qanastek/EMEA-V3 huggingface dataset:
Pregnancy and breast feeding Generally, you should not be given NeuroBloc if you are pregnant or breast-feeding, this is because there is not enough information about the use of NeuroBloc in patients who are pregnant and it is not known if breast milk contains NeuroBloc in nursing mothers treated with the medicine.
Tqala u Treddigħ Ġeneralment m' għandekx tingħata NeuroBloc jekk int tqila jew qed tredda ’, dan minħabba li m’ hemmx tagħrif biżżejjed dwar l- użu ta ’ NeuroBloc f’ pazjenti li huma tqal u mhux magħruf jekk il - ħalib tas- sider f’ ommijiet ikkurati bil- mediċina li qed ireddgħu fihx NeuroBloc.
Driving and using machines If you feel tired, have any loss of sensation or blurred vision take care when driving or operating machinery.
Sewqan u tħaddim ta ’ magni Jekk tħossok għajjien, għandek xi nuqqas ta ’ sensazzjoni jew vista mċajpra, oqgħod attent meta ssuq u tħaddem il- magni.
Important information about some of the ingredients of NeuroBloc The medicinal product contains less than 1 mmol sodium (23 mg) per 10,000 units of NeuroBloc, i. e. essentially “ sodium free”.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ NeuroBloc Il- prodott mediċinali fih inqas minn 1 mmol ta ’ sodju (23 mg) kull 10, 000 unità ta ’ NeuroBloc, i. e. essenzjalment “ bla sodju ”.
HOW YOU WILL BE GIVEN NEUROBLOC
KIF GĦANDEK TUŻA NEUROBLOC
Your doctor will decide how much NeuroBloc to give you.
It- tabib tiegħek ser jiddeċiedi kemm ser jagħtik NeuroBloc.
The dose will usually be 10,000 Units, but it can be higher or lower, depending on your doctor’ s decision and your response to any previous injections of NeuroBloc.
Id- doża ġeneralment tkun ta ’ 10, 000 Unità, imma tista ’ tkun ogħla jew aktar baxxa, skond id- deċiżjoni tat- tabib tiegħek u r- respons tiegħek għal kull injezzjoni mogħtija qabel ta ’ NeuroBloc.
If you have the impression that the effect of NeuroBloc is too strong or too weak, talk to your doctor.
Jekk tħoss li l- effett ta ’ NeuroBloc huwa qawwi wisq, jew dgħajjef wisq, kellem lit- tabib tiegħek.
NeuroBloc will be injected into your neck and/ or shoulder muscles, depending on which ones are causing the problem.
NeuroBloc ser jiġi injettat ġo għonqok u/ jew ġol- muskoli ta ’ l- ispalla, skond liema minnhom qed jikkawżaw il- problema.
Your doctor will decide into which muscles to inject NeuroBloc and may inject part of the dose into different places in the muscles.
It- tabib tiegħek ser jiddeċiedi f’ liema muskoli għandu jiġi njettat NeuroBloc u jista ’ jinjetta parti mid- doża f’ partijiet differenti ġol- muskoli.
The effects of NeuroBloc will usually wear off after approximately 12 to 16 weeks.
L- effetti ta ’ NeuroBloc ġeneralment jgħibu wara madwar 12 sa 16- il ġimgħa.
Your doctor will decide when you need another injection and how much to give you.
It- tabib tiegħek ser jiddeċiedi meta ser ikollok bżonn tieħu injezzjoni oħra u kemm għandu jagħtik.
You can continue injections of NeuroBloc as long as it gives you relief from your symptoms.
Tista ’ tibqa tieħu injezzjonijiet ta ’ NeuroBloc sakemm jibqa ’ ikollok serħan mis- sintomi tiegħek.
After you have had a number of injections, your body may produce antibodies that may make the treatment less effective.
Wara li tkun ħadt numru ta ’ injezzjonijiet, ġismek jista ’ jipproduċi anti- korpi li jistgħu jdgħajjfu l- effettività tal- kura.
Your doctor knows about this and will look for signs of it.
It- tabib tiegħek jaf b’ dan u ser ifittex għal sinjali għalih.
If you are given more NeuroBloc than you need, some of your muscles that were not injected may feel weak.
Jekk tingħata aktar NeuroBloc milli għandek bżonn, xi ftit muskoli li ma kinux injettati jistgħu jinħassu dgħajfa.
If this happens you should speak to your doctor immediately.
Jekk dan jiġri għandek tkellem lit- tabib tiegħek minnufih.
Tell your doctor immediately if you have difficulty breathing.
Għid lit- tabib tiegħek immedjatament jekk issib diffikultà biex tieħu n- nifs.
If he/ she is unavailable seek emergency assistance.
Jekk hu/ hi mhux disponibbli fittex assistenza ta ’ emerġenza.
If you forget to visit your doctor to receive your injection The effects of NeuroBloc will gradually wear off and the abnormal muscle contractions may come back.
L- effetti ta ’ NeuroBloc ser jgħibu bil- mod u l- kontrazzjonijiet anormali tal- muskolu jistgħu jiġu lura.
Like all medicines, NeuroBloc can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, NeuroBloc jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
You may feel pain at the place where you had the injection but this should wear off after a few minutes.
Għandek mnejn tħoss uġigħ fil- post ta ’ fejn ingħatajt l- injezzjoni imma dan għandu jgħaddi wara ftit minuti.
27 Effects may be seen in other areas than where you have received the injection and may occur days to weeks after injection.
Apparti mill- post fejn inti rċevejt l- injezzjoni, jistgħu jseħħu effetti f’ postijiet oħra minn ġranet sa ġimgħat wara l- injezzjoni.
You may find that your mouth feels dry and/ or that swallowing becomes difficult.
Għandek mnejn tħoss ħalqek xott u/ jew issibha diffiċli biex tibla ’ jew tesperjenza nifs qasir.
In rare cases difficulty in swallowing may be severe and choking is possible.
F’ każijiet rari diffikultà biex tibla ’ tista ’ tkun severa u huwa possibli li tifga.
If you develop new or worsening swallowing difficulty, choking or breathing problems seek medical help immediately.
Jekk tiżviluppa diffikultà biex tibla ’, tifġa ’ jew diffikultà biex tieħu nifs ġodda jew li marru għall - agħar fittex minnufih għajnuna medika.
