Registered Rwanda · Rwanda FDA

BioUcenta

Ranibizumab

RWANDA-FDA25/HM/0400/0023 Solution for Injection 10mg/ml INN generic

What it does

Ranibizumab is a medicine used to treat specific eye conditions that affect vision.

Commonly used for: age-related macular degeneration, diabetic macular edema, retinal vein occlusion

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

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Sourcing - Kenya only

Registration & product details

Registration no.
RWANDA-FDA25/HM/0400/0023
Registration date
16/10/2025
Expiry date
15/10/2030
Status
Registered
Active ingredient
Ranibizumab
Strength
10mg/ml
Pack size
one vial of 0.23 ml sterile solution
Therapeutic class
-
Manufacturer / MAH
Polpharma Biologics
Country of origin
Poland
Manufacturer location
Spółdzielcza 4, 05-850 Duchnice, Poland

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:02 · updated 2026-09-17 02:30:42

Drug Interactions

5
Check interactions

Unknown (5)

Argatroban - increases risk of bleeding events

Ranibizumab is predicted to increase the risk of bleeding events when given with thrombin inhibitors (argatroban).

Unknown Theoretical

Bivalirudin - increases risk of bleeding events

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Unknown Theoretical

Danaparoid - increases risk of bleeding events

Ranibizumab is predicted to increase the risk of bleeding events when given with danaparoid. Dantrolene → see TABLE 1 p. 1517 (hepatotoxicity)

Unknown Theoretical

Phenindione - increases risk of bleeding events

Ranibizumab is predicted to increase the risk of bleeding events when given with phenindione.

Unknown Theoretical

Thrombin Inhibitors - increases risk of bleeding events

Ranibizumab is predicted to increase the risk of bleeding events when given with thrombin inhibitors (argatroban).

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About this medicine

Ranibizumab is a medicine used to treat specific eye conditions that affect vision.

What it treats

  • age-related macular degeneration
  • diabetic macular edema
  • retinal vein occlusion

How it works

It works by blocking a protein that causes abnormal blood vessel growth in the eye, helping to preserve vision.

Who it's for

This medicine is for adults with certain eye diseases that can lead to vision loss.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Ranibizumab

BNF-referenced

Ranibizumab is a monoclonal antibody fragment that inhibits vascular endothelial growth factor (VEGF), a key mediator in angiogenesis, promoting abnormal blood vessel growth in the eye. It is primarily used to treat neovascular (wet) age-related macular degeneration and diabetic macular edema, conditions that can lead to vision loss due to retinal damage.

Indications

  • Neovascular (wet) age-related macular degeneration
  • Diabetic macular edema

Dosage

Children: Dosage information for pediatric patients is not established; refer to the BNF for Children for specific guidelines.

Adults: The recommended dose for adults is usually 0.5 mg (0.05 ml) administered as an intravitreal injection, with treatment intervals typically every month or as directed by a specialist based on the patient's response.

Mechanism of action

Ranibizumab binds to and inhibits the activity of VEGF-A, preventing it from interacting with its receptors on the surface of endothelial cells. This action reduces vascular permeability and neovascularization, stabilizing the retinal tissue and improving visual function.

Pharmacodynamics

The pharmacodynamic effects of ranibizumab include the reduction of fluid leakage from retinal vessels and the regression of newly formed blood vessels, which improves the visual acuity in patients with retinal disorders. The effects are generally seen within a few weeks of administration.

Pharmacokinetics

Ranibizumab is administered via intravitreal injection, leading to localized concentrations in the eye. Systemic absorption is minimal due to the large molecular weight of the drug. It has a half-life of approximately 9 days in the vitreous humor. Clearance is primarily via retinal and choroidal mechanisms.

Contra-indications

  • Intra-ocular inflammation (active)
  • Ocular or periocular infection
  • Previous retinal detachment or macular hole with visual impairment due to diabetic macular oedema

Adverse effects

  • Endophthalmitis
  • Intra-ocular pressure increase
  • Retinal detachment
  • Vitreous hemorrhage
  • Cataract formation

Interactions

  • Danaparoid: Unknown (increases risk of bleeding events)
  • Phenindione: Unknown (increases risk of bleeding events)
  • Thrombin inhibitors: Unknown (increases risk of bleeding events)
  • Argatroban: Unknown (increases risk of bleeding events)
  • Bivalirudin: Unknown (increases risk of bleeding events)

Precautions

  • Monitor intra-ocular pressure and perfusion of the optic nerve head following injection
  • Counsel patients or their carers to report symptoms suggestive of endophthalmitis, retinal detachment or intra-ocular inflammation
  • Use with caution in patients with a history of ocular or periocular infections

Pregnancy

Avoid unless potential benefit outweighs risk-systemic exposure very low; limited information available.

Breast-feeding

Specialist sources indicate use with caution-no information available. Large molecular weight suggests limited excretion into milk and likely partial destruction in the infant’s gastrointestinal tract.

Storage

Store in a refrigerator (2–8°C). May be stored unopened at room temperature (20–25°C) for up to 24 hours before use; protect from light.

Formulations

  • Solution for injection (pre-filled disposable injection)
BNF 85 (British National Formulary) p.1326 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.