qanastek/EMEA-V3 huggingface dataset:
Other side effects include pain or redness (inflammation) and increased eye pressure.
Is- sintomi li tista ’ tħoss qegħdin elenkati f’ sezzjoni 2 ta ’ dan il- fuljett.
The symptoms you might experience are described in section 2 of this leaflet (“ Take special care with Lucentis ”).
(“ Oqgħod attent ħafna b’ Lucentis ”).
Please read section 2.
Jekk jogħġbok aqra sezzjoni 2.
It tells you what to do if you have any of these symptoms.
Tgħidlek x’ għandek tgħamel jekk ikollok xi wieħed minn dawn is- sintomi.
Very common side effects (These may affect 10 or more in every 100 patients) The most common side effects in the eye reported to be possibly caused by the medicinal product or by the injection procedure include:
Effetti sekondarji komuni ħafna (Dawn jistgħu jeffettwaw 10 jew aktar minn 100 pazjent) L- aktar effetti sekondarji komuni fl- għajn li kienu rappurtati u li jistgħu jkunu ġejjin mill- prodott mediċinali jew mill- proċedura ta ’ l- injezzjoni jinkludu:
Inflammation of the eye, blurred vision, bleeding in the back of the eye (retinal bleeding), visual disturbances, eye pain, small particles or spots in your vision (floaters), bloodshot eye, eye irritation, a feeling of having something in the eye, increased tear production, inflammation or infection of the eyelid margins, dry eye, redness or itching of the eye.
Infjammazzjoni ta ’ l- għajn, vista mċajpra, fsada fuq wara ta ’ l- għajn (fsada mir- retina), disturbi fil- vista, uġigħ fl- għajn, frak żgħir jew tikek fil - vista (ħjut fil- vitriju), għajn ħamra, irritazzjoni fl- għajn, sensazzjoni li hemm xi ħaġa fl- għajn, żieda fil- produzzjoni fid- dmugħ, infjammazzjoni jew infezzjoni tax- xfar ta ’ tebqet l- għajn, għajn xotta, ħmura jew ħakk fl- għajn.
Increased eye pressure has been observed very commonly.
Żieda fil- pressjoni ta ’ l- għajn ġiet osservata b’ mod komuni ħafna.
The most common non-visual side effects reported to be possibly caused by the medicinal product or by the injection procedure include:
L- aktar effett sekondarju li m’ għandux x’ jaqsam mal- vista li kien rappurtat u li jista ’ jkun kawżat mill - prodott mediċinali jew mill- proċedura ta ’ l- injezzjoni jinkludi:
Sore throat, headache and joint pain.
Uġigħ fil- gerżuma, uġigħ ta ’ ras u uġigħ fil- ġogi.
Common side effects (These may affect between 1 and 10 in every 100 patients) Other common side effects in the eye reported to be possibly caused by the medicinal product or by the injection procedure include:
Effetti sekondarji komuni (Dawn jistgħu jeffettwaw bejn 1 u 10 f’ kull 100 pazjent) Effetti sekondarji oħrajn fl- għajn li kienu rappurtati u li jistgħu jkunu ġejjin mill- prodott mediċinali jew mill- proċedura ta ’ l- injezzjoni jinkludu:
Seeing flashes of light with floaters progressing to a loss of sight, decreased sharpness of vision, swelling of a section of the eye (uvea, cornea), clouding of the lens, small marks on the surface of the eye, bleeding in the eye, discharge from the eye with itching, redness and swelling (conjunctivitis), light sensitivity, eye discomfort, swelling of the eyelid, eyelid pain.
Tara beraq dawl bi ħjut li jwassal għal telf ta ’ dawl, tnaqqis fl- akutezza tal- vista, nefħa ta ’ sezzjoni ta ’ l- għajn (uvea, kornea), lenti mtappna, marki żgħar fuq is- superfiċje ta ’ l- għajn, fsada fl- għajn, taħmiġ ta ’ l- għajn b’ ħakk, ħmura u nefħa (konġunktivite), sensittività għad- dawl, skomfort fl- għajn, nefħa ta ’ tebqet l- għajn, uġigħ ta ’ tebqet l- għajn.
Other common non-visual side effects reported to be possibly caused by the medicinal product or by the injection procedure include:
Effetti sekondarji komuni oħrajn li m’ għandhomx x’ jaqsmu mal- vista li kienu rappurtati u li jistgħu jkunu ġejjin mill- prodott mediċinali jew mill- proċedura ta ’ l- injezzjoni jinkludu:
Fatigue, general feeling of being unwell, anxiety, cough, nausea, allergic reactions like rash, itching, skin reddening.
Għejja, ma tħossokx tiflaħ b’ mod ġenerali, ansjetà, sogħla, tqalligħ, reazzjonijiet allerġiċi bħal raxx, ħakk, ħmura fil- ġilda.
Uncommon side effects (These may affect less than 1 in every 100 patients) Uncommon side effects in the eye reported to be possibly caused by the medicinal product or by the injection procedure include:
Effetti sekondarji mhux komuni (Dawn jistgħu jeffettwaw anqas minn 1 f’ kull 100 pazjent) Effetti sekondarji mhux komuni fl- għajn li kienu rappurtati u li jistgħu jkunu ġejjin mill- prodott mediċinali jew mill- proċedura ta ’ l- injezzjoni jinkludu:
Blindness, infection of the eye globe (endophthalmitis), inflammation and bleeding in the front part of the eye, sac of pus on the eye, changes of the central part of the eye surface, pain or irritation at the site of injection, abnormal sensation in the eye, irritation of the eyelid.
Telf ta ’ dawl, infezzjoni tal- balla tal- għajn (endoftalmite), infjammazzjoni u fsada fil- parti ta ’ quddiem tal- għajn, kapsula ta ’ materja fl- għajn, bidliet fis- superfiċje tal- parti ċentrali tal- għajn, uġigħ jew irritazzjoni fis- sit ta ’ l- injezzjoni, sensazzjoni mhux normali fl- għajn, irritazzjoni ta ’ tebqet l- għajn.
If any of the side effects you experience gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Jekk xi wieħed mill- effetti sekondarji li tħoss jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
HOW TO STORE LUCENTIS
KIF TAĦŻEN LUCENTIS
- Keep Lucentis out of the reach and sight of children.
- Żomm Lucentis fejn ma jintlaħaqx u ma jidhirx mit- tfal.
- Do not use Lucentis after the expiry date which is stated on the carton and vial label after EXP.
- Tużax Lucentis wara d- data ta ’ skadenza li tidher fuq il- kartuna u t- tikketta tal- kunjett wara
- Store in a refrigerator (2°C – 8°C).
- Aħżen fi friġġ (2°C – 8°C).
- Keep the vial in the outer carton in order to protect from light.
- Żomm il- kunjett fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
- Do not use any pack that is damaged.
- Tużax jekk xi pakkett ikun danneġġjat.
