| Product Name: | Methylergometrine Maleate Injection USP |
| Brand Name: | (GENERICS) |
| Strength: | 0.2mg/ml |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 1ml Ampoule |
| Route of Administration: | For IM/ IV 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: | Ergot alkaloids, Uterotonic, Gynaecology |
| Indication: | This Injection belongs to the class of medication called ‘ergot alkaloids’ or ‘uterotonic’ primarily used to prevent and stop heavy bleeding (postpartum-third stage of labor bleeding) after childbirth or after a miscarriage in cesarean section. |
| Storage: | Store in refrigerator at 2°C -8°C (36°F-46°F). Protect from light. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Methylergometrine Maleate Injection USP 0.2mg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Methylergometrine Maleate Injection USP 0.2mg/ml
Each ml. contains:
Methylergometrine Maleate USP…………..0.2mg
Excipients:
Maleic acid USP…………………………………..0.10mg
Sodium chloride USP………………………….10 mg
Water for Injection USP…………………….qs to 1ml
THERAPEUTIC INDICATION:
This Injection belongs to the class of medication called ‘ergot alkaloids’ or ‘uterotonic’ primarily used to prevent and stop heavy bleeding (postpartum-third stage of labor bleeding) after childbirth or after a miscarriage in cesarean section.
CAUTION & WARNING:
CAUTION: Administer only if the solution is clear and colorless.
DO NOT ACCEPT IF THE VIAL SEAL IS BROKEN.
Discard any unused solution.
KEEP OUT OF REACH OF CHILDREN.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store in refrigerator at 2°C -8°C (36°F-46°F). Protect from light.
Dosage: Usual dose: One ml. intravenously or intramuscularly after delivery of anterior shoulder, after delivery of the placenta, or during the puerperium.
See package insert for further dosage information.