natgillin/translations-raw huggingface dataset:
The safety data described below summarise all procedure and drug potentially related adverse events in the 295 patients in the 0.3 mg treatment group.
Spodaj opisani podatki o varnosti povzemajo vse neželene učinke, potencialno povezane s postopkom injiciranja in z zdravilom, pri 295 bolnikih v skupini, ki je dobivala odmerek 0, 3 mg.
The adverse reactions are listed by system organ class and frequency (very common (≥ 1/ 10), common (≥ 1/ 100 and < 1/ 10), and uncommon (≥ 1/ 1000 and < 1/ 100).
Neželeni učinki so našteti po organskem sistemu in pogostnosti (zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 in < 1/ 10) in občasni (≥ 1/ 1. 000 in < 1/ 100)).
nightmare, depression
mora, depresija
Eye
zelo pogosti
disorders
pogosti
These ocular adverse reactions were considered potentially related to treatment with Macugen (either injection procedure or due to Macugen), and for the most part were considered related to the injection procedure.
nenormalen občutek v očesu, katarakta, veznična krvavitev, veznična hiperemija, edem veznice, konjunktivitis, distrofija roženice, okvara roženičnega epitelija, motnja roženičnega epitelija, edem roženice, suho oko, endoftalmitis, izcedek iz očesa, vnetje očesa, draženje očesa, srbenje očesa, pordelost očesa, oteklost očesa, edem veke, močnejše solzenje, degeneracija makule, midriaza, nelagodje v očesu, očesna hipertenzija, periorbitalni hematom, fotofobija, fotopsija, mrežnična krvavitev, zamegljen vid, zmanjšanje ostrine vida, motnje vida, odstop steklovine in motnje steklovine
asthenopia, blepharitis, conjunctivitis allergic, corneal deposits, eye haemorrhage, eyelids pruritus, keratitis, vitreous haemorrhage, pupillary reflex impaired, corneal abrasion, retinal exudates, eyelid ptosis, retinal scar, chalazion, corneal erosion, decreased intraocular pressure, injection site reaction, injection site vesicles, retinal detachment, corneal disorder, retinal artery occlusion, retinal tear, ectropion, eye movement disorder, eyelid irritation, hyphaema, pupillary disorder, iris disorder, ocular icterus, anterior uveitis, deposit eye, iritis, optic nerve cupping, pupillary deformity, retinal vein occlusion, and vitreous prolapse
astenopija, blefaritis, alergijski konjunktivitis, odložki v roženici, očesna krvavitev, srbenje vek, keratitis, krvavitev v steklovino, okvarjen zenični refleks, abrazija roženice, mrežnični eksudati, ptoza veke, mrežnična brazgotina, halazij, erozija roženice, znižan očesni tlak, reakcija na injekcijskem mestu, mehurčki na injekcijskem mestu, odstop mrežnice, motnje roženice, zapora mrežnične arterije, pretrganje roženice, ektropij, motnja gibanja očesa, draženje veke, hifema, zenična motnja, šarenična motnja, očesni ikterus, sprednji uveitis, očesni odložki, iritis, uvlek vidnega živca, deformacija zenice, zapora mrežnične vene in prolaps steklovine
deafness, Meniere's disease aggravated, vertigo
naglušnost, poslabšanje Ménièrove bolezni, vrtoglavica
hypertension, aortic aneurysm
hipertenzija, anevrizma aorte
common uncommon
pogosti občasni
rhinorrhea nasopharyngitis
rinoreja nazofaringitis
vomiting, dyspepsia
bruhanje, dispepsija
contact dermatitis, eczema, hair colour changes, rash, pruritus, night sweats
kontaktni dermatitis, ekcem, spremembe barve las, izpuščaj, pruritus, nočno znojenje
fatigue, rigors, tenderness, chest pain, influenza like illness
utrujenost, mrzlica, bolečnost, bolečina v prsih, gripi podobna bolezen
5 Investigations
Preiskave
increased gamma-glutamyltransferase activity
zvišanje aktivnosti gama- glutamiltransferaze
Injury, poisoning and procedural complications
Poškodbe, zastrupitve in postopkovni zapleti
Three hundred seventy four (374) patients received continuous treatment with Macugen for up to 2 years (128 at 0.3 mg, 126 at 1 mg, and 120 at 3 mg).
