČLANICE
The Member States must ensure that the education plans for physicians, health care providers, and patients contain the measures a) to m) as detailed below, and are suitable for the purpose of minimising adverse events associated with the intravitreal injection procedure (e. g. endophthalmitis) prior to marketing.
Države članice morajo zagotoviti, da bodo v izobraževalne programe za zdravnike, zdravstvene delavce in bolnike vključeni ukrepi od a) do m), kot je navedeno v nadaljevanju, in da bodo ti programi primerni za cilj kar najbolj učinkovitega zmanjševanja neželenih dogodkov, povezanih s postopkom intravitrealnega injiciranja (npr. endoftalmitisa), pred dajanjem zdravila v promet.
An educational plan for physicians and health care providers which is aimed at risk minimisation and to support safe and effective use for the product.
Izobraževalni program za zdravnike in zdravstvene delavce, katerega namen je zmanjševanje tveganj na najmanjšo mogočo mero in podpora varni in učinkoviti uporabi zdravila.
This pl an shall consist of measures aiming to minimise adverse events associated with the intravitreal injection procedure (e.g. endophthalmitis) through adequate education about:
Ta program mora biti sestavljen iz ukrepov, katerih cilj je kar najbolj zmanjšati neželene dogodke, povezane s postopkom intravitrealnega injiciranja (npr. endoftalmitisa), prek ustreznega izobraževanja o:
b) Sterile techniques to minimize risk of infection c) Use of antibiotics d) Use of povidone iodine e) Performing lid scrubs f) Use of anesthetic to ensure patient comfort g) Techniques for the intravitreal injection h) Management of intraocular pressure (IOP) i) Management of endophthalmitis j) Understanding the risk factors involved in developing endophthalmitis k) Reporting of serious adverse events • An educational plan for patients which is aimed at risk minimisation and to support safe and effective use for the product.
a) intravitrealnem postopku, kot so ga opravljali v ključnih kliničnih študijah b) sterilnih tehnikah za zmanjševanje tveganja okužbe na najmanjšo mogočo mero c) uporabi antibiotikov d) uporabi povidon jodida e) opravljanju čiščenja vek f) uporabi anestetika za preprečevanje neprijetnosti postopka za bolnika g) tehnikah intravitrealnega injiciranja h) urejanju intraokularnega tlaka (IOP – » intraocular pressure «) i) zdravljenju endoftalmitisa j) poznavanju dejavnikov tveganja za nastanek endoftalmitisa k) prijavljanju resnih neželenih dogodkov • Izobraževalni program za bolnike, katerega namen je zmanjševanje tveganj na najmanjšo mogočo mero in podpora varni in učinkoviti uporabi zdravila.
Its purpose is to explain how the assessment done by the Committee for Medicinal products for Human Use (CHMP) on the basis of the studies performed, led to the recommendations on the conditions of use.
Njegov namen je pojasniti, kako je ocena Odbora za zdravila za uporabo v humani medicini (CHMP), ki temelji na opravljenih raziskavah, pripeljala do priporočil glede pogojev uporabe.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Če potrebujete več informacij o vašem zdravstvenem stanju ali zdravljenju, preberite Navodilo za uporabo (ki so del EPAR) ali se posvetujte z svojim zdravnikom ali farmacevtom.
Macugen is a solution for intraocular injection (injection into the eye).
Macugen je raztopina za intraokularno injiciranje (injiciranje v oko).
It is given by an ophthalmologist (eye specialist) who is skilled at this type of injection.
Daje ga oftalmolog (specialist za oči), ki ima izkušnje s tovrstnim injiciranjem.
Macugen contains the active ingredient pegaptanib sodium.
Macugen vsebuje zdravilno učinkovino natrijev pegaptanib.
What is Macugen used for?
Za kaj zdravilo Macugen uporabljamo?
Macugen is used to treat patients with the wet form of age-related macular degeneration (AMD).
