Methylprednisolone-BP (powder)

Methylprednisolonum

1 ml of suspension for injection contains methylprednisolone acetate 40 mg. Excipient with known effect: sodium.

Indication: Intramuscular anti-inflammatory/maintenance treatment for rheumatic conditions and collagenoses (e.g. psoriatic arthritis, ankylosing spondylitis, post-traumatic osteoarthritis, synovitis in osteoarthritis, rheumatoid arthritis including the juvenile form, acute and subacute bursitis, epicondylitis, acute non-specific tenosynovitis, acute gouty arthritis), when oral administration is not possible; not intended for acute life-threatening conditions.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Intrathecal administration - Intravenous administration - Epidural (peridural) administration - Intranasal, ophthalmic administration or administration at various injection sites (scalp, oropharynx, sphenopalatine ganglion) - Systemic mycoses

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use This product is not suitable for multiple dosing. After the desired dose has been administered, the remaining suspension must be discarded (see section 6.6). To minimise dermal or subdermal atrophy, care must be taken not to exceed the recommended doses. Where possible, several small injections should be given into the lesion area. Intra-articular and intramuscular injection technique should also include precautions to prevent intradermal injection or infiltration. Injection into the deltoid muscle should be avoided because of the significant incidence of subcutaneous atrophy. Severe adverse events have been reported in association with the following contraindicated routes of administration: intrathecal/peridural, intranasal, ophthalmic, and administration at certain injection sites (see section 4.8). Precautions must be taken […]