qanastek/EMEA-V3 huggingface dataset:
Duration of treatment Livensa treatment response should be evaluated within 3-6 months of initiation, to determine if continued therapy is appropriate.
Tul tat- trattament Ir- rispons għat- trattament b’ Livensa għandu jiġi evalwat fi żmien 3- 6 xhur minn meta jibda, biex jiġi stabbilit jekk it- tkomplija tat- terapija hix adattata.
As the efficacy and safety of Livensa have not been evaluated in studies of longer duration than 1 year, it is recommended that an appraisal of the treatment is undertaken every 6 months.
Minħabba li l- effikaċja u s- sigurtà ta ’ Livensa ma kienux evalwati fi studji ta ’ iktar minn sena, hu rakkomandat li ssir evalwazzjoni tat- trattament kull 6 xhur.
There is no relevant indication for use of Livensa in children and adolescents.
M’ hemmx indikazzjoni rilevanti għall- użu ta ’ Livensa fit- tfal u adolexxenti.
The safety of Livensa has not been evaluated in double blind placebo controlled studies of longer than 1 year duration.
Is- sigurtà ta ’ Livensa ma kinitx evalwata fi studji double blind ikkontrollati bil- plaċebo li damu iktar minn sena.
However, this is not expected from the low dose of testosterone delivered by the Livensa patch.
Madankollu, dan mhuwiex mistenni minħabba doża baxxa ta ’ testosterone fornuta mill- garża ta ’ Livensa.
3 Livensa is recommended for use in surgically menopausal women up to the age of 60.
Livensa hu rakkomandat għall- użu f’ nisa sa l- età ta ’ 60 sena, li fihom il- menopawsa kienet ikkaġunata b’ mod kirurġiku.
Efficacy and safety of Livensa 300 micrograms in naturally menopausal women with HSDD on concomitant estrogen, with or without progestogen, have not been evaluated.
L- effikaċja u s- sigurtà ta ’ Livensa 300 mikrogramma f’ nisa li jkollhom menopawsa naturali, bl- HSDD u qed jużaw l- estroġenu fl- istess ħin, bi jew mingħajr progestogen, ma kienux evalwati.
Livensa 300 micrograms is not recommended in naturally menopausal women.
Livensa 300 mikrogramma mhux rakkomandat f’ nisa li jkollhom menopawsa naturali.
Whereas Livensa is indicated with concomitant estrogen therapy, the subgroup of patients receiving oral conjugated equine estrogens (CEE) did not demonstrate a significant improvement in sexual function.
Filwaqt li Livensa hu indikat biex jintuża fl- istess ħin ma ’ terapija bl- estroġenu, is- sotto- grupp ta ’ pazjenti li kienu qed jirċievu conjugated equine estrogens (CEE) orali, ma wrewx titjib sinifikanti fil - funzjoni sesswali.
Therefore, Livensa should not be used in women on concomitant CEE (see sections 4.2 and 5.1).
Għalhekk, Livensa m’ għandux jintuża f’ nisa li qed jużaw CEE fl- istess ħin (ara sezzjonijiet 4. 2 u 5. 1).
Livensa must not be used in women who are or may become pregnant or by breast-feeding women.
Livensa m’ għandux jintuża f’ nisa li huma tqal jew li jistgħu joħorġu tqal, jew minn nisa li qed ireddgħu.
In case of inadvertent exposure during pregnancy, use of Livensa must be discontinued.
F’ każ ta ’ espożizzjoni nvolontarja waqt it- tqala, l- użu ta ’ Livensa jrid jitwaqqaf.
Livensa has no influence on the ability to drive and use machines.
Livensa m’ għandu l- ebda effett fuq il- ħila biex issuq u tħaddem magni.
During 6-month double blind exposure the following adverse reactions occurred in the treatment group (n=549) at a greater incidence than placebo (n=545) and were assessed by the investigators as possibly or probably related to Livensa treatment.
Matul l- espożizzjoni double blind għal 6 xhur, ir- reazzjonijiet avversi li ġejjin seħħew fil- grupp tat - trattament (n=549) f’ inċidenza akbar milli fil- grupp tal- plaċebo (n=545) u kienu evalwati mill - investigaturi bħala possibbilment jew probabbilment relatati mat- trattament ta ’ Livensa.
If an adverse reaction occurred at a higher frequency in the integrated phase III studies (Livensa patients n=1,498, placebo patients n=1,297), this frequency is reported in the table.
Jekk reazzjoni avversa seħħet fi frekwenza ogħla fl- istudji integrati ta ’ fazi III (pazjenti fuq Livensa n=1, 498, pazjenti fuq il- plaċebo n=1, 297), din il- frekwenza hi rrappurtata fit- tabella.
The mode of administration of Livensa makes overdose unlikely.
Il- metodu ta ’ kif jingħata Livensa jagħmel doża eċċessiva mhux probabbli.
Livensa is a transdermal therapy for HSDD, which improves sexual desire while achieving testosterone concentrations compatible with premenopausal levels.
Livensa hu terapija transdermali għal HSDD, li ttejjeb ix- xewqa sesswali filwaqt li tilħaq konċentrazzjonijiet tat- testosterone li huma kompatibbli ma ’ livelli ta ’ qabel il- menopawsa.
Two multi-centre, double-blind, placebo-controlled six month studies in 562 (INTIMATE SM1) and 533 (INTIMATE SM2) oophorectomised and hysterectomised women (surgically induced menopause), aged 20 to 70 years, with HSDD on concomitant estrogen were used to evaluate the efficacy and safety of Livensa.
Żewġ studji multi- ċentriċi, double- blind, ikkontrollati bil- plaċebo, li damu sitt xhur, f’ 562 (INTIMATE SM1) u 533 (INTIMATE SM2) nisa li kellhom ooforektomija u isterektomija (menopawsa ikkaġunata b’ mod kirurġiku), li kellhom minn 20 sa 70 sena, bl- HSDD u bl- użu fl- istess ħin ta ’ l- estroġenu, intużaw biex tiġi evalwata l- effikaċja u s- sigurtà ta ’ Livensa.
In the combined study analysis at 24 weeks, the difference in the mean frequency of total satisfying episodes between Livensa and placebo was 1.07 per 4 weeks.
Fl- analiżi ta ’ l- istudju kombinat wara 24 ġimgħa, id- differenza fil- medja tal- frekwenza ta ’ episodji totali li jissodisfa bejn Livensa u l- plaċebo kienet ta ’ 1. 07 kull 4 ġimgħat.
A significantly higher percentage of women who received Livensa reported a benefit in the three endpoints, that they considered clinically meaningful compared to women who received placebo.