You may also notice one or more of the following effects after injection:
Għandek mnejn tinnota wieħed jew aktar mill- effetti li ġejjin wara l- injezzjoni:
Very common reported side effects (likely to occur in more than 1 in 10 patients)
Effetti sekondarji rrappurtati b’ mod komuni ħafna (probabbli li jseħħu f’ aktar minn 1 minn kull 10 pazjenti)
- Dry mouth
- Ħalq xott
- Difficulty swallowing
- Diffikultà biex tibla ’
Common reported side effects (likely to occur in fewer than 1 in 10 patients). weakness, pain or muscle stiffness around your body
Effetti sekondarji rrappurtati b’ mod komuni (probabbli li jseħħu f’ inqas minn 1 minn kull 10 pazjenti).
- neck pain
- uġigħ fl- għonq
- indigestion
- indiġestjoni
- changes in the taste of your food and drink
- bidliet fit- togħma ta ’ l- ikel u x- xorb tiegħek
- changes in the sound of your voice.
- tibdil fil- ħoss tal- vuċi tiegħek.
- blurred vision
- vista mċajpra
- drooping of the upper eyelid
- tebqet il- għajn ta ’ fuq titbaxxa
- flu-like symptoms
- sintomi bħal ta ’ l- influwenza
- loss of strength or energy
- nuqqas ta ’ saħħa jew enerġija
It is also possible that torticollis (turning of your head which you cannot control) could become worse after you have had your injection.
Huwa possibbli wkoll li torticollis (it- tidwir tar- ras mingħajr il- kontroll tiegħek) tiggrava wara li tkun ħadt l- injezzjoni tiegħek.
If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE NEUROBLOC
KIF TAĦŻEN NEUROBLOC
Do not use after the expiry date stated on the carton.
Tużax wara d- data ta ’ skadenza li tidher fuq il- kartuna.
Keep the container in the outer carton in order to protect from light.
Żomm il- kontenitur fil- kartuna ta ’ barra sabiex tilqa 'mid- dawl.
At the end of this period, the product should not be put back in the refrigerator and should be disposed of.
Fit- tmiem ta ’ dan il- perjodu, il- prodott m’ għandux jitpoġġa lura fil- friġġ u għandu jintrema.
The date at which the product was taken out of the refrigerator should be mentioned on the outer carton.
Id- data li fiha l- prodott ikun inħareġ mill- friġġ għandha tinkiteb fuq il- kartuna ta ’ barra.
Due to the special nature of NeuroBloc, used vials, needles and syringes must be processed as Medical Biohazardous Waste in accordance with local requirements.
Minħabba n- natura speċjali ta ’ NeuroBloc, kunjetti, labar u siringi wżati għandhom jiġu pproċessati bħala Skart Mediku Bijoperikoluż skond il- ħtiġijiet lokali.
What NeuroBloc contains
X’ fih NeuroBloc
- The active substance is Botulinum Toxin Type B.
- Is- sustanza attiva hija Botulinum Toxin Tip B.
One ml contains 5000 U Botulinum Toxin Type B.
Millilitru fih 5000 U ta ’ Botulinum Toxin Tip B.
- The other ingredients are disodium succinate, sodium chloride, human serum albumin (containing
- Is- sustanzi l- oħra huma disodium succinate, sodium chloride, human serum albumin (li fiħ
sodium caprylate and sodium acetyltryptophanate as excipients), hydrochloric acid (for pH adjustment) and water for injections.
sodium caprylate u sodium acetyltryptophanate bħala sustanzi mhux attivi), hydrochloric acid (għal aġġustament tal- pH), u ilma għall- injezzjonijiet.
What NeuroBloc looks like and contents of the pack
Id- Dehra ta ’ NeuroBloc u l- kontenuti tal- pakkett
NeuroBloc is a clear and colourless to pale yellow solution supplied in a glass vial that contains 0.5ml (2500Units), 1.0ml (5000 Units) or 2.0ml (10,000 Units) of solution for injection.
NeuroBloc hija soluzzjoni ċara u mingħajr kulur li jagħti fl- isfar ċar f kunjett tal- ħġieġ li fih 0. 5ml (2500 Unità), 1. 0ml (5000 Unità) jew 2. 0ml (10, 000 Unità) ta ’ soluzzjoni għall- injezzjoni.
Marketing Authorisation holder:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Eisai Limited Mosquito Way Hatfield Hertfordshire AL10 9SN United Kingdom
Eisai Limited Mosquito Way Hatfield Herts AL10 9SN Ir- Renju Unit
Eisai Manufacturing Limited Mosquito Way Hatfield Hertfordshire AL10 9SN United Kingdom
Eisai Manufacturing Limited Mosquito Way Hatfield Herts AL10 9SN Ir- Renju Unit
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
Deutschland Eisai GmbH Tel: + 49 (0) 696 65 85-0
Deutschland Eisai GmbH Tel: + 49 (0) 696 65 85- 0 Eesti Eisai Ltd.
This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar f ’ -------------------------------------------------------------------------------------------------------------------------
31 ------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL
STRUZZJONIJIET GĦALL- UŻU U MANIĠĠAR U GĦAR- RIMI
The solution in the vials is ready for use.
Is- soluzzjoni f’ kunjetti hija lesta sabiex tintuża.
NeuroBloc is provided as a clear and colourless to light yellow sterile injectable solution in vials for single use only.
NeuroBloc huwa pprovdut bħala soluzzjoni għall- injezzjoni, sterili, ċara u bla kulur sa isfar ċar, f’ kunjetti għall- użu ta ’ darba biss.
NeuroBloc may be diluted with sodium chloride 9 mg/ ml (0.9%) solution for injection.
NeuroBloc jista ’ jiġi dilwit ma ’ soluzzjoni għall- injezzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%).
Decontaminate any spill with 10% caustic solution, or sodium hypochlorite (household chlorine bleach – 2 ml (0.5%):
Iddikontamina kwalunkwe tixrid b’ 10% soluzzjoni kawstika, jew b’ soluzzjoni ta ’ sodium hypochlorite (bliċ tal- chlorine għall- użu fid- djar – 2 ml (0. 5%):
Due to the special nature of NeuroBloc, used vials, needles and syringes must be processed as Medical Biohazardous Waste in accordance with local requirements.
Minħabba n- natura speċjali ta ’ NeuroBloc, kunjetti, labar u siringi wżati għandhom jiġu pproċessati bħala Skart Mediku Bioperikoluż kif jitolbu l- liġijiet lokali.
What is NEVANAC?
X’ inhu NEVANAC?
NEVANAC is a yellow eye drop suspension that contains the active substance nepafenac.
NEVANAC huwa sospensjoni safra għat- taqtir fl- għajnejn li fiha s- sustanza attiva nepafenac.
What is NEVANAC used for?
Għal xiex jintuża NEVANAC?
NEVANAC is used to prevent and treat the pain and inflammation that can occur after an operation to remove a cataract from the eye.
