NUBAIN Solution for injection Ref.[27884] Active ingredients: Nalbuphine

Source: Health Products and Food Branch (CA)  Revision Year: 2018 

Product name

NUBAIN – Nalbuphine Hydrochloride Injection, 10 mg/mL.

Summary product information

Route of AdministrationDosage Form/StrengthClinically Relevant Nonmedicinal Ingredients
Subcutaneously, intramuscularly or intravenouslySolution for injectionSodium chloride, sodium citrate dihydrate, citric acid and water for injection. For a complete listing see Dosage Forms, Composition and Packaging section.

Dosage forms, composition and packaging

NUBAIN (10.0 mg/mL) 1 mL Ampoule: Each mL contains 10.0 mg nalbuphine hydrochloride, 2.0 mg sodium chloride, 9.41 mg sodium citrate dihydrate, 12.62 mg citric acid and water for injection; pH adjusted with hydrochloric acid.

NUBAIN is available in 1 mL ampoules, boxes of 2 × 5 ampoules.

Marketing Informations Authorization Dates
Authorization holder:

Sandoz Canada Inc., 145 Jules-Lรฉger, Boucherville, Quebec, J4B 7K8

Submission control number:

213120

Date of revision:

April 3, 2018

Drugs

Drug Countries
NUBAIN Austria, Brazil, Canada

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