Perċentwali ogħla b’ mod sinifikanti ta ’ nisa li rċivew Livensa rrappurtaw benefiċċju fil- tliet riżultati aħħarin, li huma kkunsidraw li kien klinikament sinifikanti meta mqabbel ma ’ nisa li rċivew il - plaċebo.
In the combined phase III data, excluding patients taking oral CEE, in whom there was no significant improvement in sexual function, 50.7% of women (n=274) treated with Livensa and 29.4% of those treated with placebo (n=269) were responders with regard to total satisfying sexual activity (primary endpoint), when a responder was predefined as having an increase in the 4-week frequency of satisfying activities of > 1.
Fl- informazzjoni kombinata ta ’ fażi III, li jeskludi l- pazjenti li kienu qed jieħdu CEE orali, li fihom ma kien hemm l- ebda titjib sinifikanti fil- funzjoni sesswali, 50. 7% tan- nisa (n=274) trattati b’ Livensa u 29. 4% ta ’ dawk trattati bil- plaċebo (n=269) irrispondew rigward l- attività sesswali li tissodisfa (riżultat aħħari primarju), meta min irrisponda kien definit minn qabel bħala li kellha żieda fuq medda ta ’ 4- ġimgħat fil- frekwenza ta ’ attivitajiet li jissodisfaw ta ’ > 1.
Effects of Livensa were observed at 4 weeks after initiation of therapy (the first measured time point) and at all monthly efficacy time points thereafter.
6 L- effetti ta ’ Livensa kienu osservati wara 4 ġimgħat mill- bidu tat- terapija (l- ewwel punt fiż- żmien li fih sar il- kejl) u wara dan, l- effikaċja fil- punti kollha taż- żmien ta ’ kull xahar.
Testosterone from Livensa is transported across intact skin by a passive diffusion process that is primarily controlled by permeation across the stratum corneum.
Testosterone minn Livensa, jiġi ttrasportat minn ġol- ġilda intatta permezz ta ’ proċess passiv tad - diffużjoni, li huwa primarjament ikkontrollat mix- xterid minn naħa għal oħra ta ’ l- istratum corneum.
Livensa is designed to systemically deliver 300 micrograms/ day.
Livensa hu maħsub biex iforni b’ mod sistemiku, 300 mikrogramma kuljum.
Livensa did not influence serum concentrations of sex hormone binding globulin (SHBG), estrogens or adrenal hormones.
Livensa ma nfluwenzax il- konċentrazzjonijiet fis- serum tas- sex hormone binding globulin (SHBG), estroġeni jew ormoni adrenali.
Serum Concentrations of Testosterone and SHBG in Patients Receiving Livensa in Clinical Safety and Efficacy Studies Hormone
Il- Konċentrazzjonijiet fis- Serum tat- Testosterone u SHBG f’ Pazjenti li Kienu Qed Jirċievu Livensa fi Studji Kliniċi dwar is- Sigurtà u l- Effikaċja Ormon
DHT concentrations increased in parallel with testosterone concentrations during Livensa treatment.
Il- konċentrazzjonijiet tad- DHT żdiedu b’ mod parallel mal- konċentrazzjonijiet ta ’ testosterone matul it- trattament b’ Livensa.
There were no significant differences in serum estradiol and estrone levels in patients treated with Livensa for up to 52 weeks compared to baseline.
Ma kien hemm l- ebda differenzi 7 sinifikanti fl- estradiol tas- serum u fil- livelli ta ’ estrone f’ pazjenti trattati b’ Livensa sa 52 ġimgħa meta mqabbla mal- linja bażi.
On removal of an Livensa patch, testosterone serum concentrations return to near baseline values within 12 hours due to its short terminal exponential half-life (approximately 2 hours).
Meta l- garża Livensa titneħħa, il- konċentrazzjonijiet tat- testosterone fis- serum jerġgħu lura għal qrib il- valuri tal- linja bażi fi żmien 12- il siegħa, minħabba l- half- life esponenzjali terminali qasira tiegħu (madwar sagħtejn).
The significance of these data for the use of Livensa in patients is not known.
Is- sinifikat ta ’ din l- informazzjoni għall- użu ta ’ Livensa fil- pazjenti mhuwiex magħruf.
Livensa 300 micrograms/ 24 hours transdermal patch Testosterone
Livensa 300 mikrogramma/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda Testosterone
Livensa 300 micrograms/ 24 hours transdermal patch Testosterone Transdermal use
Livensa 300 mikrogramma/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda Testosterone Użu minn fuq il- ġilda
What Livensa is and what it is used for 2.
X’ inhu Livensa u għalxiex jintuża 2.
What you should consider before you use Livensa 3.
X’ għandek tikkunsidra qabel ma tuża Livensa 3.
How to use Livensa 4.
Kif għandek tuża Livensa 4.
How to store Livensa 6.
Kif taħżen Livensa 6.
WHAT LIVENSA IS AND WHAT IT IS USED FOR
X’ INHU LIVENSA U GĦALXIEX JINTUŻA
Livensa is a transdermal patch which constantly releases small amounts of testosterone that is absorbed through your skin into the bloodstream.
Livensa hi garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda li l- ħin kollu terħi ammonti żgħar ta ’ testosterone li jiġi assorbit minn ġol- ġilda tiegħek fiċ- ċirkolazzjoni tad- demm.
The testosterone in Livensa is the same hormone as that produced naturally in men and women.
It- testosterone f’ Livensa hu l- istess ormon bħal dak li hu prodott b’ mod naturali fl- irġiel u fin- nisa.
Livensa is used to treat HSDD.
Livensa jintuża għat- trattament ta ’ HSDD.
Livensa is intended for use by women up to the age of 60 years who:  have a low sexual desire which is causing distress or concern, and  have had both of their ovaries removed, and  have had their womb removed (hysterectomy), and  are receiving estrogen therapy.
Livensa hu intenzjonat biex jintuża minn nisa li għandhom sa 60 sena, li:  jkollhom xewqa sesswali baxxa li tkun qed tikkawża inkwiet jew problemi, u  li kellhom l- ovarji t- tnejn imneħħija, u  li kellhom l- utru mneħħi (isterektomija), u  li qed jirċievu terapija bl- estroġenu.
If you have not experienced a positive effect of Livensa within 3-6 months, you should inform your doctor, who will suggest that treatment be discontinued.
Jekk ma jkollokx effett pożittiv b’ Livensa fi żmien 3- 6 xhur, għandek tinforma lit- tabib tiegħek, li ser jissuġġerixxi li t- trattament għandu jitwaqqaf.