Tristoštiriinsedemdeset (374) bolnikov je dobivalo stalno terapijo z zdravilom Macugen do 2 leti (128 po 0, 3 mg, 126 po 1 mg in 120 po 3 mg).
The overall safety data were consistent with the Year 1 safety data, and no new safety signals emerged.
Celotni podatki o varnosti so se skladali s podatki o varnosti v 1. letu in ugotovili niso nobenih novih varnostnih signalov.
In the 128 patients who were treated with the recommended dose of 0.3 mg for up to 2 years (total number of injections in second year = 913, mean number of injections in the second year = 6.9), there was no evidence of increased in frequency of adverse events compared to those seen during the first year.
Med 128 bolniki, ki so do 2 leti dobivali priporočeni odmerek 0, 3 mg (celotno število injiciranj v drugem letu = 913, povprečno število injiciranj v drugem letu = 6, 9), niso ugotovili doslednega porasta pogostnosti neželenih učinkov v primerjavi s tistimi, ki so jih zabeležili v prvem letu.
Rare cases of anaphylaxis/ anaphylactoid reactions, including angioedema, have been reported in patients within several hours after administration of pegaptanib along with various medications administered as part of the injection preparation procedure (see sections 4.2 and 4.4).
Pomarketinške izkušnje: pri bolnikih so v nekaj urah po uporabi pegaptaniba skupaj z različnimi zdravili, ki so del postopka priprave na injiciranje, poročali o redkih primerih anafilaksije / anafilaktoidnih reakcij, vključno z angioedemom (glejte poglavji 4. 2 in 4. 4).
4.9 Overdose
5 4. 9 Preveliko odmerjanje
Overdosage with Macugen has not been reported in clinical trials.
Preveliko odmerjanje v kliničnih preskušanjih zdravila Macugen ni bilo opisano.
Pegaptanib is a pegylated modified oligonucleotide that binds with high specificity and affinity to extracellular Vascular Endothelial Growth Factor (VEGF165) inhibiting its activity.
Pegaptanib je pegiliran modificiran oligonukleotid, ki se zelo specifično in z veliko afiniteto veže na zunajcelični žilni endotelijski rastni faktor (VEGF165 – „ Vascular Endothelial Growth Factor “) in zavre njegovo delovanje.
VEGF is a secreted protein that induces angiogenesis, vascular permeability and inflammation, all of which are thought to contribute to the progression of the neovascular (wet) form of AMD.
Domnevno vse to pripomore k napredovanju neovaskularne (vlažne) oblike AMD.
VEGF165 is the VEGF isoform preferentially involved in pathological ocular neovascularisation.
VEGF165 je izooblika VEGF, ki je predvsem vpletena v patološko neovaskularizacijo v očesu.
Reductions in the growth of mean total lesion size, choroidal neovascularisation (CNV size), and fluorescein leak size, have been shown in patients with AMD treated with Macugen.
Pri bolnikih s AMD, ki so dobivali zdravilo Macugen, so ugotovili manjši porast srednje celotne velikosti lezije, manjšo horoidno neovaskularizacijo in manjše izstopanje fluoresceina.
A total of 1190 patients were treated (892 pegaptanib, 298 sham (control)) with a median age of 77 years.
Skupaj je bilo zdravljenih 1. 190 bolnikov (892 jih je dobivalo zdravilo Macugen in 298 placebo (kontrolno snov)); mediana starost je bila 77 let.
Patients received a mean of between 8.4-8.6 treatments out of possible 9 total across all treatment arms in the first year.
Bolniki v vseh krakih študije so v prvem letu dobili povprečno 8, 4– 8, 6 odmerkov od skupno možnih 9.
Patients were randomised to receive sham or 0.3 mg, 1 mg or 3 mg pegaptanib administered as intravitreal injections every 6 weeks for 48 weeks.
Bolniki so bili randomizirani na prejemanje kontrolne snovi (placebo) ali 0, 3 mg, 1 mg ali 3 mg pegaptaniba v intravitrealnih injekcijah vsakih 6 tednov v obdobju 48 tednov.
Verteporfin photodynamic therapy (PDT) was permitted in patients with predominantly classic lesions at the discretion of the investigators.
Pri bolnikih s pretežno klasičnimi lezijami je bila dovoljena fotodinamična terapija z verteporfinom (PDT – “ photodynamic therapy ”) po presoji raziskovalcev.