NEVANAC jintuża għall- prevenzjoni u t- trattament ta ’ l- uġigħ u l- infjammazzjoni li tista ’ sseħħ wara operazzjoni għat- tneħħija ta ’ katarretta mill- għajn.
How is NEVANAC used?
Kif jintuża NEVANAC?
The dose of NEVANAC is one drop into the affected eye(s) three times a day beginning one day before the cataract operation.
Id- doża ta ’ NEVANAC hi ta ’ qatra waħda fl- għajn( ejn) affettwata( i) tliet darbiet kuljum minn jum wieħed qabel l- operazzjoni tal- katarretta.
Treatment is continued for two to three weeks after the operation.
It- trattament jitkompla għal bejn ġimagħtejn u tliet ġimgħat wara l- operazzjoni.
An extra drop should be given 30 to 120 minutes before the operation begins.
Għandha tingħata qatra waħda żejda bejn 30 u 120 minuta qabel tibda l - operazzjoni.
If other eye medicines are also being used, there should be a gap of at least five minutes between using each medicine.
Jekk ikunu qed jintużaw mediċini oħra tal- għajnejn, għandhom jgħaddu ta ’ l- anqas ħames minuti bejn mediċina u oħra.
How does NEVANAC work?
Kif jaħdem NEVANAC?
The active substance in NEVANAC, nepafenac, is a ‘ prodrug ’ of amfenac.
Is- sustanza attiva f’ NEVANAC, nepafenac, hija l - ‘ prodroga ’ ta ’ amfenac.
This means that it is converted into amfenac in the eye.
Dan ifisser li din tinbidel f’ amfenac fil- għajn.
Amfenac is a non-steroidal anti-inflammatory drug (NSAID).
Amfenac hija mediċina antinfjammatorja mhux sterojdali (NSAID).
It works by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation process.
Taħdem billi timblokka enzima magħrufa bħala ċikloossiġenażi (cyclo- oxygenase), li tipproduċi prostaglandini, sustanzi li għandhom x’ jaqsmu mal- proċess ta ’ l- infjammazzjoni.
By reducing the production of prostaglandins in the eye, NEVANAC can reduce the inflammation and pain caused by eye surgery.
Bit- tnaqqis tal- produzzjoni tal - prostaglandini fil- għajn, NEVANAC jista ’ jnaqqas l- infjammazzjoni u l- uġigħ ikkawżati minn operazzjoni fil- għajn.
How has NEVANAC been studied?
Kif ġie studjat NEVANAC?
The effects of NEVANAC were first tested in experimental models before being studied in humans.
L- effetti ta ’ NEVANAC għall- ewwel ġew ittestjati f’ mudelli sperimentali qabel ma ġew studjati fil - bniedem.
The effectiveness of NEVANAC has been studied in four main studies involving a total of 1,201 patients undergoing cataract surgery.
L- effikaċja ta ’ NEVANAC ġiet studjata f’ erba ’ studji ewlenin li fihom b’ kollox ħadu sehem 1, 201 pazjent li kienet se ssirilhom operazzjoni għat- tneħħija tal- katarretti.
One study compared NEVANAC used once, twice or three times a day with placebo (dummy eye drops) in 220 patients.
Studju minnhom qabbel NEVANAC użat darba, darbtejn jew tliet darbiet kuljum ma ’ plaċebo (qtar ta ’ l- għajnejn finti) f’ 220 pazjent.
The other three studies, in a total of 981 patients, compared NEVANAC used three times a day, either with placebo, with ketorolac eye drops (another NSAID) or with both placebo and ketorolac.
It- tliet studji l- oħra, f’ total ta ’ 981 pazjent, qabblu NEVANAC użat tliet darbiet kuljum, jew mal- plaċebo, jew ma ’ qtar tal- għajnejn jisimhom ketorolac (NSAID ieħor) jew kemm mal- plaċebo kif ukoll ma ’ ketorolac.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Il- mezz ewlieni għall- kejl ta ’ l- effikaċja kien il- proporzjon ta ’ pazjenti li fihom it- trattament wassal għal suċċess (bi ftit jew xejn sinjali ta ’ infjammazzjoni fil- għajn), jew il - 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has NEVANAC shown during the studies?
Dawn tkejlu ġimagħtejn wara l- operazzjoni.
NEVANAC was more effective than placebo and as effective as ketorolac in reducing signs of inflammation.
NEVANAC kien iktar effikaċi mill- plaċebo u effikaċi daqs ketorolac fit- tnaqqis tas- sinjali ta ’ l - infjammazzjoni.
In the study comparing different doses, the patients using NEVANAC three times a day had the lowest failure rate.
Fl- istudju li qabbel dożi differenti, il- pazjenti li użaw NEVANAC tliet darbiet kuljum kellhom l- iktar rata ta ’ falliment baxxa.
When NEVANAC was compared with placebo, around 70% of the patients using NEVANAC had no signs of inflammation after two weeks, compared with 17% to 59% of those using placebo.
Meta NEVANAC tqabbel mal- plaċebo, madwar 70% tal - pazjenti li kienu qed jużaw NEVANAC ma kellhom l- ebda sinjal ta ’ infjammazzjoni wara ġimagħtejn meta mqabbla ma ’ bejn 17% u 59% ta ’ dawk li kienu qed jużaw il- plaċebo.
In the study comparing NEVANAC with ketorolac, around 65% of both groups of patients showed no or few signs of inflammation.
Fl- istudju li qabbel NEVANAC ma ’ ketorolac, madwar 65% taż- żewġ gruppi ta ’ pazjenti kellhom ftit jew xejn sinjali ta ’ infjammazzjoni.
What is the risk associated with NEVANAC?
X’ inhu r- riskju assoċjat ma ’ NEVANAC?
The most common side effects with NEVANAC (seen in between 1 and 10 patients in 100) are headache, punctate keratitis (spots of inflammation in the cornea, the transparent layer in front of the pupil), eye pain, blurred vision, eye pruritis (itching), dry eye, a sensation of a foreign body in the eyes and crusting at the edge of the eyelid.
L- aktar effetti kollaterali komuni ta ’ NEVANAC (li dehru f’ bejn pazjent wieħed u għaxra minn kull mija) huma l- uġigħ ta ’ ras, keratite puntata (punctate keratitis - tbajja ’ ta ’ infjammazzjoni fil- kornea, is- saff trasparenti quddiem il- ħabba), uġigħ fil- għajn, viżta mċajpra, prurite (ħakk) fil- għajn, nixfa fl - għajn, sensazzjoni ta ’ xi ħaġa barranija fil- għajnejn u qxur fit- tarf tal- kappell tal- għajn.
Similar side effects were seen in patients using placebo or ketorolac eye drops.
