| Product Name: | Naloxone Hydrochloride Injection USP |
| Brand Name: | Generic |
| Strength: | 400mcg/ml |
| Dosage Form: | Liquid Injection |
| Packing: | 1ml ampoule, 10ml vial |
| Route of Administration: | For I.M./I.V./S.C. 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: | opiate antagonists |
| Indication: | Naloxone is a medication approved by the Food and Drug Administration (FDA) designed to rapidly reverse opioid overdose. It is an opioid antagonist—meaning that it binds to opioid receptors and can reverse and block the effects of other opioids, such as heroin, morphine, and oxycodone. |
| Storage: | Store at 20 to 25°C Protect from light. |
GENERIC NAME OF MEDICINAL PRODUCT:
Naloxone Hydrochloride Injection USP 400mcg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Naloxone Hydrochloride Injection USP 400mcg/ml
Each ml contains
Naloxone Hydrochloride Dihydrate USP Equivalent to
Anhydrous Naloxone Hydrochloride………………………400 mcg
Water for injection………………………………………………..q.s.
Therapeutic indication:
Naloxone is a medication approved by the Food and Drug Administration (FDA) designed to rapidly reverse opioid overdose. It is an opioid antagonist—meaning that it binds to opioid receptors and can reverse and block the effects of other opioids, such as heroin,
morphine, and oxycodone.
Caution & warning:
Caution: keep out of reach of children.
If any foreign particle is visible in the vial after dissolving the contents. Please do not use the solution & return it for a replacement.
WARNING: Not to be sold by retail without the prescription of a registered medical practitioner
Storage & dosage:
Storage:
Store at 20 to 25°C Protect from light.
Dosage:
As directed by the physician.