Summary of Cingal® Instructions for use
NAME
Cingal, cross-linked hyaluronic acid with ancillary triamcinolone hexacetonide
APPLICATION
Cingal cross-linked hyaluronic acid with ancillary triamcinolone hexacetonide is a single, intra-articular injection into the synovial cavity of a human knee joint to relieve the symptoms of osteoarthritis.
INDICATIONS
Cingal is CE mark indicated as a viscoelastic supplement or a replacement for synovial fluid in human knee joints. Cingal is well suited for rapid and long term relief of the symptoms of human knee joint dysfunctions such as osteoarthritis. The actions of Cingal are long term relief of symptoms by lubrication and mechanical support supplemented by short-term pain relief provided by triamcinolone hexacetonide.
In Canada, Cingal is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g. acetaminophen). Cingal includes an ancillary steroid to provide additional short term pain relief.
INSTRUCTIONS FOR USE
Cingal is injected through a sterile, disposable, hypodermic needle of suitable gauge into the knee joint space. The sterile needle should be attached to the Cingal syringe by a health care professional using health care facility approved aseptic technique. Recommended needle size for injections into the knee is 18-21 gauge. The final needle selection for any procedure is determined by the physician. The health care provider should ensure proper penetration into knee joint synovial space prior to injecting Cingal.
CONTRAINDICATIONS
Cingal is composed of cross-linked hyaluronic acid, triamcinolone hexacetonide and inactive ingredients. The following pre-existing conditions may constitute relative or absolute contraindications to the use of Cingal:
- Hypersensitivity to the active substance or to any of the excipients contained in Cingal
- Pre-existing infections of the skin region of the intended injection site
- Known infection of the index joint
- Known systemic bleeding disorders
- Weak populations including children and pregnant or lactating women
The ancillary medicinal substance, triamcinolone hexacetonide, is contraindicated in the case of:
- Active tuberculosis
- Herpes simplex keratitis
- Acute psychoses
- Systemic mycoses and parasitoses (strongyloid infections)
FERTILITY, PREGNANCY AND LACTATION
The safety of Cingal in pregnant and lactating women has not been established.
UNDESIRABLE EFFECTS
Effects associated with Hyaluronic Acid
Hyaluronic acid is a naturally-occurring component of the tissues of the body. Cingal is thoroughly tested to determine that each batch conforms to the product quality attributes. Mild to moderate episodes of transient swelling and discomfort have occasionally been observed following intra-articular injection of hyaluronic acid preparations. A risk of infection is possible with the procedure of injecting substances into knee joints.
Effects associated with Triamcinolone Hexacetonide
For assessment of adverse reactions (ADRs), the following terms regarding frequency are used:
- very common (≥1/10)
- common (≥1/100 to <1/10)
- uncommon (≥1/1,000 to <1/100)
- rare (≥1/10,000 to 1</1,000)
- very rare (<1/10,000)
- not known (cannot be estimated from the available data)
Adverse effects depend on the dose and the duration of treatment. Systemic adverse effects are rare, but may occur as a result of repeated periarticular injection. As with other intraarticular steroid treatments, transient adrenocortical suppression has been observed during the first week after injection. This effect is enhanced if corticotropin or oral steroids are used concomitantly.
Common adverse effects include local reactions, including sterile abscesses, post-injection erythema, pain, swelling and necrosis at the injection site.
Rare adverse effects include vertigo and excess dosage or too-frequent administration of injections into the same site causing local subcutaneous atrophy, which, due to the properties of the drug, will only return to normal after several months.
Very rare adverse effects include anaphylaxis-type reactions, thromboembolism, hyperpigmentation or hypopigmentation, calcinosis and tendon rupture.
Effects on endocrine disorders, psychiatric disorders, nervous system disorders, eye disorders, cardiac disorders, vascular disorders, gastrointestinal disorders, skin and subcutaneous tissue disorders, musculoskeletal and connective tissue disorders, and renal and urinary disorders are not known.
For additional details and information about the product, please refer to the Instructions for Use that are included in the product’s packaging.