Macugen se uporablja za zdravljenje bolnikov vlažne oblike starostne degeneracije makule (age- related macular degeneration, AMD).
This disease affects the central part of the retina (called the macula), at the back of the eye and causes loss of vision.
Ta bolezen prizadene osrednji del mrežnice (imenovan makula), ki leži na zadnji strani očesa, ter povzroči izgubljanje vida.
The macula provides central vision that is needed for driving a car, reading fine print, and other similar tasks.
Makula omogoča centralni vid, potreben za vožnjo avtomobila, branje drobnega tiska in podobne naloge.
The wet form of the disease is caused by abnormal blood vessels under the retina and the macula, which may bleed and leak fluid.
Vlažno obliko te bolezni povzročajo nenormalne žile pod mrežnico in makulo, ki utegnejo krvaveti in prepuščati tekočino.
This causes the loss of vision.
To povzroči izgubljanje vida.
AMD is rare in people under 55 years of age.
Bolezen AMD je redka pri ljudeh, mlajših od 55 let.
It is more common in people 75 years of age or older (1 in 20 people of this age group are affected by AMD).
Pogostejša je pri ljudeh, starih 75 let in več (1 od 20 ljudi iz te starostne skupine je prizadetih zaradi AMD).
Macugen is given as one injection into the affected eye every 6 weeks.
Macugen se daje z enkratnim injiciranjem v prizadeto oko vsakih 6 tednov.
An ophthalmologist who is skilled at this type of injection should give Macugen.
Macugen naj daje oftalmolog, ki ima izkušnje s tovrstnim injiciranjem.
Before each injection, a local anaesthetic will be given to reduce or prevent any pain from the injection.
Pred vsako injekcijo bo bolnik prejel lokalen anestetik, kar bo zmanjšalo ali preprečilo vse bolečine, ki bi se lahko pojavile med injiciranjem.
Antibiotic eye drops may also be given before and after the Macugen injection, to prevent eye infection.
Za zaščito pred okužbo utegne bolnik pred in po injiciranju zdravila Macugen prejeti antibiotične kapljice za oko.
Macugen blocks a substance called Vascular Endothelial Growth Factor which makes the blood vessels grow, and also causes fluid to leak from the vessels and swelling.
Macugen blokira snov, imenovano zunajcelični žilni endotelijski rastni faktor, ki omogoča rast žilja ter tudi povzroča prepuščanje tekočine iz žil in otekanje.
All these effects are thought to worsen the disease.
Vsi ti pojavi po predvidevanjih poslabšujejo bolezensko stanje.
Macugen blocks this factor so there is less growth of these blood vessels, and less bleeding and leakage.
Macugen blokira ta faktor, zato žilje manj raste in pojavlja se manj krvavenja in prepuščanja tekočine.
Macugen has been investigated in two main clinical studies.
Macugen so preučevali v okviru dveh glavnih kliničnih raziskav.
The studies included 1190 patients and lasted up to two years.
Raziskavi sta vključevali 1190 bolnikov in sta trajali do dve leti.
The safety and efficacy of three different doses of Macugen were studied (0.3 mg, 1 mg and 3 mg).
Preučevali so varnost in učinkovitost treh odmerkov zdravila Macugen (0, 3 mg, 1 mg in 3 mg).
These were compared with usual care consisting of a sham intervention (exactly the same procedure but without Macugen, and using no needle).
Le- te so primerjali z običajno oskrbo, ki je vključevala zdravljenje s placebom (natanko isti postopek, vendar brez zdravila Macugen in brez uporabe igle).
(44-20) 74 18 84 00 Fax (44-20) 74 18 8613 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged During the studies, the use of Photodynamic Therapy was permitted in addition to Macugen/ sham intervention.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 8613 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kakšne koristi je zdravilo Macugen izkazalo med raziskavami?
After one year of treatment, the group of patients treated with Macugen 0.3 mg and 1 mg had less visual loss, compared with the group treated with usual care sham intervention.