WHAT YOU SHOULD CONSIDER BEFORE YOU USE LIVENSA
X’ GĦANDEK TIKKUNSIDRA QABEL MA TUŻA LIVENSA
Do not use Livensa  if you are allergic (hypersensitive) to testosterone or any of the other ingredients of Livensa.  if you know that you have had in the past, currently have, or think that you might have, breast cancer or any other cancer which your doctor has described as being caused or stimulated by the female hormone estrogen, also called ‘ estrogen-dependent’ cancers.  if you have other conditions that your doctor may consider not appropriate for the use of estrogen and/ or testosterone.
Tużax Livensa  jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għat- testosterone jew sustanzi oħra ta ’ Livensa.  jekk taf li kellek fil- passat, jekk għandek, jew jekk taħseb li jista ’ jkollok, kanċer tas- sider jew kwalunkwe kanċer ieħor li t- tabib tiegħek iddeskriva li kien ikkawżat jew stimulat mill- ormon femminili, l- estroġenu, imsejħin ukoll kanċers ‘ dipendenti fuq l- estroġenu ’.
19 Take special care with Livensa  if you have a history of heart, liver or kidney disease.  if you are diabetic, as testosterone may lower blood glucose levels.  if you have a history of excessive adult acne, body or facial hair, hair loss, enlargement of the clitoris or voice deepening or hoarseness.
19  jekk inti għandek kundizzjonijiet oħrajn li t- tabib tiegħek jista ’ jikkunsidra li mhumiex adattati għall- użu ta ’ l- estroġenu u/ jew tat- testosterone.
If you have any of the above, tell your doctor before you start to use Livensa.
Jekk għandek kwalunkwe minn dawn t’ hawn fuq, għid it- tabib tiegħek qabel ma tibda tuża Livensa.
The efficacy of Livensa is reduced if your estrogen therapy is of a certain type (‘ conjugated equine estrogens’).
L- effikaċja ta ’ Livensa titnaqqas jekk it- terapija tiegħek bl- estroġenu tkun ta ’ ċertu tip (‘ conjugated equine estrogens ’).
Therefore, you need to discuss your type of estrogen with your doctor, who could advise you which type of estrogen is suitable together with Livensa.
Għalhekk, jeħtieġ li tiddiskuti t- tip ta ’ estroġenu tiegħek mat- tabib tiegħek, li jista ’ jagħtik parir dwar liema tip ta ’ estroġenu hu adattat għalik flimkien ma ’ Livensa.
If you stop estrogen therapy you must also stop using Livensa.
Jekk twaqqaf it - terapija bl- estroġenu, għandek tieqaf tuża Livensa wkoll.
Use Livensa only as long as you experience a positive effect of the treatment.
Użu Livensa biss sakemm ikollok effett pożittiv tat- trattament.
There is no information on the safety of Livensa beyond 12 months.
M’ hemm l- ebda informazzjoni dwar is - sigurtà ta ’ Livensa wara iktar minn 12- il xahar.
It is not known whether Livensa increases the risk of breast cancer.
Mhux magħruf jekk Livensa jżidx ir- riskju ta ’ kanċer tas- sider.
Children and adolescents Livensa is not for use in children and adolescents.
Tfal u adoloxxenti Livensa mhuwiex għall- użu fit- tfal u fl- adolexxenti.
Livensa is only indicated for women in their menopause after the ovaries and uterus have been removed.
Livensa hu indikat biss għal nisa li jkollhom il- menopawsa wara li l- ovarji u l- utru jkunu tneħħew.
Do not use Livensa if you are, or suspect that you may be pregnant or are able to become pregnant, because it may cause harm to the unborn child.
Tużax Livensa jekk inti tqila, jew tissuspetta li tista ’ tkun tqila jew jekk tista ’ toħroġ tqila, minħabba li dan jista ’ jikkawża ħsara lit- tarbija mhix imwielda.
Do not use Livensa in case of breast-feeding because it may cause harm to the child.
Tużax Livensa f’ każ jekk qed tredda ’, minħabba li dan jista ’ jikkawża ħsara lit- tarbija.
Driving and using machines You can drive and use machines while using Livensa.
Sewqan u tħaddim ta ’ magni Inti tista ’ ssuq u tuża l- magni waqt li tkun qed tuża Livensa.
Livensa should be replaced twice weekly (each 3 to 4 days).
KIF GĦANDEK TUŻA LIVENSA
Always use Livensa exactly as your doctor has told you.
Dejjem għandek tuża Livensa skond il- parir tat- tabib.
Step 4 Fold back the patch and carefully remove the other half of the liner.
21 Pass 4 Itwi lura l- garża u neħħi b’ attenzjoni n- nofs l- ieħor ta ’ l- inforra.
Use your fingers to
Agħfas l- garża kollha fuq il - ġilda tiegħek bil- keffa ta ’ idejk għal madwar 10 sekondi.
21 make sure the edges of the patch stick to the skin.
Uża s- swaba ’ tiegħek biex taċċerta ruħek li t- truf tal- garża jeħlu mal- ġilda.
If you use more patches than you should If you have applied more than one patch at a time Remove all the patches sticking on to your skin and consult your doctor or pharmacist for further information on how to continue treatment with Livensa.
Jekk tuża iktar garżi milli suppost Jekk tkun waħħalt iktar minn garża waħda fl- istess ħin Neħħi l- garżi kollha li jkollok imwaħħlin fuq il- ġilda tiegħek u kellem lit- tabib jew l- ispiżjar tiegħek għal informazzjoni addizzjonali dwar kif tkompli t- trattament b’ Livensa.
Overdosing with Livensa is unlikely when used as directed, because once the patch is taken off testosterone is quickly removed by the body.
Mhux mistenni li jkun hemm doża eċċessiva b’ Livensa meta jintuża skond l- istruzzjonijiet, minħabba li, ġaladarba l- garża tinqala ’ t - testosterone jitneħħa malajr mill- ġisem.
22 If you forget to use a patch If you forget to change your patch Change your patch as soon as you remember, and then continue with your regular schedule of patch- change days, even if this means discarding a patch after you have worn it for less than 3-4 days.
Jekk tinsa tuża garża Jekk tinsa tibdel il- garża tiegħek Ibdel il- garża tiegħek hekk kif tiftakar, u mbagħad kompli bl- iskeda regolari tiegħek tal- jiem li fihom tibdel il- garża, anki jekk dan ifisser li tarmi garża wara li tkun ilha fuqek għal inqas minn 3- 4 ijiem.
Like all medicines, Livensa can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Livensa jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
They are usually reversible if Livensa treatment is discontinued.