What Lucentis contains
X’ fih Lucentis
- The active substance in Lucentis is ranibizumab (10 mg/ ml).
- Is- sustanza attiva f’ Lucentis hi ranibizumab (10 mg/ ml).
Each ml contains 10 mg
Kull ml fih 10 mg ranibizumab.
- The other ingredients are: α ,α -trehalose dihydrate; histidine hydrochloride, monohydrate;
- Is- sustanzi l- oħra huma α, α- trehalose dihydrate; histidine hydrochloride, monohydrate; histidine;
histidine; polysorbate 20; water for injections.
polysorbate 20; ilma għall- injezzjonijiet.
24 What Lucentis looks like and contents of the pack Lucentis is a solution for injection in a vial (0.23 ml).
24 Id- Dehra ta ’ Lucentis u l- kontenuti tal- pakkett Lucentis huwa soluzzjoni għall- injezzjoni f’ kunjett (0. 23 ml).
The solution is clear, colourless to pale yellow and aqueous.
Is- soluzzjoni hija ċara, mingħajr kulur tagħti fl- isfar ċar u magħmul mill- ilma.
Lucentis is supplied as a pack containing one glass vial of ranibizumab with chlorobutyl rubber stopper, one filter needle for withdrawal of the vial contents, one injection needle and one syringe for withdrawal of the vial contents and for intravitreal injection.
Lucentis jiġi f’ pakkett li jkun fih kunjett tal- ħġieġ ta ’ ranibizumab wieħed b’ tapp tal- lasktu tal - chlorobutyl, labra waħda b’ filtru għall- ġbid tal- kontenuti tal- kunjett, labra waħda għall- injezzjoni u siringa waħda għall- ġbid tal- kontenuti tal- kunjett u għall- injezzjoni fil- vitreju.
Centre de Biotechnologie 8, rue de l’ Industrie F-68330 Huningue France
Centre de Biotechnologie 8, rue de l’ Industrie F- 68330 Huningue Franza
Tél: +33 1 55 47 66 00
25 România France Novartis Pharma Services Inc.
Tel: +371 7 887 070
Tel: +371 7 887. 070
26 INFORMATION FOR THE HEALTHCARE PROFESSIONAL
26 TAGĦRIF GĦALL- PROFESSJONISTI FIL- QASAM TAL- KURA TAS- SAĦĦA
How to prepare and administer Lucentis
Kif tipprepara u tagħti Lucentis
Single-use vial for intravitreal use only
Kunjett għal użu ta ’ darba għal użu ġol- vitriju biss
Lucentis must be administered by a qualified ophthalmologist experienced in intravitreal injections.
Lucentis għandu jingħata minn oftalmologu kwalifikat b’ esperjenza fl- injezzjonijiet ġol- vitriju.
Lucentis treatment is initiated with a loading phase of one injection per month for three consecutive months, followed by a maintenance phase in which patients should be monitored for visual acuity on a monthly basis.
Il- kura b’ Lucentis tinbeda b’ fażi ta ’ tgħabija b‘ injezzjoni waħda fix- xahar għal tlett xhur wara xulxin, segwiti b’ fażi ta ’ manteniment li fiha l- pazjenti għandhom ikunu monitorjati għal kemm tkun akuta l - vista tagħhom kull xahar.
If the patient experiences a loss of greater than 5 letters in visual acuity (ETDRS or one Snellen line equivalent), Lucentis should be administered.
Jekk il- pazjent ikollu avvanz telf ta ’ l- akutezza tal- vista b’ aktar minn 5 ittri (ETDRS jew ekwivalenti għal rig wieħed Snellen), Lucentis għandu jingħata.
As with all medicinal products for parenteral use, Lucentis should be inspected visually for particulate matter and discoloration prior to administration.
Bħal prodotti mediċinali kollha li jingħataw b’ injezzjonijiet, Lucentis għandu jkun mifli għal frak jew telf tal- kulur qabel jingħata.
Before treatment, the patient should be instructed to self-administer antimicrobial drops (four times daily for 3 days before and following each injection).
Qabel il- kura, l- pazjent għandhu jingħata struzzjonijiet dwar kif jinjetta lilu nnifsu t- taqtir kontra l - mikrobi (erba ’ darbiet kuljum u wara kull injezzjoni).
The patient’ s medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure.
L- istorja medika tal- pazjent għal reazzjonijiet ta ’ sensitività eċċessiva għandha tiġi evalwata sew qabel ma tibda il - proċedura fil- vitriju.
To prepare Lucentis for intravitreal administration, please adhere to the following instructions:
Biex tipprepara Lucentis għall- għotja ġol- vitriju, jekk jogħġbok żomm ma ’ l- istruzzjonijiet li ġejjin:
Before withdrawal, the outer part of the rubber stopper of the vial should be disinfected.
1. Qabel jinġibed, il- parti ta ’ barra tat- tapp tal- lasktu tal- kunjett għandu jiġi diżinfettat.
Push the blunt filter needle into the centre of the vial stopper until the needle touches the bottom edge of the vial.
Imbotta l- ponta tal- labra b’ filtru li ma taqtax fiċ- ċentru tat- tapp tal - kunjett sakemm il- labra tmiss it- tarf tal- qiegħ tal- kunjett.
Leave the blunt filter needle in the vial and disconnect the syringe from the blunt filter needle.
Ħalli l- labra b’ filtru li ma taqtax fil- kunjett u aqla ’ s- siringa mill - labra b’ filtru li ma taqtax.
The filter needle should be discarded after withdrawal of the vial contents and should not be used for the intravitreal injection.
Il- labra b’ filtru ghandha timtrema wara li jkunu nġibdu l- kontenuti tal- kunjett u m’ għandhomx jintużaw għall - injezzjoni fil- vitriju.
The syringe is ready for injection.
Is- siringa lesta għall- injezzjoni.
The injection needle should be inserted 3.5-4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe.
Il- labra ta ’ l- injezzjoni għandha tiddaħħal bejn 3. 5- 4. 0 mm wara l- limbus fil- ħofra tal- vitriju, billi jiġi evitat il- meridjan orizzontali u tinżamm il- mira lejn iċ- ċentru tal- globu.
The injection volume of 0.05 ml is then delivered; a different scleral site should be used for subsequent injections.
Il- volum ta ’ l- injezzjoni imbagħad għandu jingħata; għandu jintuża sit sklerali differenti għall- injezzjonijiet ta ’ wara.
This document is a summary of the European Public Assessment Report (EPAR).
Dan id- dokument huwa sommarju tar- Rapport tal- Valutazzjoni Pubblika Ewropewa (EPAR).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqin, biex jissodisfa r- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (li huwa wkoll parti mill- EPAR) jew kellem lit- tabib jew lill- ispiżjar tiegħek Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is LUMIGAN?
X’ inhu LUMIGAN?
LUMIGAN is a clear eye drop solution containing the active substance bimatoprost.
