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Nalbuphine Hydrochloride (Nalbuphine Hydrochloride)

Trade Name : Nalbuphine Hydrochloride

Medical Purchasing Solutions, LLC

INJECTION, SOLUTION

Strength 10 mg/mL

NALBUPHINE HYDROCHLORIDE Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA]

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Nalbuphine Hydrochloride (Nalbuphine Hydrochloride) which is also known as Nalbuphine Hydrochloride and Manufactured by Medical Purchasing Solutions, LLC. It is available in strength of 10 mg/mL per ml. Read more

Nalbuphine Hydrochloride (Nalbuphine Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Injectionn n n Ampuln n n Fliptop Vialn n n Protect from light.n n n
  • Rx only
  • No data
  • Nalbuphine hydrochloride is a synthetic opioid agonist-antagonist analgesic of the phenanthrene series. It is chemically related to both the widely used opioid antagonist, naloxone, and the potent opioid analgesic, oxymorphone. Chemically nalbuphine hydrochloride is 17-(cyclobutylmethyl)-4,5u03b1-epoxymorphinan-3,6u03b1,14-triol hydrochloride. Nalbuphine hydrochloride molecular weight is 393.91 and is soluble in Hn n n O (35.5 mg/mL at 25u00b0C) and ethanol (0.8%); insoluble in CHCln n n and ether. Nalbuphine hydrochloride has pKa values of 8.71 and 9.96. The molecular formula is Cn n n Hn n n NOn n n u2219 HCl. The structural formula is:n nn
  • Nalbuphine Hydrochloride Injection is a sterile, nonpyrogenic solution of nalbuphine hydrochloride in water for injection. This product may be administered by subcutaneous, intramuscular or intravenous injection.
  • Each milliliter (mL) contains nalbuphine hydrochloride 10 mg or 20 mg; sodium citrate, dihydrate 0.47 mg and citric acid, anhydrous 0.63 mg added as buffers and may contain sodium hydroxide and/or hydrochloric acid for pH adjustment; pH 3.7 (3.0 to 4.5). Contains sodium chloride for tonicity adjustment.
  • Multiple-dose vials contain 1.8 mg/mL methylparaben and 0.2 mg/mL propylparaben added as preservatives. Single-dose products contain no bacteriostat or antimicrobial agent and unused portions must be discarded.
  • Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date.
  • Nalbuphine Hydrochloride Injection is a potent analgesic. Its analgesic potency is essentially equivalent to that of morphine on a milligram basis. Receptor studies show that nalbuphine hydrochloride binds to mu, kappa, and delta receptors, but not to sigma receptors. Nalbuphine hydrochloride is primarily a kappa agonist/partial mu antagonist analgesic.
  • The onset of action of nalbuphine hydrochloride occurs within 2 to 3 minutes after intravenous administration, and in less than 15 minutes following subcutaneous or intramuscular injection. The plasma half-life of nalbuphine is 5 hours, and in clinical studies the duration of analgesic activity has been reported to range from 3 to 6 hours.
  • The opioid antagonist activity of nalbuphine hydrochloride is one-fourth as potent as nalorphine and 10 times that of pentazocine.
  • Nalbuphine hydrochloride may produce the same degree of respiratory depression as equianalgesic doses of morphine. However, Nalbuphine Hydrochloride Injection exhibits a ceiling effect such that increases in dose greater than 30 mg do not produce further respiratory depression in the absence of other CNS active medications affecting respiration.
  • Nalbuphine hydrochloride by itself has potent opioid antagonist activity at doses equal to or lower than its analgesic dose. When administered following or concurrent with mu00b5 agonist opioid analgesics (e.g., morphine, oxymorphone, fentanyl), nalbuphine hydrochloride may partially reverse or block opioid-induced respiratory depression from the mu00b5 agonist analgesic. Nalbuphine Hydrochloride Injection may precipitate withdrawal in patients dependent on opioid drugs. Nalbuphine Hydrochloride Injection should be used with caution in patients who have been receiving mu opioid analgesics on a regular basis.
  • Nalbuphine Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Nalbuphine Hydrochloride Injection can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery.
  • Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see n n n ], reserve Nalbuphine Hydrochloride Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]n nn
  • Nalbuphine Hydrochloride Injection is contraindicated in patients with:
  • No data
  • No data
  • The most frequent adverse reaction in 1066 patients treated in clinical studies with Nalbuphine Hydrochloride Injection was sedation 381 (36%).
  • Less frequent reactions were: sweaty/clammy 99 (9%), nausea/vomiting 68 (6%), dizziness/vertigo 58 (5%), dry mouth 44 (4%), and headache 27 (3%).
  • Other adverse reactions which occurred (reported incidence of 1% or less) were:
  • CNS Effects:
  • Cardiovascular:
  • Gastrointestinal:
  • Respiratory:
  • Dermatologic:
  • Miscellaneous:
  • Allergic Reactions:
  • Due to the nature and limitations of spontaneous reporting, causality has not been established for the following adverse events received for Nalbuphine Hydrochloride Injection: abdominal pain, pyrexia, depressed level or loss of consciousness, somnolence, tremor, anxiety, pulmonary edema, agitation, seizures, and injection site reactions such as pain, swelling, redness, burning, and hot sensations. Death has been reported from severe allergic reactions to Nalbuphine Hydrochloride Injection treatment. Fetal death has been reported where mothers received Nalbuphine Hydrochloride Injection during labor and delivery.
  • Serotonin syndrome:
  • Adrenal insufficiency:
  • No data
  • No data
  • No data
  • Nalbuphine Hydrochloride Injection for intramuscular, subcutaneous, or intravenous use is a sterile solution available in:
  • Store at 20 to 25u00b0C (68 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Protect from excessive light.
  • LAB-0839-2.0
  • 12/2016
  • Hospira, Inc., Lake Forest, IL 60045 USA
  • NDC 71872-7114-1
  • Nalbuphine HCI Ing.
  • 10mg/mL
  • 1 - 10 mL Multiple Dose Vial
  • FOR I.V, I.M, or S.C. use.
  • Rx Only
  • 10 mL Multiple-dose
  • NALBUPHINE
  • 10 mg/mL
  • For I.V., I.M., or S.C. use.

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Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

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Name Patient Supply

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Validated Cold Chain Shipment

Validated Cold Chain Shipment

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Clinical Trials Supply

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