qanastek/EMEA-V3 huggingface dataset:
(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.
Dawn tqabblu mal- kura solita li tikkonsisti minn intervent magħruf bħala sham intervention (eżatt l- istess proċedura iżda mingħajr Macugen, u mingħajr l- użu ta ’ labra).
What benefit has Macugen shown during the studies?
X’ benefiċċji ta ’ Macugen ntwerew f’ dawn l- istudji?
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.
Wara sena trattament, il- grupp ta ’ pazjenti ttrattati b’ Macugen ta ’ 0. 3 mg u tal- 1 mg kellhom inqas telf fil- viżta, meta mqabbla ma ’ l- interventi sham bil- kura tas- soltu.
This improvement lasted for patients who were given Macugen for 2 years.
Dan it- titjib inżamm f’ pazjenti li ngħataw Macugen għal sentejn.
What is the risk associated with Macugen?
X’ inhu r- riskju assoċjat ma ’ Macugen?
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.
L- iktar effetti sekondarji komuni (li dehru f’ iktar minn pazjent wieħed minn kull 10 fl- istudji kliniċi) huma l- problemi fil- għajn ikkawżati mill- injezzjoni iktar milli mill- mediċina.
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.
Per eżempju, il - pressjoni fil- għajn tista ’ tiżdied temporanjament; l- oftalmogu tiegħek jiċċekkja għal dan wara l - injezzjoni u jieħu miżuri korrettivi jekk ikun hemm bżonn.
Sometimes, endophthalmitis (an infection inside the eye) can occur after Macugen treatment.
Xi drabi jista ’ jkun hemm endoftalmite (infezzjoni fil- għajn) wara t- trattament b’ Macugen.
It is important to treat this type of infection as soon as possible.
Importanti li din it- tip ta ’ infezzjoni tiġi ttrattata malajr kemm jista ’ jkun.
The symptoms of this infection and instructions about what to do if a patient has these symptoms are explained in the package leaflet.
Is- sintomi ta ’ din l- infezzjoni u l - istruzzjonijiet dwar x’ għandu jsir mill- pazjent jekk ikun hemm dawn is- sintomi huwa mfisser fil - fuljett ta ’ tagħrif.
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.
Macugen m’ għandux jingħata biex jittratta pazjenti li jkollhom jew li jista ’ jkollhom infezzjoni ġo jew madwar l- għajn.
Macugen should not be used in people who may be hypersensitive (allergic) to pegaptanib sodium or any of the other ingredients.
Macugen m’ għandux jingħata lil persuni li jistgħu jkunu allerġiċi għal pegaptanib sodium jew għal kwalunkwe sustanza oħra tiegħu.
In rare cases, serious allergic reaction has been reported soon after the injection.
F’ każijiet rari ġew rappurtati reazzjonijiet allerġiċi serji wara l- injezzjoni.
The package leaflet advises patients to tell their doctor if they know to be allergic to any substance.
Il- fuljett ta ’ tagħrif jirrikmanda li l- pazjenti jgħarrfu lit- tabib tagħhom jekk ikunu allerġiċi għal xi sustanza.
Why has Macugen been approved?
Għaliex ġie approvat Macugen?
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.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- pazjenti bl- AMD umda, sena wara t- trattament b’ Macugen (0. 3 mg jew 1 mg) inaqqas it- telf fil- viżta meta mqabbel ma ’ pazjenti li jkunu ngħataw intervent sham.
The effects of Macugen 0.3 mg and 1 mg are almost identical, so the lower dose of 0.3 mg was approved.
L- effetti ta ’ Macugen taż- 0. 3 mg u tal- 1 mg huma kważi identiċi, u għalhekk ġiet approvata d- doża iktar baxxa ta ’ 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.
Huwa importanti li wieħed jirrealizza li Macugen ibaxxi biss xi ftit it- telf fil- viżta iżda din il- marda hija severa u hemm bżonn ta ’ trattamenti oħra.
The CHMP decided that Macugen’ s benefits are greater than its risks and recommended that Macugen be given marketing authorisation (made available to doctors).
Il- CHMP iddeċieda li l- benefiċċji ta ’ Macugen huma ikbar mir- riskji tiegħu u rrakkomanda li Macugen jingħata l- awtorizzazzjoni għat- tqegħid fis- suq (magħmul disponibbli għat- tobba).
What are the measures to minimise the risk associated with Macugen?
X’ inhuma l- miżuri għat- tnaqqis tar- riskju assoċjat ma ’ Macugen?
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).
Il- kumpanija li tagħmel Macugen se tipprovdi edukazzjoni għat- tobba (biex tnaqqas ir- riskji assoċjati ma ’ l- injezzjoni fil- għajn) u għal pazjenti (biex ikunu jistgħu jagħrfu kwalunkwe effetti sekondarji serji, u jkunu jafu meta jkollhom jiksbu parir urġenti mingħand it- tabib tagħhom).
The company will also study if some patients could be more at risk of side effects compared to others.
Il- kumpanija se tistudja wkoll jekk xi pazjenti jistgħux ikollhom riskju ikbar ta ’ effetti sekondarji meta mqabbla ma ’ oħrajn.
Other information about Macugen:
Tagħrif ieħor dwar Macugen:
The European Commission granted a marketing authorisation valid throughout the European Union, for Macugen to Pfizer Limited on 31 January 2006.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Macugen lil Pfizer Limited fil- 31 ta ’ Jannar 2006.
The full EPAR for Macugen can be found here.
L- EPAR sħiħ għal Macugen huwa disponibbli minn hawn.
This summary was last updated in 1-2006.
Dan is- sommarju ġie aġġornat l- aħħar f’ 1- 2006.
