| Product Name: | Nalbuphine Hydrochloride Dihydrate |
| Brand Name: | Generic |
| Strength: | 10mg, 20mg |
| Dosage Form: | Liquid Injection |
| Route of Administration: | For Intravenous, Intramuscular, or Subcutaneous |
| Packing: | 1 ml single dose 10 ampule |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Narcotic Analgesic |
| Indication: | Nalbuphine Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. |
| Storage: | Protect from light. Keep ampuls in tray until time of use. Store at 20 to 25°C (68 to 77°F) |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Nalbuphine Hydrochloride Dihydrate 10mg
B) Nalbuphine Hydrochloride Dihydrate 20mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Nalbuphine Hydrochloride Dihydrate 10mg
Each mL contains
nalbuphine HCI ……………………10 mg
sodium citrate, dihydrate…… 0.47 mg
citric acid, anhydrous ………….0.63 mg
B) Nalbuphine Hydrochloride Dihydrate 20mg
Each mL contains
nalbuphine HCI ……………………20 mg
sodium citrate, dihydrate…… 0.47 mg
citric acid, anhydrous ………….0.63 mg
THERAPEUTIC INDICATIONS:
Nalbuphine Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Direction of Use:
Administered as a supplement to general anesthesia only by persons specifically trained in the use of intravenous anesthetics and management of the respiratory effects of potent opioids.
STORAGE & DOSAGE:
Storage: Store at 20 to 25°C (68 to 77°F).
Protect from light by retaining in carton until contents are used.
Dosage: Sterile, non-pyrogenic. Use aseptic technique.
Remove cover from flip top vial and cleanse stopper with antiseptic.