Dawn is- sintomi normalment huma riversibbli jekk it- trattament b’ Livensa jitwaqqaf.
You should self assess for increased acne, increased hair growth on your face, loss of hair, deepening of your voice or enlargement of your clitoris, which all could be signs of adverse effects of testosterone, which is the active substance in Livensa.
Għandek tagħmel evalwazzjoni tiegħek innifsek għal żieda fl- akne, żieda fit- tkabbir tax- xagħar f’ wiċċek, telf ta ’ xagħar, il- vuċi tiegħek issir ħoxna jew ikollok tkabbir fil- klitoris, li kollha jistgħu jkunu sinjali ta ’ effetti avversi tat- testosterone, li hi s- sustanza attiva f’ Livensa.
HOW TO STORE LIVENSA
KIF TAĦŻEN LIVENSA
Do not use Livensa after the expiry date which is stated on the carton and sachet.
Tużax Livensa wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- qartas.
What Livensa contains The active substance is testosterone.
X’ fih Livensa Is- sustanza attiva hi testosterone.
What Livensa looks like and contents of the pack Livensa is a thin, clear, oval patch with PG T001 stamped on the back.
Id- dehra tal- prodott u d- daqs tal- pakkett Livensa hi garża rqiqa, ċara u ovali bil- kliem PG T001 stampat fuq in- naħa ta ’ wara.
Marketing Authorisation Holder and Manufacturer
Jista ’ jkun li mhux il- pakketti tad - daqsijiet kollha jkunu għal skop kummerċjali.
Procter & Gamble Pharmaceuticals - Germany GmbH Dr. -Otto-Röhm-Strasse 2-4 D-64331 Weiterstadt Germany
Id- Detentur Ta ’ l- Awtorizzazzjoni għat- Tqegħid Fis- Suq u l- Manifattur Procter & Gamble Pharmaceuticals – Germany GmbH Dr. - Otto- Röhm- Strasse 2- 4 D- 64331 Weiterstadt Il- Ġermanja
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. eu. int/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /
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 hu wkoll parti mill- EPAR) jew kellem lit- tabib jew lill- ispiżjar tiegħek Jekk tixtieq aktar informazzjoni relatata mar- rakkomandazzjonijiet tas- CHMP, aqra d - Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Lucentis?
X’ inhu Lucentis?
Lucentis is a solution for injection into the eye.
Lucentis huwa soluzzjoni għal injezzjoni fl- għajn.
It contains the active substance ranibizumab.
Fih is- sustanza attiva ranibizumab.
What is Lucentis used for?
Għal xiex jintuża Lucentis?
Lucentis is used to treat patients with the ‘ wet’ form of age-related macular degeneration (AMD).
Lucentis jintuża fit- trattament ta ’ pazjenti bil- forma ‘ umda ’ ta ’ deġenerazzjoni makulari marbuta mal - età (AMD).
This disease affects the central part of the retina (called the macula) at the back of the eye and causes loss of ‘ straight-ahead’ vision.
Din il- marda tolqot il- parti ċentrali tar- retina (magħrufa bħala l- makula) fil- parti ta ’ wara tal- għajn u tikkawża nuqqas ta ’ vista fiż- żona ċentrali tal- kamp viżiv.
The macula provides central vision that is needed to see detail for everyday tasks such as driving, reading and recognising faces.
Il- makula tipprovdi l- vista ċentrali meħtieġa biex naraw id- dettall għall- funzjonijiet ta ’ kuljum bħas- sewqan, il- qari u l- għarfien ta ’ wċuħ.
The wet form of AMD is caused by the formation of abnormal blood vessels under the macula, which may leak fluid and bleed.
Il- forma umda tal- AMD hija kkawżata mill- formazzjoni ta ’ arterji u vini anomali taħt il - ġilda, li minnhom jista ’ joħroġ fluwidu u demm.
This causes the loss of vision.
Dan jikkawża nuqqas ta ’ vista.
How is Lucentis used?
Kif jintuża Lucentis?
Lucentis is given as an injection into the affected eye.
Lucentis jingħata b’ injezzjoni fl- għajn milquta.
For the first three months, one injection is given every month.
Għall- ewwel tliet xhur, tingħata injezzjoni waħda kull xahar.
After this, the patient’ s vision should be checked every month and another injection given if the vision has become worse.
Wara dan, il- vista tal- pazjent għandha tiġi kkontrollata kull xahar u tingħata injezzjoni oħra jekk il- vista tmur għall- agħar.
The interval between injections must be at least one month.
L- intervall bejn l- injezzjonijiet għandu jkun mill- inqas xahar.
Lucentis must be given by a qualified ophthalmologist (eye specialist) who is experienced at giving this type of injection.
Lucentis għandu jingħata minn oftalmologu (speċjalista tal- għajnejn) kwalifikat b' esperjenza fl- għoti ta 'dan it - tip ta' injezzjoni.
Before each injection, a local anaesthetic is given to reduce or prevent any pain from the injection, and the eye, eyelid and skin around the eye are disinfected.
Qabel kull injezzjoni, tingħata l- anestesija (loppju) lokali biex tnaqqas jew tipprevjeni kull uġigħ mill- injezzjoni, u l- għajn, il- kappell tal- għajn u l- ġilda ta ’ madwar l- għajn jiġu diżinfettati.
Antibiotic eye drops are given for three days before the injection and for three days afterwards to prevent eye infection.
Il- qtar antibijotiċi fl- għajn jingħataw kull tlett ijiem qabel l- injezzjoni u għal tlett ijiem wara biex tiġi evitata infezzjoni tal- għajn.
Patients will be taught how to use the eye drops by themselves.
Il- pazjenti jiġu mgħallma kif jużaw il- qtar tal- għajn weħidhom.
How does Lucentis work?
Kif jaħdem Lucentis?
The active substance in Lucentis, ranibizumab, is a small piece of a monoclonal antibody.
Is- sustanza attiva f’ Lucentis, ranibizumab, hija biċċa żgħira minn antikorp monoklonali.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in certain cells in the body.
Antikorp monoklonali hu tip ta ’ antikorp (tip ta ’ proteina) maħsub biex jagħraf u jintrabat ma ’ struttura speċifika (magħrufa bħala antiġene) li jinstab fuq ċerti ċelloli fil- ġisem.
Ranibizumab has been designed to block a substance called vascular endothelial growth factor A (VEGF-A).
Ranibizumab huwa maħsub biex jimblokka sustanza magħrufa bħala l- fattur tat- tkabbir tal- endotelju vaskolari (vascular endothelial growth factor) A (VEGF- A).