EU Number EU/ 1/ 05/ 325/ 002
Numru ta ’ l- EU EU/ 1/ 05/ 325/ 002
Invented name Macugen
Isem inventat Macugen
Strength 0.3 mg
Qawwa 0. 3 mg
Pharmaceutical Form Solution for injection
Għamla farmaċewtika soluzzjoni għall- injezzjoni
Route of Administration Intravitreal use
Mnejn jingħata Użu għal ġol- vitriju
Packaging pre-filled syringe (glass)
Il- pakkett siringa mimlija għal- lest (ħġieġ)
Content 90 µl
Kontenut 90 µl
Package size 1 pre-filled syringe with pre-attached plunger rod, without a needle
Daqs tal- pakkett Siringa 1 mimlija għal- lest b ’ qasba tal - plunġer mwaħħla lesta mingħajr labra
Macugen 0.3 mg solution for injection
Macugen 0. 3 mg soluzzjoni għall- injezzjoni
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.
Siringa ta 'doża waħda mimlija bil- lest tagħti 1. 65 mg pegaptanib sodium, li jikkorrispondu għal 0. 3 mg tal- forma ta' aċidu liberu ta 'l- oligonucleotide, f' volum nominali ta' 90 mikrolitru.
For a full list excipients, see section 6.1.
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
The solution is clear and colourless.
Is- soluzzjoni għandha tkun ċara u bla kulur.
Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD) (see section 5.1).
Macugen hu indikat għall- kura tad- deġenerazzjoni makulari neovaskulari (imxarrba) relatata ma 'l- eta' (AMD - age- related macular degeneration) (ara sezzjoni 5. 1).
FOR INTRAVITREAL USE ONLY.
GĦAL UŻU ĠOL- VITRIJU BISS.
Treatment with Macugen is for intravitreal injection only and should be administered by ophthalmologists experienced in intravitreal injections.
It- trattament b' Macugen hu għal injezzjoni ġol- vitriju biss u għandu jiġi amministrat minn oftalmologi b' esperjenza f' injezzjonijiet ġol- vitriju.
Macugen 0.3 mg should be administered once every six weeks (9 injections per year) by intravitreal injection into the affected eye.
Macugen 0. 3 mg għandu jingħata darba kull sitt ġimgħat (9 injezzjonijiet fis- sena) permezz ta 'injezzjoni ġol- vitriju fl- għajn affettwata.
Macugen should be inspected visually for particulate matter and discoloration prior to administration (see section 6.6).
Macugen għandu jiġi eżaminat b' mod viżwali għal frak u telf tal- kulur qabel ma jingħata (ara sezzjoni 6. 6).
The injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent) and the availability of sterile paracentesis (if required).
Il- proċedura ta 'l- injezzjoni għandha titwettaq taħt kondizzjonijiet asettiċi, li jinkludu l- użu ta' diżinfezzjoni kirurġika ta 'l- idejn, ingwanti sterilizzati, ċarruta sterilizzata u speculum sterilizzat għall - kappell ta' l- għajn (jew ekwivalenti) u d- disponibilità ta 'paracentesis sterilizzat (jekk meħtieġ).
The patient’ s medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see section 4.4).
L - istorja medika tal- pazjent għal reazzjonijiet ta 'sensittività eċċessiva għandha tiġi evalwata bir- reqqa qabel ma titwettaq il- proċedura ġol- vitriju (ara sezzjoni 4. 4).
Adequate anaesthesia and a broad-spectrum topical microbicide should be administered prior to the injection.
Qabel l- injezzjoni għandhom jiġu amministrati anestesija xierqa u mikrobiċida topiku bi spettru wiesa '.
Following the injection, transient increases in intraocular pressure were seen in Macugen treated patients.
Wara l- injezzjoni, dehru żidiet transitorji fil- pressjoni ġo l- għajn fil- pazjenti kkurati b' Macugen.
Therefore, the perfusion of the optic nerve head and intraocular pressure should be monitored.
Għalhekk, il- perfużjoni ta 'ras in- nerv ottiku u l- pressjoni ġo l- għajn għandhom jiġu mmonitorjati.
Moreover patients should be closely monitored for endophthalmitis in the two weeks following the injection.
Barra minn hekk il- pazjenti għandhom jiġu mmonitorjati mill- qrib għall- endophthalmitis fil - ġimagħtejn ta 'wara l- injezzjoni.
Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay (see section 4.4).
Il- pazjenti għandhom jingħataw struzzjonijiet biex jirrapportaw kwalunkwe sintomi li jissuġġerixxu endophthalmitis mingħajr dewmien (ara sezzjoni 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.
Wara żewġ injezzjonijiet konsekuttivi ta ’ Macugen, jekk pazjent ma jurix benefiċċju tat- trattament (tnaqqis ta ’ inqas minn 15- il ittra ta ’ akutezza viżwali) fil- viżta tat- 12 il- ġimgħa, twaqqif jew trażżin tat- terapija bil- Macugen għandha tkun ikkunsidrata.
2 Specific patient groups:
2 Gruppi ta 'pazjenti speċifiċi:
Macugen has not been studied in patients with hepatic impairment.
Macugen ma ġiex studjat f' pazjenti b' indeboliment tal- fwied.
However, no special considerations are needed in this population (see section 5.2)
Madankollu, m' hemmx bżonn konsiderazzjonijiet speċjali f' din il- popolazzjoni (ara sezzjoni 5. 2)
Macugen has not been adequately studied in patients with creatinine clearance < 20 ml/ min.
Macugen ma ġiex studjat biżżejjed f' pazjenti bi clearance tal- kreatinina < 20 ml/ min.
No special considerations are needed in patients with creatinine clearance above 20 ml/ min (see section 5.2).
M' hemmx bżonn konsiderazzjonijiet speċjali f' pazjenti bi clearance tal- kreatinina ta '' l fuq minn 20 ml/ min (ara sezzjoni 5. 2).
Macugen has not been studied in patients below the age of 18 years.
Tfal u adoloxxenti Macugen ma ġiex studjat f' pazjenti ta 'taħt it- 18- il sena.
Use in children and adolescents is therefore not recommended.
L- użu tiegħu fit- tfal u l- adoloxxenti għalhekk mhux rakkomandat.
No special considerations are needed.
M' hemmx bżonn konsiderazzjonijiet speċjali.
