| Product Name: | L-Ornithine-L-Aspartate Infusion |
| Brand Name: | Generic |
| Strength: | 5g/10ml |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 10ml Ampoule |
| Route of Administration: | Infusion concentrate for I.V. slow drip infusion |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Hepatology |
| Indication: | L-ornithine-L-aspartate belongs to the group of medicines called a hepatoprotective agents. It is used in the treatment of hepatic encephalopathy. Hepatic encephalopathy is defined as a series of neuropsychiatric abnormalities in patients with liver dysfunction, after the exclusion of brain disease. |
| Storage: | Store protected from light at a temperature not exceeding 30°C. |
GENERIC NAME OF MEDICINAL PRODUCT
- L-Ornithine-L-Aspartate Infusion 5g/10ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- L-Ornithine-L-Aspartate Infusion 5g/10ml
Each 10 ml contains:
L-Ornithine-L-Aspartate…………….5 g
Water for Injection BP…………………..q.s.
THERAPEUTIC INDICATION:
L-ornithine-L-aspartate belongs to the group of medicines called a hepatoprotective agents. It is used in the treatment of hepatic encephalopathy. Hepatic encephalopathy is defined as a series of neuropsychiatric abnormalities in patients with liver dysfunction, after the exclusion of brain disease.
DIRECTION OF USE:
Infusion concentrate for I.V. slow drip infusion Guidelines for the Administration: Infusion Concentrate can be added to any of the conventional Intravenous Fluids (saline or Dextrose).
The normal rate is one ampoule per 100ml IV fluids. However, the dose should not exceed ampoules per 500ml IV fluids.
CAUTION AND WARNING:
CAUTION: Do not use if any particle or suspended matter or any breakage is visible.Discard any unused portion
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE AND DOSAGE:
STORAGE: Store protected from light at a temperature not exceeding 30°C.
KEEP OUT OF REACH OF CHILDREN.
DOSAGE: As directed by the Physician.