Po enoletnem zdravljenju je skupina bolnikov, zdravljenih z zdravilom Macugen v odmerku 0, 3 mg in 1 mg, izkazala manjšo izgubo vida v primerjavi s skupino, zdravljeno z običajno oskrbo s placebom.
This improvement lasted for patients who were given Macugen for 2 years.
To izboljšanje je pri bolnikih, ki so prejemali Macugen, trajalo 2 leti.
The most common side effects (more than 1 in 10 patients in clinical trials) are eye problems caused by the injection rather than the medicine.
Najpogostejši neželeni stranski učinki (v okviru kliničnih raziskav prizadetih več kot 1 izmed 10 bolnikov) so očesne težave, ki so posledica injiciranja in ne samega zdravila.
For instance, the pressure in the eye may temporarily increase; your ophthalmologist will check for this after the injection and will take corrective measures if needed.
Tako utegne npr. začasno narasti tlak v očesu; slednjega bo Vaš oftalmolog po injiciranju preveril in po potrebi sprejel ustrezne ukrepe.
Sometimes, endophthalmitis (an infection inside the eye) can occur after Macugen treatment.
Včasih se utegne po zdravljenju z zdravilom Macugen pojaviti endoftalmitis (okužba notranjosti očesa).
It is important to treat this type of infection as soon as possible.
Pomembno je, da se ta tip okužbe zdravi čimprej.
The symptoms of this infection and instructions about what to do if a patient has these symptoms are explained in the package leaflet.
Za celovit opis neželenih stranskih učinkov, o katerih so poročali pri uporabi zdravila Macugen, glejte prosim Navodila za uporabo.
For the full description of the side effects reported with Macugen, please see the package leaflet Macugen must not be used to treat patients who have or may have an infection in or around the eye.
Zdravila Macugen ni dovoljeno uporabljati za zdravljenje bolnikov, ki imajo ali utegnejo imeti okužbo v ali okoli očesa.
Macugen should not be used in people who may be hypersensitive (allergic) to pegaptanib sodium or any of the other ingredients.
Zdravila Macugen ni dovoljeno uporabljati pri ljudeh, ki utegnejo biti preobčutljivi (alergični) na natrijev pegaptanib ali katero drugo sestavino.
In rare cases, serious allergic reaction has been reported soon after the injection.
V redkih primerih so poročali o resnih alergijskih reakcijah kmalu po injiciranju.
The package leaflet advises patients to tell their doctor if they know to be allergic to any substance.
Navodilo za uporabo svetuje bolnikom, da povedo svojim zdravnikom, če vedo, da so alergični na katerokoli snov.
The Committee for Medicinal products for Human Use (CHMP) decided that in patients with wet AMD, 1 year of treatment with Macugen (0.3 mg or 1 mg) reduces vision loss when compared with patients given sham intervention.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da pri bolnikih z vlažno obliko AMD enoletno zdravljenje z zdravilom Macugen (0, 3 mg ali 0, 1 mg) zmanjša izgubo vida v primerjavi z bolniki, ki prejemajo placebo.
The effects of Macugen 0.3 mg and 1 mg are almost identical, so the lower dose of 0.3 mg was approved.
Učinki zdravila Macugen v odmerku 0, 3 mg in 1 mg so skoraj enaki, zato je bil odobren manjši odmerek 0, 3 mg.
It is important to realise that Macugen only slightly slows down vision loss but this disease is severe and there is a need for other treatments.
Pomembno se je zavedati, da zdravilo Macugen le malo upočasni izgubljanje vida, vendar pa gre za resno bolezen in obstaja potreba po drugih oblikah zdravljenja.
The CHMP decided that Macugen’ s benefits are greater than its risks and recommended that Macugen be given marketing authorisation (made available to doctors).
CHMP je odločil, da so koristi zdravila Macugen večje od z njim povezanih tveganj, zato je priporočil podelitev dovoljenja za promet za Macugen (dan na razpolago zdravnikom).