Active or suspected ocular or periocular infection.
Infezzjoni attiva jew suspettata fl- għajn jew madwar l- għajn.
Known hypersensitivity to the active substance or to any of the excipients.
Sensittività eċċessiva magħrufa għas- sustanza attiva jew għal xi sustanzi mhux attivi.
As expected with intravitreal injections, transient increases in intraocular pressure may be seen.
Kif inhu mistenni b' injezzjonijiet ġol- vitriju, jistgħu jidhru żidiet għaddiena tal- pressjoni fil- għajn.
Therefore, the perfusion of the optic nerve head should be verified and elevation of intraocular pressure should be managed appropriately post injection.
Għalhekk, il- perfużjoni ta 'ras in- nerv ottiku għandha tiġi verifikata u ż- żieda tal- pressjoni fil- għajn għandha tiġi ġestita b' mod xieraq wara l- injezzjoni.
Immediate (on the day of injection) and delayed intravitreous haemorrhages may occur following pegaptanib injections.
Jistgħu jseħħu emorraġiji immedjati (fil- jum ta 'l- injezzjoni) jew aktar tard ġol- vitriji wara injezzjonijiet ta' pegaptanib.
Intravitreal injection procedures are associated with a risk of endophthalmitis; in Macugen clinical trials, the incidence of endophthalmitis was 0.1% per injection.
Il- proċeduri ta 'injezzjoni ġol- vitriju huma assoċjati ma' riskju ta 'endophthalmitis; fi provi kliniċi b' Macugen, l- inċidenza ta' endophthalmitis kienet 0. 1% kull injezzjoni.
Cases of anaphylaxis/ anaphylactoid reactions, including angioedema, have been observed within several hours after the pegaptanib intravitreal administration procedure in the post-marketing experience.
Każijiet ta 'anafilassi/ reazzjonijiet anaphylactoid, fosthom anġoedema, ġew osservati sa bosta sigħat wara l- proċedura ta' amministrazzjoni ta 'pegaptanib ġol- vitriju fl- esperjenza wara t- tqegħid fis- suq.
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.
Relazzjoni diretta ma 'Macugen jew ma' xi waħda mid- diversi medikazzjonijiet amministrati bħala parti mill- proċedura ta 'preparazzjoni għall- injezzjoni, jew ma' fatturi oħra ma ġietx stabbilita f' dawn il- każijiet.
Drug interaction studies have not been conducted with Macugen.
Ma sarux studji dwar l- interazzjoni ta 'Macugen ma' mediċini oħra.
Pegaptanib is metabolised by nucleases and therefore cytochrome P450 mediated drug interactions are unlikely.
Pegabtanib jiġi metabolizzat minn enzimi li jikkawżaw l- idrolisi ta 'l- aċidi nuklejċi u għalhekk mhumiex probabbli interazzjonijiet ma' mediċini oħra medjati miċ- ċitokromu P450.
Two early clinical studies conducted in patients who received Macugen alone and in combination with PDT (photodynamic therapy) revealed no apparent difference in the plasma pharmacokinetics of pegaptanib.
Żewġ studji kliniċi bikrija li saru fuq pazjenti li rċevew Macugen waħdu jew flimkien ma 'PDT (terapija fotodinamika) ma wrew l- ebda differenza apparenti fil- farmakokinetiċi ta' pegabtanib ġol - plasma.
3 4.6 Pregnancy and lactation
3 4. 6 Tqala u Treddigħ
Pegaptanib has not been studied in pregnant women.
Pegabtanib ma ġiex studjat f' nisa tqal.
Animal studies are insufficient, but have shown reproductive toxicity at high systemic exposure levels (see section 5.3).
Studji li saru fuq bhejjem m’ humiex biżżejjed rigward l- effetti fuq is- sistema riproduttiva f' livelli ta 'espożizzjoni sistemika għoljin (ara sezzjoni 5. 3).
The potential risk to humans is unknown.
Mhux magħruf ir- riskju potenzjali għall- bniedem.
The systemic exposure to pegaptanib is expected to be very low after ocular administration.
L- espożizzjoni sistemika għal pegaptanib hi mistennija li tkun baxxa ħafna wara amministrazzjoni fl- għajnejn.
Nevertheless, Macugen should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus.
Madankollu, Macugen għandu jintuża waqt it- tqala biss jekk il- benefiċċju potenzjali għall- omm jiġġustifika r- riskju potenzjali għall- fetu.
It is not known whether Macugen is excreted in human milk.
Mhux magħruf jekk Macugen jitneħħiex fil- ħalib uman.
Macugen is not recommended during breast-feeding.
Macugen mhux rakkomandat waqt it - treddigħ.
Patients may experience temporary visual blurring after receiving Macugen by intravitreal injection.
Il- pazjenti jistgħu jesperjenzaw tiċpir temporanju tal- vista wara li jirċievu Macugen b' injezzjoni ġol - vitriju.
They should not drive or use machines until this has resolved
Huma m' għandhomx isuqu jew iħaddmu magni sakemm dan jirrisolvi ruħu.
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.
Macugen ġie mogħti lil 892 pazjent fi studji kkontrollati għal sena (ammont totali ta 'injezzjonijiet = 7545, għadd medju ta' injezzjonijiet/ pazjent = 8. 5) f' dożi ta '0. 3, 1. 0 u 3. 0 mg.
All three doses shared a similar safety profile.
It- tliet dożi kellhom profil tas- sigurtà simili.
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.
Fil- 295 pazjent li ġew ikkurati bid- doża rakkomandata ta '0. 3 mg għal sena (ammont totali ta' injezzjonijiet = 2478, ammont medju ta 'injezzjonijiet/ pazjent = 8. 4), 84% tal - pazjenti esperjenzaw episodju avvers li ġie attribwit mill- investigaturi bħala relatat mal- proċedura ta' l - injezzjoni, 3% tal- pazjenti esperjenzaw Episodju Avvers Serju li seta 'kien relatat mal- proċedura ta' l - injezzjoni, u 1% esperjenzaw episodju avvers potenzjalment relatat mal- proċedura ta 'l- injezzjoni li wassal għal twaqqif tal- kura fl- istudju.