Kien hemm effetti kollaterali simili f’ pazjenti li kienu qed jużaw il- plaċebo jew il- qtar jew ketorolac.
For the full list of all side effects reported with NEVANAC, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti kollaterali rrappurtati għal NEVANAC, ara l- Fuljett ta ’ Tagħrif.
NEVANAC should not be used in people who may be hypersensitive (allergic) to nepafenac, to any of the other ingredients or to other NSAIDs.
NEVANAC m’ għandux jintuża f’ persuni allerġiċi għal nepafenac, jew għal xi sustanza oħra tiegħu jew għal NSAIDs oħra.
Like other NSAIDs, NEVANAC should not be used in patients who have previously had an attack of asthma, hives or inflammation of the nasal passages when they take aspirin or other NSAIDs.
Bħal NSAIDs oħra, NEVANAC m’ għandux jintuża f’ pazjenti li qabel kien tahom attakk ta ’ l- ażżma, ħorriqija jew infjammazzjoni tal- passaġġi nasali meta jieħdu l- aspirina jew NSAIDs oħra.
NEVANAC contains benzalkonium chloride, which is known to discolour soft contact lenses.
NEVANAC fih benzalkonju klorur (benzalkonium chloride), li huwa magħruf li jibdel il- kulur ta ’ lentijiet ta ’ kuntatt rotob.
Therefore, care should be taken by people who wear soft contact lenses.
Għalhekk, min jilbes il- lentijiet ta ’ kuntatt għandu joqgħod attent ħafna.
Why has NEVANAC been approved?
Għaliex ġie approvat NEVANAC?
The Committee for Medicinal Products for Human Use (CHMP) decided that NEVANAC’ s benefits are greater than its risks for prevention and treatment of postoperative pain and inflammation associated with cataract surgery.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ NEVANAC huma ikbar mir- riskji tiegħu meta jintuża għall- prevenzjoni u t- trattament ta ’ uġigħ u infjammazzjoni ta ’ wara l- operazzjoni assoċjata ma ’ kirurġija tal- għajnejn.
The Committee recommended that NEVANAC be given marketing authorisation.
Il- Kumitat irrakkomanda li NEVANAC jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about NEVANAC:
Tagħrif ieħor dwar NEVANAC:
The European Commission granted a marketing authorisation valid throughout the European Union for NEVANAC to Alcon Laboratories (UK) Ltd. on 11 December 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal NEVANAC lil Alcon Laboratories (UK) Ltd. fit- 11 ta ’ Diċembru 2007.
The full EPAR for NEVANAC can be found here.
L- EPAR sħiħ għal NEVANAC jista ’ jinstab hawnhekk.
Pharmaceutical Form Route of administration
Għamla farmaċewtika
Eye drops, suspension Ocular use
qtar għall- għajnejn, suspensjoni
Bottle (LDPE)
Flixkun (LDPE)
1 bottle
1 Flixkun
NEVANAC 1 mg/ ml eye drops, suspension
NEVANAC 1 mg/ ml qtar għall- għajnejn, suspensjoni
1 ml of suspension contains 1 mg nepafenac.
1 ml ta ’ suspensjoni fiha 1 mg ta ’ nepafenac.
Excipients: benzalkonium chloride 0.05 mg.
Sustanzi mhux attivi: benzalkonium chloride 0. 05 mg.
Eye drops, suspension (eye drops) Light yellow to dark yellow uniform suspension, pH 7.4 (approximately).
Qtar għall- għajnejn, suspensjoni (qtar għall- għajnejn) Suspensjoni uniformi, safra ċara sa safra skura, pH 7. 4 (ftit jew wisq).
Prevention and treatment of postoperative pain and inflammation associated with cataract surgery (see section 5.1).
Prevenzjoni u kura ta ’ uġigħ u nfjammazzjoni ta ’ wara operazzjoni assoċjati ma ’ kirurġija tal- katarretti (ara sezzjoni 5. 1).
Use in adults, including the elderly The dose is one drop of NEVANAC in the conjunctival sac of the affected eye(s) 3 times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and for the first 2 weeks of the postoperative period.
Użu fl- adulti, inkluż l- anzjani Id- doża hija qatra waħda ta ’ NEVANAC fil- borża konġunktivali ta ’ l- għajn( ejn) affettwata 3 darbiet kuljum li tinbeda ġurnata qabel il- kirurġija tal- katarretta, titkompla fil- ġurnata tal- kirurġija u fl- ewwel ġimagħtejn wara l- kirurġija.
Treatment can be extended to the first 3 weeks of the postoperative period, as directed by the clinician.
Il- kura tista ’ tiġi mtawwla sa l- ewwel 3 ġimgħat wara l- kirurġija, kif indikat mit- tabib.
An additional drop should be administered 30-120 minutes prior to surgery.
Qatra oħra għandha tiġi amministrata 30- 120 minuta qabel il- kirurġija.
Paediatric patients NEVANAC is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Pazjenti pedjatriċi NEVANAC mhux irrakkomandat għall- użu fit- tfal taħt 18- il sena, peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Use in hepatic and renal impairment NEVANAC has not been studied in patients with hepatic disease or renal impairment.
Użu f’ indeboliment epatiku u renali NEVANAC ma ġiex studjat f’ pazjenti b’ marda epatika jew indeboliment renali.
Nepafenac is eliminated primarily through biotransformation and the systemic exposure is very low following topical ocular administration.
Nepafenac huwa eliminat primarjament permezz ta ’ biotransformazzjoni u l- esponiment sistemiku huwa baxx ħafna wara għoti topiku ġo l- għajn.
No dose adjustment is warranted in these patients.
M’ hemmx bżonn ta ’ aġġustament fid- doża f’ dawn il- pazjenti.
Method of administration For ocular use.
Metodu ta ’ l- għoti Użu għall- għajnejn.
Instruct patients to shake the bottle well before use.
Għarraf lill- pazjenti biex iħawwdu l- flixkun sew qabel l- użu.
If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart.
Jekk qed jintuża aktar minn prodott mediċinali oftalmiku topiku wieħed, l- mediċini għandhom jingħataw ta ’ l- inqas 5 minuti minn xulxin.
To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.
Għall- prevenzjoni ta ’ kontaminazzjoni tal- ponta ta ’ l- applikattur tat- tqattir u tas- soluzzjoni, għandha tittieħed attenzjoni biex ma jintmissux l- kpiepel ta ’ l- għajnejn, l- erja tal- madwar jew uċuħ oħra ma ’ l- applikattur tat- tqattir tal- flixkun.
Instruct patients to keep the bottle tightly closed when not in use.
Għarraf lill- pazjenti biex iżommu l- flixkun magħluq sew meta ma jkunx qed jintuża.
