GENERIC NAME OF MEDICINAL PRODUCT:

A. Hydrocortisone Sodium Succinate Injection USP 100mg (HYDROTAJ)
B. Hydrocortisone Sodium Succinate Injection USP 200mg (HYDROTAJ)
C. Hydrocortisone Sodium Succinate Injection USP 250mg (HYDROTAJ)
D. Hydrocortisone Sodium Succinate Injection USP 500mg (HYDROTAJ)
E. Hydrocortisone Sodium Succinate Injection USP 1000mg (HYDROTAJ)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Hydrocortisone Sodium Succinate Injection USP 100mg
a) Each vial contains:
Hydrocortisone Sodium Succinate U.S.P (Sterile)
Eq. to Hydrocortisone……………….100 mg
b) Dissolve the contents of vial in
Sterile Water for Injections USP…..5ml

B. Hydrocortisone Sodium Succinate Injection USP 200mg
a) Each vial contains:
Hydrocortisone Sodium Succinate U.S.P (Sterile)
Eq. to Hydrocortisone……………….200 mg
b) Dissolve the contents of vial in
Sterile Water for Injections USP…..5ml

C. Hydrocortisone Sodium Succinate Injection USP 250mg
a) Each vial contains:
Hydrocortisone Sodium Succinate U.S.P (Sterile)
Eq. to Hydrocortisone……………….250 mg
b) Dissolve the contents of vial in
Sterile Water for Injections USP…..5ml


D. Hydrocortisone Sodium Succinate Injection USP 500mg
a) Each vial contains:
Hydrocortisone Sodium Succinate U.S.P (Sterile)
Eq. to Hydrocortisone……………….500 mg
b) Dissolve the contents of vial in
Sterile Water for Injections USP………..10ml

E. Hydrocortisone Sodium Succinate Injection USP 1000mg
a) Each vial contains:
Hydrocortisone Sodium Succinate U.S.P (Sterile)
Eq. to Hydrocortisone……………….1000 mg
b) Dissolve the contents of vial in
Sterile Water for Injections USP……..10ml

THERAPEUTIC INDICATION:

This medication is used to treat various conditions such as arthritis, severe allergies, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders, and skin diseases.
Hydrocortisone Sodium Succinate relieves inflammation in various part of the body. To treat or prevent allergic reaction. As treatment of certain kids of autoimmune disease, skin condition, asthma and other lung condition. As treatment for a variety of cancers, such as leukemia and multiple myeloma.

DIRECTION OF USE:

The Reconstituted with the 5ml/10ml of Water for Injection USP.
The constituted solution should be used immediately after preparation.
For administration and detailed direction for use, see the pack insert.

CAUTION & WARNING:

CAUTION: Do not use, if constituted solution contains Particles/suspended matter.
DO NOT ACCEPT IF VIAL SEAL IS BROKEN.
Discard unused portion.
FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE.
Warning: To sold by the retail on the prescription of a registered medical practitioner only.

STORAGE & DOSAGE:

Storage: Store below 25°C.
Store in a cool, dry & dark place.
Protect from light & Moisture.
Dosage: As directed by the Physician.

Hydrocortisone Sodium Succinate Injection USP 250mg Technical Specification:

Product Name:Hydrocortisone Sodium Succinate Injection USP
Brand Name:HYDROTAJ
Strength:100mg, 200mg, 250mg, 500mg, 1000mg
Dosage Form:Dry Powder for Injection (Sterile) *Preservative Free
Packing:1 Single Dose Vial + WFI in a Tray
Route of Administration:For I.M or Slow I.V use
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Steroids, Corticosteroids, Anti-inflammatory
Indication: This medication is used to treat various conditions such as severe allergies, certain cancers, eye diseases, and skin diseases.
Storage:Store in a cool, dry & dark place. Store below 25°C.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Hydrocortisone Sodium Succinate Injection USP 250mg (HYDROTAJ)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Hydrocortisone Sodium Succinate Injection USP 250mg
    a. Each vial contains:
    Hydrocortisone Sodium Succinate U.S.P (Sterile)
    Eq. to Hydrocortisone……………….250mg
    b. Dissolve the contents of vial in
    Sterile Water for Injections USP…..5ml

THERAPEUTIC INDICATION:

This medication is used to treat various conditions such as arthritis, severe allergies, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders, and skin diseases.
Hydrocortisone Sodium Succinate relieves inflammation in various part of the body. To treat or prevent allergic reaction. As treatment of certain kids of autoimmune disease, skin condition, asthma and other lung condition. As treatment for a variety of cancers, such as leukemia and multiple myeloma.

DIRECTION OF USE:

The Reconstituted with the 5ml/10ml of Water for Injection USP.
The constituted solution should be used immediately after preparation.
For administration and detailed direction for use, see the pack insert.

CAUTION & WARNING:

CAUTION: Do not use, if constituted solution contains Particles/suspended matter.
DO NOT ACCEPT IF VIAL SEAL IS BROKEN.
Discard unused portion.
FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE.

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

STORAGE & DOSAGE:

Storage:  Store below 25°C.
Store in a cool, dry & dark place.
Protect from light & Moisture.

Dosage: As directed by the Physician.