Table of Contents
1. Name of the medicinal product
2. Qualitative and quantitative composition
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. Pharmacological properties
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
Legal category

1. Name of the medicinal product
 ▼Lucentis 10 mg/ml solution for injection
2. Qualitative and quantitative composition
 One ml contains 10 mg ranibizumab*. Each vial contains 2.3 mg of ranibizumab in 0.23 ml solution.
*Ranibizumab is a humanised monoclonal antibody fragment produced in Escherichia coli cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Clear, colourless to pale yellow aqueous solution.
4. Clinical particulars
4.1 Therapeutic indications
 Lucentis is indicated in adults for:
• The treatment of neovascular (wet) age-related macular degeneration (AMD)
• The treatment of visual impairment due to diabetic macular oedema (DME)
• The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)
• The treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM)
4.2 Posology and method of administration
 Lucentis must be administered by a qualified ophthalmologist experienced in intravitreal injections.
Posology for the treatment of wet AMD
The recommended dose for Lucentis is 0.5 mg given monthly as a single intravitreal injection. This corresponds to an injection volume of 0.05 ml.
Treatment is given monthly and continued until maximum visual acuity is achieved i.e. the patient`s visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment.
Thereafter patients should be monitored monthly for visual acuity.
Treatment is resumed when monitoring indicates loss of visual acuity due to wet AMD. 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.
Posology for the treatment of visual impairment due to either DME or macular oedema secondary to RVO
The recommended dose for Lucentis is 0.5 mg given monthly as a single intravitreal injection. This corresponds to an injection volume of 0.05 ml.
Treatment is given monthly and continued until maximum visual acuity is achieved i.e the patient's visual acuity is s