| Product Name: | Magnesium Sulfate Injection USP |
| Brand Name: | (GENERICS) |
| Strength: | 1g/2ml , 5g/10ml , 10g/20ml |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 2ml, 10ml, 20ml Vial & 2ml, 5ml, 10ml Ampoule |
| Route of Administration: | For I.M./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: | Antiepileptic, Anticonvulsant, Minerals |
| Indication: | This Injection is a mineral supplement, and an anticonvulsant primarily used to prevent and control seizures (fits) in preeclampsia and eclampsia, serious complications in pregnancy that occur due to high blood pressure. It is also used to treat acute hypomagnesaemia, a condition characterized by abnormally low magnesium levels in the blood. |
| Storage: | Store at 20°C to 25°C (68° to 77°). See USP controlled room temperature. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Magnesium Sulfate Injection USP 1g/2ml
- Magnesium Sulfate Injection USP 5g/10ml
- Magnesium Sulfate Injection USP 10g/20ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Magnesium Sulfate Injection USP 1g/2ml
Each ml contains:
Magnesium Sulfate USP (as Heptahydrate) …………….1g
Water for Injection USP……………………. q.s.
- Magnesium Sulfate Injection USP 5g/10ml
Each ml contains:
Magnesium Sulfate USP (as Heptahydrate) ……………… 5g
Water for Injection USP……………………. q.s.
- Magnesium Sulfate Injection USP 10g/20ml
Each ml contains:
Magnesium Sulfate USP (as Heptahydrate) ………………10g
Water for Injection USP……………………. q.s.
THERAPEUTIC INDICATION:
This Injection is a mineral supplement, and an anticonvulsant primarily used to prevent and control seizures (fits) in preeclampsia and eclampsia, serious complications in pregnancy that occur due to high blood pressure. It is also used to treat acute hypomagnesaemia, a condition characterized by abnormally low magnesium levels in the blood.
DIRECTION OF USE:
For I.M. /I. V use only.
Refer enclosed leaflet for further information.
CAUTION & Warning:
CAUTION:
Do not use if any foreign particulate matter is visible.
DO NOT ACCEPT IF VIAL SEAL IS BROKEN.
Must Dilute before IV Infusion
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° to 77°). See USP controlled room temperature.
*Total Osmolar concentration is approx. 4.060 mOsmol/ml*
Sterile
Non pyrogenic
Preservative free
Dosage: As directed by Physician.