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 Vial + WFI
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 1 gm (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) 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.

SCHEDULE: SCHEDULE H Drug: 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.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
KEEP OUT OF REACH OF CHILDREN

DOSAGE:  As directed by Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1) Methylprednisolone Sodium Succinate for Injection USP 1gm
a) Each Vial Contains:
Methylprednisolone Sodium Succinate U.S.P. (Sterile)
Eq. to Methylprednisolone…………………………1000mg
b) Water for Injection I.P…………………………………...20ml


2) Methylprednisolone Sodium Succinate for Injection USP 500mg
a) Each Vial Contains:
Methylprednisolone Sodium Succinate U.S.P. (Sterile)
Eq. to Methylprednisolone…………………………500 mg
b) Water for Injection I.P………………………………….10ml

3) Methylprednisolone Sodium Succinate for Injection USP 125mg
a) Each Vial Contains:
Methylprednisolone Sodium Succinate U.S.P. (Sterile)
Eq. to Methylprednisolone…………………………125 mg
b) Water for Injection I.P……………………………………5ml

4) Methylprednisolone Sodium Succinate for Injection USP 40 mg
a) Each Vial Contains:
Methylprednisolone Sodium Succinate U.S.P. (Sterile)
Eq. to Methylprednisolone…………………………40 mg
b) Water for Injection I.P…………………………………5 ml

THERAPEUTIC INDICATIONS:

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.
SCHEDULE: SCHEDULE H Drug: 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.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
KEEP OUT OF REACH OF CHILDREN
DOSAGE: As directed by Physician.