What are the measures to minimise the risk associated with Macugen?
S katerimi ukrepi se tveganje, povezano z zdravilom Macugen, zmanjša na najmanjšo možno mero?
The company that makes Macugen will provide education for doctors (to minimise the risks associated with the injection in the eye) and for patients (so they can recognise any serious side effects, and know when to seek urgent attention from their doctor).
Podjetje, ki proizvaja Macugen, bo zagotovilo izobraževanje za zdravnike (da bi tako čimbolj zmanjšali tveganja, povezana z injiciranjem v oko) ter bolnike (da bi lahko prepoznali morebitne resne stranske učinke ter tako vedeli, kdaj naj poiščejo nujno pomoč pri svojem zdravniku).
The company will also study if some patients could be more at risk of side effects compared to others.
Podjetje bo tudi preučilo, ali bi lahko bili nekateri bolniki izpostavljeni večjemu tveganju za neželene stranske učinke kot drugi.
Other information about Macugen:
Druge informacije o zdravilu Macugen:
The European Commission granted a marketing authorisation valid throughout the European Union, for Macugen to Pfizer Limited on 31 January 2006.
Evropska komisija je dovoljenje za promet z zdravilom, veljavno po vsej Evropski uniji, odobrila družbi Pfizer Limited za zdravilo Macugen dne 31. januarja 2006.
The full EPAR for Macugen can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Macugen je na voljo tukaj.
This summary was last updated in 1-2006.
Ta povzetek je bil nazadnje posodobljen 1- 2006.
EU Number EU/ 1/ 05/ 325/ 002
Številka EU EU/ 1/ 05/ 325/ 002
Invented name Macugen
Izmišljeno ime Macugen
Strength 0.3 mg
Jakost 0, 3 mg
Pharmaceutical Form Solution for injection
Farmacevtska oblika Raztopina za injiciranje
Route of Administration Intravitreal use
Pot uporabe Intravitrealna uporaba
Packaging pre-filled syringe (glass)
Pakiranje Napolnjena injekcijska brizga (steklena)
Content 90 µl
Vsebina 90 µl
Package size 1 pre-filled syringe with pre-attached plunger rod, without a needle
Velikost pakiranja 1 napolnjena injekcijska brizga z že vstavljenim potisnim batom, brez igle
Macugen 0.3 mg solution for injection
Macugen 0, 3 mg raztopina za injiciranje
A single dose pre-filled syringe delivers 1.65 mg pegaptanib sodium, corresponding to 0.3 mg of the free acid form of the oligonucleotide, in a nominal volume of 90 microlitres.
Ena enoodmerna napolnjena injekcijska brizga vsebuje 1, 65 mg natrijevega pegaptaniba, kar ustreza 0, 3 mg oligonukleotida v obliki proste kisline, v nominalnem volumnu 90 mikrolitrov.
For a full list excipients, see section 6.1.
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD) (see section 5.1).
Zdravilo Macugen je indicirano za zdravljenje neovaskularne (vlažne) starostne degeneracije makule (AMD – „ age- related macular degeneration “) (glejte poglavje 5. 1).
FOR INTRAVITREAL USE ONLY.
SAMO ZA INTRAVITREALNO UPORABO.
Treatment with Macugen is for intravitreal injection only and should be administered by ophthalmologists experienced in intravitreal injections.
Zdravilo Macugen je namenjeno za injiciranje v steklovino in ga sme aplicirati le oftalmolog, ki ima izkušnje z injiciranjem v steklovino.
Macugen 0.3 mg should be administered once every six weeks (9 injections per year) by intravitreal injection into the affected eye.
Zdravilo Macugen 0, 3 mg je treba uporabiti enkrat na šest tednov (9 injekcij na leto), in sicer z injiciranjem v steklovino bolnega očesa.
Macugen should be inspected visually for particulate matter and discoloration prior to administration (see section 6.6).
