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Bain
  Nalbuphine
       10mg/1ml




         華宇藥品股份有限公司
    高啟峰 arguskao@gmail.com
Nubain
          Bain
非管制麻醉用藥
唯一
非管制的麻醉藥品
How
to control
 Pain
Morphine
              Fentanyl
Nacortic      Demerol
              Tramadol



NSAIDs     Ketorolac
Bain  injection
Nalbuphine HCl



  • Kappa-agonist/mu-receptor antagonist analgesic1
      –     Faster onset and long-acting , Potent analgesic
      –     Minimal respiratory depression
      –     Lower incidence of post-OP ileus, constipation, biliary spasm,
            and pruritus
      –     Lower incidence of euphoria and morphine-like dependence
      –     Lower incidence of nausea and vomiting




    Reference:   1. Schmidt WK, Tam SW, Shotzberger GS, Smith DH, Clark R, Vernier VE. Nalbuphine. Drug and Alcohol
                 Dependence. 1985;14:339-362.
Mu Receptor

      Morphine
                         Bain
       Agonist           Antagonist
                         Lower respiratory depression

Fentanyl     Pethidine
Kappa Receptor




 Morphine
                  Bain
                     Agonist
Weak Agonist
Duration(hours)
Recommended Dosage

       5-10mg
      0.1mg/kg
Adverse reactions
 Sedations(36%)
 Sweaty/clammy(9%)
 Nausea(6%)
 Dizziness/vertigo(5%)
 Dry mouth(4%)
 Headache(3%)
Bain  injection           Established Clinical Profile
Nalbuphine HCl                               in Pain Management

   Features                           Bain (nalbuphine HCl)
                                                       HCl)                    .

   Indication                         Moderate to severe pain
                                      Supplement to balanced anesthesia
                                      Pre-op and post-op analgesia
                                      Pre-        post-
                                      Obstetrical analgesia during labor and
                                      delivery*


   Route of Administration            IM, IV, SC

   Recommended Dose                   5-10 mg (0.1 mg/kg; 10 mg/1 ml)
   Onset of Action                    2-3 minutes IV

   Duration of Analgesia              3-6 hours (Plasma t1/2 = 5 hr)

   Respiratory Depressant Effect      “Ceiling Effect”7,8
                                               Effect”

   Cardiovascular Effect              Slightly lowers cardiac workload 9-11
Bain  injection
                         Nalbuphine HCl




Safety and Efficacy in a broad spectrum of
Clinical Settings:
   Added Comfort to Patients
Recovery Room:
 Rapid Return to Spontaneous Respiration and Full Consciousness
 Adequate Post-operative Ventilation
 Cardiovascular Stability
 Very Low Incidence of Nausea/Vomiting
 Shorter Stay in the Recovery Room
Bain      injection
                        Nalbuphine HCl




Safety and Efficacy in a broad spectrum of
Clinical Settings:
   Added Comfort to Patients
Post-Operative Setting:
   Minimal Respiratory Depression            Treatment for Morphine-induced Pruritus
   Faster Onset and Long-acting Analgesia    Treatment for Post-op Shivering
   Lower Incidence of GI Distress            Maintenance of Analgesia while Treating
   A Very Low Incidence of Nausea/Vomiting    Morphine-induced Adverse Effects
Bain  injection
Nalbuphine HCl

• Safety and Efficacy in a Broad Spectrum of Clinical
 Settings

                                                                             Emergency Room*
                                                                             • Rapid onset – within 2 to 3
                                                                                minutes IV, less than 15
                                                                                minutes IM or SC.
                                                                             • Favorable haemodynamic
                                                                               profile compared to that of
                                                                               morphine.9
                                                                             • Concomitant use may
                                                                               produce an additive effect
                                                                               with other narcotics,
                                                                               tranquilizers, and
                                                                               sedatives.
    Reference:   9. Lee G, Low RI, Amsterdam EA, DeMaria AN, Huber PW, Mason DT. Haemodynamic effects of morphine and nalbuphine
                 in acute myocardial infarction. Clinical Pharmacology and Therapeutics. 1981;29(5):576-581.
                 *. Maintain patient under observation until recovered from Nubain effects. Nubain may impair mental or physical abilities
                 required for the performance of potentially dangerous tasks such as driving a car or operating machinery.
Reference (I)                   - Respiratory depression

• Clin Pharmacol Ther 1980 Apr; 27(4): 478-485
• Ceiling effect for respiratory depression by nalbuphine
   • Narcotic antagonist analgesic: nalorphine (X), nalbuphine
       - lower abuse liability
       - ceiling effect for respiratory depression
       - potency comparable to that of morphine

   • Maximum respiratory depression occurred at 30 mg/70 kg.
• The ceiling effect for respiratory depression by
  nalbuphine provides a unique safety factor among
  potent analgesics.
Reference (II)                      - Gastrointestinal
• Br J Anaesth 1987; 59: 581-584
• Recovery of bowel motility after surgery
   • Clinical indication of the return of coordinated bowel motility following
       surgery is the passage of flatus
    • Flatus: 5-80% CO   2