LUMIGAN huwa soluzzjoni ta ’ qtar trasparenti għall- għajnejn li fih is- sustanza attiva bimatoprost.
What is LUMIGAN used for?
Għal x’ hiex jintuża LUMIGAN?
LUMIGAN is used to reduce intraocular pressure (pressure inside the eye).
LUMIGAN jintuża biex inaqqas il- pressjoni għolja ta ’ ġo l- għajn.
It is used in patients with long-term open angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) and in patients with ocular hypertension (when the pressure in the eye is higher than normal).
Jintuża f’ pazjenti li għal żmien twil kellhom glawkoma open- angle (marda fejn il- pressjoni fl- għajn togħla minħabba li l- fluwidu ma jkunx jista ’ joħroġ mill- għajn) u f’ pazjenti bi pressjoni għolja fl- għajnejn (meta l- pressjoni fl- għajn tkun ogħla min- normal).
LUMIGAN can be used alone or with beta-blocker eye drops (other medicines used for these conditions).
LUMIGAN jista ’ jintuża waħdu jew flimkien ma ’ qtar għall- għajnejn b’ imblokkaturi tar- riċetturi beta (mediċini oħra li jintużaw għal dawn il- kundizzjonijiet).
How is LUMIGAN used?
Kif jintuża LUMIGAN?
The recommended dose is one drop of LUMIGAN in the affected eye(s) once a day in the evening.
Id- doża rakkomandata hija ta ’ qatra waħda ta ’ LUMIGAN fl- għajn( ejn) milquta darba kuljum filgħaxija.
If more than one type of eye drop is being used, each one should be given at least five minutes apart.
Jekk qed jintuża aktar minn tip wieħed ta ’ qtar għall- għajnejn, kull wieħed għandu jingħata mill- inqas ħames minuti wara ta ’ qablu.
LUMIGAN is not recommended for patients less than 18 years old.
LUMIGAN mhuwiex rakkomandat għal pazjenti li għandhom inqas minn 18- il sena.
How does LUMIGAN work?
Kif jaħdem LUMIGAN?
When intraocular pressure is raised, it causes damage to the retina (the light-sensitive membrane at the back of the eye) and to the optic nerve that sends signals from the eye to the brain.
Meta l- pressjoni ta ’ ġo l- għajn togħla, tagħmel ħsara lir- retina (ir- rita sensittiva għad- dawl fuq wara ta ’ l- għajn) u lin- nerv ottiku li jibgħat sinjali mill- għajn għall- moħħ.
This can result in serious vision loss and even blindness.
Dan jista ’ jwassal għal nuqqas serju fil- viżta u saħansitra għal telf tad- dawl għal kollox.
The active substance in LUMIGAN, bimatoprost, is a prostaglandin analogue (a man-made copy of a natural substance, prostaglandin).
Is- sustanza attiva f’ LUMIGAN, bimatoprost, hija analogu ta ’ prostaglandin (kopja ta ’ sustanza naturali, prostaglandin, magħmula mill- bniedem).
In the eye, prostaglandin increases the drainage of the watery fluid (aqueous humour) out of the eyeball.
Fl - għajn il- prostaglandin iżid il- ħruġ tal- fluwidu ċar (aqueous humour) barra mill- boċċa ta ’ l- għajn.
LUMIGAN acts in the same way and increases the flow of fluid out of the eye.
LUMIGAN jaħdem bl- istess mod u jżid il- fluss ta ’ fluwidu mill- għajn.
This helps to reduce the pressure inside the eye and the risk of damage.
Dan jgħin biex titnaqqas il - pressjoni ġewwa l- għajn kif ukoll ir- riskju ta ’ ħsara.
How has LUMIGAN been studied?
Kif ġie studjat LUMIGAN?
LUMIGAN used on its own has been compared with timolol (a beta-blocker used to treat glaucoma) in two 12-month studies involving a total of 1,198 patients.
LUMIGAN użat waħdu tqabbel ma ’ timolol (imblokkatur tar- riċetturi beta użat għall- kura ta ’ glawkoma) f’ żewġ studji ta ’ 12- il xahar li kienu jinvolvu total ta ’ 1, 198 pazjent.
Some of these patients carried on receiving the medicines for up to two or three years (379 and 183 patients, respectively).
Xi wħud mill- pazjenti baqgħu jirċievu l- mediċini għal sentejn jew tliet snin (379 u 183 pazjent rispettivament).
LUMIGAN has also been compared with latanoprost (another prostaglandin analogue used in glaucoma) in a six- month study involving 269 patients.
LUMIGAN tqabbel ukoll ma ’ latanoprost (analogu ieħor ta ’ prostaglandin użat fi glawkoma) fi studju ta ’ sitt xhur li kien jinvolvi 269 pazjent.
(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 latanoprost in another study in 437 patients.
(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 L- effikaċja li żżid LUMIGAN ma ’ kura diġà eżistenti bi qtar għall- għajnejn beta- blocker ġiet imqabbla ma ’ waħda li żżid plaċebo (qtar għall- għajnejn finta) fi studju wieħed li kien jinvolvi 285 pazjent.
In all of the studies, the main measure of effectiveness was the reduction in eye pressure.
L- effikaċja ta ’ LUMIGAN meta ġie miżjud ma ’ kura b’ beta- blocker ġiet ukoll imqabbla ma ’ latanoprost fi studju ieħor ta ’ 437 pazjent.
Eye pressure is measured in ‘ millimetres of mercury’ (mmHg).
Il- pressjoni fl- għajn hija mkejla f ’ ‘ millimetri ta ’ merkurju ’ (mmHg).
In a patient with ocular hypertension or glaucoma, the value is generally higher than 21 mmHg.
F’ pazjent bi pressjoni għolja fl- għajn jew bi glawkoma, il- valur ikun ġeneralment aktar minn 21 mmHg.
What benefit has LUMIGAN shown during the studies?
X’ benefiċċji wera LUMIGAN waqt l- istudji?
LUMIGAN on its own was more effective than timolol at reducing eye pressure.
LUMIGAN waħdu kien aktar effettiv minn timolol biex inaqqas il- pressjoni fl- għajn.
This effect was maintained after two or three years of treatment, with an average reduction in eye pressure of between 7.1 and 8.6 mmHg with LUMIGAN used once a day, compared with 4.6 to 6.4 mmHg with timolol.
Dan l- effett inżamm wara sentejn jew tliet snin ta ’ kura, bi tnaqqis medju fil- pressjoni ta ’ l- għajnejn li jvarja bejn 7. 1 u 8. 6 mmHg b’ LUMIGAN użat darba kuljum, meta imqabbel ma ’ tnaqqis minn 4. 6 sa 6. 4 mmHg b’ timolol.
LUMIGAN was also more effective than latanoprost, with patients using LUMIGAN achieving a reduction in eye pressure of 6.0 to 8.2 mmHg after six months of treatment compared with 4.9 to 7.2 mmHg with latanoprost.