Hypersensitivity to the active substance, to any of the excipients, or to other nonsteroidal anti-inflammatory drugs (NSAIDs).
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi, jew għall- mediċini anti- infjammatorji mhux sterojdi (NSAIDs).
Like other NSAIDs, NEVANAC is also contraindicated in patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs.
Bħal NSAIDs oħra, NEVANAC ukoll huwa kontra- indikat f’ pazjenti li jkollhom attakki ta ’ l- ażma, urtikarja, jew rinite akuta li huma ppreċipitati minn acetylsalicylic acid jew NSAIDs oħra.
Do not inject.
Tinjettax.
Instruct patients not to swallow NEVANAC.
Għarraf lill- pazjenti biex ma jibilgħux NEVANAC.
Instruct patients to avoid sunlight during treatment with NEVANAC.
Għarraf lill- pazjenti biex jevitaw id- dawl tax- xemx waqt il- kura b’ NEVANAC.
Use of topical NSAIDs may result in keratitis.
L- użu ta ’ NSAIDs topiċi jista ’ jwassawl għall- keratite.
In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation.
F’ ċertu pazjenti suxxettibli, l- użu kontinwu ta ’ NSAIDs topiċi jista ’ jwassal għal kollass ta ’ l- epitilju, korneja li tirqaq, taħfir tal- kornea, ulċerazzjoni tal- korneja jew perforazzjoni tal- korneja.
These events may be sight threatening.
Dawn l- episodji jistgħu jipperikolaw il- vista.
Patients with evidence of corneal epithelial breakdown should immediately discontinue use of NEVANAC and should be monitored closely for corneal health.
Pazjenti b’ evidenza ta ’ kollass ta ’ l- epitilju tal- korneja għandhom iwaqqfu l- użu ta ’ NEVANAC immedjatament u għandhom jiġu sorveljati mill- viċin għas- saħħa tal- korneja.
Topical NSAIDs may slow or delay healing.
NSAIDs topiċi jistgħu jnaqqsu jew jittardjaw il- fejqan.
Topical corticosteroids are also known to slow or delay healing.
Kortikosterojdi topiċi wkoll huma magħrufa li jnaqqsu jew jittardjaw il- fejqan.
Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
L- użu fl- istess waqt ta ’ NSAIDs topiċi u sterojdi topiċi jistgħu jżidu l - potenzjal ta ’ problemi fil- fejqan.
Post-marketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e. g., dry eye syndrome), rheumatoid arthritis or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse reactions which may become sight threatening.
Esperjenza wara t- tqegħid fis- suq b’ NSAIDs topiċi tissuġġerixxi li pazjenti b’ kirurġiji komplikati ta ’ l- għajn, denervazzjoni tal- korneja, difetti fl- epitilju tal- korneja, dijabete mellitus, mard fis- superfiċje ta 'l- għajn (e. ż., sindrome ta ’ l- għajn xotta), artrite rewmatojda jew kirurġiji ripetuti fl- għajn f’ perjodu qasir ta ’ żmien, jistgħu jkunu f’ riskju ikbar ta ’ reazzjonijiet avversi tal- korneja li jistgħu jsiru ta ’ periklu għall- vista.
Topical NSAIDs should be used with caution in these patients.
NSAIDs topiċi għandhom jintużaw b’ attenzjoni f’ dawn l- pazjenti.
Prolonged use of topical NSAIDs may increase patient risk for occurrence and severity of corneal adverse reactions.
L- użu ta ’ NSAIDs topiċi għall- perijodu twil jista ’ jżid ir- riskju tal- pazjent għall- okkorrenza u għas- severità ta ’ reazzjonijiet avversi tal- korneja.
There have been reports that ophthalmic NSAIDs may cause increased bleeding of ocular tissues (including hyphaemas) in conjunction with ocular surgery.
Kien hemm rapporti li NSAIDs għall- għajnejn jistgħu jikkawżaw żieda fil- fsada tat- tessuti tal- għajnejn (inkluż ifemiji) meta jintużaw f’ konġunzjoni ma ’ kirurġija okulari.
Use NEVANAC with caution in patients with known bleeding tendencies or who are receiving other medicinal products which may prolong bleeding time.
Uża NEVANAC b’ attenzjoni f’ pazjenti b’ tendenzi magħrufa ta ’ fsada jew li qed jirċievu prodotti mediċinali oħra li jistgħu jtawwlu il- ħin ta ’ fsada.
There are no data on the concomitant use of prostaglandin analogues and NEVANAC.
M’ hemmx informazzjoni dwar l- użu ta ’ analogi ta ’ prostaglandin flimkien ma ’ NEVANAC.
Considering their mechanisms of action, the concomitant use of these medicinal products is not recommended.
Meta tqis il- mekkaniżmu t’ azzjoni tagħhom, l- użu ta ’ dawn il- prodotti mediċinali fl- istess waqt mhux rakkomandat.
NEVANAC contains benzalkonium chloride which may cause irritation and is known to discolour soft contact lenses.
NEVANAC fiħ benzalkonium chloride li jista ’ jikkawża irritazzjoni u huwa magħruf li jbiddel il- kulur ta ’ lentijiet tal- kuntatt rotob.
Additionally, contact lens wear is not recommended during the postoperative period following cataract surgery.
Barra minn hekk, mhux rakkomandat li jintlibsu lentijiet tal- kuntatt waqt il- perijodu ta ’ wara kirurġija tal- katarretti.
Therefore, patients should be advised not to wear contact lenses during treatment with NEVANAC.
Għalhekk, pazjenti għandhom jiġu avżati biex ma jilbsux lentijiet tal- kuntatt waqt kura b’ NEVANAC.
Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/ or toxic ulcerative keratopathy.
Benzalkonium chloride, li jintuża b’ mod komuni bħala preservattiv f’ prodotti għall- għajnejn, kien irrapportat li jikkawża punctate keratopathy u/ jew keratopathy ulċerattiva, tossika.
Since NEVANAC contains benzalkonium chloride, close monitoring is required with frequent or prolonged use.
Minħabba li NEVANAC fiħ benzalkonium chloride, huwa meħtieġ sorveljanza mill- viċin b’ użu frekwenti jew fit- tul.
An acute ocular infection may be masked by the topical use of anti-inflammatory medicines.
Infezzjoni tal- għajnejn akuta tista ’ tiġi mgħottija bl- użu topiku ta ’ mediċini anti- infjammatorji.
NSAIDs do not have any antimicrobial properties.
NSAIDs m’ għandhom l- ebda propjetajiet kontra l- mikrobi.
In case of ocular infection, their use with anti-infectives should be undertaken with care.
