| Product Name: | Haloperidol Injection |
| Brand Name: | (Generic) |
| Strength: | 5mg/ml, 50mg/10ml |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 1mL Ampoule |
| Route of Administration: | For I.M./I.V. use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Product Permission, Stability Studies, GMP |
| Therapeutic use: | Antipsychotics |
| Indication: | For Rapid control of severe acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder when oral therapy is not appropriate |
| Storage: | Store Protected from moisture at a temperature Between 15°C and 25°C. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Haloperidol Injection 5mg/ml
- Haloperidol Injection 50mg/10ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Haloperidol Injection 5mg/ml
Haloperidol Injection
a) Each ampoule of 1ml contains:
Haloperidol IP
Equivalent to Haloperidol…………….. 5mg
b) Water for Injection…………………………q.s - Haloperidol Injection 50mg/10ml
Haloperidol Injection
a) Each ampoule of 1ml contains:
Haloperidol IP
Equivalent to Haloperidol…………….. 50mg
b) Water for Injection…………………………q.s
THERAPEUTIC INDICATION:
It is used for Rapid control of severe acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder when oral therapy is not appropriate.
DIRECTION OF USE:
For Intramuscular or Intravenous use.
Your doctor or nurse will give you this medicine. Kindly do not self-administer.
CAUTION AND SCHEDULE:
CAUTION: Do not use it if the solution is not clear or has suspended matter.
KEEP OUT OF REACH OF CHILDREN.
SCHEDULE ‘H’ PRESCRIPTION DRUG:
WARNING: Not to be sold by retail without the prescription of a registered Medical Practitioner.
STORAGE AND DOSAGE:
STORAGE: Store Protected from Light at a temperature between 15°C and 25°C.
DOSAGE: As directed by the Physician.