INTRODUCTION

MONOVISC INJECTION contains Sodium Hyaluronate which belongs to the group of medicines called Musculo-skeletal agents. It is used to treat pain in osteoarthritis of the knee. Osteoarthritis is a type of arthritis that occurs when flexible tissue at the ends of bones wears down.

MONOVISC INJECTION is not recommended for use in patients with infection of the knee joint, infection and diseases of the skin at the injection site and systemic bleeding disorders. Before receiving MONOVISC INJECTION, inform your doctor if you have severe inflammation of the knee, lymphatic or venous stasis (in the leg to be injected) and chondrocalcinosis (mineralization of hyaline cartilage).

If you are pregnant, planning to get pregnant or breast-feeding women, consult your doctor for advice before receiving MONOVISC INJECTION.

It should be used with caution in elderly patients. Consult your doctor before receiving MONOVISC INJECTION.

The most common side effects of MONOVISC INJECTION are joint pain or inflammation, injection site pain and joint effusion. Consult your doctor if any of the side effects worsen.

USES OF MONOVISC INJECTION

• Treats pain in osteoarthritis of the knee

HOW MONOVISC INJECTION WORKS

MONOVISC INJECTION supports tendon and bone regeneration by improving oxygen and nutrient supply to the joints. In osteoarthritis, the joints lack nutrition and become inflamed. MONOVISC INJECTION contains hyaluronic acid that acts as a nutritional supplement and helps to reduce inflammation and degradation of joints.

DIRECTIONS FOR USE

MONOVISC INJECTION is administered by a doctor or a nurse directly into the knee joint. Your doctor will decide the correct dose, duration of MONOVISC INJECTION for you depending upon your age and disease condition.

SIDE EFFECTS OF MONOVISC INJECTION

HOW TO MANAGE SIDE EFFECTS

Headache:

Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the forehead if required. Inform your doctor if the symptom does not improve.

Skin rash:

Do not scratch the affected area. Wear protective clothing while going outdoors. Regularly moisturize your skin. Inform your doctor if the symptoms worsen.

Dizziness:

Lie down until dizziness passes away and then move slowly and carefully. Take plenty amount of rest and drink plenty of fluids. Consult your doctor if the symptoms worsen.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug Interactions:

Before receiving MONOVISC INJECTION, inform your doctor if you are using any of the following medicines:

• skin disinfectants containing quaternary ammonium salts and compounds
• chlorhexidine (skin preparation agents)

Overdosage:

MONOVISC INJECTION will be administered to you only by a doctor or a nurse in a hospital and so it is unlikely to receive an overdose. However, consult your doctor or nurse if you experience any unusual symptoms after receiving MONOVISC INJECTION.

SYNOPSIS

MORE INFORMATION

• Store at room temperature

FAQs ABOUT MONOVISC INJECTION

What is MONOVISC INJECTION used for?

MONOVISC INJECTION contains Sodium Hyaluronate, which is used in the treatment of pain in osteoarthritis of the knee. Osteoarthritis is wearing down of the protective tissue at the ends of bones (cartilage), occurs gradually and worsens over time. Joint pain in the hands, neck, lower back, knees or hips is the most common symptom.

For how long should I receive MONOVISC INJECTION?

Your doctor might advise you on how long you should continue to receive MONOVISC INJECTION. You will need to consult your doctor from time to time to review your treatment and assess your symptoms.

How does MONOVISC INJECTION work?

MONOVISC INJECTION supports tendon and bone regeneration by improving oxygen and nutrient supply to the joints. In osteoarthritis, the joints lack nutrition and become inflamed. MONOVISC INJECTION contains hyaluronic acid that acts as a nutritional supplement and helps to reduce inflammation and degradation of joints.

What are the common side effects of MONOVISC INJECTION?

The most common side effects of receiving MONOVISC INJECTION are joint pain or inflammation, injection site pain, joint effusion and joints disease (arthropathy). Consult your doctor if any of the side effects worsen.

How is MONOVISC INJECTION administered?

MONOVISC INJECTION is administered by a doctor or a nurse directly into the knee joint. Your doctor will decide the correct dose, duration of MONOVISC INJECTION for you depending upon your age and disease condition.

REFERENCES

1. KD. Tripathi. Section 3, Antirheumatic and Antigout Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page –210 -218.

2. Huang TL, Chang CC, Lee CH, Chen SC, Lai CH, Tsai CL. Intra-articular injections of sodium hyaluronate (Hyalgan) in osteoarthritis of the knee. a randomized, controlled, double-blind, multicenter trial in the Asian population. NIH. National Library of Medicine, National center for biotechnology information. October 2011. [Accessed on 20th September 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3203101/

3. Guarda-Nardini, L., Masiero, S. and Marioni, G., 2005. Conservative treatment of temporomandibular joint osteoarthrosis: intra-articular injection of sodium hyaluronate. Journal of Oral Rehabilitation. September 2005. [Accessed on 20th September 2022] https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1365-2842.2005.01505.x

4. Genzyme Biosurgery. Synvisc One. [Revised in September 2014] [Accessed on 20th September 2022] https://products.sanofi.us/synviscone/synviscone.pdf

5. Fidia Farmaceutici S.p.A. Hyalgan. Health Products Regulatory Authority (HPRA). [Revised in December 2009] [Accessed on 20th September 2022] https://www.hpra.ie/img/uploaded/swedocuments/LicenseSPC_PA0814-001-001_05042016103037.pdf

6. Hanmi Pharm Co. Ltd. Synojoynt. U.S. Food & Drug Administration. [Accessed on 20th September 2022] https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170016D.pdf

7. Anika Therapeutics, Inc. Monovisc. [Accessed on 20th September 2022] http://synthes.vo.llnwd.net/o16/LLNWMB8/IFUs/US/Monovisc-US-IFU_Word.pdf