| Product Name: | Chlorpromazine Hydrochloride Injection USP |
| Brand Name: | Generic |
| Strength: | 25mg/ml |
| Dosage Form: | Liquid Injection |
| Packing: | Single Dose Ampoule |
| Route of Administration: | For deep intramuscular 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: | Antipsychotics |
| Indication: | This medication is used to treat certain mental/mood disorders (such as schizophrenia, psychotic disorders, the manic phase of bipolar disorder, and severe behavioral problems in children). |
| Storage: | Store protected from light. |
Chlorpromazine Hydrochloride Injection USP 25mg/ml Technical Specification:
GENERIC NAME OF THE MEDICINAL PRODUCT:
Chlorpromazine Hydrochloride Injection USP 25mg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Chlorpromazine Hydrochloride Injection USP 25mg/ml
Each ml contains:
Chlorpromazine Hydrochloride USP…………………25mg
Water for Injection USP…………………………………. q.s.
THERAPEUTIC INDICATION:
This medication is used to treat certain mental/mood disorders (such as schizophrenia, psychotic disorders, the manic phase of bipolar disorder, and severe behavioral problems in children).
Chlorpromazine HCL 25mg/ml; for IV injection after dilution or IM injection; contains sulfites; multi-dose vial contains benzyl alcohol.
PACKING:
25mg/ml
DIRECTION OF USE:
For deep intramuscular use.
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 a Registered Medical Practitioner.
Discard the Unused portion.
Keep medicine out of reach of children.
STORAGE & DOSAGE:
Storage: Store protected from light.
Dosage: As directed by the Physician.