LUMIGAN kien ukoll aktar effettiv minn latanoprost, fejn pazjenti li użaw LUMIGAN kisbu tnaqqis fil- pressjoni ta ’ l- għajn li jvarja bejn 6. 0 sa 8. 2 mmHg wara sitt xhur ta ’ kura meta mqabbla ma ’ tnaqqis ta ’ 4. 9 sa 7. 2 mmHg b’ latanoprost.
Adding LUMIGAN to existing treatment with a beta-blocker was more effective than continuing to use the beta-blocker on its own.
Iż- żieda ta ’ LUMIGAN ma ’ kura eżistenti b’ imblokkatur tar- riċetturi beta kienet aktar effettiva milli l - użu mkompli ta ’ imblokkatur tar- riċetturi beta waħdu.
After three months, eye pressure was lowered by 7.4 mmHg in the group adding LUMIGAN, compared with 3.6 mmHg in the group adding placebo.
Wara tliet xhur, il- pressjoni fl- għajn tnaqqset b’ 7. 4 mmHg fil- grupp li żied LUMIGAN, meta mqabbel ma ’ 3. 6 mmHg fil- grupp li żied plaċebo.
LUMIGAN was at least as effective as latanoprost when added to beta-blocker treatment, with reductions in eye pressure of 8.0 and 7.4 mmHg, respectively, after three months.
LUMIGAN kien mill- inqas effettiv daqs latanoprost meta żdied ma ’ kura b’ imblokkatur tar- riċetturi beta, bi tnaqqis fil- pressjoni ta ’ l- għajn ta ’ 8. 0 u 7. 4 mmHg, rispettivament, wara tliet xhur.
What is the risk associated with LUMIGAN?
X’ inhu ir- riskju assoċjat ma ’ LUMIGAN?
The most common side effects with LUMIGAN (seen in more than 1 patient in 10) are conjunctival hyperaemia (increased blood supply to the eye, leading to eye irritation and redness), growth of eyelashes and ocular pruritus (itchy eye).
L- aktar effetti sekondarji komuni b’ LUMIGAN (li jidhru f’ aktar minn pazjent wieħed minn kull 10) huma iperimija konġunktivali (żieda fil- provvista ta ’ demm għall- għajn, li twassal għal irritazzjoni fl - għajn u ħmura), żieda fit- tul tax- xagħar ta ’ xfar- il għajn u ħakk fl- għajn (għajn li tieklok).
For the full list of all side effects reported with LUMIGAN, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati b’ LUMIGAN, ara l- Fuljett ta ’ Tagħrif.
LUMIGAN should not be used in people who may be hypersensitive (allergic) to bimatoprost or any of the other ingredients.
LUMIGAN m’ għandux jintuża minn persuni li għandhom sensittività eċċessiva (allerġiċi) għal bimatoprost jew għal xi wieħed mill- ingredjenti l- oħra.
LUMIGAN contains benzalkonium chloride, which is known to discolour soft contact lenses.
LUMIGAN fih benzalkonium chloride, li huwa magħruf li jtebba ’ lentijiet tal- kuntatt rotob.
Therefore, care should be taken by people who wear soft contact lenses.
Għalhekk, għandhom jittieħdu prekawzjonijiet f’ persuni li jilbsu lentijiet tal- kuntatt rotob
Why has LUMIGAN been approved?
Għalfejn ġie approvat LUMIGAN?
The Committee for Medicinal products for Human Use (CHMP) decided that LUMIGAN’ s benefits are greater than its risks for the reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension (as monotherapy or as adjunctive therapy to beta-blockers).
Il- Kumitat għall- Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ LUMIGAN huma akbar mir- riskji għat- tnaqqis tal- pressjoni għolja fl- għajnejn f’ open- angle glawkoma kronika u fi pressjoni għolja ġo l- għajn (bħala monoterapija jew kura miżjuda ma ’ imblokkaturi tar- riċetturi beta).
The Committee recommended that LUMIGAN be given marketing authorisation.
Il- Kumitat jirrakkomanda li LUMIGAN jingħata awtorizzazzjoni għat - tqegħid fis- suq.
Other information about LUMIGAN:
Tagħrif ieħor dwar LUMIGAN:
The European Commission granted a marketing authorisation valid throughout the European Union for LUMIGAN to Allergan Pharmaceuticals Ireland on 8 March 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal LUMIGAN lil Allergan Pharmaceuticals Ireland fit- 8 ta ’ Marzu 2002.
The marketing authorisation was renewed on 8 March 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 8 ta ’ Marzu 2007.
The full EPAR for LUMIGAN is available here.
L- EPAR sħiħ għal LUMIGAN huwa disponibbli minn hawnhekk.
EU/ 1/ 02/ 205/ 001
Numru ta ’ l- EU EU/ 1/ 02/ 205/ 001 EU/ 1/ 02/ 205/ 002
Lumigan
Isem inventat Lumigan Lumigan
0.3 mg/ ml
Qawwa 0. 3mg/ ml 0. 3mg/ ml
Eye drops, solution
Għamla farmaċewtika Qtar tal- ghajnejn, soluzzjoni Qtar tal- ghajnejn, soluzzjoni
Ocular use
Mnejn jingħata Ghal ghajnejn Ghal ghajnejn
Bottle (LDPE)
Il- pakkett Flixkun (LDPE) Flixkun (LDPE)
EU/ 1/ 02/ 205/ 002
Kontenut 3ml 3ml
3 bottles
Daqs tal- pakkett Flixkun 3 Fliexken
LUMIGAN 0.3 mg/ ml eye drops, solution
LUMIGAN 0. 3 mg/ ml qtar għall- għajnejn, soluzzjoni
One ml of solution contains 0.3 mg bimatoprost.
Ml wieħed fih 0. 3 mg bimatoprost.
Excipient: benzalkonium chloride 0.05 mg/ ml.
Sustanza mhux attiva: benzalkonium chloride 0. 05mg/ ml.
For a full list of excipients, see section 6.1.
Għal sustanzi mhux attivi, ara Sezzjoni 6. 1.
Colourless to slightly yellow solution.
Soluzzjoni mingħajr kulur kemmxejn tagħti fl- isfar.
Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension (as monotherapy or as adjunctive therapy to beta-blockers).
Tnaqqis ta ’ pressjoni għolja ġo l- għajn f’ open- angle glawkoma u pressjoni għolja fl- għajn (bħala monoterapija jew bħala terapija miżjuda ma ’ imblokkaturi tar- riċetturi beta).
The recommended dose is one drop in the affected eye(s) once daily, administered in the evening.
Għandha tingħata qatra waħda fl- għajn( ejn) milquta darba kuljum, filgħaxija.
The dose should not exceed once daily as more frequent administration may lessen the intraocular pressure lowering effect.
Id- doża m’ għandiex tkun aktar minn darba kuljum għaliex dożi żejda jistgħu jtellfu mill- effett ta ’ tnaqqis tal- pressjoni ġo l - għajnejn.