The two trials enrolled patients, including all neovascular AMD lesion subtypes (25% predominantly classic, 39% occult with no classic and 36% minimally classic), lesion sizes up to 12 disc areas, of which up to 50% could be comprised of subretinal haemorrhage and/ or up to 25% fibrotic scar or atrophic damage.
Preskušanji sta vključevali bolnike z vsemi podvrstami lezij neovaskularne AMD (25% pretežno klasičnih, 39% prikritih brez klasičnih in 36% osnovnih klasičnih), velikostjo lezij do 12 površin diskusa, od katerih jih je bilo lahko do 50% zapletenih s podmrežnično krvavitvijo in/ ali do 25% s fibrotičnim brazgotinjenjem ali atrofično okvaro.
Patients had up to one prior PDT and baseline visual acuity in the study eye between 20/ 40 and 20/ 320.
Bolniki so imeli do eno predhodno PDT in izhodiščno ostrino vida na proučevanem očesu med 20/ 40 in 20/ 320.
6 At one year, pegaptanib 0.3 mg exhibited a statistically significant treatment benefit for the primary efficacy endpoint; proportion of patients losing less than 15 letters of visual acuity (prespecified pooled analysis, pegaptanib 0.3 mg 70% versus Sham 55%, p = 0.0001; EOP 1003 pegaptanib 0.3 mg 73% versus Sham 59%, p = 0.0105; EOP1004 pegaptanib 0.3 mg 67% versus Sham 52%, p = .0031).
Po enem letu je pegaptanib v odmerku 0, 3 mg v obeh preskušanjih pokazal statistično pomembno korist zdravljenja, kar zadeva učinkovitost kot primarni opazovani dogodek, tj. delež bolnikov, ki se jim je ostrina vida zmanjšala za manj kot 15 črk (vnaprej določena kumulativna analiza, pegaptanib 0, 3 mg 70%, placebo 55%, p=0, 0001; EOP1003 pegaptanib 0, 3 mg 73%, placebo 59%, p=0, 0105; EOP1004 pegaptanib 0, 3 mg 67%, placebo 52%, p=0, 0031).
Mean Change in Visual Acuity Over Time; Year 1; ITT (LOCF) Mean Change in VA from Week 0 (Letters)
6 Povprečna sprememba ostrine vida (VA – “ visual acuity ”) v 1. letu; populacija, ki so jo želeli zdraviti (ITT – “ intent- to- treat ”) (zadnje izvedeno opazovanje (LOCF – “ Last Observation Carried Forward ”)
5
Sprememba VA od tedna 0 (velikost črk) 5 00, 3 mg N=265
0.3 mg N=265
. 3 mg N=265
Sham N=272
Sham N=272 0
-15
1. leto - 15
-20
- 20
Weeks N: number of patients enrolled
Tedni N: število vključenih bolnikov
Pegaptanib 0.3mg showed treatment benefit regardless of baseline lesion subtype, lesion size and visual acuity as well as age, gender, iris pigmentation and prior and/ or baseline PDT usage.
Zdravljenje s pegaptanibom v odmerku 0, 3 mg je koristilo ne glede na vrsto izhodiščne lezije, velikost lezije ali ostrino vida in prav tako ne glede na starost, spol, pigmentacijo šarenice ter predhodno in/ ali izhodiščno PDT.
At the end of the first year (week 54), 1053 patients were re-randomized to either continue or discontinue treatment through week 102.
Na koncu prvega leta (54. teden) so približno 1. 053 bolnikov ponovno randomizirali, bodisi na nadaljevanje zdravljenja ali na njegovo prekinitev do 102. tedna.
On average, the treatment benefit was maintained at 102 weeks with continuing preservation of visual acuity for patients re-randomized to continue pegaptanib.
V povprečju se je korist zdravljenja ohranila do 102. tedna z nadaljno ohranitvijo ostrine vida pri bolnikih, ponovno randominiziranih na nadaljevanje zdravljenja z pegaptanibom.
Patients who were re-randomized to discontinue pegaptanib after one year, lost visual acuity during the second year.
Bolnikom, ki so bili ob ponovni randomizaciji po enem letu razvrščeni za prekinitev zdravljenja z pegaptanibom, se je ostrina vida v drugem letu zmanjšala.
