Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1    List of excipients
Act-O-Vial System (Single Dose Vial)
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SOLU-MEDROL® Sterile Powder 40 mg:
Each 1 ml Act-O-Vial contains:
I. Powder compartment: Lactose, Dibasic sodium phosphate dried, Monobasic sodium phosphate monohydrate, Sodium hydroxide, Water for injection
II. Diluent compartment: Water for injection

SOLU-MEDROL® Sterile Powder 125 mg:
Each 2 ml Act-O-Vial contains:
I. Powder compartment: Dibasic sodium phosphate Dried,
Monobasic sodium phosphate monohydrate, Sodium hydroxide, Water for injection II. Diluent compartment: Water for injection

Vial with Diluent

SOLU-MEDROL® Sterile Powder 500 mg:
I. Each powder vial contains: Dibasic sodium phosphate dried, Monobasic sodium phosphate monohydrate, Sodium hydroxide, Water for injection
II. Each diluent vial (8 ml) contains: Benzyl alcohol, Water for injection 
SOLU-MEDROL® Sterile Powder 1000 mg:
I. Each powder vial contains: Dibasic sodium phosphate dried, Monobasic sodium phosphate monohydrate, Sodium hydroxide, Water for injection
II. Each diluent vial (16 ml) contains: Benzyl alcohol, Water for injection 
Solu-Medrol 500 mg & 1000 mg contain Benzyl alcohol (see Section 4.4 Special warnings and precautions for use).


6.2     Incompatibilities
NA

6.3    Shelf-life
The expiry date of the product is indicated on the packaging materials.

SOLU-MEDROL® Sterile Powder 40mg, 125 mg, 500 mg and 1000mg: After reconstitution with the diluents provided: Chemically, the product is stable for 12 hours at a temperature of 25ºC. In the aspect of microbiology, the product should be used immediately.

6.4     Special precautions for storage

Store below 25°C.
SOLU-MEDROL® 40mg & 125 mg, After reconstitution with solvent:
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 12 hours , stored below 25°C .

From a microbiological point of view, unless the method of opening/ reconstitution/ dilution precludes the risk of microbial contamination, the product should be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility of user.

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Refer to Section 6.6. No diluents other than those referred to are recommended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

6.5   Nature and contents of container
Act-O-Vial System (Single-Dose Vial)
Hydrolytic glass class I Act-O-Vial with Halobutyl rubber stoppers.

Each Act-O-Vial of Solu-Medrol 40 mg contains the equivalent of 40 mg of methylprednisolone as the sodium succinate (Powder compartment) for reconstitution with 1 ml of Water for Injections (Diluent compartment).

Each Act-O-Vial of Solu-Medrol 125 mg contains the equivalent of 125 mg of methylprednisolone as the sodium succinate (Powder compartment) for reconstitution with 2 ml of Water for Injections (Diluent compartment).

Vial with Diluent
1 Powder vial+1 Diluent vial: glass class I vials with butyl rubber plug and flip top seals.

Each vial of Solu-Medrol 500 mg contains the equivalent of 500 mg of methylprednisolone as the sodium succinate for reconstitution with 8 ml of Bacteriostatic Water for Injections.

Each vial of Solu-Medrol 1000 mg contains the equivalent of 1000 mg of methylprednisolone as the sodium succinate for reconstitution with 16 ml of Bacteriostatic Water for Injections.

6.6    Special precautions for disposal and other handling

Precautions for disposal:
No special requirement.
Directions for use:

Directions for Use of the Act-O-Vial
1. Press down on plastic activator to force diluent into the lower compartment.
2. Gently agitate to effect solution.
3. Remove plastic tab covering center of stopper.
4. Sterilize top of stopper with a suitable germicide.
5. Insert needle squarely through center of stopper until tip is just visible. Invert vial and withdraw dose.

Directions for Use of the Vial
Under aseptic conditions add the diluent to the vial with sterile powder. Do only use the special diluent.

Preparation of Solutions -
To prepare solutions for intravenous infusion, first reconstitute methylprednisolone sodium succinate as directed. Therapy may be initiated by administering methylprednisolone sodium succinate intravenously over a period of at least five minutes (e.g, doses up to 250 mg) to at least 30 minutes (e.g, doses of 250 mg or more). Subsequent doses may be withdrawn and administered similarly. If desired, the medication may be administered in dilute solutions by Page 26 of 27                                        2024-0092703;   6 admixing the reconstituted product with Dextrose 5% in Water, Normal Saline, Dextrose 5% in 0.45% or 0.9% Sodium Chloride.