Twenty seven percent (27%) of the patients experienced an adverse event attributed by the investigators as being related to the study drug.
Sebgħa u għoxrin fil- mija (27%) tal- pazjenti esperjenzaw episodju avvers li ġie attribwit mill- investigaturi bħala relatat mal- mediċina fl- istudju.
Two patients (0.7%) experienced Serious Adverse Events potentially related to study drug.
Żewġ pazjenti (0. 7%) esperjenzaw Episodji Avversi Serji potenzjalment relatati mal- mediċina fl- istudju.
One of these patients had an aortic aneurysm; the other had a retinal detachment and retinal haemorrhage, which led to discontinuation of treatment.
Wieħed minn dawn il- pazjenti kellu anewriżma ta 'l- aorta; l- ieħor kellu stakkar tar- retina u emorraġija fir - retina, li wasslu għal twaqqif tal- kura.
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%).
L- Episodji Avversi Serji ta 'l- għajnejn li ġew irrapportati f' pazjenti kkurati b' Macugen kienu jinkludu endophthalmitis (12- il każ, 1%), emorraġija fir- retina (3 każijiet, < 1%), emorraġija ġol- vitriju (2 każijiet, < 1%), u stakkar tar- retina (4 każijiet, < 1%).
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.
It- tagħrif dwar is- sigurtà deskritt hawn isfel jiġbor fil- qosor l- episodji avversi kollha relatati mal - proċedura u l- mediċina fil- 295 pazjent fil- grupp ta 'kura b' 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).
Ir- reazzjonijiet avversi huma elenkati bis- sistema tal- klassifika ta 'l- organi u l- frekwenza (komuni ħafna (≥1/ 10), komuni (≥1/ 100 u < 1/ 10), u mhux komuni ((≥1/ 1000 u < 1/ 100).
nightmare, depression
ħmar il- lejl, depressjoni
headache
uġigħ ta 'ras
Eye
Disturbi fl- għajnejn Dawn ir- reazzjonijiet avversi ta 'l- għajnejn kienu kkunsidrati potenzjalment relatati mal- kura b' Macugen (jew il- proċedura ta' l- injezzjoni jew minħabba Macugen), u fil- parti l- kbira kienu kkunsidrati marbuta mal- proċedura ta 'l- injezzjoni.
disorders
komuni ħafna
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.
infjammazzjoni tal- kompartiment anterjuri, uġigħ fl- għajnejn, pressjoni għolja fl- għajnejn, keratite mimlija punti, floaters fil- vitriju u opaċitajiet fil- vitriju
abnormal sensation in eye, cataract, conjunctival haemorrhage, conjunctival hyperaemia, conjunctival oedema, conjunctivitis, corneal dystrophy, corneal epithelium defect, corneal epithelium disorder, corneal oedema, dry eye, endophthalmitis, eye discharge, eye inflammation, eye irritation, eye pruritus, eye redness, eye swelling, eyelid oedema, lacrimation increased, macular degeneration, mydriasis, ocular discomfort, ocular hypertension, periorbital haematoma, photophobia, photopsia, retinal haemorrhage, vision blurred, visual acuity reduced, visual disturbance, vitreous detachment, and vitreous disorder
sensazzjoni abnormali fl- għajn, katarretta, emorraġija konġunktivali, iperimija konġunktivali, edema konġunktivali, konġuntivite, distrofija tal- kornea, difett fl- epithelium tal- kornea, disturb fl- epithelium tal - kornea, edema tal- kornea, għajn xotta, endophthalmitis, tnixxija mill - għajn, infjammazzjoni ta 'l- għajn, irritazzjoni ta' l- għajn, ħakk fl - għajn, ħmura fl- għajn, nefħa fl- għajn, edema fil- kappell ta 'l- għajn, żieda fit- tidmigħ, deġenerazzjoni makulari, mydriasis, diqa fl- għajn, pressjoni għolja fl- għajn, ematoma madwar l- orbita, fotofobija, fotopsja, emorraġija mir- retina, vista mċajpra, tnaqqis ta' l- akutezza viżwali, disturb viżwali, stakkar tal- vitriju, u disturb tal- vitriju
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
asthenopia, blefarite, konġuntivite allerġika, depożiti tal- kornea, emorraġija fl- għajn, ħakk fil- kpiepel ta 'l- għajnejn, keratite, emorraġija fil- vitriju, indeboliment tar- rifless pupillari, brix tal - kornea, effużjonijiet tar- retina, ptosi tal- kappell ta' l- għajn, ċikatriċi tar- retina, chalazion, erużjoni tal- kornea, tnaqqis tal- pressjoni ġo l - għajn, reazzjoni fil- post ta 'l- injezzjoni, bżieżaq fil- post ta' l - injezzjoni, stakkar tar- retina, disturb fil- kornea, okklużjoni ta 'l- arterja tar- retina, tiċrit tar- retina, ectropion, disturb fil- moviment ta' l- għajn, irritazzjoni fil- kappell ta 'l- għajn, hyphaema, disturb fil- pupilla, disturb fil- ħabba ta' l- għajn, icterus ta 'l- għajn, uveite anterjuri, depożitu fl- għajn, infjammazzjoni tal- ħabba ta' l- għajn, cupping tan - nerv ottiku, deformazzjoni tal- pupilla, okklużjoni tal- vina tar- retina, u prolass tal- vitriju
deafness, Meniere's disease aggravated, vertigo
truxija, aggravament tal- marda ta 'Meniere, vertigo
palpitations
palpitazzjonijiet
hypertension, aortic aneurysm
pressjoni għolja, anewriżma ta 'l- aorta
rhinorrhea nasopharyngitis
mħat infjammazzjoni ta ’ l- imnieħer u tal- farinġi
vomiting, dyspepsia
rimettar, dispepsja
Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta 'taħt il- ġilda
contact dermatitis, eczema, hair colour changes, rash, pruritus, night sweats
dermatite ta 'kuntatt, ekżema, bidliet fil- kulur tax- xagħar, raxx, ħakk, tagħriq bil- lejl
back pain
mhux komuni
General disorders and administration site conditions
għeja, tertir, sensibilità, uġigħ fis- sider, mard bħall- influwenza
fatigue, rigors, tenderness, chest pain, influenza like illness
Korriment, avvelenament u kumplikazzjonijiet proċedurali
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).