7 Summary of Mean Changes in Visual Acuity from Baseline to Weeks 6, 12, 54 and 102 (LOCF)
Povzetek spremembe VA od začetka do tedna 6, 12, 54 in 102 (zadnje izvedeno opazovanje)
Sham-
placebo -
0.3-0.3
0, 3 -
discontinued
0, 3- 0, 3
sham/ sham+ 0.3-0.3 discontinued
0, 3 -
sham/ sham+ discontinued
placebo/ placebo
Mean
placebo/ placebo
66
66 54 66 66
in VA Week 6 Mean change
tednu 6
-0.0
- 1, 9
-4.4
- 0, 0
-1.9
- 4, 4 - 1, 9
in VA Week 12 Mean change
Sprememba VA v tednu 12 Sprememba
in VA Week 54 Mean change
VA v tednu 54 Sprememba
in VA Week 102
VA v tednu 102
Data over a two-year period indicate that Macugen treatment should be initiated as early as possible.
7 Podatki dveletnega obdobja kažejo, da je treba zdravljenje z zdravilom Macugen začeti čim prej.
The safety and efficacy of Macugen beyond two years has not been demonstrated.
Varnost in učinkovitost zdravila Macugen pri terapiji, daljši od dveh let, niso spremljali.
In humans, the average ± standard deviation apparent plasma half-life of pegaptanib after a 3 mg (10-times the recommended dose) monocular dose is 10 ± 4 days.
Pri človeku je navidezni razpolovni čas pegaptaniba v plazmi (povprečje ± standardni odklon) po 3 mg (kar je 10- kratni priporočeni odmerek) na eno oko 10 ± 4 dni.
A mean maximum plasma concentration of about 80 ng/ ml occurs within 1 to 4 days after a 3 mg monocular dose in humans.
Povprečna najvišja plazemska koncentracija približno 80 ng/ ml se pri človeku pojavi v 1 do 4 dneh po odmerku 3 mg na eno oko.
The mean area under the plasma concentration-time curve (AUC) is about 25 μ g·hr/ ml at this dose.
Ob tem odmerku je povprečna površina pod krivuljo plazemske koncentracije po času (AUC) približno 25 μg· uro/ ml.
At doses below 0.5 mg/ eye, pegaptanib plasma concentrations do not likely exceed 10 ng/ ml.
Če so odmerki manjši od 0, 5 mg/ oko, ni verjetno, da bi koncentracija pegaptaniba v plazmi presegla 10 ng/ ml.
The absolute bioavailability of pegaptanib after intravitreal administration has not been assessed in humans, but is approximately 70-100% in rabbits, dogs and monkeys.
Pri kuncih, psih in opicah znaša približno 70– 100%.
In animals that received doses of pegaptanib up to 0.5 mg/ eye to both eyes, plasma concentrations were 0.03% to 0.15% of those in the vitreous humour.
Pri živalih, ki so dobile pegaptanib v odmerkih do 0, 5 mg/ oko v obe očesi, je koncentracija v plazmi znašala od 0, 03 do 0, 15% tiste v steklovini.
8 Distribution/ Metabolism/ Excretion:
Porazdelitev/ presnova/ izločanje:
In mice, rats, rabbits, dogs and monkeys, pegaptanib distributes primarily into plasma volume and is not extensively distributed to peripheral tissues after intravenous administration.
Pri miših, podganah, kuncih, psih in opicah se pegaptanib porazdeli predvsem v plazemskem volumnu in se po intravenski uporabi ne porazdeli izdatno v periferna tkiva.
After intravitreal and intravenous administrations of radiolabeled pegaptanib to rabbits, the highest concentrations of radioactivity (excluding the eye for the intravitreal dose) were obtained in the kidney.
Po intravitrealni in intravenski aplikaciji radioaktivno označenega pegaptaniba kuncem je zdravilo doseglo najvišjo koncentracijo v ledvicah (če izvzamemo oko pri intravitrealni uporabi).
In rabbits, the component nucleotide, 2’ -fluorouridine is found in plasma and urine after single radiolabeled pegaptanib intravenous and intravitreal doses.
Pri kuncih je mogoče po enem intravenskem in intravitrealnem odmerku radioaktivno označenega zdravila Macugen najti sestavni nukleotid, 2 '- fluorouridin, v plazmi in urinu.
Pegaptanib is metabolised by endo- and exonucleases.
Pegaptanib presnavljajo endo - in eksonukleaze.
