| Product Name: | Haloperidol Decanoate injection |
| Brand Name: | Generic |
| Strength: | 5mg/ml, 50mg/ml |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 1mL Ampoule |
| Route of Administration: | For I.M. use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antipsychotics |
| Indication: | For treatment of schizophrenic patients who require prolonged parenteral antipsychotic therapy. |
| Storage: | Store at 20°C to 25°C (68°F to 77°F) see USP controlled room temperature. Do not refrigerate or freeze. Protected from light. |
GENERIC NAME OF MEDICINAL PRODUCT
- Haloperidol Decanoate Injection 5mg/ml
- Haloperidol Decanoate Injection 50mg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Haloperidol Decanoate Injection 5mg/ml
Each ml contains
Haloperidol…………………………………………..5mg
equivalent to Haloperidol Decanoate ……….. 70.52mg
(seasame oil as a vehicle)
Benzyl alcohol IP………………………..1.2% w/v
(as preservative)
Excipients………………………………….q.s - Haloperidol Decanoate Injection 50mg/ml
Each ml contains
Haloperidol…………………………………………..50mg
equivalent to Haloperidol Decanoate ……….. 141.04mg
(seasame oil as a vehicle)
Benzyl alcohol IP………………………..1.2% w/v
(as preservative)
Excipients………………………………….q.s
THERAPEUTIC INDICATION:
For treatment of schizophrenic patients who require prolonged parenteral antipsychotic therapy.
DIRECTION OF USE:
For Intramuscular use only
Your doctor or nurse will give you this medicine. Kindly do not self-administer.
CAUTION AND WARNING:
CAUTION:retain in carton until content are used.
KEEP OUT OF REACH OF CHILDREN.WARNING: to be sold by retail on the prescription of a registered medical practitioner only.
STORAGE AND DOSAGE:
STORAGE: Store at 20°C to 25°C (68°F to 77°F) see USP controlled room temperature. Do not refrigerate or freeze. Protected from light.
DOSAGE: As directed by the Physician.