GENERIC NAME OF MEDICINAL PRODUCT:

A. Methylprednisolone Sodium Succinate for Injection USP 2gm
B. Methylprednisolone Sodium Succinate for Injection USP 1gm
C. Methylprednisolone Sodium Succinate for Injection USP 500mg
D. Methylprednisolone Sodium Succinate for Injection USP 125mg
E. Methylprednisolone Sodium Succinate for Injection USP 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Methylprednisolone Sodium Succinate for Injection USP 2gm
a. Each vial contains:
Methylprednisolone Sodium Succinate USP
Eq. to Methylprednisolone………2g
b. This pack is also contains:
One FFS ampule of Sterile Water For Injection USP………20ml


B. Methylprednisolone Sodium Succinate for Injection USP 1gm
a. Each vial contains:
Methylprednisolone Sodium Succinate USP
Eq. to Methylprednisolone………1g
b. This pack is also contains:
One FFS ampule of Sterile Water For Injection USP…………20ml

C. Methylprednisolone Sodium Succinate for Injection USP 500mg
a. Each vial contains:
Methylprednisolone Sodium Succinate USP
Eq. to Methylprednisolone………0.5g
b. This pack is also contains:
One FFS ampule of Sterile Water For Injection USP……….10ml

D. Methylprednisolone Sodium Succinate for Injection USP 125mg
a. Each vial contains:
Methylprednisolone Sodium Succinate USP
Eq. to Methylprednisolone………125mg
b. This pack is also contains:
One FFS ampule of Sterile Water For Injection USP………5ml

E. Methylprednisolone Sodium Succinate for Injection USP 40mg
a. Each vial contains:
Methylprednisolone Sodium Succinate USP
Eq. to Methylprednisolone………40mg
b. This pack is also contains:
One FFS ampule of Sterile Water For Injection USP……..5ml

THERAPEUTIC INDICATION:

Methylprednisolone is a Corticosteroid that prevents the release of substances in the body that cause inflammation. Methylprednisolone is used to treat many different inflammatory conditions such as arthritis, lupus, psoriasis, ulcerative colitis, allergic disorders, gland (endocrine) disorders, and conditions that affect the skin, eyes, lungs, stomach, nervous system, or blood cells.

DIRECTION OF USE:

Reconstitute using Sterile Water for injection USP.
Reconstituted solution should be use immediately after preparation.
Administer/assist with patient provided emergency Injection. If not available use one locally approved steroid IM/IV.
Read enclosed leaflet before reconstitution and use.

CAUTION & WARNING:

CAUTION: Do not use, if constituent solution content Particle/suspended material.
If any particle is visible after dissolving the content do not use & return for replacement.
The formulations containing benzyl alcohol should not be used in neonates.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: To be sold by the retail on the prescription of a registered medical practitioner only.
Keep out of reach of medicine children.

STORAGE & DOSAGE:

Storage: Store below 25°C. Protect from light. Do not freeze.
Dosage: As directed by Physician.

Methylprednisolone Sodium Succinate for Injection USP 2gm Technical Specification:

Product Name:Methylprednisolone Sodium Succinate for Injection USP 2gm
Brand Name:M-Prednitaj
Strength:2gm, 1gm,  500mg, 125mg, 40mg
Dosage Form:Lyophilized Powder for Injection (Sterile)
Packing:1 Vial + WFI
Route of Administration:For I.V. used only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Corticosteroid, Anti-inflammatory, Anti-allergic
Indication: Methylprednisolone is a Corticosteroid that prevents the release of substances in the body that cause inflammation. Methylprednisolone is used to treat many different inflammatory conditions such as arthritis, lupus, psoriasis, ulcerative colitis, allergic disorders, gland (endocrine) disorders, and conditions that affect the skin, eyes, lungs, stomach, nervous system, or blood cells.
Storage:Store below 25°C. Protect from light. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Methylprednisolone Sodium Succinate for Injection USP 2gm

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Methylprednisolone Sodium Succinate for Injection USP 2gm
    a. Each vial contains:
    Methylprednisolone Sodium Succinate USP
    Eq. to Methylprednisolone……2g
    b. This pack is also contains:
    One FFS ampule of Sterile Water For Injection USP……20ml

THERAPEUTIC INDICATION:

Methylprednisolone is a Corticosteroid that prevents the release of substances in the body that cause inflammation. Methylprednisolone is used to treat many different inflammatory conditions such as arthritis, lupus, psoriasis, ulcerative colitis, allergic disorders, gland (endocrine) disorders, and conditions that affect the skin, eyes, lungs, stomach, nervous system, or blood cells.

DIRECTION OF USE:

Reconstitute using Sterile Water for injection USP.

Reconstituted solution should be use immediately after preparation.

Administer/assist with patient provided emergency Injection. If not available use one locally approved steroid IM/IV.

Read enclosed leaflet before reconstitution and use.

CAUTION & Warning:

CAUTION:  Do not use, if constituent solution content Particle/suspended material.

If any particle is visible after dissolving the content do not use & return for replacement.

The formulations containing benzyl alcohol should not be used in neonates.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

Warning: To be sold by the retail on the prescription of a registered medical practitioner only.

Keep out of reach of medicine children.

STORAGE & DOSAGE:

Storage: Store below 25°C. Protect from light. Do not freeze.

Dosage: As directed by Physician.