F’ każ ta ’ infezzjoni tal- għajnejn, l- użu tagħhom flimkien ma ’ anti- infettivi għandha ssir b’ attenzjoni.
Cross-sensitivity There is a potential for cross-sensitivity of nepafenac to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs.
3 Cross- sensitivity Hemm potenzjal ta ’ cross- sensitivity ta ’ nepafenac għal acetylsalicylic acid, derivati ta ’ phenylacetic acid, u NSAIDs oħra.
In vitro studies have demonstrated a very low potential for interaction with other medicinal products and protein binding interactions (see section 5.2).
Studji in vitro wrew potenzjal baxx ħafna ta ’ interazzjoni ma ’ prodotti mediċinali oħra u nterazzjonijiet ta ’ twaħħil mal- proteini (ara sezzjoni 5. 2).
Pregnancy There are no adequate data from the use of nepafenac in pregnant women.
Tqala M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ nepafenac waqt it- tqala.
Since the systemic exposure in non-pregnant women is negligible after treatment with NEVANAC, the risk during pregnancy could be considered low.
Minħabba li l - esponiment sistemiku f’ nisa mhux tqal huwa negliġibbli wara kura b’ NEVANAC, ir- riskju waqt it - tqala jista ’ jiġi kkunsidrat bħala baxx.
Nevertheless, as inhibition of prostaglandin synthesis may negatively affect pregnancy and/ or embryonal/ foetal development and/ or parturition and/ or postnatal development, NEVANAC is not recommended during pregnancy unless the benefit outweighs the potential risk.
Iżda, minħabba li inibizzjoni tas- sintesi ta ’ prostaglandin tista ’ taffettwa b’ mod negattiv it- tqala u/ jew l- iżvilupp tal- embriju/ fetu u/ jew l- ħlas u/ jew l- iżvilupp ta ’ wara t- twelid, NEVANAC mhux rakkomandat waqt it- tqala sakemm il- benefiċċju mhux akbar mir- riskju potenzjali.
Lactation It is unknown whether nepafenac is excreted in human milk.
Treddigħ Mhux magħruf jekk nepafenac jitneħħiex fil- ħalib uman.
Animal studies have shown excretion of nepafenac in the milk of rats.
Studji fl- annimali wrew tneħħijja ta ’ nepafenac fil- ħalib tal- firien.
However, no effects on the suckling child are anticipated since the systemic exposure of the breastfeeding woman to nepafenac is negligible.
Madanakollu, peress li l- esponiment sistemiku tal- mara li qed tredda ’ għal nepafenac huwa negliġibli, m’ huwa mistenni l- ebda effett fuq it- tarbija li qed terda ’.
NEVANAC can be used during lactation.
NEVANAC jista ’ jintuża waqt it- treddigħ.
As with any eye drops, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines.
Bħal b’ kull qtar għall- għajnejn, vista temporanjament mċajpra jew disturbi oħra fil- vista jistgħu jaffettwaw il- ħila biex issuq u tħaddem magni.
If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machinery.
Jekk ikun hemm vista mċajpra meta jiġi applikat, il - pazjent għandu jistenna sakemm il- vista tiċċara qabel isuq jew iħaddem magni.
In clinical studies involving over 800 patients receiving NEVANAC eye drops, approximately 5% of patients experienced adverse reactions.
Fi studji kliniċi fejn ħadu sehem aktar minn 800 pazjent li kienu qed jirċievu qtar għall- għajnejn NEVANAC, madwar 5% tal- pazjenti kellhom esperjenza ta ’ reazzjonijiet avversi.
These events led to discontinuation in 0.5% of patients, which was less than placebo-treated patients (1.3%) in these same studies.
Dawn l- episodji wasslu għall- waqfien f’ 0. 5% tal- pazjenti, li kien inqas mill- pazjenti kkurati bil- plaċebo (1. 3%) f’ dawn l- istess studji.
No serious adverse events related to NEVANAC were reported in these studies.
Ma kienu rrappurtati l- ebda episodji avversi serji relatati ma ’ NEVANAC f’ dawn l - istudji.
The following undesirable effects were assessed to be treatment-related and are classified according to the following convention: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000), or very rare < 1/ 10,000).
L- effetti mhux mixtieqa li ġejjin kienu meqjusa li huma relatati mal- kura u huma kklassifikati skond il- konvenzjoni li ġejja: komuni ħafna( ≥1/ 10), komuni (≥1/ 100 sa < 1/ 10), mhux komuni (≥1/ 1, 000 sa < 1/ 100), rari (≥1/ 10, 000 sa < 1/ 1, 000), jew rari ħafna (< 1/ 10, 000).
Eye disorders
uġigħ ta ’ ras
headache
Disturbi fl- għajnejn
punctate keratitis, eye pain, blurred vision, eye pruritus, dry eye, foreign body sensation in eyes, eyelid margin crusting
punctate keratitis, uġigħ fl- għajn, vista mċajpra, ħakk fl- għajn, għajn tinħass xotta, sensazzjoni ta’ oġġett barrani fl- għajnejn, qxur fix- xifer tal- kappell ta ’ l - għajn
iritis, keratitis, corneal deposits, choroidal effusion, eye discharge, photophobia, eye irritation, allergic conjunctivitis, ocular discomfort, eyelid disorder, increased lacrimation, conjunctival hyperaemia
irite, keratite, depożiti fil- korneja, effużjoni korojdali, tnixxija ta ’ l- għajn, fotofobja, irritazzjoni fl- għajn, konġuntivite, skomdità fl- għajn, disturb fil - kappell ta ’ l- għajn, żieda fid- dmugħ, iperimja konġuntivali
Gastrointestinal disorders Uncommon:
4 Disturbi gastro- intestinali Mhux komuni:
nausea, dry mouth
tqalligħ, ħalq xott
Skin and subcutaneous tissue disorders Uncommon:
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Mhux komuni:
cutis laxa (dermatochalasis)
cutis laxa (dermatkalasis)
Immune system disorders Uncommon:
Disturbi fis- sistema immuni Mhux komuni:
Adverse reactions identified from post-marketing experience that have not been reported previously in clinical trials with NEVANAC include the following.
Reazzjonijiet avversi identifikati minn esperjenza wara t- tqegħid fis- suq li ma ġewx irrappurtati qabel fi provi kliniċi b’ NEVANAC jinkludu li ġejjin.
The frequency category in which these adverse reactions occur is not known and cannot be estimated from the available data.