Tliet mija u erbgħa u sebgħin (374) pazjent irċevew kura kontinwa b' Macugen sa sentejn (128 f' doża ta '0. 3 mg, 126 f' doża ta' 1 mg, u 120 f' doża ta '3 mg).
The overall safety data were consistent with the Year 1 safety data, and no new safety signals emerged.
L- informazzjoni globali dwar is- sigurtà kienet konsistenti ma 'l- informazzjoni dwar is- sigurtà għall- Ewwel Sena, u ma ħarġu ebda sinjali ġodda ta' sigurtà.
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.
Fil- 128 pazjent li ngħataw kura bid- doża rakkomandata ta '0. 3 mg għal perjodu ta' żmien sa sentejn (ammont totali ta 'injezzjonijiet fit- tieni sena = 913, ammont medju ta' injezzjonijiet fit- tieni sena = 6. 9), ma kienx hemm evidenza ta 'żidiet fil- frekwenza ta' l- episodji avversi meta mqabbel ma 'dawk li dehru matul l- ewwel sena.
Post-Marketing Experience:
Esperjenza Wara t- Tqegħid fis- Suq:
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).
Każijiet rari ta 'anafilassi/ reazzjonijiet anaphylactoid, fosthom anġoedema, ġew irrapportati fil- pazjenti sa diversi sigħat wara l- amministrazzjoni ta' pegaptanib ma 'diversi medikazzjonijiet mogħtija bħala parti mill- proċedura ta' preparazzjoni għall- injezzjoni (ara sezzjonijiet 4. 2 u 4. 4).
Overdosage with Macugen has not been reported in clinical trials.
L- ebda każ ta 'doża eċċessiva b' Macugen ma ġie rrapportat.
Pegaptanib is a pegylated modified oligonucleotide that binds with high specificity and affinity to extracellular Vascular Endothelial Growth Factor (VEGF165) inhibiting its activity.
Pegaptanib hu pegylated modified oligonucleotide li jaqbad bi speċifiċità u affinità kbira mal- Fattur Endoteljali Vaskulari ekstraċellulari tat- Tkabbir (VEGF165) biex jimpedixxi l- attività tiegħu.
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.
VEGF hija proteina merħija li tinduċi anġoġenesi, permeabilità vaskulari u infjammazzjoni, li kollha huma maħsuba li jikkontribwixxu għall- progressjoni tal- forma neovaskulari (imxarrba) ta 'AMD.
VEGF165 is the VEGF isoform preferentially involved in pathological ocular neovascularisation.
VEGF165 hija l- iżoforma VEGF preferenzjalment involuta f' neovaskularizzazzjoni patoloġika ta 'l- għajnejn.
The selective inhibition in animals with pegaptanib proved as effective at suppressing pathological neovascularisation as pan-VEGF inhibition, however pegaptanib spared the normal vasculature whereas pan-VEGF inhibition did not.
L - inibizzjoni selettiva fl- annimali b' pegaptanib irriżultat effettiva fit- trażżin tan- neovaskularizzazzjoni patoloġika daqs l- inibizzjoni pan- VEGF, madankollu pegaptanib m' għamilx ħsara lill- vaskulatura normali filwaqt li inibizzjoni pan- VEGF għamlet.
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.
Tnaqqis fit- tkabbir tad- daqs totali medju tal- ferita, neovaskularizzazzjoni choroidal (daqs tal- CNV), u d- daqs tat- tnixxija ta 'fluorescein, ġew murija f' pazjenti b' AMD ikkurati b' Macugen.
Pegaptanib was studied in two controlled, double-masked, and identically designed randomised studies (EOP1003; EOP1004) in patients with neovascular AMD.
Pegaptanib ġie studjat f' żewġ studji kkontrollati, double- masked, imfasslin b' mod identiku u mwettqa b' għażla kawżwali (EOP1003; EOP1004) f' pazjenti b' AMD neovaskulari.
A total of 1190 patients were treated (892 pegaptanib, 298 sham (control)) with a median age of 77 years.
Kienu kkurati b' kollox 1190 pazjent (892 pegaptanib, 298 sham (kontroll) b' eta 'medjana ta' 77 sena.
Patients received a mean of between 8.4-8.6 treatments out of possible 9 total across all treatment arms in the first year.
Il- pazjenti rċevew medja ta '8. 4- 8. 6 trattamenti minn total ta' 9 possibbli fil- gruppi kollha ta 'kura fl- ewwel sena.
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.
Il- pazjenti ġew magħżula b' mod każwali biex jirċievu sham jew 0. 3 mg, 1 mg jew 3 mg pegaptanib mogħti bħala injezzjonijiet ġol- vitriju kull 6 ġimgħat għal 48 ġimgħa.
Verteporfin photodynamic therapy (PDT) was permitted in patients with predominantly classic lesions at the discretion of the investigators.
Terapija fotodinamika b' verteporfin (PDT) kienet permessa f' pazjenti li kellhom feriti l- biċċa l- kbira klassiċi fid- diskrezzjoni ta 'l- investigaturi.
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.
Iż- żewġ studji rreġistraw pazjenti, li kienu jinkludu s- sottotipi kollha tal- feriti minn AMD neovaskulari (25% il- biċċa l- kbira klassiċi, 39% okkulti mingħajr ebda ferita klassika u 36% minimament klassiċi), daqsijiet tal- ferita sa 12 disc areas, li minnhom sa 50% setgħu jkunu ffurmati minn emorraġija taħt ir- retina u/ jew sa 25% ċikatriċi fibrotika jew ħsara atrofika.
