| Product Name: | Lorazepam Injection USP |
| Brand Name: | (GENERICS) |
| Strength: | 2mg/ml, 4mg/ml, 20mg/10ml, 40mg/10ml |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 1ml(single-dose), 10ml (multi-dose) Vial |
| Route of Administration: | For I.M. /I. V 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: | Anti-anxiety |
| Indication: | Lorazepam injection is used before certain medical procedures, including surgery, to relieve anxiety. |
| Storage: | Store at 2°C to 8°C. Refrigerate. Protect from light. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Lorazepam Injection USP 2mg/1ml
- Lorazepam Injection USP 4mg/1ml
- Lorazepam Injection USP 20mg/10ml
- Lorazepam Injection USP 40mg/10ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Lorazepam Injection USP 2mg/ml
Each ml contains:
Lorazepam USP………………………….2mg
Polyethylene glycol USP……………….0.18ml
Benzyl Alcohol USP……………2 % v/v
Water for Injections USP………………………………….q.s. - Lorazepam Injection USP 4mg/ml
Each ml contains:
Lorazepam USP………………………….4mg
Polyethylene glycol USP……………….0.18ml
Benzyl Alcohol USP……………2 % v/v
Water for Injections USP………………………………….q.s. - Lorazepam Injection USP 20mg/10ml
Each ml contains:
Lorazepam USP………………………….2mg
Polyethylene glycol USP……………….0.18ml
Benzyl Alcohol USP……………2 % v/v
Water for Injections USP………………………………….q.s. - Lorazepam Injection USP 40mg/10ml
Each ml contains:
Lorazepam USP………………………….4mg
Polyethylene glycol USP……………….0.18ml
Benzyl Alcohol USP……………2 % v/v
Water for Injections USP………………………………….q.s.
THERAPEUTIC INDICATION:
Lorazepam injection is used before certain medical procedures, including surgery, to relieve anxiety.
DIRECTION OF USE:
For I.M./I.V. (after dilution)
Refer enclosed leaflet for further information.
CAUTION & Warning:
CAUTION:
- Do not use it if any foreign particulate matter is visible.
- Do not use if the solution is discolored or contains any precipitate.
- DO NOT ACCEPT IF THE VIAL SEAL IS BROKEN.
- KEEP OUT OF REACH AND SIGHT OF CHILDREN.
WARNING: It is dangerous to take this preparation except in accordance with medical advice.
Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at 2°C to 8°C. Refrigerate. Protect from light.
Dosage: As directed by the Physician.