Il- kategorija ta ’ frekwenza li fiha jseħħu dawn ir- reazzjonijiet avversi mhux magħrufa u ma tistax tiġi stmata mit- tagħrif disponibbli.
ulcerative keratitis, corneal epithelium defect/ disorder, corneal abrasion, anterior chamber inflammation, impaired healing (cornea), reduced visual acuity, corneal scar, corneal opacity
keratite ulċerattiva, difett/ disturb fl- epitilju tal- korneja, ġrif tal- korneja, infjammazzjoni tal- kompartiment anterjuri, fejqan imnaqqas (korneja), akutezza tal- vista mnaqqsa, ċikatriċi tal- korneja, opaċità tal- korneja
Patients with evidence of corneal epithelial breakdown should immediately discontinue use of NEVANAC and should be monitored closely for corneal health (see section 4.4).
Pazjenti b’ evidenza ta ’ kollass tal- epitilju tal- korneja għandhom iwaqqfu minnufiħ l- użu ta ’ NEVANAC u għandhom jiġu sorveljati mill- viċin għas- saħħa tal- korneja (ara sezzjoni 4. 4).
Post-marketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e. g., dry eye syndrome), rheumatoid arthritis or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse reactions which may become sight threatening.
Esperjenza ta ’ wara t- tqegħid fis- suq b’ NSAIDs topiċi tissuġġerixxi li pazjenti b’ kirurġiji komplikati tal- għajn, denervazzjoni tal- korneja, difetti fl- epitilju tal- korneja, dijabete mellitus, mard fis- superfiċje ta 'l- għajn (e. ż., sindrome ta ’ l- għajn xotta), artrite rewmatojda jew kirurġiji ripetuti fl- għajn f’ perjodu qasir ta ’ żmien, jistgħu jkunu f’ riskju ikbar ta ’ reazzjonijiet avversi tal- korneja li jistgħu jsiru ta ’ periklu għall- vista.
There is no experience of overdose with ocular use.
M’ hemm l- ebda esperjenza ta ’ doża eċċessiva b’ użu fl- għajnejn.
The application of more than one drop per eye is unlikely to lead to unwanted side-effects.
L- applikazzjoni ta ’ aktar minn qatra waħda kull għajn mhux probabbli li twassal għall- effetti sekondarji mhux mixtieqa.
There is practically no risk of adverse effects due to accidental oral ingestion.
Prattikament m’ hemm l- ebda riskju ta ’ effetti avversi minħabba inġestjoni aċċidentali mill- ħalq.
Antiinflammatory agents, non-steroids, ATC code:
Sustanzi anti- infjammatorji, mhux sterojdi, Kodiċi ATC:
Mechanism of action Nepafenac is a non-steroidal anti-inflammatory and analgesic prodrug.
Mekkaniżmu ta ’ azzjoni Nepafenac huwa prodrug anti- infjammatorju mhux sterojd, u analġesiku.
After topical ocular dosing, nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, a nonsteroidal anti-inflammatory drug.
Wara doża topika ġo l - għajnejn, nepafenac jippenetra l- korneja u jiġi mibdul minn hydrolases tat- tessut tal- għajnejn għal amfenac, mediċina anti- infjammatorja mhux sterojda.
Amfenac inhibits the action of prostaglandin H synthase (cyclooxygenase), an enzyme required for prostaglandin production.
Amfenac jinibixxi l- azzjoni ta ’ prostaglandin H synthase (cyclooxygenase), enżima meħtieġa għall- produzzjoni ta ’ prostaglandin.
Secondary Pharmacology In rabbits, nepafenac has been shown to inhibit blood-retinal-barrier breakdown, concomitant with suppression of PGE2 synthesis.
Farmakoloġija Sekondarja Fil- fniek, nepafenac intwera li jinibixxi l- kollass tad- diviżorju ta ’ bejn id- demm u r- retina, flimkien mas- soppressjoni tas- sintesi ta ’ PGE2.
Ex vivo, a single topical ocular dose of nepafenac was shown to inhibit prostaglandin synthesis in the iris/ ciliary body (85%-95%) and the retina/ choroid (55%) for up to 6 hours and 4 hours, respectively.
Ex vivo, doża waħda topika ġo l- għajn ta ’ nepafenac intweriet li tinibixxi s- sintesi ta ’ prostaglandin fil- ħabba/ organu ċiljari (85% - 95%) u fir- retina/ korojd (55%) għall - perjodu sa 6 sigħat u 4 sigħat, rispettivament.
Pharmacodynamic effects The majority of hydrolytic conversion is in the retina/ choroid followed by the iris/ ciliary body and cornea, consistent with the degree of vascularised tissue.
5 Effetti farmakodinamiċi Il- maġġoranza tal- bidla idrolitika hija fir- retina/ korojd segwita mill- ħabba/ organu ċiljari u l- korneja, konsistenti mal- kwantità ta ’ tessut vaskularizzat.
Results from clinical studies indicate that NEVANAC eye drops have no significant effect on intraocular pressure.
Riżultati minn studji kliniċi jindikaw li qtar għall- għajnejn NEVANAC m’ għandu l- ebda effett sinnifikanti fuq il- pressjoni ta ’ ġo l- għajn.
Clinical Effects Three pivotal studies were conducted to assess the efficacy and safety of NEVANAC dosed 3 times daily as compared to placebo and/ or ketorolac trometamol in the prevention and treatment of postoperative pain and inflammation in patients undergoing cataract surgery.
Effetti Kliniċi Twettqu tliet studji pivitali biex jiġu stmati l- effikaċja u s- sigurtà ta ’ NEVANAC mogħti 3 darbiet kuljum kif imqabbel mal- plaċebo u/ jew ketorolac trometamol fil- prevenzjoni u l- kura ta ’ uġigħ u infjammazzjoni wara operazzjoni f’ pazjenti li għamlu kirurġija tal- katarretti.
In these studies, study medication was initiated the day prior to surgery, continued on the day of surgery and for up to 2-4 weeks of the postoperative period.
F’ dawn l- istudji, il- mediċina taħt studju inbdiet ġurnata qabel il- kirurġija, tkompliet fil- ġurnata tal- kirurġija u sa 2- 4 ġimgħat wara l- kirurġija.
Additionally, nearly all patients received prophylactic treatment with antibiotics, according to clinical practice at each of the clinical trial sites 5 In two double-masked, randomised placebo-controlled studies, patients treated with NEVANAC had significantly less inflammation (aqueous cells and flare) from the early postoperative period through the end of treatment than those treated with placebo.
F’ żewġ studji double- masked, randomised u kkontrollati bil- plaċebo, pazjenti kkurati b’ NEVANAC kellhom b’ mod sinifikattiv inqas infjammazzjoni (ċelluli akweji u ħmura) mill- perjodu bikri wara l- kirurġija sat- tmiem tal- kura, minn dawk ikkurati bil- plaċebo.
