| Product Name: | Ketamine HCl Injection USP |
| Brand Name: | Generic |
| Strength: | 10mg/ml, 50mg/ml, 100mg/ml |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 2ml, 5ml, 10ml, 20 mL vial |
| Route of Administration: | For IM/ slow IV/ I.V. Infusion 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: | General Anaesthesia. |
| Indication: | Ketamine hydrochloride injection is indicated as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. Ketamine hydrochloride is best suited for short procedures but it can be used, with additional doses, for longer procedures. |
| Storage: | Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Ketamine HCl Injection USP 10mg/ml
- Ketamine HCl Injection USP 50mg/ml
- Ketamine HCl Injection USP 100mg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Ketamine HCl Injection USP 10mg/ml
Each ml contains:
Ketamine Hydrochloride USP
equivalent to Ketamine………………………………………..10 mg
Benzethonium Chloride USP (as preservative) ……………..0.01% w/v
Water for Injections USP……………………………………………….q.s. - Ketamine HCl Injection USP 50mg/ml
Each ml contains:
Ketamine Hydrochloride USP
equivalent to Ketamine………………………………………..50 mg
Benzethonium Chloride USP (as preservative) ……………..0.01% w/v
Water for Injections USP……………………………………………….q.s. - Ketamine HCl Injection USP 100mg/ml
Each ml contains:
Ketamine Hydrochloride USP
equivalent to Ketamine………………………………………..100 mg
Benzethonium Chloride USP (as preservative) ……………..0.01% w/v
Water for Injections USP……………………………………………….q.s.
THERAPEUTIC INDICATION:
Ketamine hydrochloride injection is indicated as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. Ketamine hydrochloride is best suited for short procedures but it can be used, with additional doses, for longer procedures.
DIRECTION OF USE:
Concentrate on IM or Slow IV use.
Dilute before IV use.
CAUTION & WARNING:
CAUTION: Do not use if the solution is not clear or has suspended matter/particles and ask for a replacement.
Discard the unused portion.
The Colour of the solution may vary from colorless to very slightly yellowish & may darken upon prolonged exposure to light.
Do not use if precipitate appears.
The darkening of the solution does not affect potency.
Keep the medicine out of reach of children.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature.
Dosage: As directed by Physician.