VEGF-A is found in high levels in the eyes of patients with AMD and makes blood vessels grow and leak fluid.
VEGF- A jinstab f’ livelli għoljin fl - għajnejn ta ’ pazjenti bl- AMD u jġiegħel l- arterji u l- vini tad- demm jikbru u jnixxu fluwidu.
These effects worsen the disease.
Dawn l - effetti jagħmlu l- marda agħar.
By blocking this factor, ranibizumab reduces the growth of the blood vessels and leakage.
Bl- imblukkar ta ’ dan il- fattur, ranibizumab inaqqas il- kobor ta ’ arterji u vini u l- ħruġ ta ’ fluwidu minnhom.
How has Lucentis been studied?
Kif ġie studjat Lucentis?
The effects of Lucentis were first tested in experimental models before being studied in humans.
L- effetti ta ’ Lucentis għall- ewwel ġew ittestjati f’ mudelli sperimentali qabel ma ġew studjati fil - bnedmin.
The three main studies of Lucentis involved 1,323 patients with the wet form of AMD.
Fit- tliet studji ewlenin ta ’ Lucentis ħadu sehem 1, 323 pazjent bil- forma umda tal- AMD.
All of the patients were over 50 years of age and had not been treated for wet AMD before.
Il - pazjenti kollha kellhom iktar minn 50 sena u ma kinux ġew ittrattati għall- AMD umda qabel.
Two doses of Lucentis were tested:
Ġew ittestjati tliet dożi ta 'Lucentis:
0.3 mg and 0.5 mg.
0. 3 mg u 0. 5 mg.
The studies were designed to last up to two years, but only one of the studies had been completed by the time the medicine was assessed.
L- istudji kienu maħsuba biex iservu sa sentejn, iżda studju wieħed biss kien tlesta sakemm ġiet valutata l- mediċina.
Two of the studies compared Lucentis to a sham injection.
Tnejn mill- istudji qabblu Lucentis ma ’ injezzjoni finta (sham injection).
This is a procedure that is similar to a Lucentis injection, but with no Lucentis and no needle, in which the syringe is pressed against the surface of the eye but no actual injection is carried out.
Din hija proċedura simili għal injezzjoni ta ’ Lucentis, iżda mingħajr Lucentis u mingħajr labra li fiha s- siringa tingħafas fuq il- wiċċ tal- għajn iżda mingħajr ma ssir injezzjoni fir- realtà.
The patients cannot tell whether they received Lucentis or the sham procedure.
Il- pazjenti ma jkunux jistgħu jgħidu jekk ingħatawx Lucentis jew il- proċedura simulata.
The third study compared Lucentis to verteporfin photodynamic therapy (PDT, another treatment for AMD).
It- tielet studju qabbel Lucentis mat- terapija fotodinamika b’ verteporfin (PDT, trattament ieħor għall- AMD).
The main measure of effectiveness was the change in vision in the affected eye after a year of treatment, using a standard eye test with a letter chart.
Il- mezz ewlieni għall- kejl tal - effikaċja kien il- bidla fil- vista fl- għajn affettwata wara sena trattament, bl- użu ta ’ test tal- għajnejn standard bit- tabella tal- ittri.
Patients were classified as having experienced no significant worsening of vision if the number of letters that they could see increased, stayed the same, or fell by less than 15.
Il- pazjenti ġew ikklassifikati bħala li ma esperjenzawx aggravazzjoni sinifikanti fil- vista skont jekk l- għadd ta ’ ittri li ma setgħux jaraw żdiedx, baqax l- istess, jew naqasx b’ inqas minn 15.
What benefit has Lucentis shown during the studies?
X’ inhu l- benefiċċju ta ’ Lucentis li ntwera f’ dawn l- istudji?
Lucentis was more effective at preventing a worsening of vision than its comparators.
Lucentis kien iktar effikaċi mill- mediċini li tqabbel magħhom biex ma jħallux il- vista tmur għall - agħar.
Between 94 and 96% of the patients receiving Lucentis every month experienced no significant worsening of their vision, compared with 62% of those receiving sham injections and 64% of those treated with verteporfin PDT.
Bejn 94% u 96% tal- pazjenti li kienu qed jingħataw Lucentis kull xahar ma kellhom l- ebda aggravazzjoni sinifikanti fil- vista, meta mqabbla ma ’ 62% ta ’ dawk li kienu qed jingħataw injezzjonijiet finta u 64% ta ’ dawk ittrattati b’ verteporfin PDT.
The 0.5 mg dose appeared to be more effective than the 0.3 mg dose.
Id- doża ta ’ 0. 5 mg dehret iktar effikaċi mid- doża ta ’ 0. 3 mg.
The vision of patients receiving Lucentis also remained better than the vision of those receiving sham injections in a study in which injections were given less frequently, with injections every month for the first three months and then every three months.
Il- vista ta ’ pazjenti li kienu qed jingħataw Lucentis ukoll baqgħet aħjar mill- vista ta ’ dawk li kienu qed jingħataw injezzjonijiet finta fi studju li fih, l- injezzjonijiet kienu qed jingħataw inqas ta ’ spiss, b’ injezzjonijiet kull xahar għall- ewwel tliet xhur u mbagħad kull tliet xhur.
What is the risk associated with Lucentis?
X’ inhu r- riskju assoċjat ma ’ Lucentis?
The most common side effects with Lucentis (seen in more than 1 in 10 patients) are increased intraocular pressure (pressure within the eye), headache, vitritis (inflammation in the eye), vitreous detachment (separation of the fluid in the eye from the back of the eye), retinal haemorrhage (bleeding at the back of the eye), visual disturbance, eye pain, vitreous floaters (spots in the vision), conjunctival haemorrhage (bleeding at the front of the eye), eye irritation, sensation of a foreign body in the eye, increased lacrimation (tear production), blepharitis (inflammation of the eyelids), dry eye, ocular hyperaemia (red eye), eye pruritis (itching), arthralgia (joint pain) and nasopharyngitis (inflammation of the nose and throat).