Pred uporabo je treba zdravilo Macugen pregledati in se prepričati, da ne vsebuje delcev in ni obarvano (glejte poglavje 6. 6).
The patient’ s medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see section 4.4).
Pred izvedbo intravitrealnega postopka je treba skrbno preučiti bolnikovo anamnezo preobčutljivostnih reakcij.
Adequate anaesthesia and a broad-spectrum topical microbicide should be administered prior to the injection.
Pred injiciranjem mora bolnik dobiti ustrezno anestezijo in širokospektralen lokalen mikrobicid.
Moreover patients should be closely monitored for endophthalmitis in the two weeks following the injection.
Poleg tega je treba bolnike dva tedna po injekciji natančno nadzirati glede endoftalmitisa.
Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay (see section 4.4).
Bolnikom je treba naročiti, naj nemudoma povedo za vsak simptom, ki bi lahko nakazoval endoftalmitis (glejte poglavje 4. 4).
After 2 consecutive injections of Macugen, if a patient does not demonstrate a treatment benefit (loss of less than 15 letters of visual acuity) at the 12-week visit, consideration should be given to stopping or withholding Macugen therapy.
Če pri bolniku po 2 zaporednih prejetih injekcijah zdravila Macugen na pregledu 12. teden ni opazne koristi zdravljenja (izguba ostrine vida manj kot 15 črk), je treba razmisliti o prekinitvi ali začasni prekinitvi zdravljenja z zdravilom Macugen.
2 Specific patient groups:
2 Posebne skupine bolnikov:
However, no special considerations are needed in this population (see section 5.2)
Zdravila Macugen niso preučevali pri bolnikih z okvaro jeter, vendar posebna pazljivost v tej populaciji ni potrebna (glejte poglavje 5. 2).
Macugen has not been adequately studied in patients with creatinine clearance < 20 ml/ min.
Zdravila Macugen niso ustrezno preučevali pri bolnikih z očistkom kreatinina < 20 ml/ min.
No special considerations are needed in patients with creatinine clearance above 20 ml/ min (see section 5.2).
Pri bolnikih z očistkom kreatinina nad 20 ml/ min posebna pazljivost ni potrebna (glejte poglavje 5. 2).
Macugen has not been studied in patients below the age of 18 years.
Zdravila Macugen niso preučevali pri bolnikih, mlajših od 18 let.
Use in children and adolescents is therefore not recommended.
Njegova uporaba pri otrocih in mladostnikih zato ni priporočljiva.
Known hypersensitivity to the active substance or to any of the excipients.
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov.
Immediate (on the day of injection) and delayed intravitreous haemorrhages may occur following pegaptanib injections.
Po injiciranju pegaptaniba se lahko pojavijo takojšnje (na dan injiciranja) in zapoznele intravitrealne krvavitve.
Intravitreal injection procedures are associated with a risk of endophthalmitis; in Macugen clinical trials, the incidence of endophthalmitis was 0.1% per injection.
Postopke intravitrealnega injiciranja spremlja tveganje za endoftalmitis; v kliničnih preskušanjih zdravila Macugen je bila pogostnost endoftalmitisa 0, 1% na injekcijo.
Cases of anaphylaxis/ anaphylactoid reactions, including angioedema, have been observed within several hours after the pegaptanib intravitreal administration procedure in the post-marketing experience.
V pomarketinških izkušnjah so v nekaj urah po intravitrealni uporabi pegaptaniba opažali primere anafilaksije/ anafilaktoidnih reakcij, vključno z angioedemom.
A direct relationship to Macugen or any of the various medications administered as part of the injection preparation procedure, or to other factors has not been established in these cases.
Direktna povezava z zdravilom Macugen, drugimi uporabljenimi zdravili, ki se uporabljajo pri postopku priprave na injiciranje, ali z drugimi faktorji v teh primerih ni bila dokazana.
Drug interaction studies have not been conducted with Macugen.