In one double-masked, randomised, placebo-and active-controlled study, patients treated with NEVANAC had significantly less inflammation than those treated with placebo.
Fi studju double- masked, randomised, ikkontrollat bil- plaċebo u bl- attiv, pazjenti kkurati b’ NEVANAC kellhom sinifikattivament inqas infjammazzjoni minn dawk ikkurati bil- plaċebo.
Additionally, NEVANAC was non-inferior to ketorolac 5 mg/ ml in reducing inflammation and ocular pain, and was slightly more comfortable upon instillation.
Barra minn hekk, NEVANAC ma kienx inferjuri għal ketorolac 5 mg/ ml biex inaqqas l- infjammazzjoni u l- uġigħ ġo l- għajn, u kien kemmxejn aktar komdu wara l- għoti.
A significantly higher percentage of patients in the NEVANAC group reported no ocular pain following cataract surgery compared to those in the placebo group.
Persentaġġ sinifikattivament ogħla ta ’ pazjenti fil- grupp ta ’ NEVANAC ma rrapporta l- ebda uġigħ wara kirurġija tal- katarretti meta mqabbel ma dawk fil- grupp tal- plaċebo.
Absorption Following three-times-daily dosing of NEVANAC eye drops in both eyes, low but quantifiable plasma concentrations of nepafenac and amfenac were observed in the majority of subjects 2 and 3 hours post-dose, respectively.
Assorbiment Wara dożaġġ ta ’ tliet darbiet kuljum ta ’ qtar għall- għajnejn NEVANAC fiż- żewġ għajnejn, konċentrazzjonijiet fil- plażma baxxi iżda li jistgħu jitkejjlu ta ’ nepafenac u amfenac kienu osservati fil- maġġoranza ta ’ l- individwi sagħtejn u 3 sigħat wara d- doża, rispettivament.
The mean steady-state plasma Cmax for nepafenac and for amfenac were 0.310 ± 0.104 ng/ ml and 0.422 ± 0.121 ng/ ml, respectively, following ocular administration.
Cmax medja fil- plażma fi stat fiss għal nepafenac u għal amfenac kienet 0. 310 ± 0. 104 ng/ ml u 0. 422 ± 0. 121 ng/ ml, rispettivament, wara għoti ġo l- għajn.
Distribution Amfenac has a high affinity toward serum albumin proteins.
Distribuzzjoni Amfenac għandu affinità għolja lejn proteini ta ’ l- albumina fis- serum.
In vitro, the percent bound to rat albumin, human albumin and human serum was 98.4%, 95.4% and 99.1%, respectively.
In vitro, il- persentaġġ marbut ma ’ l- albumina tal- firien, albumina umana u serum uman kien 98. 4%, 95. 4% u 99. 1%, rispettivament.
Studies in rats have shown that radioactive labelled active substance-related materials distribute widely in the body following single and multiple oral doses of 14C-nepafenac.
Studji fil- firien wrew li materjali relatati mas- sustanza attiva tikketjati b’ mod radjuattiv jiddistribwixxu ruħhom b’ mod vast fil- ġisem wara dożi orali singoli jew multipli ta ’ 14C- nepafenac.
Metabolism Nepafenac undergoes relatively rapid bioactivation to amfenac via intraocular hydrolases.
Metaboliżmu Nepafenac jgħaddi minn bioattivazzjoni relattivament rapida għal amfenac permezz ta ’ hydrolases ġo l- għajn.
Subsequently, amfenac undergoes extensive metabolism to more polar metabolites involving hydroxylation of the aromatic ring leading to glucuronide conjugate formation.
Wara dan, amfenac jgħaddi minn metaboliżmu estensiv għall- metaboliti aktar polari li jinvolvi idroksilazzjoni taċ- ċirku aromatiku li jwassal għall- formazzjoni ta ’ konjugat ta ’ glucuronide.
Radiochromatographic analyses before and after β -glucuronidase hydrolysis indicated that all metabolites were in the form of glucuronide conjugates, with the exception of amfenac.
Analiżi radjukromatografika qabel u wara l- idrolisi ta ’ β- glucuronidase tindika li l- metaboliti kollha kienu fil - forma ta ’ konjugat ta ’ glucuronide, bl- eċċezzjoni ta ’ amfenac.
Amfenac was the major metabolite in plasma, representing approximately 13% of total plasma radioactivity.
Amfenac kien il- metabolita maġġuri fil- plażma, li jirrappreżenta madwar 13% tar- radjuattività totali fil- plażma.
The second most abundant plasma metabolite was identified as 5-hydroxy nepafenac, representing approximately 9% of total radioactivity at Cmax.
It- tieni metabolita l- aktar abbundanti fil- plażma kien identifikat bħala 5- hydroxy nepafenac, li jirrappreżenta madwar 9% tar - radjuattività totali ta ’ Cmax.
Interactions with other medicinal products:
Interazzjonijiet ma ’ prodotti mediċinali oħra:
Neither nepafenac nor amfenac inhibit any of the major human cytochrome P450 (CYP1A2, 2C9, 2C19, 2D6, 2E1 and 3A4) metabolic activities in vitro at concentrations up to 300 ng/ ml.
La nepafenac u lanqas amfenac ma jinibixxu l- ebda mill - attivitajiet metaboliċi in vivo taċ- ċitokromju maġġuri uman P450 (CYP1A2, 2C9, 2C19, 2D6, 2E1 u 3A4) f’ konċentrazzjonijiet sa 300 ng/ ml.
Therefore, interactions involving CYP-mediated metabolism of concomitantly administered medicinal products are unlikely.
Għalhekk, interazzjonijiet li jinvolvu metaboliżmu medjat minn CYP ta ’ prodotti mediċinali mogħtija fl- istess ħin mhux probabbli.
Interactions mediated by protein binding are also unlikely.
Interazzjonijiet medjati minn twaħħil mal- proteini wkoll x’ aktarx li ma jseħħux.
Excretion/ Elimination After oral administration of 14C-nepafenac to healthy volunteers, urinary excretion was found to be the major route of radioactive excretions, accounting for approximately 85% while faecal excretion represented approximately 6% of the dose.
6 Tneħħijja/ Eliminazzjoni Wara għoti orali ta ’ 14C- nepafenac lill- voluntiera f’ saħħithom, tneħħijja fl- awrina nstabet li kienet ir- rotta maġġuri tat- tneħħijiet radjuattivi, li tgħodd għal madwar 85% filwaqt li tneħħijja fl- ippurgar tirrappreżenta madwar 6% tad- doża.
Nepafenac and amfenac were not quantifiable in the urine.
Nepafenac u amfenac ma setgħux jitkejjlu fl- awrina.