SOLU-MEDROL Powder for injection Ref.[50793] Active ingredients: Methylprednisolone

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2021  Publisher: Pfizer New Zealand Ltd, PO Box 3998, Auckland, NEW ZEALAND, Toll Free Number: 0800 736 363

Product name and form

SOLU-MEDROL 1 g powder for injection.
SOLU-MEDROL 2 g powder for injection*.
SOLU-MEDROL ACT-O-VIAL 40 mg/mL powder for injection.
SOLU-MEDROL ACT-O-VIAL 125 mg/2 mL powder for injection.
SOLU-MEDROL ACT-O-VIAL 500 mg/4 mL injection with diluent.

* Not available.

Pharmaceutical Form

SOLU-MEDROL:

  • powder for injection: white, freeze-dried cake
  • diluent: clear, colourless liquid.

SOLU-MEDROL ACT-O-VIAL:

  • powder for injection: white, freeze-dried cake
  • diluent: clear, colourless liquid.

Qualitative and quantitative composition

SOLU-MEDROL 1 g powder for injection

Each vial with active constituent contains methylprednisolone sodium succinate equivalent to methylprednisolone 1 g.

Excipients with known effect: Each vial of diluent contains benzyl alcohol 140.4 mg as preservative.

When mixed as directed, each 16 mL contains methylprednisolone sodium succinate equivalent to methylprednisolone 1 g.

SOLU-MEDROL 2 g powder for injection

Each vial with active constituent contains methylprednisolone sodium succinate equivalent to methylprednisolone 2 g.

Excipients with known effect: Each vial of diluent contains benzyl alcohol 280.8 mg as preservative.

When mixed as directed, each 31.2 mL contains methylprednisolone sodium succinate equivalent to methylprednisolone 2 g.

SOLU-MEDROL ACT-O-VIAL 40 mg/mL powder for injection

The vial compartment with the active constituent contains methylprednisolone sodium succinate equivalent to methylprednisolone 40 mg.

When mixed, each mL contains methylprednisolone sodium succinate equivalent to 40 mg methylprednisolone.

SOLU-MEDROL ACT-O-VIAL 125 mg/2 mL powder for injection

The vial compartment with the active constituent contains methylprednisolone sodium succinate equivalent to methylprednisolone 125 mg.

When mixed, each 2 mL contains methylprednisolone sodium succinate equivalent to 125 mg methylprednisolone.

SOLU-MEDROL ACT-O-VIAL 500 mg/4 mL

The vial compartment with the active constituent contains methylprednisolone sodium succinate equivalent to methylprednisolone 575 mg.

When mixed each 4 mL contains methylprednisolone sodium succinate equivalent to 500 mg methylprednisolone.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Methylprednisolone

Methylprednisolone is a synthetic glucocorticoid and a methyl derivative of prednisolone. Methylprednisolone is a potent anti-inflammatory agent with the capacity to profoundly inhibit the immune system.

List of Excipients

SOLU-MEDROL ACT-O-VIAL 40 mg/mL powder for injection

Powder for injection compartment:

  • monobasic sodium phosphate
  • dibasic sodium phosphate
  • lactose monohydrate
  • sodium hydroxide.

Diluent compartment:

  • water for injections.

SOLU-MEDROL ACT-O-VIAL 125 mg/2 mL powder for injection

Powder for injection compartment:

  • monobasic sodium phosphate
  • dibasic sodium phosphate
  • sodium hydroxide.

Diluent compartment:

  • water for injections.

SOLU-MEDROL ACT-O-VIAL 500 mg/4 mL

Powder for injection compartment:

  • monobasic sodium phosphate
  • dibasic sodium phosphate
  • sodium hydroxide.

Diluent compartment:

  • water for injections

SOLU-MEDROL 1 g powder for injection

Powder for injection vial:

  • monobasic sodium phosphate monohydrate
  • dibasic sodium phosphate
  • sodium hydroxide.

Diluent vial:

  • water for injections
  • benzyl alcohol as preservative 140.4 mg.

SOLU-MEDROL 2 g powder for injection

Powder for injection vial:

  • monobasic sodium phosphate monohydrate
  • dibasic sodium phosphate
  • sodium hydroxide.

Diluent vial:

  • water for injections
  • benzyl alcohol as preservative 280.8 mg.

Pack sizes and marketing

SOLU-MEDROL is available in the following pack sizes:

  • SOLU-MEDROL ACT-O-VIAL 40 mg/mL powder for injection: two-compartment vial in pack sizes of 1 or 20 dose units
  • SOLU-MEDROL ACT-O-VIAL 125 mg/2 mL powder for injection: twocompartment vial in pack sizes of 1 or 25 dose units
  • SOLU-MEDROL ACT-O-VIAL 500 mg/4 mL injection with diluent: twocompartment glass ampoule in a pack size of 1
  • SOLU-MEDROL 1 g powder for injection: 1 glass vial
  • SOLU-MEDROL 2 g powder for injection: 1 glass vial.

Not all presentations may be marketed.

SOLU-MEDROL is available in preservative and preservative-free formulations.

Marketing authorization holder

Pfizer New Zealand Ltd, PO Box 3998, Auckland, NEW ZEALAND, Toll Free Number: 0800 736 363

Marketing authorization dates and numbers

SOLU-MEDROL ACT-O-VIAL 40 mg/mL powder for injection: 26 July 1973
SOLU-MEDROL ACT-O-VIAL 125 mg/2 mL powder for injection: 21 January 1972
SOLU-MEDROL ACT-O-VIAL 500 mg/4 mL injection with diluent: 16 September 1999
SOLU-MEDROL 1 g powder for injection: 21 January 1972
SOLU-MEDROL 2 g powder for injection: 21 January 1972

Drugs

Drug Countries
SOLU-MEDROL Austria, Australia, Brazil, Canada, Ecuador, Estonia, Finland, France, Hong Kong, Croatia, Israel, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, United States, South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.