Študije medsebojnega delovanja z zdravilom Macugen niso bile izvedene.
3 4.6 Pregnancy and lactation
Študije na živalih niso bile zadostne, vendar so pokazale toksične učinke na sposobnost razmnoževanja pri veliki sistemski izpostavljenosti (glejte poglavje 5. 3).
Pegaptanib has not been studied in pregnant women.
Možno tveganje za ljudi ni znano.
Nevertheless, Macugen should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus.
Kljub tem je dovoljeno zdravilo Macugen med nosečnostjo uporabiti le, če možna korist za mater upravičuje potencialno tveganje za plod.
It is not known whether Macugen is excreted in human milk.
3 Ni znano, ali se zdravilo Macugen pri človeku izloča v materino mleko.
Patients may experience temporary visual blurring after receiving Macugen by intravitreal injection.
Po injiciranju zdravila Macugen v steklovino lahko bolniki doživijo prehodno zameglitev vida.
They should not drive or use machines until this has resolved
Dokler to ne mine, ne smejo voziti ali upravljati s stroji.
Macugen was administered to 892 patients in controlled studies for one year (total number of injections = 7545, mean number of injections/ patient = 8.5) at doses of 0.3, 1.0 and 3.0 mg.
Zdravilo Macugen so v kontroliranih študijah eno leto aplicirali 892 bolnikom (skupno število injiciranj = 7. 545, povprečno število injekcij/ bolnika = 8, 5), in sicer v odmerkih 0, 3, 1, 0 in 3, 0 mg.
All three doses shared a similar safety profile.
Varnostni profil vseh treh odmerkov je bil podoben.
In the 295 patients who were treated with the recommended dose of 0.3 mg for one year (total number of injections = 2478, mean number of injections/ patient = 8.4), 84% of the patients experienced an adverse event attributed by the investigators as being related to the injection procedure, 3% of the patients experienced a Serious Adverse Event potentially related to the injection procedure, and 1% experienced an adverse event potentially related to the injection procedure that led to study treatment discontinuation.
Med 295 bolniki, ki so eno leto dobivali priporočeni odmerek 0, 3 mg (skupno število injiciranj = 2. 478, povprečno število injekcij/ bolnika = 8, 4), jih je 84% doživelo neželen učinek, ki so ga raziskovalci povezovali s postopkom injiciranja, 3% bolnikov so doživeli resen neželen učinek, potencialno povezan s postopkom injiciranja, 1% pa jih je doživel neželen učinek, ki je povzročil prekinitev uporabe zdravila in je bil potencialno povezan s postopkom injiciranja.
Twenty seven percent (27%) of the patients experienced an adverse event attributed by the investigators as being related to the study drug.
Sedemindvajset odstotkov (27%) bolnikov je doživelo neželen učinek, ki so ga raziskovalci pripisali raziskovanemu zdravilu.
Two patients (0.7%) experienced Serious Adverse Events potentially related to study drug.
Dva bolnika (0. 7%) sta doživela resen neželen učinek, potencialno povezan z raziskovanim zdravilom.
One of these patients had an aortic aneurysm; the other had a retinal detachment and retinal haemorrhage, which led to discontinuation of treatment.
Eden od njiju je imel anevrizmo aorte, drugi pa odstop mrežnice in mrežnično krvavitev, zaradi česar je bilo zdravljenje prekinjeno.
Serious ocular Adverse Events reported in Macugen treated patients included endophthalmitis (12 cases, 1%), retinal haemorrhage (3 cases, < 1%), vitreous haemorrhage (2 cases, < 1%) and retinal detachment (4 cases, < 1%).
Med resnimi očesnimi neželenimi učinki, ki so bili opisani pri bolnikih, zdravljenih z zdravilom Macugen, so bili endoftalmitis (12 primerov, 1%), mrežnična krvavitev (3 primeri, < 1%), krvavitev v steklovino (2 primera, < 1%) in odstop mrežnice (4 primeri, < 1%).