table for three consecutive monthly assessments performed while on ranibizumab treatment. If there is no improvement in visual acuity over the course of the first three injections, continued treatment is not recommended.
Thereafter patients should be monitored monthly for visual acuity.
Treatment is resumed when monitoring indicates loss of visual acuity due to DME or to macular oedema secondary to RVO. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than one month.
Lucentis and laser photocoagulation in DME and in macular oedema secondary to BRVO
There is some experience of Lucentis administered concomitantly with laser photocoagulation (see section 5.1). When given on the same day, Lucentis should be administered at least 30 minutes after laser photocoagulation. Lucentis can be administered in patients who have received previous laser photocoagulation.
Posology for the treatment of visual impairment due to CNV secondary to PM
Treatment is initiated with a single injection.
If monitoring reveals signs of disease activity, e.g. reduced visual acuity and/or signs of lesion activity, further treatment is recommended.
Monitoring for disease activity may include clinical examination, optical coherence tomography (OCT) or fluorescein angiography (FA).
While many patients may only need one or two injections during the first year, some patients may need more frequent treatment (see section 5.1). Therefore, monitoring is recommended monthly for the first two months and at least every three months thereafter during the first year. After the first year, the frequency of monitoring should be determined by the treating physician.
The interval between two doses should not be shorter than one month.
Lucentis and Visudyne photodynamic therapy in CNV secondary to PM
There is no experience of concomitant administration of Lucentis and Visudyne.
Special populations
Hepatic impairment
Lucentis has not been studied in patients with hepatic impairment. However, no special considerations are needed in this population.
Renal impairment
Dose adjustment is not needed in patients with renal impairment (see section 5.2).
Elderly
No dose adjustment is required in the elderly. There is limited experience in patients older than 75 years with DME.
Paediatric population
The safety and efficacy of Lucentis in children and adolescents below 18 years of age have not been established. No data are available.
Method of administration
Single-use vial for intravitreal use only.
Lucentis should be inspected visually for particulate matter and discoloration prior to administration.
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). The patient's medical history for hypersensitivity reactions should be carefully eva luated prior to performing the intravitreal procedure (see section 4.4). Adequate anaesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection, in accordance with local practice.
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