Patients had up to one prior PDT and baseline visual acuity in the study eye between 20/ 40 and 20/ 320.
Il- pazjenti kellhom sa PDT waħda preċedenti u akutezza viżwali bażika fl- għajn studjata ta 'bejn 20/ 40 u 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).
6 Wara sena, pegaptanib 0. 3 mg wera benefiċċju statistikament sinifikanti tal- kura għall- endpoint primarju ta 'l- effikaċja; proporzjon tal- pazjenti li tilfu anqas minn 15- il ittra ta' akutezza viżwali (analiżi miġbura speċifikata minn qabel, pegaptanib 0. 3 mg 70% kontra Sham 55%, p = 0. 0001; EOP 1003 pegaptanib 0. 3 mg 73% kontra Sham 59%, p = 0. 0105; EOP1004 pegaptanib 0. 3 mg 67% kontra Sham 52%, p = 0. 0031).
Mean Change in Visual Acuity Over Time; Year 1; ITT (LOCF) Mean Change in VA from Week 0 (Letters)
Bidla Medja fl- Akutezza Viżwali Maż- Żmien; L- Ewwel Sena; ITT (LOCF) Bidla Medja fil- VA minn Ġimgħa 0 (Ittri)
Weeks N: number of patients enrolled
Ġimgħat N: numru ta 'pazjenti rreġistrati
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.
Pegaptanib 0. 3 mg wera benefiċċju tal- kura irrispettivament mis- sottotip tal- ferita bażika, id- daqs tal - ferita u l- akutezza viżwali kif ukoll l- eta ', is- sess tal- persuna, il- pigmentazzjoni tal- ħabba ta' l- għajn u l- użu preċedenti u/ jew bażiku ta 'PDT.
At the end of the first year (week 54), 1053 patients were re-randomized to either continue or discontinue treatment through week 102.
Fit- tmiem ta 'l- ewwel sena (ġimgħa 54), 1053 pazjent reġgħu ġew magħżula b' mod każwali biex jew ikomplu jew iwaqqfu l- kura sa ġimgħa 102.
On average, the treatment benefit was maintained at 102 weeks with continuing preservation of visual acuity for patients re-randomized to continue pegaptanib.
B' mod ġenerali, il- benefiċċju tal- kura nżamm wara 102 ġimgħa bi preservazzjoni kontinwa ta 'l - akutezza viżwali għall- pazjenti magħżula b' mod każwali biex ikomplu pegaptanib.
Patients who were re-randomized to discontinue pegaptanib after one year, lost visual acuity during the second year.
Il- pazjenti li ġew magħżula b' mod każwali biex iwaqqfu pegaptanib wara sena, tilfu l- akutezza viżwali matul it- tieni sena.
7 Summary of Mean Changes in Visual Acuity from Baseline to Weeks 6, 12, 54 and 102 (LOCF)
7 Sommarju tal- Bidliet Medji fl- Akutezza Viżwali mil- Linja Bażika sa Ġimgħa 6, 12, 54 u 102 (LOCF)
EOP 1003 0.3-
EOP 1004 EOP 1003
discontinued
0. 3- imwaqqaf
sham/ sham+ 0.3-0.3 discontinued
sham/ sham+ 0. 3- 0. 3 0. 3- imwaqqaf imwaqqaf
sham/ sham+ discontinued
sham/ sham+ imwaqqaf
in VA Week 6 Mean change
Bidla medja fil - VA Ġimgħa 6 Bidla medja fil -
in VA Week 12 Mean change
VA Ġimgħa 12 Bidla medja fil -
in VA Week 54 Mean change
VA Ġimgħa 54 Bidla medja fil -
in VA Week 102
VA Ġimgħa 102
Data over a two-year period indicate that Macugen treatment should be initiated as early as possible.
L- informazzjoni fuq perjodu ta 'sentejn tindika li l- kura b' Macugen għandha tinbeda kmieni kemm jista' jkun.
In advanced disease the initiation and continuation of Macugen therapy should consider the potential for useful vision in the eye.
Fil- każ ta 'mard avanzat il- bidu u t- tkomplija ta' terapija b' Macugen għandu jqis il- potenzjal għal vista siewja fl- għajn.
Macugen therapy administered to both eyes concurrently has not been studied.
It- terapija b' Macugen amministrat fiż- żewġ għajnejn fl- istess ħin ma ġietx studjata.
The safety and efficacy of Macugen beyond two years has not been demonstrated.
Is- sigurtà u l- effikaċja ta 'Macugen wara sentejn ma ġietx ippruvata.
In animals, pegaptanib is slowly absorbed into the systemic circulation from the eye after intravitreal administration.
Fl- annimali, pegaptanib jiġi assorbit bil- mod fiċ- ċirkolazzjoni sistemika mill- għajn wara amministrazzjoni ġol- vitriju.
The rate of absorption from the eye is the rate-limiting step in the disposition of pegaptanib in animals and is likely to be in humans.
Ir- rata ta 'assorbiment mill- għajn hija l- pass li jillimita r- rata fid - disposizzjoni ta' pegaptanib fl- annimali u probabbli hija l- istess fil- bniedem.
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.
Fil- bniedem, il- half life medja ± devjazzjoni standard apparenti ta 'pegaptanib fil- plasma wara doża ta' 3 mg (10 darbiet id - doża rakkomandata) għal għajn waħda hi 10 ± 4 ijiem.
A mean maximum plasma concentration of about 80 ng/ ml occurs within 1 to 4 days after a 3 mg monocular dose in humans.
Konċentrazzjoni massima medja fil- plasma ta 'madwar 80 ng/ ml isseħħ fi żmien 1 sa 4 ijiem wara doża ta' 3 mg għal għajn waħda fil- bniedem.
The mean area under the plasma concentration-time curve (AUC) is about 25 μ g·hr/ ml at this dose.
L- erja medja taħt il- kurva tal- konċentrazzjoni fil- plasma mal- ħin (AUC) hi madwar 25 μg hr/ ml f' din id- doża.