In rabbits, pegaptanib is eliminated as parent drug and metabolites primarily in the urine.
Pri kuncih se pegaptanib izloča kot matično zdravilo in v obliki presnovkov, predvsem v urinu.
Pegaptanib pharmacokinetics is similar in female and male patients and within the age range 50 to 90 years.
Farmakokinetika pegaptaniba je enaka pri bolnikih ženskega in moškega spola, starih od 50 do 90 let.
Pegaptanib sodium has not been adequately studied in patients with creatinine clearance below 20 ml/ min.
Natrijev pegaptanib ni ustrezno raziskan pri bolnikih z očistkom kreatinina pod 20 ml/ min.
A decrease in creatinine clearance down to 20 ml/ min may be associated with up to a 2.3-fold increase in pegaptanib AUC.
Zmanjšanje očistka kreatinina do 20 ml/ min lahko spremlja do 2, 3- kratno povečanje AUC pegaptaniba.
No special considerations are needed in patients with creatinine clearance above 20 ml/ min who are treated with the recommended dose of pegaptanib sodium 0.3 mg.
Pri bolnikih, ki imajo očistek kreatinina nad 20 ml/ min in dobivajo priporočeni odmerek 0, 3 mg pegaptaniba, niso potrebni posebni previdnostni ukrepi.
The systemic exposure is expected to be within a well tolerated range in patients with hepatic impairment, as a 10 fold higher dose (3 mg/ eye) was well tolerated.
Po pričakovanju naj bi bila sistemska izpostavljenost pri bolnikih z okvaro jeter v območju, ki ga bolniki dobro prenesejo, saj so dobro prenašali do 10- krat večji odmerek (3 mg/ oko).
Pegaptanib produced no maternal toxicity and no evidence of teratogenicity or foetal mortality in mice at intravenous doses of 1 to 40 mg/ kg/ day.
8 Pegaptanib, uporabljen pri miših v intravenskih odmerkih od 1 do 40 mg/ kg/ dan, ni povzročil toksičnih učinkov pri samicah in nobenih znakov teratogenosti ali fetalne umrljivosti.
Reduced body weight (5%) and minimal delayed ossification in forepaw phalanges were observed, only at exposure levels based on AUC of over 300 fold greater than that expected in humans.
Opažali so zmanjšanje telesne mase (5%) in minimalno zamudo pri osifikaciji falang sprednjih tac, a le pri izpostavljenostih, ki so bile na podlagi AUC več kot 300- krat večje, kot so pričakovane pri človeku.
In the 40 mg/ kg/ day group, pegaptanib concentrations in the amniotic fluid were 0.05% of the maternal plasma levels.
V skupini, ki je dobivala 40 mg/ kg/ dan, so bile koncentracije pegaptaniba v amnijski tekočini 0, 05% plazemske koncentracije pri samicah.
Sodium chloride Monobasic sodium phosphate monohydrate Dibasic sodium phosphate heptahydrate Sodium hydroxide Hydrochloric acid Water for injections
natrijev klorid natrijev dihidrogenfosfat monohidrat natrijev hidrogenfosfat heptahidrat natrijev hidroksid klorovodikova kislina voda za injekcije
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Ker študij kompatibilnosti ni, tega zdravila ne smete mešati z drugimi zdravili.
9 6.3 Shelf life
6. 3 Rok uporabnosti
Store in a refrigerator (2 oC -8oC).
Shranjujte v hladilniku (2 °C - 8 °C).
Macugen is supplied in a single dose pack.
Zdravilo Macugen je na voljo v enoodmernem pakiranju.
Each pack contains a pouch in a carton containing a 1 ml pre-filled syringe, Type 1 glass, sealed with an elastomeric plunger stopper and a pre-attached plunger rod, held by a plastic clip.
Potisni bat drži na mestu plastični zatič.
The syringe has a pre-attached polycarbonate plastic luer lock adaptor and the tip is sealed with an elastomeric tip cap.
Injekcijska brizga ima že nameščen zaskočni nastavek „ luer lock “ iz polikarbonatne plastike, na vrhu pa je zaprta z gumijasto zaporko.
6.6 Special precautions for disposal
6. 6 Posebna navodila za odlaganje
If the solution appears cloudy, particles are observed or if there is evidence of damage to the syringe, or if the plastic clip is missing or not attached to the syringe, Macugen should not be used.