If more than one topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart.
Jekk qed jintuża aktar minn prodott wieħed mediċinali topiku għall- għajn, kull wieħed għandu jittieħed mill- anqas 5 minuti wara ta ’ qablu.
Use in children and adolescents (under the age of 18):
Użu f’ tfal u adoloxxenti (taħt l- età ta ’ 18- il sena):
LUMIGAN has only been studied in adults and therefore its use is not recommended in children or adolescents.
LUMIGAN kien studjat biss fl- adulti u għalhekk l- użu tiegħu mhux rakkomandat fit- tfal jew fl - adoloxxenti.
LUMIGAN has not been studied in patients with renal or moderate to severe hepatic impairment and should therefore be used with caution in such patients.
Użu f’ indeboliment tal- fwied u tal- kliewi LUMIGAN ma kienx studjat f’ pazjenti b’ indeboliment renali jew indeboliment moderat jew serju tal - fwied u għalhekk għandha tingħata attenzjoni meta jintuża f’ dawn il- pazjenti.
In patients with a history of mild liver disease or abnormal ALT, AST and/ or bilirubin at baseline, LUMIGAN had no adverse effect on liver function over 24 months.
Fil- każ ta ’ pazjenti bi storja ta ’ mard ħafif tal- fwied jew ALT abnormali, AST u/ jew bilirubin fil- linja bażi, LUMIGAN ma kellux effett avvers fuq il- funzjoni tal- fwied fuq perjodu ta ’ 24 xahar.
Hypersensitivity to the active substance or to any of the excipients.
Sensittività eċċessiva għas - sustanza attiva jew għal xi sustanzi mhux attivi.
Before treatment is initiated, patients should be informed of the possibility of eyelash growth, darkening of the eyelid skin and increased iris pigmentation since these have been observed during treatment with LUMIGAN.
Qabel ma tingħata bidu għall- kura, il- pazjenti għandhom ikunu infurmati bil- possibilità ta ’ żjieda fit - tul tax- xagħar ta ’ xfar – il għajn, skurament tal- ġilda tal- kappell ta ’ l- għajn u żjieda fil- pigmentazzjoni tal- ħabba ta ’ l- għajn billi dawn kienu osservati matul il- kura b’ LUMIGAN.
Some of these changes may be permanent, and may lead to differences in appearance between the eyes when only one eye is treated.
Uħud minn dawn il - bidliet jistgħu jkunu permanenti, u jistgħu jwasslu għal differenzi fid- dehra bejn l- għajnejn meta l- kura ssir fuq għajn waħda biss.
The change in iris pigmentation occurs slowly and may not be noticeable for several months.
Il- bidla fil- pigmentazzjoni tal- ħabba ta ’ l- għajn isseħħ bil- mod u l- effett tagħha jista ’ ma jidhirx qabel bosta xhur.
At 12 months, the incidence was 1.5% and did not increase following 3 years treatment.
Wara 12- il xahar, l- inċidenza kienet ta ’ 1. 5% u ma żdiedetx wara 3 snin ta ’ kura.
LUMIGAN contains the preservative benzalkonium chloride, which may be absorbed by soft contact lenses.
LUMIGAN fih il- preservattiv benzalkonium chloride, li jista ’ jiġi assorbit mill- lentijiet tal- kuntatt rotob.
Contact lenses should be removed prior to instillation and may be reinserted 15 minutes following administration.
Il- lentijiet tal- kuntatt għandhom jitneħħew qabel il- qtar u għandhom jerġgħu jintliebsu 15- il minuta wara l- qtar.
Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/ or toxic ulcerative keratopathy.
Kien irrapurtat li benzalkonium chloride, li ġeneralment jintuża bħala preservattiv fi prodotti għall - għajnejn, jikkawża punctate keratopathy u/ jew ulcerative keratopathy tossika.
Since LUMIGAN contains benzalkonium chloride, monitoring is required with frequent or prolonged use in dry eye patients or where the cornea is compromised.
Minħabba li Lumigan fih benzalkonium chloride, hu meħtieġ li jsir monitoraġġ ta ’ pazjenti li jużaw LUMIGAN b’ mod regolari jew fit- tul meta dawn ikollhom għajn xotta jew fejn il- korneja tkun qed titpoġġa f’ periklu.
LUMIGAN has not been studied in patients with compromised respiratory function and should therefore be used with caution in such patients.
LUMIGAN ma kienx studjat f’ pazjenti b’ funzjoni respiratorja kompromessa u għalhekk għandu jintuża b’ attenzjoni f’ dawn il- pazjenti.
In clinical studies, in those patients with a history of a compromised respiratory function, no significant untoward respiratory effects have been seen.
Fi studji kliniċi, f’ dawk il- pazjenti bi storja ta ’ funzjoni respiratorja kompromessa, ma dehru l- ebda effetti respiratorji sinifikanti li ma kienux mixtieqa.
LUMIGAN has not been studied in patients with heart block more severe than first degree or uncontrolled congestive heart failure.
LUMIGAN ma kienx studjat f’ pazjenti b’ heart block ta ’ severità akbar mill- ewwel grad jew b’ insuffiċjenza tal- qalb konġestiva mhux ikkontrollata.
LUMIGAN has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.
LUMIGAN ma kienx studjat f’ pazjenti b’ kundizzjonijiet infjammatorji fl- għajn, neovaskolari, infjammatorji, angle- closure glaucoma, glawkoma konġenitali jew narrow- angle glaucoma.
Cystoid macular oedema has been uncommonly reported (≥ 1/ 1000 to < 1/ 100) following treatment with LUMIGAN and should therefore be used with caution in patients with known risk factors for macular oedema (e. g. aphakic patients, pseudophakic patients with a torn posterior lens capsule).
Edema makulari taċ- ċistojde kienet rappurtata rarament (≥1/ 1000 sa < 1/ 100) wara l- kura b’ LUMIGAN u għalhekk għandu jintuża b’ attenzjoni f’ pazjenti li hu magħruf li għandhom riskju ta ’ edema makulari (eż pazjenti afakiċi, pazjenti psewdofakiċi bil- kapsula tal- lenti ta ’ wara mċarrta).
No interaction studies have been performed.
Studji speċifiċi dwar l- interazzjoni ma ’ prodotti mediċinali oħra ma kienux imwettqa b’ Lumigan.
No interactions are anticipated in humans, since systemic concentrations of bimatoprost are extremely low (less than 0.2 ng/ ml) following ocular dosing.
L- ebda interazzjoni ma hi mistennija fin- nies, minħabba li l- konċentrazzjonijiet sistemiċi ta ’ bimatoprost huma baxxi ħafna (inqas minn 0. 2 ng/ ml) wara l- użu fl- għajn.
Bimatoprost is biotransformed by any of multiple enzymes and pathways, and no effects on hepatic drug metabolising enzymes were observed in preclinical studies..
