GENERIC NAME OF MEDICINAL PRODUCT:

A. Methylprednisolone Sodium Succinate for Injection USP 1gm (M-PREDNITAJ)
B. Methylprednisolone Sodium Succinate for Injection USP 500mg (M-PREDNITAJ)
C. Methylprednisolone Sodium Succinate for Injection USP 125mg (M-PREDNITAJ)
D. Methylprednisolone Sodium Succinate for Injection USP 40mg (M-PREDNITAJ)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Methylprednisolone Sodium Succinate for Injection USP 1gm
a. Each Vial Contains:
Methylprednisolone Sodium Succinate U.S.P. (Sterile)
Eq. to Methylprednisolone…………………………1000mg
b. This pack is also contains:
One FFS ampule of Sterile Water for Injection I.P……20ml


B. Methylprednisolone Sodium Succinate for Injection USP 500mg
a. Each Vial Contains:
Methylprednisolone Sodium Succinate U.S.P. (Sterile)
Eq. to Methylprednisolone…………………………500mg
b. This pack is also contains:
One FFS ampule of Sterile Water for Injection I.P…….10ml

C. Methylprednisolone Sodium Succinate for Injection USP 125mg
a. Each Vial Contains:
Methylprednisolone Sodium Succinate U.S.P. (Sterile)
Eq. to Methylprednisolone…………………………125mg
b. This pack is also contains:
One FFS ampule of Sterile Water for Injection I.P……5ml

D. Methylprednisolone Sodium Succinate for Injection USP 40mg
a. Each Vial Contains:
Methylprednisolone Sodium Succinate U.S.P. (Sterile)
Eq. to Methylprednisolone…………………………40mg
b. This pack is also contains:
One FFS ampule of Sterile Water for Injection I.P…….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 IP.
Reconstituted solution should be use immediately after preparation.
Read enclosed leaflet before reconstitution and use.

CAUTION AND SCHEDULE:

CAUTION: Do not use if container is found leaking or solution is not clear.
Solutions containing visible solid particles must not be used.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
SCHEDULE: SCHEDULE 'H PRESCRIPTION DRUG-CAUTION To be sold by retail on the prescription of Registered Medical Practitioner only.

STORAGE AND DOSAGE:

STORAGE: Store below 25°C. Protect from light. Do not Freeze.
KEEP OUT OF REACH OF CHILDREN.
DOSAGE: As directed by Physician.

Methylprednisolone Sodium Succinate for Injection USP 1gm Technical Specification:

Product Name:Methylprednisolone Sodium Succinate for Injection USP
Brand Name:M-Prednitaj
Strength:1gm, 500mg, 125mg, 40mg
Dosage Form:Dry Powder for Injection (Sterile)
Packing:1 Single Dose Vial + WFI Tray 
Route of Administration:For I.V./I.M. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
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 1gm (M-PREDNITAJ)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Methylprednisolone Sodium Succinate for Injection USP 1gm
    a. Each Vial Contains:
    Methylprednisolone Sodium Succinate U.S.P. (Sterile)
    Eq. to Methylprednisolone…………………………1000mg
    b. This pack is also contains:
    One FFS ampule of Sterile Water for Injection I.P……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 IP.
Reconstituted solution should be use immediately after preparation.
Read enclosed leaflet before reconstitution and use.

CAUTION AND SCHEDULE:

CAUTION: Do not use if container is found leaking or solution is not clear. Solutions containing visible solid particles must not be used.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

SCHEDULE: SCHEDULE ‘H PRESCRIPTION DRUG-CAUTION To be sold by retail on the prescription of Registered Medical Practitioner only.

STORAGE AND DOSAGE:

STORAGE: Store below 25°C. Protect from light. Do not Freeze.
KEEP OUT OF REACH OF CHILDREN.

DOSAGE: As directed by Physician.