Dexamethasone Sodium Phosphate Injection USP 4 mg/ml (8mg/2ml) Technical Specification:

Product Name:Dexamethasone Sodium Phosphate Injection USP 4 mg/ml (8mg/2ml)
Brand Name:Dexataj
Strength:4 mg/ml (8mg/2ml, 20mg/5ml, 120mg/30ml), 10mg/ml (100mg/10ml)
Dosage Form:Liquid Injection (Ampoule/Vial)
Packing:1 mL, 5 mL, 10 mL, 30 mL
Route of Administration:For Intravenous/Intramuscular use 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:Corticosteroids
Indication: Dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions, skin diseases, eye problems, breathing problems, bowel disorders, cancer, and immune system disorders. It is also used as a test for an adrenal gland disorder (Cushing’s syndrome).
Storage:Store at 20° to 25°C. Protected from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Dexamethasone Sodium Phosphate Injection USP 4 mg/ml (8mg/2ml, 20mg/5ml, 120mg/30ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Dexamethasone Sodium Phosphate Injection USP 4 mg/ml (8mg/2ml, 20mg/5ml, 120mg/30ml)
    Each ml contains:
    Dexamethasone Sodium Phosphate USP
    Equivalent to Dexamethasone phosphate…………4mg
    Water for Injection USP…………………………………. q.s.

THERAPEUTIC INDICATION:

Dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions, skin diseases, eye problems, breathing problems, bowel disorders, cancer, and immune system disorders. It is also used as a test for an adrenal gland disorder (Cushing’s syndrome).

The use of Dexamethasone Sodium Phosphate Injection USP in active tuberculosis should be restricted to those cases of fulminating or disseminated.

Dexamethasone Injection is used to treat severe allergic reactions.

PACKING:

  • 4mg/ml
  1. 8mg/2ml
  2. 20mg/5ml
  3. 120mg/30ml
  • 10mg/ml
  1. 100mg/10ml

DIRECTION OF USE:

For Intravenous/Intramuscular use only.

See insert for detailed dosage, directions for use and precautions.

CAUTION & WARNING:

CAUTION: The injection should be discarded if any visible particle appears.

Discard any unused product immediately after use.

WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.

Discard Unused portion.

Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C. Protected from light.

Dosage:  As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Dexamethasone Sodium Phosphate Injection USP 4 mg/ml (8mg/2ml, 20mg/5ml, 120mg/30ml)
B. Dexamethasone Sodium Phosphate Injection USP 10mg/ml (100mg/10ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Dexamethasone Sodium Phosphate Injection USP 4 mg/ml (8mg/2ml, 20mg/5ml, 120mg/30ml)
Each ml contains:
Dexamethasone Sodium Phosphate USP
Equivalent to Dexamethasone phosphate…………4mg
Water for Injection USP…………………………………. q.s.


B. Dexamethasone Sodium Phosphate Injection USP 10mg/ml (100mg/10ml)
Each ml contains:
Dexamethasone Sodium Phosphate USP
Equivalent to Dexamethasone phosphate…………10mg
Water for Injection USP…………………………………. q.s.

THERAPEUTIC INDICATIONS:

Dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions, skin diseases, eye problems, breathing problems, bowel disorders, cancer, and immune system disorders. It is also used as a test for an adrenal gland disorder (Cushing's syndrome).
The use of Dexamethasone Sodium Phosphate Injection USP in active tuberculosis should be restricted to those cases of fulminating or disseminated.
Dexamethasone Injection is used to treat severe allergic reactions.

PACKING:

1) 4mg/ml
a. 8mg/2ml
b. 20mg/5ml
c. 120mg/30ml
2) 10mg/ml
a. 100mg/10ml

DIRECTION OF USE:

For Intravenous/Intramuscular use only.
See insert for detailed dosage, directions for use and precautions.

CAUTION AND WARNING:

CAUTION: The injection should be discarded if any visible particle appears.
Discard any unused product immediately after use.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.
Discard Unused portion.
Keep medicine out of reach of children.

STORAGE AND DOSAGE:

Storage: Store at 20° to 25°C.
Protected from light.
Dosage: As directed by the Physician.