Če je raztopina motna, so v njej vidni delci ali je injekcijska brizga poškodovana, ali če plastičnega zatiča ni oziroma ni pritrjen na brizgo, zdravila Macugen ne smete uporabiti.
A 27 or 30 G x ½ inch needle should be attached to the luer lock adaptor, to allow the administration of the product.
Za aplikacijo zdravila morate na nastavek „ luer lock “ namestiti iglo 27 G ali 30 G.
The syringe should be checked with the needle pointing up regarding the presence of bubbles.
9 Injekcijsko brizgo obrnite z iglo navzgor in poglejte, ali so v brizgi prisotni mehurčki.
Then, the plunger should be slowly pushed up to force the bubbles out of the syringe.
Potem bat počasi potisnite navzgor, da iztisnete mehurčke iz injekcijske brizge.
The plunger stopper should not be pulled back.
Potisnega bata ne smete potegniti nazaj.
The last rib of the plunger stopper (closest to the plunger rod) should not be pushed past the dose line printed on the syringe.
Zadnjega rebra na gumijastem tesnilu (ki je najbližji potisnemu batu) ne smete potisniti prek odmerne črte, ki je odtisnjena na injekcijski brizgi.
Immediately prior to administration this last rib of the plunger should be aligned with the dose line to ensure the delivery of the appropriate dose.
Tik pred apliciranjem je potrebno to zadnje rebro na gumijastem tesnilu poravnati z odmerno črto, s čimer zagotovimo injiciranje ustreznega odmerka.
At this point, the entire content of the syringe should be injected.
Nato injiciramo celotno vsebino injekcijske brizge.
Macugen should be stored in a refrigerator.
Zdravilo Macugen morate hraniti v hladilniku.
The solution to be injected should reach room temperature before injecting.
Raztopino za injiciranje je treba pred injiciranjem ogreti na sobno temperaturo.
Macugen should be discarded if kept at room temperature for more than two weeks.
Zdravilo Macugen, ki je bilo več kot dva tedna shranjeno na sobni temperaturi, morate zavreči.
To prevent contamination, the Macugen syringe should not be removed from the pouch until the patient has been prepared for injection.
Da bi preprečili kontaminacijo, injekcijske brizge z zdravilom Macugen ne smete vzeti iz vrečke, dokler bolnik ni pripravljen za injiciranje.
Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom
Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ Velika Britanija
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE DOVOLJENJA ZA PROMET
31/ 01/ 2006
31. 1. 2006
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA): http: / /www. emea. europa. eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
Pfizer Ireland Pharmaceuticals Pottery Road Dun Laoghaire Co Dublin Ireland
Pfizer Ireland Pharmaceuticals Pottery Road Dun Laoghaire Co Dublin Irska
The Marketing Authorisation Holder must implement nationally, prior to marketing, and as agreed with the competent authorities in the Member States:
Imetnik dovoljenja za promet mora pred trženjem zdravila v svoji državi izvajati naslednje programe, kot je dogovorjeno s pristojnimi organi v državah članicah:
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:
Izobraževalni program za zdravnike in zdravstvene delavce, katerega namen je zmanjševanje tveganj na najmanjšo mogočo mero in podpora varni in učinkoviti uporabi zdravila.
intravitreal procedure as it was performed in the pivotal clinical studies
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:
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.1 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora pred prihodom zdravila na trg in dokler bo zdravilo na trgu in v uporabi zagotoviti vzpostavitev in delovanje sistema farmakovigilance, kot je opisan v verziji 1. 1 v Modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom.
13 Risk Management Plan The Marketing Authorisation Holder has committed to performing the studies and monitoring which are detailed in the risk management plan, as part of the Pharmacovigilance plan.
12 Načrt upravljanja tveganjaImetnik dovoljenja za promet se je zavezal, da bo izvajal študije in nadzor, kot je podrobneje navedeno v načrtu upravljanja tveganja v okviru Farmakovigilančnega načrta.
In addition, the Marketing Authorisation Holder committed to provide a proposal for a methodology to assess the effectiveness of risk minimisation measures across the EU, including milestones for such assessment.
Poleg tega se je imetnik dovoljenja za promet zavezal tudi, da bo pripravil predlog metodologije za oceno učinkovitosti ukrepov za zmanjševanje tveganja na najmanjšo mogočo mero po vsej EU, vključno z mejniki za tovrstno oceno.