Registered Rwanda · Rwanda FDA

POLYFRESH EXTRA SDU OPHTHALMIC SOLUTION

Sodium Hyaluronate 1mg/ml/, Carboxymethylcellulose sodium 5mg/ml

Rwanda FDA-HMP-MA- 0965 Eye Drops 1mg/ml/, 5mg/ml dermatologicals INN generic

What it does

Carboxymethylcellulose is a substance used to relieve dryness in the eyes and mouth.

Commonly used for: dry eyes (keratoconjunctivitis sicca), dry mouth (xerostomia)

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

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Registration & product details

Registration no.
Rwanda FDA-HMP-MA- 0965
Registration date
26/02/2024
Expiry date
25/02/2029
Status
Registered
Active ingredient
Sodium Hyaluronate 1mg/ml/, Carboxymethylcellulose sodium 5mg/ml
Dosage form
Eye Drops
Strength
1mg/ml/, 5mg/ml
Pack size
30 units Bottles conatining 0.4ml solution
Therapeutic class
-
ATC class (WHO)
D03AX - Other cicatrizants
Drug group
DERMATOLOGICALS
RxNorm RxCUI
62372
Country of origin
EGYPT
Manufacturer location
Street 110, Obour, Dakahlia Governorate 35511, Egypt

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:20 · updated 2026-09-21 02:30:20

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

About carboxymethylcellulose

Carboxymethylcellulose is a substance used to relieve dryness in the eyes and mouth.

What it treats

  • dry eyes (keratoconjunctivitis sicca)
  • dry mouth (xerostomia)

How it works

It works by forming a protective layer on the surface of the eyes or mouth, helping to retain moisture.

Who it's for

It is suitable for people experiencing dryness in their eyes or mouth due to various reasons, including certain medical conditions, medications, or environmental factors.

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

About hyaluronate

Hyaluronate is a substance that helps to keep tissues in the body hydrated and lubricated.

What it treats

  • joint pain
  • osteoarthritis
  • eye conditions (like dry eyes)

How it works

Hyaluronate acts by attracting water, which helps to cushion and lubricate joints and tissues.

Who it's for

It is used for people with joint pain or certain eye conditions, particularly in older adults.

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

Clinical monograph: carboxymethylcellulose

Carboxymethylcellulose (CMC) is a cellulose derivative used primarily as a thickening agent, stabilizer, and emulsifier in various pharmaceutical and food formulations. It is an anionic, water-soluble polymer that enhances the viscosity of solutions and suspensions. CMC is also utilized as a lubricant in dry eye treatments and has applications in the formulation of tablets and other dosage forms.

Indications

  • Dry eye syndrome
  • Ocular lubrication
  • Thickening agent in pharmaceutical formulations
  • Food industry as a stabilizer and emulsifier

Dosage

Children: For paediatric use, refer to specific product guidelines and consult a healthcare professional for appropriate advice.

Adults: For dry eye treatment, apply as needed, typically 1 drop in each affected eye. Refer to specific product guidelines for exact formulation and frequency.

Mechanism of action

Carboxymethylcellulose works by forming a gel-like structure when it interacts with water, which helps retain moisture and provide lubrication. In ophthalmic applications, it acts as a protective agent for the ocular surface, reducing friction and providing comfort to patients with dry eye conditions.

Pharmacodynamics

The pharmacodynamic properties of carboxymethylcellulose are primarily related to its ability to increase viscosity and improve the stability of formulations. It does not undergo significant systemic absorption and exerts its effects locally, particularly in the gastrointestinal tract and on the ocular surface as a lubricant.

Pharmacokinetics

Carboxymethylcellulose is not absorbed significantly through the gastrointestinal tract when ingested, and its systemic bioavailability is negligible. When used in ophthalmic formulations, it acts locally on the eye without significant systemic effects. The elimination pathway is primarily through natural degradation and excretion of unabsorbed material.

Adverse effects

  • Allergic reactions
  • Skin irritation
  • Gastrointestinal discomfort

Precautions

  • Use with caution in patients with known hypersensitivity to cellulose derivatives
  • Monitor for allergic reactions

Pregnancy

Carboxymethylcellulose is generally considered safe during pregnancy as it is not absorbed systemically.

Breast-feeding

Carboxymethylcellulose is considered safe during breastfeeding as it is not absorbed systemically.

Storage

Store in a cool, dry place away from direct sunlight.

Formulations

  • Eye drops
  • Oral suspensions
  • Topical gels

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

Clinical monograph: hyaluronate

Hyaluronate, also known as hyaluronic acid, is a naturally occurring glycosaminoglycan (GAG) that is a crucial component of connective tissues. It is widely used in various medical fields, including orthopedics, dermatology, and ophthalmology, due to its ability to retain water and provide lubrication. In joint health, hyaluronate is utilized as a viscosupplement to relieve pain in osteoarthritis, particularly in the knee. It is also employed in ocular surgeries and for the treatment of dry eyes.

Indications

  • Osteoarthritis of the knee
  • Viscosupplementation for joint pain
  • Dry eye syndrome
  • Ocular surgeries (e.g., cataract surgery)
  • Wound healing

Dosage

Adults: Refer to specific guidelines or literature for adult dosing recommendations, as they can vary based on

Mechanism of action

Hyaluronate acts by increasing the viscosity and elasticity of synovial fluid in joints, leading to improved lubrication and shock absorption. It binds to water molecules, thus enhancing the hydration of tissues. In the context of osteoarthritis, it helps to restore the normal viscoelastic properties of the joint fluid, which can help alleviate pain and improve joint function. In ocular applications, it serves to lubricate the surface of the eye, aiding in the comfort and healing of the cornea.

Pharmacodynamics

Hyaluronate's pharmacodynamic effects are primarily related to its hydrophilic nature and its ability to form a gel-like consistency when mixed with water. This property allows it to provide mechanical support and cushioning in joints, reducing friction and wear in the articular cartilage. It also plays a role in cell signaling and tissue hydration, influencing cell proliferation and migration in wound healing.

Pharmacokinetics

Hyaluronate is administered via injection or topical application, depending on the indication. After injection into the joint space, it can remain for several weeks, but its half-life is influenced by factors such as the degree of synovial fluid viscosity and the presence of inflammation. Systemic absorption is minimal, and it is primarily metabolized by hyaluronidase enzymes found in various tissues, leading to fragmentation and clearance from the body. In ocular formulations, its retention time on the eye surface can vary based on the formulation and the presence of preservatives.

Contra-indications

  • Hypersensitivity to hyaluronate or any component of the formulation
  • Infection at the injection site
  • Active skin diseases

Adverse effects

  • Injection site reactions (pain, swelling, redness)
  • Allergic reactions
  • Joint effusion
  • Increased joint pain
  • Headache

Precautions

  • Use with caution in patients with bleeding disorders
  • Careful consideration in patients with a history of allergic reactions
  • Not recommended for intra-articular injection in patients with active infections

Pregnancy

Safety in pregnancy has not been established. Use only if clearly needed and the potential benefits justify the risks.

Breast-feeding

It is not known if hyaluronate is excreted in human milk. Use with caution and only if clearly needed.

Storage

Store at 2-25 degrees Celsius. Protect from light. Do not freeze.

Formulations

  • Sodium hyaluronate injection
  • Hyaluronic acid gel

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.