Bimatoprost jiġi biotrasformat minn kwalunkwe minn ħafna enżimi u, u l- ebda effetti fuq l- enżimi epatiċi li jimmetabolizzaw il- mediċina ma kienu osservati fi studji ta ’ qabel l- użu kliniku.
In clinical studies, LUMIGAN was used concomitantly with a number of different ophthalmic beta-blocking agents without evidence of interactions.
Fi studji kliniċi, LUMIGAN intuża flimkien ma ’ numru differenti ta ’ imblokkaturi tar- riċetturi beta ta ’ l- għajnejn mingħajr l- ebda evidenza ta ’ interazzjoni.
Concomitant use of LUMIGAN and antiglaucomatous agents other than topical beta-blockers has not been evaluated during adjunctive glaucoma therapy.
L- użu flimkien ta ’ LUMIGAN u sustanzi ta ’ kontra l- glawkoma, bl- eċċezzjoni ta ’ imblokkaturi tar - riċetturi beta għall- użu topiku, ma kienux evalwati matul it- terapija miżjuda għall- glawkoma.
4.6 Pregnancy and lactation
4. 6 Tqala u Treddigh
Pregnancy There are no adequate data from the use of bimatoprost in pregnant women.
Tqala M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ bimatoprost waqt it- tqala.
Animal studies have shown reproductive toxicity at high maternotoxic doses (see section 5.3).
(ara 5. 3).
LUMIGAN should not be used during pregnancy unless clearly necessary.
3 LUMIGAN m’ għandux jintuża waqt it- tqala jekk m’ hemmx bzonn ċar.
3 Lactation It is not known if bimatoprost is excreted in human milk, however, this substance is excreted in rat milk after intravenous administration.
Treddigħ Mhux magħruf jekk bimatoprost jiġi eliminat fil- ħalib uman, iżda din is- sustanza giet eliminata fil - ħalib tal- firien wara li l- mediċina ngħatat minn ġol- vina.
It is recommended that LUMIGAN is not used in nursing mothers.
Hu rakkomandat li LUMIGAN ma jintużax minn nisa li qed ireddgħu.
LUMIGAN has negligible influence on the ability to drive and use machines.
LUMIGAN m’ għandu l- ebda effett fuq il- ħila ta ’ sewqan u l- użu ta ’ magni..
As with any ocular treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machinery.
Bħal f’ kull każ ta ’ kura fl- għajn, jekk hekk kif tqattar tara mċajpar għal żmien qasir, il- pazjent għandu jistenna sakemm il - vista tiċċara qabel ma jsuq jew iħaddem magni.
In clinical studies, over 1800 patients have been treated with LUMIGAN.
Fi studji kliniċi, aktar minn 1800 pazjent ngħataw il- kura permezz ta ’ LUMIGAN.
On combining the data from phase III monotherapy and adjunctive LUMIGAN usage, the most frequently reported treatment- related adverse events were: growth of eyelashes in up to 45% in the first year with the incidence of new reports decreasing to 7% at 2 years and 2% at 3 years, conjunctival hyperaemia (mostly trace to mild and thought to be of a non-inflammatory nature) in up to 44% in the first year with the incidence of new reports decreasing to 13% at 2 years and 12% at 3 years and ocular pruritus in up to 14% of patients in the first year with the incidence of new reports decreasing to 3% at 2 years and 0% at 3 years.
Meta tinġabar l - informazzjoni minn fażi III ta ’ monoterapija u użu flimkien ma ’ LUMIGAN, l- aktar effetti avversi frekwenti marbuta ma ’ din il- kura li kienu rrapurtati kienu: żjieda fit- tul tax- xagħar ta ’ xfar – il għajn f’ 45% fl- ewwel sena, bin- numru ta ’ każijiet ġodda jonqos għal 7% wara sentejn u 2% wara tliet snin; iperimija konġunktivali (minn ftit sa ħafifa u maħsuba li hi ta ’ natura mhux infjammatorja) f’ 44% fl - ewwel sena bin- numru ta ’ każijiet ġodda jonqos għal 13% wara sentejn u 12% wara tliet snin, u hakk fl- għajn f’ 14% tal- pazjenti fl- ewwel sena bin- numru ta ’ każijiet ġodda jonqos għal 3% wara sentejn u 0% wara tliet snin.
Less than 9% of patients discontinued due to any adverse event in the first year with the incidence of additional patient discontinuations being 3% at both 2 and 3 years.
Inqas minn 9% tal- pazjenti waqfu t- terapija minħabba xi effett avvers fl- ewwel sena u l- ammont ta ’ pazjenti oħra li waqfu l- kura kienet ta ’ 3% kemm wara sentejn kif ukoll wara tliet snin.
The following undesirable effects definitely, probably or possibly related to treatment were reported during clinical trials with LUMIGAN.
L- effetti mhux mixtieqa segwenti, li kienu marbuta żgur, probabilment jew possibilment mal- kura kienu rappurtati matul provi kliniċi permezz ta ’ LUMIGAN.
Most were ocular, mild to moderate, and none was serious:
Il- parti l- kbira kienu fl- għajn, ħfief sa moderati, u l- ebda wieħed ma kien serju.
With each frequency grouping, undesirable effects are presented in order of decreasing seriousness
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetata ’ tagħhom.
Infections and infestations Uncommon (≥ 1/ 1000 to < 1/ 100): infection (primarily colds and upper respiratory tract infections)
Infezzjonijiet u infestazzjonijiet Mhux komuni (≥1/ 1000 sa < 1/ 100): infezzjoni (primarjament irjiħat u infezzjonijiet fit- tratt respiratorju ta ’ fuq)
Nervous system disorders Common (≥ 1/ 100 to < 1/ 10): headache Uncommon (≥ 1/ 1000 to < 1/ 100): dizziness
Mard tas- sistema nervuża Komuni (≥1/ 100 sa < 1/ 10): uġigħ ta ’ ras Mhux Komuni (≥1/ 1000 sa < 1/ 100): sturdament
Eye disorders Very common (≥ 1/ 10): conjunctival hyperaemia, growth of eyelashes, ocular pruritus
Mard ta ’ l- għajnejn Komuni ħafna (≥1/ 10): iperimija konġunktivali, żjieda fid- daqs tax- xagħar ta ’ xfar- il għajn, ħakk fl - għajn
Common (≥ 1/ 100 to < 1/ 10): allergic conjunctivitis, asthenopia, blepharitis, cataract, conjunctival oedema, corneal erosion, eye discharge, eyelash darkening, eye pain, foreign body sensation, increased iris pigmentation, ocular burning, ocular dryness, ocular irritation, photophobia, superficial punctate keratitis, tearing, visual disturbance and worsening of visual acuity
Komuni (≥1/ 100 sa < 1/ 10): konġunktivite allerġika, astenopja, blefarite, katarretta, edema konġunktivali, erożjoni tal- korneja, tħammig ta ’ l- għajn, skurament tax- xagħar ta ’ l- għajn, uġigħ fl - għajn, sensazzjoni ta ’ xi haġa li daħlet fl- għajn, żjieda fil- pigmentazzjoni tal- ħabba ta ’ l- għajn, ħruq fl - għajn, nixfa fl- għajn, irritazzjoni fl- għajn, fotofobija, superficial punctate keratitis, dmugħ, disturbi fil- vista, u tnaqqis fl- akutezza fil- vista
Uncommon (≥ 1/ 1000 to < 1/ 100): blepharospasm, cystoid macular oedema, eyelid retraction, iritis, retinal haemorrhage, uveitis.