Pegaptanib does not accumulate in the plasma when administered intravitreally every 6 weeks.
Pegaptanib ma jakkumulax fil- plasma meta jingħata ġol- vitriju kull 6 ġimgħat.
At doses below 0.5 mg/ eye, pegaptanib plasma concentrations do not likely exceed 10 ng/ ml.
F' dożi taħt 0. 5 mg/ għajn, il- konċentrazzjonijiet ta 'pegaptanib fil - plasma aktarx li ma jaqbżux 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.
Il- bijodisponibilità assoluta ta 'pegaptanib wara amministrazzjoni ġol- vitriju ma ġietx imkejla fil - bniedem, iżda hija madwar 70- 100% fil- fniek, il- klieb u x- xadini.
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.
Fl- annimali li rċevew dożi ta 'pegaptanib sa 0. 5 mg/ għajn fiż- żewġ għajnejn, il- konċentrazzjonijiet fil - plasma kienu 0. 03% sa 0. 15% ta' dawk fil- likwidu tal- vitriju.
8 Distribution/ Metabolism/ Excretion:
8 Distribuzzjoni/ Metaboliżmu/ Tneħħija:
In mice, rats, rabbits, dogs and monkeys, pegaptanib distributes primarily into plasma volume and is not extensively distributed to peripheral tissues after intravenous administration.
Fil- ġrieden, firien, fniek, klieb u xadini, pegaptanib jitqassam prinċipalment ġol- volum tal- plasma u ma jitqassamx b' mod estensiv fit- tessuti periferali wara amministrazzjoni ġol- vitriju.
Twenty-four hours after intravitreous administration of a radiolabeled dose of pegaptanib to both eyes of rabbits, radioactivity was mainly distributed in vitreous humour, retina and aqueous humour.
Erbgħa u għoxrin siegħa wara l- amministrazzjoni ġol- vitriju ta 'doża radjutikkettata ta' pegaptanib fiż- żewġ għajnejn tal - fniek, ir- radjuattività ġiet distribwita prinċipalment fit- tessut li jimla l- ħabba ta 'l- għajn, ir- retina u l - fluwidu ta' bejn il- lenti ta 'l- għajn u l- kornea.
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.
Wara l- amministrazzjoni ġol- vitriju u fil- vina ta 'pegaptanib radjutikkettat lil fniek, l- akbar konċentrazzjonijiet ta' radjuattività (teskludi l- għajn fil- każ tad- doża ġol- vitriju) nkisbu fil- kliewi.
In rabbits, the component nucleotide, 2’ -fluorouridine is found in plasma and urine after single radiolabeled pegaptanib intravenous and intravitreal doses.
Fil- fniek, in- nucleotide komponenti, 2 ’ - fluorouridine jinstab fil - plasma u fl- awrina wara dożi waħdiena ta 'pegaptanib radjutikkettat ġol- vitriju jew fil- plasma.
Pegaptanib is metabolised by endo- and exonucleases.
Pegaptanib jiġi metabolizzat b' endo - u exonucleases.
In rabbits, pegaptanib is eliminated as parent drug and metabolites primarily in the urine.
Fil- fniek, pegaptanib jiġi eliminat bħala droga oriġinali u metaboliti prinċipalment fl- awrina.
Pegaptanib pharmacokinetics is similar in female and male patients and within the age range 50 to 90 years.
Il- farmakokinetika ta 'pegaptanib hija simili fil- pazjenti nisa u rġiel u fil- medda ta' etajiet ta '50 sa 90 sena.
Pegaptanib sodium has not been adequately studied in patients with creatinine clearance below 20 ml/ min.
Pegaptanib sodium ma ġiex studjat b' mod adegwat f' pazjenti bi clearance tal- kreatinina taħt 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.
Tnaqqis fi clearance tal- kreatinina sa 20 ml/ min jista 'jkun assoċjat ma' żieda ta '2. 3 drabi fl - AUC ta' pegaptanib.
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.
L- ebda konsiderazzjonijiet speċjali ma huma meħtieġa f' pazjenti bi clearance tal - kreatinina ta '' l fuq minn 20 ml/ min li jiġu kkurati bid- doża rakkomandata ta 'pegaptanib sodium 0. 3 mg.
Pegaptanib pharmacokinetics have not been studied in patients with hepatic impairment.
Il- farmakokinetika ta 'pegaptanib ma ġiex studjat f' pazjenti b' indeboliment tal- fwied.
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.
L- espożizzjoni sistemika hi mistennija li tkun f' medda ttollerata sewwa f' pazjenti b' indeboliment tal- fwied, billi doża 10 darbiet ogħla (3 mg/ għajn) kienet ittollerata sewwa.
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Informazzjoni li mhiex klinika magħmula fuq studji konvenzjonali ta 'sigurtà farmakoloġika, effett tossiku fuq il- ġeni, riskju ta ’ kanċer, effett tossiku fuq is- sistema riproduttiva, ma turi l- ebda periklu speċjali għall- bnedmin.
There are no studies on the carcinogenic potential of pegaptanib.
M' hemmx studji dwar il- potenzjal karċinoġeniku ta 'pegaptanib.
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.
Pegaptanib ma pproduċa ebda tossiċità fl- omm u ebda evidenza ta 'teratoġeniċità jew mortalità tal- fetu fil- ġrieden b' dożi ġol- vina ta' 1 sa 40 mg/ kg/ ġurnata.
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.
Kienu osservati tnaqqis fil- piż tal- ġisem (5%) u ossifikazzjoni ttardjata minima fil- falanġi tas- swaba 'ta' quddiem, iżda biss f' livelli ta 'espożizzjoni bbażati fuq AUC ta' 'l fuq minn 300 darba aktar minn dak mistenni fil- bniedem.
These finding are therefore considered to be of limited clinical relevance.
Dawn is- sejbiet għalhekk huma kkunsidrati bħala ta 'rilevanza klinika limitata.
