Lucentis solution for injections 10 mg/ml. 0.23 ml. vial (1 needle)

Description

Lucentis composition
active substance: ranibizumab;
1 ml of solution contains 10 mg of ranibizumab;
excipients: α, α-trehalose dihydrate; L-histidine hydrochloride, monohydrate; L-histidine; polysorbate 20; water for injections.

Dosage form
Solution for injection.

Pharmacological properties
Ranibizumab is a fragment of a recombinant humanized monoclonal antibody against human vascular endothelial growth factor A (VEGF-A). It has a high affinity for VEGF-A isoforms (eg VEGF110, VEGF121 and VEGF165) and thus prevents VEGF-A from attaching to its VEGFR-1 and VEGFR-2 receptors. Attachment of VEGF-A to its receptors leads to endothelial cell proliferation and neovascularization, as well as vascular permeability, which is thought to contribute to the development of neovascular form of age-related macular degeneration (AMD), pathological myopia and choroidal neovascularization (CHD). macular edema or macular edema due to retinal vein thrombosis.

Indication:

• treatment of neovascular (exudative) age-related macular degeneration (AMD);
• treatment of visual impairment in diabetic macular edema (DMN);
• treatment of visual impairment in macular edema caused by retinal vein thrombosis (thrombosis of the central retinal vein or thrombosis of the branches of the central retinal vein);
• treatment of visual impairment due to choroidal neovascularization (CRV), secondary to pathological myopia (PM).

Contraindication:

• hypersensitivity to the active substance or any other ingredient of the drug;
• active / suspected ocular or periocular infectious process;
• active severe intraocular inflammatory process.

Children
The safety and efficacy of ranibizumab in children and adolescents (under 18 years of age) have not been established, therefore the drug is not used in this group of patients.

Use during pregnancy or breastfeeding
Ranibizumab has not been studied during pregnancy, so ranibizumab should not be used during pregnancy unless the potential benefit outweighs the risk to the fetus.

Method of application and dosage
Lucentis should only be administered by a qualified ophthalmologist with experience in intravitreal injections.
The recommended dose of Lucentis is 0.5 mg as a single intravitreal injection. This dose corresponds to an injection volume of 0.05 ml. The interval between injections of two doses in one eye should be at least 4 weeks.
Treatment should be started with one injection per month and continued until maximum visual acuity is reached and / or signs of disease activity, ie changes in visual acuity and other symptoms, disappear. Patients with exudative AMD, DMN, and retinal vein thrombosis may initially require three or more monthly injections in a row.
Thus, the regularity of monitoring and the intervals between administrations of the drug should be determined by the physician depending on the activity of the disease, which is assessed on the basis of visual acuity and / or anatomical parameters.
If, in the opinion of the physician, visual acuity or anatomical parameters indicate no benefit from continuing treatment for the patient, Lucentis should be discontinued.
Monitoring of disease activity may include clinical examination, functional testing, or imaging techniques (eg, optical coherence tomography or fluorescent angiography).

Overdose
Accidental overdose has been reported in clinical trials of exudative AMD and post-marketing studies. The most common side effects associated with overdose are increased intraocular pressure, transient blindness, decreased visual acuity, corneal edema, corneal pain, and eye pain. In case of overdose, the intraocular pressure should be checked and appropriate treatment should be given if the doctor deems it necessary.

Adverse reactions:

• Infections and invasions: rhinopharyngitis;
• From the blood and lymphatic system: anemia;
• From the immune system: hypersensitivity;
• Mental disorders: anxiety;
• From the nervous system: headache;
• On the part of the visual organs: vitreous inflammation, vitreous detachment, retinal hemorrhage, visual disturbances, eye pain, floating vitreous opacity, conjunctival hemorrhage, eye irritation, foreign body sensation in the eye, increased tearing, blepharitis, dry eyes, redness of the eyes, itching in the eye;
• From the respiratory system, chest and mediastinum: cough;
• From the gastrointestinal tract: nausea;
• From the skin and subcutaneous tissues: allergic reactions (rash, urticaria, itching, erythema);
• From the musculoskeletal system and connective tissue: arthralgia;
• Surveys: increase in intraocular pressure.

Expiration date
3 years.

Storage conditions
Store Lucentis in a refrigerator (2 to 8 ° C). Do not freeze.
Store in the original package and out of reach of children.