Mhux komuni (≥1/ 1000 sa < 1/ 100): blefarospażmi, edema makulari fiċ- ċistojde,, infjammazzjoni tal - habba ta ’ l- għajn emorraġġija retinali, uvite.
Vascular disorders Common (≥ 1/ 100 to < 1/ 10): hypertension
4 Mard vaskulari Komuni (≥1/ 100 sa < 1/ 10): pressjoni għolja
Skin and subcutaneous tissue disorders Common (≥ 1/ 100 to < 1/ 10): eyelid erythema, eyelid pruritus, pigmentation of periocular skin Uncommon (≥ 1/ 1000 to < 1/ 100): eyelid oedema, hirsutism.
Mard tal- ġilda u tat- tessuti ta ’ taħt il- ġilda Komuni (≥1/ 100 sa < 1/ 10): eritema ta ’ tebqet il- għajn, ħakk tal- kappell ta ’ l- għajn, pigmentazzjoni tal - ġilda ta ’ mad- dawra ta ’ l- għajn Mhux komuni (≥1/ 1000 sa < 1/ 100): edema fil- kappell ta ’ l- għajn, tkabbir eċċessiv ta ’ xagħar fuq il - wiċċ u l- ġisem
General disorders and administration site conditions Uncommon (≥ 1/ 1000 to < 1/ 100): asthenia, peripheral oedema
Mard ġenerali u kundizzjonijiet fis- sit minn fejn tingħata l- mediċina Mhux komuni (≥1/ 1000 sa < 1/ 100): astenja, edema periferika
4 Investigations Common (≥ 1/ 100 to < 1/ 10): liver function test abnormal
Investigazzjonijiet Komuni (≥1/ 100 sa < 1/ 10): eżami tal- funzjoni tal- fwied abnormali
If overdosage occurs, treatment should be symptomatic and supportive.
Jekk tittieħed doża eċċessiva, il- kura għandha tkun sintomatika u ta ’ appoġġ.
If LUMIGAN is accidentally ingested, the following information may be useful: in two-week oral rat and mouse studies, doses up to 100 mg/ kg/ day did not produce any toxicity.
Jekk LUMIGAN jittieħed bi żball mill- ħalq, din l- informazzjoni li ġejja għandha tkun utli: f’ studji orali ta ’ ħmistax fuq firien u ġrieden, dożi sa 100 mg/ kg/ kuljum ma produċew l- ebda tossiċità.
This dose expressed as mg/ m2 is at least 70-times higher than the accidental dose of one bottle of LUMIGAN in a 10 kg child.
Din id- doża espressa f’ mg/ m2 hi ta ’ mill- anqas 70 darba aktar mid- doża aċċidentali ta ’ flixkun ta ’ LUMIGAN f’ tifel ta ’ 10 kg.
Pharmacotherapeutic group: other antiglaucoma preparations; ATC code:
Kategorija farmakoterapewtika: mediċinali oħra kontra l- glawkoma; Kodiċi ATC:
The mechanism of action by which bimatoprost reduces intraocular pressure in man is by increasing aqueous humour outflow through the trabecular meshwork and enhancing uveoscleral outflow.
Il- mod kif bimatoprost inaqqas l- pressjoni fl- għajn fil- persuni hu billi jżid il- ħruġ ta ’ aqueous humour mis- sistema trabekulari u jtejjeb il- ħruġ uvejosklerali.
Reduction of the intraocular pressure starts approximately 4 hours after the first administration and maximum effect is reached within approximately 8 to 12 hours.
It- tnaqqis tal- pressjoni fl- għajn tibda madwar 4 siegħat wara l- ewwel għotja u l- effett massimu jintlaħaq f’ madwar 8 sa 12- il siegħa.
The duration of effect is maintained for at least 24 hours.
L- effett idum għal madwar 24 siegħa.
It is a synthetic prostamide, structurally related to prostaglandin F2α (PGF2α), that does not act through any known prostaglandin receptors.
Huwa prostamide sintetiku, strutturalment relatat ma ’ prostaglandin F2α (PGF2α), li ma jaħdimx permezz ta ’ xi riċetturi ta ’ prostaglandin magħruf.
Bimatoprost selectively mimics the effects of newly discovered biosynthesised substances called prostamides.
Bimatoprost selettivament jimita l- effetti tas- sustanzi biosintetizzati ġodda magħrufa bħala prostamidi.
The prostamide receptor, however, has not yet been structurally identified.
Madankollu, l- istruttura tar- riċettur ta ’ prostamide, għadha ma kienetx identifikata.
During 12 months’ monotherapy treatment, versus timolol, mean change from baseline in morning (08:00) intraocular pressure ranged from -7.9 to -8.8 mm Hg.
Matul l- ewwel 12- il xahar ta ’ kura monoterapika, imqabbel ma ’ timolol, il- bidla mill- linja bażi minn pressjoni fl- għajn ta ’ filgħodu (08: 00) varjat minn - 7. 9 sa - 8. 8 mm Hg.
At any visit, the mean diurnal IOP values measured over the 12-month study period differed by no more than 1.3 mmHg throughout the day and were never greater than 18.0 mmHg.
F’ kull analiżi, il- valuri medji ta ’ IOP ta ’ matul il- ġurnata mkejjla fuq perjodu ta ’ studju ta ’ 12- il xahar varjaw b’ mhux aktar minn 1. 3 mmHg matul il- ġurnata u qatt ma kienu aktar minn 18. 0 mmHg.
In a 6-month clinical study, versus latanoprost, a statistically superior reduction in morning mean IOP (ranging from -7.6 to -8.2 mmHg for bimatoprost versus – 6.0 to – 7.2 mmHg for latanoprost) was observed at all visits throughout the study.
Fi studju kliniku ta ’ 6 xhur, imqabbel ma ’ latanoprost, kien osservat tnaqqis statistikament superjuri fil- medja IOP ta ’ filgħodu (li tvarja minn - 7. 6 sa - 8. 2 mmHg għal bimatoprost meta mqabbel ma ’ – 6. 0 sa – 7. 2 mmHg għal latanoprost) fl- analiżi kollha li saru matul l- istudju.
Conjunctival hyperaemia, growth of eyelashes, and eye pruritus were statistically significantly higher with bimatoprost than with latanoprost, however, the discontinuation rates due to adverse events were low with no statistically significant difference.