In the 40 mg/ kg/ day group, pegaptanib concentrations in the amniotic fluid were 0.05% of the maternal plasma levels.
Fil- grupp ta '40 mg/ kg/ ġurnata, il - konċentrazzjonijiet ta' pegaptanib fil- fluwidu tal- borqom kienu 0. 05% tal- livelli fil- plasma ta 'l- omm.
There are no reproductive toxicity studies in rabbits.
M' hemmx studji dwar it- tossiċità fis- sistema riproduttiva fil- fniek.
No data are available to evaluate male or female mating or fertility indices.
M' hemmx tagħrif disponibbli biex jiġi evalwat it- tgħammir fl- irġiel jew in- nisa jew l- indiċi tal - fertilità.
Sodium chloride Monobasic sodium phosphate monohydrate Dibasic sodium phosphate heptahydrate Sodium hydroxide Hydrochloric acid Water for injections
Sodium chloride Monobasic sodium phosphate monohydrate Dibasic sodium phosphate heptahydrate Sodium hydroxide Hydrochloric acid Ilma għall- injezzjonijiet
9 6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Store in a refrigerator (2 oC -8oC).
Aħżen fi friġġ (2oC - 8oC).
Macugen is supplied in a single dose pack.
Macugen huwa għal użu ta ’ darba biss.
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.
Eżatt qabel ma jiġi amministrat, is- siringa għandha titneħħa mill- molla tal- plastik u jitneħħa il- tapp tal- kappa.
The syringe has a pre-attached polycarbonate plastic luer lock adaptor and the tip is sealed with an elastomeric tip cap.
Labbra 27 jew 30G x ½ pulzier għandha titwaħħal ma ’ l- adapter tal- lukkett luer, sabiex ikun jista 'jingħata l- prodott.
The pack is supplied without a needle.
L- istopper ma għanduz ikun miġbud lura.
6.6 Special precautions for disposal
Macugen għandu jinħażen fi friġġ.
Macugen is for single use only.
Macugen huwa għal użu ta ’ darba biss.
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.
Jekk is- soluzzjoni tidher imdardra, jiġi nnotat frak jew ikun hemm evidenza ta 'ħsara fis- siringa, jew il- molla tal- plastik hija nieqsa jew mhux imwaħħla mas - siringa, Macugen m' għandux jintuża.
Prior to the administration, the syringe should be removed from the plastic clip and the tip cap removed.
Eżatt qabel ma jiġi amministrat, is- siringa għandha titneħħa mill- molla tal- plastik u jitneħħa il- tapp tal- kappa.
A 27 or 30 G x ½ inch needle should be attached to the luer lock adaptor, to allow the administration of the product.
Labbra 27 jew 30G x ½ pulzier għandha titwaħħal ma ’ l- adapter tal- lukkett luer, sabiex ikun jista 'jingħata l- prodott.
The syringe should be checked with the needle pointing up regarding the presence of bubbles.
Is- siringa għandha tiġi ċċekkjata bil- labra ppuntata 'l fuq rigward il- preżenza ta' bżieżaq ta 'l- arja.
If there are bubbles, the syringe should be gently tapped with a finger until the bubbles rise to the top of the syringe.
Jekk ikun hemm bżieżaq, is- siringa għandha tiġi mtektka bil- mod b' saba 'sakemm il- bżieżaq jitilgħu fil - wiċċ tas- siringa.
Then, the plunger should be slowly pushed up to force the bubbles out of the syringe.
Imbagħad, il- planġer għandu jiġi imbuttat bil- mod biex il- bżieżaq jiġu sfurzati 'l barra mis- siringa.
The plunger stopper should not be pulled back.
L- istopper ma għanduz ikun miġbud lura.
The last rib of the plunger stopper (closest to the plunger rod) should not be pushed past the dose line printed on the syringe.
10 It- tarf ta ’ l- istopper tal- plunġer (dak li huwa l- iktar viċin għall- qasba tal- plunġer) ma għandux ikun imbuttat ‘ il fuq mill- aħħar linja tad- doża immarkata fuq is- siringa.
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.
Eżatt qabel ma jiġi amministrat, it- tarf tal- plunġer għandu jkun eżatt mal- linja tad- doża sabiex id- doża eżatta tkun mogħtija.
At this point, the entire content of the syringe should be injected.
F’ dan il- punt, il- kontenut tas- siringa għandu jiġi mogħti kollu.
Macugen should be stored in a refrigerator.
Macugen għandu jinħażen fi friġġ.
The solution to be injected should reach room temperature before injecting.
Is- soluzzjoni għall- injezzjoni għandha tilħaq temperatura tal- kamra qabel ma tiġi injettata.
Macugen should be discarded if kept at room temperature for more than two weeks.
Macugen għandu jintrema jekk ikun inżamm f' temperatura tal- kamra għal aktar minn ġimagħtejn.
To prevent contamination, the Macugen syringe should not be removed from the pouch until the patient has been prepared for injection.
Sabiex tiġi evitata kontaminazzjoni, is- siringa ta 'Macugen m' għandhiex titneħħa mill- borża sakemm il- pazjent ikun ġie ppreparat għall- injezzjoni.
Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom
Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ Ir- Renju Unit
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA): http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- mediċini (EMEA) http: // www. emea. europa. eu >
12 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Pfizer Ireland Pharmaceuticals Pottery Road Dun Laoghaire Co Dublin Ireland
Pfizer Ireland Pharmaceuticals Pottery Road Dun Laoghaire Co Dublin L- Irlanda
The Marketing Authorisation Holder must implement nationally, prior to marketing, and as agreed with the competent authorities in the Member States:
Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq irid jimplimenta fil- pajjiż ikkonċernat, qabel ma jpoġġi l- prodott fis- suq, u kif maqbul ma' l- awtoritajiet kompetenti fl- Istati Membri: • Pjan edukattiv għat- tobba u l- fornituri tal- kura tas- saħħa li jkun immirat sabiex jitnaqqas ir - riskju u jappoġġja l- użu bla periklu u effettiv tal- prodott.