L- iktar effetti sekondarji komuni ma ’ Lucentis (li dehru f’ iktar minn pazjent wieħed minn kull 10) huma żieda fil- pressjoni intraokulari (pressjoni ġewwa l- għajnejn), uġigħ ta ’ ras, vitrite (infjamazzjoni tal- għajn), distakk tal- vitreu (vitreous detachment, separazzjoni tal- fluwidu fl- għajn min- naħa ta ’ wara tal- għajn), emorraġija tar- retina (ħruġ ta ’ demm fuq wara tal- għajn), disturbi fil- vista, uġigħ fil- għajn, mijodesopsiji (sensazzjoni ta ’ żlieġa fil- vista - vitreous floaters), emorraġija konġuntivali (ħruġ ta ’ demm fuq quddiem tal- għajn), irritazzjoni tal- għajn, sensazzjoni ta ’ xi ħaġa barranija ġewwa l- għajn, żieda fid- dmugħ, blefarite (infjammazzjoni tal- kappell tal- għajn), nixfa okulari, iperemija okulari (ħmura fl- għajnejn), sensazzjoni ta ’ ħakk fil- għajn, artralġja (uġigħ fil- ġogi) u nażofarinġite (infjammazzjoni tal- imnieħer u tal- griżmejn).
For the full list of all side effects reported with Lucentis, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrapportati ma ’ Lucentis, ara l- Fuljett ta ’ Tagħrif.
Rarely, endophthalmitis (an infection inside the eye), serious eye inflammation, damage to the retina and cataract (clouding of the lens) can occur after Lucentis treatment.
Rarament jistgħu jseħħu każijiet ta ’ endoftalmite (infezzjoni ġewwa l- għajn), infjammazzjoni serja tal - għajn, ħsara lir- retina u katarretti (tiċpir tal- lenti) jistgħu jseħħu wara t- trattament b’ Lucentis.
It is important to treat these problems as soon as possible.
Huwa importanti li dawn il- problemi jiġu ttrattati mill- aktar fis possibbli.
Their symptoms and instructions about what to do if a patient has them are explained in the Package Leaflet.
Is- sintomi u l- istruzzjonijiet tagħhom dwar x’ għandu jsir jekk pazjent ikollu dawn is- sintomi huma mfissra fil- Fuljett ta ’ Tagħrif.
Lucentis should not be used in patients who may be hypersensitive (allergic) to ranibizumab or any of the other ingredients.
Minħabba li l- injezzjonijiet fl- għajnejn jistgħu jikkawżaw żieda temporanja fil- pressjoni ġewwa l - għajn, l- oftalmologu se jikkontrolla dan wara l- injezzjoni u jieħu l- miżuri korrettivi jekk meħtieġa Lucentis m’ għandux jintuża f’ pazjenti li jistgħu jkunu ipersensittivi (allerġiċi) għal ranibizumab jew għal kwalunkwe sustanza oħra tiegħu.
It must not be used in patients who may have an infection of the eye or the area around the eye, or who have severe inflammation within the eye.
M’ għandux jintuża f’ pazjenti li jista ’ jkollhom infezzjoni tal - għajn jew il- parti ta ’ madwar l- għajn, jew li jkollhom infjammazzjoni ġewwa l- għajn.
Why has Lucentis been approved?
Għaliex ġie approvat Lucentis?
The Committee for Medicinal Products for Human Use (CHMP) noted that Lucentis is associated with side effects, but that this is balanced by benefits that have been shown convincingly and maintained for up to two years.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (is- CHMP) innota li Lucentis huwa assoċjat ma ’ effetti sekondarji, iżda li dan huwa bbilanċjat minn benefiċċji li ntwerew b’ mod konvinċenti u baqgħu jidhru sa massimu ta ’ sentejn.
The Committee decided that Lucentis’ s benefits are greater than its risks for the treatment of neovascular (wet) AMD.
Il- Kumitat iddeċieda li l- benefiċċji ta ’ Lucentis huma ikbar mir- riskji tiegħu fit- trattament ta ’ AMD (umda) neovaskulari.
Since the effectiveness of Lucentis was slightly greater in the patients receiving the 0.5 mg dose and the most common side effects were not serious, the Committee recommended that this dose of Lucentis should be given a marketing authorisation.
Billi l- effikaċja ta ’ Lucentis kienet ftit ikbar fil- pazjenti li kienu qed jingħataw doża ta ’ 0. 5 mg u l- iktar effetti sekondarji komuni ma kinux serji, il- Kumitat irrakkomanda li din id- doża ta ’ Lucentis għandha tingħata awtorizzazzjoni għat- tqegħid fis- suq.
2/ 3 when to seek urgent attention from their doctor).
2/ 3 X’ miżuri qed jittieħdu biex ikun żgurat l- użu sigur ta ’ Lucentis?
The company will also closely monitor the side effects and safety of the medicine.
Il- kumpanija se tissorvelja bir- reqqa l- effetti sekondarji u s- sigurtà tal- mediċina.
Other information about Lucentis:
Tagħrif ieħor dwar Lucentis:
The European Commission granted a marketing authorisation valid throughout the European Union for Lucentis to Novartis Europharm Limited on 22 January 2007.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Lucentis valida fl- Unjoni Ewropea kollha lil Novartis Europharm Limited fit- 22 ta ’ Jannar 2007.
The full EPAR for Lucentis can be found here.
L- EPAR sħiħ ta ’ Lucentis jista ’ jiġi kkonsultat hawn.
This summary was last updated in 11-2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
EU/ 1/ 06/ 374/ 001
Numru ta ’ l- EU EU/ 1/ 06/ 374/ 001
Lucentis
Isem inventat Lucentis
10 mg/ ml
Qawwa 10 mg/ ml
Solution for injection
Mnejn jingħata Għal użu ġol- vitriju
Intravitreal use Vial (glass)
Il- pakkett Kunjett (ħġieġ)
Lucentis 10 mg/ ml solution for injection
Lucentis 10 mg/ ml soluzzjoni għall- injezzjoni
One ml contains 10 mg ranibizumab.
Millilitru wieħed fih 10 mg ranibizumab.
Each vial contains 2.3 mg of ranibizumab in 0.23 ml solution.
Kull kunjett fih 2. 3 mg ta ’ ranibizumab f’ 0. 23 ml ta ’ soluzzjoni.
Ranibizumab is a humanised monoclonal antibody fragment produced in Escherichia coli cells by recombinant DNA technology.
Ranibizumab huwa framment ta ’ antikorp monoklonali mgħamul għal bniedem f ’’ ċelluli ta ’ Escherichia coli bit- teknoloġija ta ’ DNA rikombinat.
Sterile, clear, colourless to pale yellow aqueous solution.
Soluzzjoni sterili, ċara, li l- kulur tagħha jvarja bejn bla kulur għal isfar ċar.
Lucentis is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD) (see section 5.1).
Lucentis jintuża għal kura ta ’ deġenerazzjoni makulari neovaskulari (mxarrba) relatata ma ’ l- età (ara sezzjoni 5. 1).
Single-use vial for intravitreal use only.
Kunjett li jintuża darba għall- użu ġol- vitriju biss.
