Active Ingredient: Ranibizumab
Ranibizumab is indicated in preterm infants for the treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 3+) or AP-ROP (aggressive posterior ROP) disease.
For this indication, competent medicine agencies globally authorize below treatments:
Intravitreal
0.2 - 0.2 mg
From 0.2 To 0.2 mg once every 60 day(s)
The recommended dose for ranibizumab in preterm infants is 0.2 mg given as an intravitreal injection. This corresponds to an injection volume of 0.02 ml. In preterm infants treatment of ROP is initiated with a single injection per eye and may be given bilaterally on the same day. In total, up to three injections per eye may be administered within six months of treatment initiation if there are signs of disease activity. Most patients (78%) in the clinical study received one injection per eye. The administration of more than three injections per eye has not been studied. The interval between two doses injected into the same eye should be at least four weeks.
In adults 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. The injection volume of 0.05 ml is then delivered; a different scleral site should be used for subsequent injections.
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