| Product Name: | Oxytocin Injection 5 I.U. |
| Brand Name: | Oxytocin Injection |
| Strength: | 5 I.U., 10 I.U. |
| Dosage Form: | Liquid Injection (SVP) |
| Packing: | 5 x 1 ml ampoules |
| Route of Administration: | For I.V. and I.M. use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Product Permission, Stability Studies, GMP |
| Therapeutic use: | Hormones |
| Indication: | Oxytocin is a sterile, clear, colourless aqueous solution of synthetic Oxytocin, for intravenous infusion or intramuscular injection. Oxytocin is a nonapeptide found in pituitary extracts from mammals. It is standardized to contain 10 units of oxytocic hormone/ml and contains 0.5% Chlorobutanol, a chloroform derivative as a preservative, with the pH adjusted with acetic acid. |
| Storage: | Store protected from moisture. Do not freeze. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Oxytocin injection 5 I.U.
- Oxytocin injection 10 I.U.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Oxytocin injection 5 I.U.
Each 1ml ampoules contains:
Oxytocin BP (Synthetic)…………………………5.0 I.U.
Chlorbutol USP…………………………………………10 I.U.
(As a Preservative)
Water for Injection USP………………………………q.s. - Oxytocin injection 10 I.U.
Each 1ml ampoules contains:
Oxytocin BP (Synthetic)…………………………10.0 I.U.
Chlorbutol USP…………………………………………10 I.U.
(As a Preservative)
Water for Injection USP………………………………q.s.
THERAPEUTIC INDICATION:
Oxytocin is a sterile, clear, colorless aqueous solution of synthetic Oxytocin, for intravenous infusion or intramuscular injection. Oxytocin is a nonapeptide found in pituitary extracts from mammals. It is standardized to contain 10 units of oxytocic hormone/ml and contains 0.5% Chlorobutanol, a chloroform derivative as a preservative, with the pH adjusted with acetic acid.
CAUTION AND SCHEDULE:
CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution
For Slow Intravenous use.
For Intramuscular use.
For Subcutaneous use.
Discard unused portions.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG-CAUTION: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE AND DOSAGE:
STORAGE: Store protected from moisture. Do not freeze.
KEEP OUT OF REACH OF CHILDREN
For indications, dosage, and administration, see the enclosed leaflet.
DOSAGE: As Prescribed by the physician.