Lucentis must be administered by a qualified ophthalmologist experienced in intravitreal injections.
Lucentis għandu jintuża minn oftalmologu kwalifikat li għandu esperjenza b’ injezzjonijiet fil- vitriju.
The recommended dose for Lucentis is 0.5 mg (0.05 ml).
Id- doża rakkomandata ta ’ Lucentis hija 0. 5 mg (0. 05 ml).
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 ghal tliet xhur wara xulxin, segwit b’ fażi ta ’ manteniment li waqtha 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 l- akutezza tal- vista tal- pazjent tonqos b’ aktar minn 5 ittri (ETDRS jew ekwivalenti għal rig wieħed Snellen), Lucentis għandu jingħata.
The interval between two doses should not be shorter than 1 month.
L- intervall bejn iż- żewġ dożi m’ għandux ikun inqas minn xahar 1.
As with all medicinal products for parenteral use, Lucentis should be inspected visually for particulate matter and discoloration prior to administration.
Bħal mediċini kollha li jingħataw b’ injezzjoni, 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, għandhom jingħataw istruzzjonijiet lill- pazjent biex iqattar taqtir kontra l- mikrobi (erba ’ darbiet kuljum għal 3 ijiem qabel u wara kull injezzjoni).
The injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent) and the availability of sterile paracentesis (if required).
Il- proċedura ta ’ l- injezzjoni għandha ssir taħt kundizzjonijiet asettiċi, li tinkludi l- ħasil ta ’ l- idejn b’ disinfettant għall- kirurġija, ingwanti sterili, kesa sterili u spekulum sterili ta ’ tebqet il- għajn (jew ekwivalenti) u li jkun hemm disponibbli paraċenteżi sterili (jekk ikun hemm bżonn).
The patient ’ s medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see section 4.4).
L- istorja medika tal- pazjent għal reazzjonijiet ta ’ sensitività eċċessiva għandha tiġi evalwata sew qabel ma tibda il - proċedura fil- vitriju (ara sezzjoni 4. 4).
The periocular skin, eyelid and ocular surface should be disinfected and adequate anaesthesia and a broad-spectrum topical microbicide should be administered prior to the injection.
Il- ġilda mad- dawra ta ’ l- għajn, tebqet il- għajn u s- superfiċje ta ’ l- għajn għandhom jiġu diżinfettati u anesteżija xierqa flimkien ma ’ mikrobiċida topiku bi spektrum wiesa ’ għandhom jingħataw qabel l- injezzjoni.
For information on preparation of Lucentis, see section 6.6.
2 Għal informazzjoni dwar il- preparazzjoni ta ’ Lucentis, ara sezzjoni 6. 6.
2 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 ta ’ 0. 05 ml imbagħad għandu jingħata; sit sklerali differenti għandu jintuża għall- injezzjonijiet ta ’ wara.
Additional information on special populations
Tagħrif ieħor dwar popolazzjonijiet speċjali
Hepatic impairment Lucentis has not been studied in patients with hepatic impairment.
Indeboliment tal- fwied Lucentis ma ġiex studjat f’ pazjenti b’ indeboliment tal- fwied.
However, no special considerations are needed in this population.
Madankollu, m’ hemmx li jitqiesu affarjiet speċjali f’ din il- popolazzjoni.
Renal impairment Dose adjustment is not needed in patients with renal impairment (see section 5.2).
Indeboliment renali M’ hemmx bżonn li tinbidel d- doża f’ pazjenti b’ indeboliment renali (ara sezzjoni 5. 2).
Children and adolescents Lucentis is not recommended for use in children and adolescents due to a lack of data on safety and efficacy in these sub-populations.
Tfal u adolexxenti Lucentuis mhux irrakkomandat għall- użu fit- tfal u adolexxenti peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja f’ dawn is- sotto- popolazzjonijiet.
Elderly No dose adjustment is required in the elderly.
Anzjani M’ hemmx bżonn ta ’ tibdil fid- doża għall- anzjani.
Ethnicity Experience with treatment is limited in groups other than Caucasians.
Razza L- esperjenza tal- kura hija limitata fi gruppi ta ’ nies minbarra Kawkażi.
Patients with active or suspected ocular or periocular infections.
Pazjenti li għandhom jew hemm suspett li jista ’ jkollhom infezzjonijiet attivi fl- għajn jew madwar l - għajn.
Patients with active severe intraocular inflammation.
Pazjenti li jkollhom infjammazzjoni fl- għajn attiva u severa.
Treatment with Lucentis is for intravitreal injection only.
Kura b’ Lucentis hija għall- injezzjoni fil- vitriju biss.
Intravitreous injections, including those with Lucentis, have been associated with endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract (see section 4.8).
Injezzjonijiet fil- vitriju, inklużi dawk b’ Lucentis, kienu assoċjati ma ’ endoftalmite, infjammazzjoni fl - għajn, qlugħ tar- retina regmatoġenuż, tiċrit tar- retina u katarretti trawmatiċi jatroġeniċi (ara sezzjoni 4. 8).
Proper aseptic injection techniques must always be used when administering Lucentis.
Teknika ta ’ injezzjoni asettika xierqa għandha dejjem tintuża meta jkun qed jingħata Lucentis.
In addition, patients should be monitored during the week following the injection to permit early treatment if an infection occurs.
Minbarra hekk, il- pazjenti għandhom jinżammu taħt osservazzjoni fil- ġimgħa ta ’ wara l- injezzjoni sabiex tkun tista ’ tibda kura kmieni jekk ikun hemm infezzjoni.
Patients should be instructed to report any symptoms suggestive of endophthalmitis or any of the above mentioned events without delay.
Il- pazjenti għandhom jingħataw instruzzjonijiet sabiex jirrappurtaw kwalunkwe sintomi li jistgħu jindikaw li hemm endoftalmite jew kwalunkwe minn dawn l- effetti imsemmija hawn fuq immedjatament.
Increases in intraocular pressure have been seen within 60 minutes of injection of Lucentis (see section 4.8).
Żiediet fil- pressjoni ta ’ ġo l- għajn dehru fi żmien 60 minuta minn meta tkun ingħatat injezzjoni b’ Lucentis (ara sezzjoni 4. 8).
Both intraocular pressure and the perfusion of the optic nerve head must therefore be monitored and managed appropriately.
Kemm il- pressjoni ta ’ ġo l- għajn kif ukoll il- perfużjoni tan- nerv ottiku għandhom għalhekk ikunu monitorjati u maniġġjati kif xieraq.
The safety and efficacy of Lucentis therapy administered to both eyes concurrently have not been studied.
