TRIAMCINOLONE Suspension for injection Ref.[6452] Active ingredients: Triamcinolone

Posology

Intraarticular injection (dosage for adults and adolescents) for all indications

The dose 2-20 mg is determined individually according to the size of the joint and the amount of articular fluid. Large joints (e.g. hip, knee, shoulder) generally require 10-20 mg (0.5-1 ml), medium-sized joints 5-10 mg (0.25-0.5 ml), and smaller joints 2-6 mg (0.1-0.3 ml). If there is a lot of articular fluid, it can be aspirated prior to administration of the drug. The next dose and the number of injections depend on the progress of the clinical condition. Because TRIAMCINOLONE HEXACETONIDE is long-acting, administration of injections into individual joints more frequently than at 3-4 week intervals is not recommended. Accumulation of the drug at the injection site must be avoided, because it may cause atrophy.

Dosage for intraarticular use in children aged 3–12 years with Juvenile Idiopathic Arthritis

The dosage regime for triamcinolone hexacetonide intraarticular injection for JIA in children is 1 mg/kg for large joints (knees, hips, and shoulders) and 0.5 mg/kg for smaller joints (ankles, wrists, and elbows). For the hands and feet, 1–2 mg/joint for metacarpophalangeal/metatarsophalangeal (MCP/MTP) joints, and 0.6–1 mg/joint for proximal interphalangeal (PIP) joints may be used.

Periarticular injection (dosage for adults and adolescents only)

Bursitis/Epicondylitis: Generally 10-20 mg (0.5-1 ml) depending on the size of the bursa and the severity of the disease. In the majority of cases a single treatment is sufficient.

Synovitis/Tendinitis: Generally 10-20 mg (0.5-1 ml). The need for additional injections should be determined on the basis of response to treatment.

Method of administration

Asepsis must be observed in the use of this product. The vial should be shaken carefully before use to ensure suspension. The injection site should be sterilised using the same technique as with lumbar puncture.

At each treatment session, an injection may be given into two joints at the most. Do not administer in unstable joints.

This formulation is intended for intraarticular, periarticular and intrasynovial use, and must not be used for intravenous, intraocular, epidural or intrathecal use.

Precautions to be taken before handling or administering the medicinal product

For instructions on dilution of the medicinal product before administration, see section 6.6.

Excess dosage or too-frequent administration of injections into the same site may cause local subcutaneous atrophy. If this occurs, recovery may take several months due to the long-term effect of the drug.

3 years.

This medicinal product does not require any special storage conditions.

Carton containing ten colourless 1 ml glass ampoules.

TRIAMCINOLONE HEXACETONIDE ampoules must be inspected for discolouration of the contents prior to administration.

Shake gently before use.

If necessary, TRIAMCINOLONE HEXACETONIDE may be mixed with 1% or 2% lidocaine hydrochloride or other similar local anaesthetics. TRIAMCINOLONE HEXACETONIDE should be drawn into the syringe before drawing in the anaesthetic to prevent contamination of TRIAMCINOLONE HEXACETONIDE. The syringe should then be shaken gently, and the resulting solution used immediately thereafter.