Iperimja konġunktivali, zieda fil- kobor tax- xagħar ta ’ xfar il- għajn, u ħakk fl- għajn kienu, b’ mod li hu statistikament sinifikanti, aktar għolja b’ bimatoprost milli b’ latanoprost, għalkemm ir- rati ta ’ twaqqif ta ’ terapija minħabba effetti avversi kienu baxxi mingħajr l- ebda differenza li hi statistikament sinifikanti.
Compared to treatment with beta-blocker alone, adjunctive therapy with beta-blocker and bimatoprost lowered mean morning (08:00) intraocular pressure by -6.5 to -8.1 mmHg.
5 Meta mqabbel mal- kura permezz ta ’ imblokkatur tar- riċetturi beta biss, it- terapija flimkien ta ’ imblokkatur tar- riċetturi beta u bimatoprost naqqsu l- medja ta ’ pressjoni fl- għajn ta ’ filgħodu (08. 00) b ’ - 6. 5 sa - 8. 1 mmHg.
Limited experience is available with the use in patients with open-angle glaucoma with pseudoexfoliative and pigmentary glaucoma, and chronic angle-closure glaucoma with patent iridotomy.
Teżisti esperjenza limitata fl- użu tal- prodott f’ pazjenti b’ open angle glaucoma u glawkoma psewdoexfoljattiva u pigmentali, u angle- closure glaucoma kronika b’ iridotomija evidenti.
No clinically relevant effects on heart rate and blood pressure have been observed in clinical trials.
L- ebda effetti klinikament relevanti fuq ir- rata tal- qalb u l- pressjoni tad- demm ma kienu osservati f’ eżamijiet kliniċi.
After once daily ocular administration of one drop of 0.03% bimatoprost to both eyes for two weeks, blood concentrations peaked within 10 minutes after dosing and declined to below the lower limit of detection (0.025 ng/ ml) within 1.5 hours after dosing.
Wara li tqattret fl- għajn ta ’ qatra waħda ta ’ 0. 03% bimatoprost kuljum fiż- żewġ għajnejn għal ħmistax, il- konċentrazzjonijiet fid- demm laħqu l- massimu f’ 10 minuti wara l- għotja tad- doża u naqsu sa taħt l - inqas limitu ta ’ osservazzjoni (0. 025 ng/ ml) f’ 1. 5 sigħat wara l- għotja tad- doża.
Mean Cmax and AUC 0-24hrs values were similar on days 7 and 14 at approximately 0.08 ng/ ml and 0.09 ng• hr/ ml respectively, indicating that a steady drug concentration was reached during the first week of ocular dosing.
Il- medja tal- valuri ta ’ Cmax u AUC 0- 24hsiegħat kienu simili fis- 7 u l- 14- il ġurnata f’ ammonti ta ’ madwar 0. 08 ng/ ml u 0. 09 ng• siegħa/ ml rispettivament, u dan jindika li konċentrazzjoni fissa tal- prodott mediċinali ntlaħaqet matul l- ewwel ġimgħa ta ’ l- għotja fl- għajn.
Bimatoprost is moderately distributed into body tissues and the systemic volume of distribution in humans at steady-state was 0.67 l/ kg.
Bimatoprost jitqassam b’ mod moderat fit- tessuti tal- ġisem u l- volum ta ’ distribuzzjoni sistemika fiss fin- nies hu ta ’ 0. 67 l/ kg.
Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation following ocular dosing.
Bimatoprost hu l- iktar sustanza li tiċċirkola fid- demm hekk kif jilħaq iċ- ċirkolazzjoni sistemika wara l - għotja fl- għajn.
The elimination half-life, determined after intravenous administration, was approximately 45 minutes; the total blood clearance was 1.5 l/ hr/ kg.
Il- half- life ta ’ l - eliminazzjoni, wara l- għoti ġol- vina, kienet ta ’ madwar 45 minuta; it- tneħħija totali mid- demm kienet ta ’ 1. 5 l/ siegha/ kg.
After twice daily dosing, the mean AUC0-24hr value of 0.0634 ng• hr/ ml bimatoprost in the elderly (subjects 65 years or older) were significantly higher than 0.0218 ng• hr/ ml in young healthy adults.
Wara li d- doża ngħatat darbtejn kuljum, il- valur medju ta ’ AUC0- 24siegħa ta ’ 0. 0634 ng• siegħa/ ml ta ’ bimatoprost fl- anzjani (individwi ta ’ 65 sena jew aktar) kien, b’ mod sinifikanti, aktar għoli minn 0. 0218 ng• siegħa/ ml f’ adulti żgħażagħ f’ saħħithom.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Fi studji li m’ humiex kliniċi, effetti dehru biss wara esponimenti meqjusa ferm aktar għolja mill- massimu ta ’ l- esponimenti lill- bnedmin, li juru ftit li xejn rilevanza ma ’ l- użu kliniku.
Monkeys administered ocular bimatoprost concentrations of ≥ 0.03% daily for 1 year had an increase in iris pigmentation and reversible dose-related periocular effects characterised by a prominent upper and/ or lower sulcus and widening of the palpebral fissure.
Meta konċentrazzjoni ta ’ ≥0. 03% ta ’ bimatoprost nghatat kuljum fl- għajn tax- xadini, irriżultat f’ żjieda fil- pigmentazzjoni tal- ħabba tal- għajn u effetti periokulari marbuta mad- doża li huma riversibbli u karaterizzati minn sulcus promininenti fuq u/ jew isfel u twessiegħ tal- fissura palpebrali.
The increased iris pigmentation appears to be caused by increased stimulation of melanin production in melanocytes and not by an increase in melanocyte number.
Iż- żjieda fil - pigmentazzjoni tal- ħabba ta ’ l- għajn jidher li hi kkaġunata minn żjieda fl- istimulazzjoni tal - produzzjoni ta ’ melanin fil- melanoċiti u mhux minn żjieda fin- numru ta ’ - melanoċiti.
No functional or microscopic changes related to the periocular effects have been observed, and the mechanism of action for the periocular changes is unknown.
L- ebda bidliet funzjonali jew mikroskopiċi marbuta ma ’ l- effetti periokulari ma kienu osservati, u l- mekkaniżmu ta ’ azzjoni għall- bidliet periokulari mhux magħruf.
Bimatoprost was not mutagenic or carcinogenic in a series of in vitro and in vivo studies.
Bimatoprost ma kienx mutaġeniku jew karċinoġeniku f’ serje ta ’ studji in vitro u in vivo.
Bimatoprost did not impair fertility in rats up to doses of 0.6 mg/ kg/ day (approximately 103-times the intended human exposure).
6 Bimatoprost ma ħalliex effetti negattivi fuq il- fertilità fil- firien b’ dożi ta ’ 0. 6 mg/ kg/ kuljum (madwar 103 darba aktar mill- espożizzjoni rakkomandata għall- persuni).