Is- sigurtà u l- effikaċja tat- terapija b’ Lucentis meta tingħata fiż- żewġ għajnejn f’ daqqa ma ġietx studjata.
If bilateral treatment is performed at the same time this could lead to an increased systemic exposure, which could increase the risk of systemic adverse events.
Jekk il- kura tingħata b’ mod bilaterali f’ daqqa dan jista ’ jwassal għal żieda fl- esponiment sistemiku, li jista ’ jżid ir- riskju ta ’ effetti avversi sistemiċi.
As with all therapeutic proteins, there is a potential for immunogenicity with Lucentis.
3 Bħall- proteini terapewtiċi kollha, hemm potenzjal ta ’ immunoġenetiċità b’ Lucentis.
Patients should be instructed to report if an intraocular inflammation increases in severity, which may be a clinical sign attributable to intraocular antibody formation.
Il- pazjenti għandhomjingħataw istruzzjonijiet biex jirrapurtaw jekk l- infjammazzjoni fl- għajn iżżid fis- severità, li jista ’ jkun sinjal kliniku li qed jiffurmaw antikorpi fl- għajn.
Lucentis has not been studied in patients who have previously received intravitreal injections.
Lucentis ma ġiex studjat f’ pazjenti li kienu ingħataw qabel injezzjonijiet fil- vitriju.
3 Lucentis should not be administered concurrently with other anti-VEGF agents (systemic or ocular).
Lucentis m’ għandux jingħata fl- istess ħin ma ’ aġenti oħra kontra l- VEGF (sistemiku jew okulari).
The dose should be withheld and treatment should not be resumed earlier than the next scheduled treatment in the event of: a decrease in best-corrected visual acuity (BCVA) of ≥ 30 letters compared with the last assessment of visual acuity; an intraocular pressure of ≥ 30 mmHg; a retinal break; a subretinal haemorrhage involving the centre of the fovea, or, if the size of the haemorrhage is ≥ 50%, of the total lesion area; performed or planned intraocular surgery within the previous or next 28 days.
Id- doża għandha titwaqqaf u l- kura m’ għandhiex terġa tingħata qabel ma jkun wasal iż- żmien tal- kura hekk kif kien skedat fil- każ li: jkun hemm tnaqqis fl- akutezza tal- vista bl- aħjar mod li tista ’ tkun korretta (BCVA) ta ’ ≥30 ittra imqabbel ma ’ l- aħħar evalwazzjoni ta ’ akutezza tal- vista; il- pressjoni ta ’ ġo l- għajn ≥30 mmHg; jkun hemm ksur tar- retina; jkun hemm emorraġġija taħt ir- retina li tinvolvi ic- ċentru tal- foveja, jew, jekk id- daqs ta ’ l - emorraġġija jkun ≥50% ta ’ l- erja tal- ferita kollha; tkun saret jew hemm pjanat li ssir operazzjoni fl- għajn fit- 28 jum li għaddew jew li ġejjin.
Treatment should be discontinued in subjects with rhegmatogenous retinal detachment or stage 3 or 4 macular holes.
Il- kura għandha titwaqqaf f’ dawk l- individwi li jkollhom qlugħ tar- retina regmatoġenuż jew toqob fil - makula ta ’ stadju 3 jew 4.
No formal interaction studies have been performed.
Ma sarux studji formali ta ’ interazzjoni.
For the adjunctive use of verteporfin photodynamic therapy (PDT) and Lucentis, see section 5.1.
Għall- użu ta ’ terapija fotodinamika b’ verteporfin (PDT) flimkien ma ’ Lucentis, ara sezzjoni 5. 1.
Pregnancy There are no data from the use of ranibizumab in pregnant women.
Tqala M’ hemmx tgħarif dwar l- użu ta ’ ranibizumab waqt it- tqala.
There are no animal studies.
M’ hemmx studji fuq annimali.
The systemic exposure to ranibizumab is expected to be very low after ocular administration, but due to its mechanism of action, ranibizumab must be regarded as potentially teratogenic and embryo-/ foetotoxic.
L - esponiment sistemiku għal ranibizumab huwa mistenni li jkun baxx ħafna wara li jingħata fl- għajn, iżda minħabba l- mekkaniżmu ta ’ kif jaħdem, ranibizumab għandu jitqies bħala teratoġeniku u tossiku għall- embriju/ fetu.
Therefore, ranibizumab should not be used during pregnancy unless the expected benefit outweighs the potential risk to the foetus.
Għaldaqstant ranibizumab m’ għandux jintuża waqt it- tqala ħlief meta l- benefiċċju ma jkunx jgħeleb ir- riskju għal fetu.
Women of childbearing potential Women of childbearing potential should use effective contraception during treatment.
Nisa li jista ’ jkollhom it- tfal Nisa li jista ’ jkollhom it- tfal għandhom jużaw sistema ta ’ kontraċezzjoni effettiva waqt il- kura.
Lactation It is not known whether Lucentis is excreted in human milk.
Treddigħ Mhux magħruf jekk Lucentis joħroġx fil- ħalib tal- mara.
Breast-feeding is not recommended during the use of Lucentis.
It- treddigħ mhux rakkomandat waqt li jkun qed jintuża Lucentis.
The Lucentis treatment procedure may induce temporary visual disturbances, which may affect the ability to drive or use machines (see section 4.8).
Il- proċedura tal- kura b’ Lucentis tista ’ tikkawża disturbi tal- mument fil- vista, li jistgħu jeffettwaw il - ħila biex issuq jew tħaddem magni (ara sezzjoni 4. 8).
Patients who experience these signs must not drive or use machines until these temporary visual disturbances subside.
Pazjenti li jkollhom dawn is- sinjali m’ għandhomx isuqu jew iħaddmu magni sakemm jgħaddu dawn id- disturbi.
A total of 1,315 patients constituted the safety population in the three phase III studies with 24 months exposure to Lucentis and 440 patients were treated with the recommended dose of 0.5 mg.
Total ta ’ 1, 315- il pazjent ikkostitwew il- popolazzjoni ta ’ sigurtà fi tliet studji ta ’ fażi III b’ 24 xahar ta ’ esponiment għal Lucentis u 440 pazjent kienu kkurati bid- doża rakkomandata ta ’ 0. 5 mg.
Serious adverse events related to the injection procedure included endophthalmitis, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract (see section 4.4).
Effetti avversi serji relatati mal- proċedura ta ’ l- injezzjoni kienu jinkludu endoftalmite, qlugħ tar- retina regmatoġenuż, tiċrit tar- retina u katarretti trawmatiċi jatroġeniċi (ara sezzjoni 4. 4).