       - Carbon dioxide analyzer to note the time to first flatus (TFF)
    • Nalbuphine, Placebo (NS), morphine
    • The median TFF:
       - Bain vs. Placebo: 212 min: 64 min (3 times)
       - IM Bain vs. morphine: 5.65 h: 11.84 h

• Nalbuphine will have considerably less adverse
   effect on recovery of bowel function than morphine.
Bain包裝規格
   中文品名:芯奔
   英文品名:Bain Injection 10Amps/box
   劑型  :注射液
   成分  :nalbuphine HCl 10mg/ml
   適應症:

   解除中度到嚴重疼痛,也可作為平衡
   麻醉的輔助劑。如手術前後之止痛,
   及在分娩陣痛過程中的產科止痛

   健保價:   52元/Amp
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Bain

  • 1. Bain Nalbuphine 10mg/1ml 華宇藥品股份有限公司 高啟峰 arguskao@gmail.com
  • 2. Nubain Bain 非管制麻醉用藥
  • 5. Morphine Fentanyl Nacortic Demerol Tramadol NSAIDs Ketorolac
  • 6.
  • 7. Bain injection Nalbuphine HCl • Kappa-agonist/mu-receptor antagonist analgesic1 – Faster onset and long-acting , Potent analgesic – Minimal respiratory depression – Lower incidence of post-OP ileus, constipation, biliary spasm, and pruritus – Lower incidence of euphoria and morphine-like dependence – Lower incidence of nausea and vomiting Reference: 1. Schmidt WK, Tam SW, Shotzberger GS, Smith DH, Clark R, Vernier VE. Nalbuphine. Drug and Alcohol Dependence. 1985;14:339-362.
  • 8. Mu Receptor Morphine Bain Agonist Antagonist Lower respiratory depression Fentanyl Pethidine
  • 9. Kappa Receptor Morphine Bain Agonist Weak Agonist
  • 11. Recommended Dosage 5-10mg 0.1mg/kg
  • 12. Adverse reactions  Sedations(36%)  Sweaty/clammy(9%)  Nausea(6%)  Dizziness/vertigo(5%)  Dry mouth(4%)  Headache(3%)
  • 13. Bain injection Established Clinical Profile Nalbuphine HCl in Pain Management Features Bain (nalbuphine HCl) HCl) . Indication Moderate to severe pain Supplement to balanced anesthesia Pre-op and post-op analgesia Pre- post- Obstetrical analgesia during labor and delivery* Route of Administration IM, IV, SC Recommended Dose 5-10 mg (0.1 mg/kg; 10 mg/1 ml) Onset of Action 2-3 minutes IV Duration of Analgesia 3-6 hours (Plasma t1/2 = 5 hr) Respiratory Depressant Effect “Ceiling Effect”7,8 Effect” Cardiovascular Effect Slightly lowers cardiac workload 9-11
  • 14. Bain injection Nalbuphine HCl Safety and Efficacy in a broad spectrum of Clinical Settings: Added Comfort to Patients Recovery Room:  Rapid Return to Spontaneous Respiration and Full Consciousness  Adequate Post-operative Ventilation  Cardiovascular Stability  Very Low Incidence of Nausea/Vomiting  Shorter Stay in the Recovery Room
  • 15. Bain injection Nalbuphine HCl Safety and Efficacy in a broad spectrum of Clinical Settings: Added Comfort to Patients Post-Operative Setting:  Minimal Respiratory Depression  Treatment for Morphine-induced Pruritus  Faster Onset and Long-acting Analgesia  Treatment for Post-op Shivering  Lower Incidence of GI Distress  Maintenance of Analgesia while Treating  A Very Low Incidence of Nausea/Vomiting Morphine-induced Adverse Effects
  • 16. Bain injection Nalbuphine HCl • Safety and Efficacy in a Broad Spectrum of Clinical Settings Emergency Room* • Rapid onset – within 2 to 3 minutes IV, less than 15 minutes IM or SC. • Favorable haemodynamic profile compared to that of morphine.9 • Concomitant use may produce an additive effect with other narcotics, tranquilizers, and sedatives. Reference: 9. Lee G, Low RI, Amsterdam EA, DeMaria AN, Huber PW, Mason DT. Haemodynamic effects of morphine and nalbuphine in acute myocardial infarction. Clinical Pharmacology and Therapeutics. 1981;29(5):576-581. *. Maintain patient under observation until recovered from Nubain effects. Nubain may impair mental or physical abilities required for the performance of potentially dangerous tasks such as driving a car or operating machinery.
  • 17. Reference (I) - Respiratory depression • Clin Pharmacol Ther 1980 Apr; 27(4): 478-485 • Ceiling effect for respiratory depression by nalbuphine • Narcotic antagonist analgesic: nalorphine (X), nalbuphine - lower abuse liability - ceiling effect for respiratory depression - potency comparable to that of morphine • Maximum respiratory depression occurred at 30 mg/70 kg. • The ceiling effect for respiratory depression by nalbuphine provides a unique safety factor among potent analgesics.
  • 18. Reference (II) - Gastrointestinal • Br J Anaesth 1987; 59: 581-584 • Recovery of bowel motility after surgery • Clinical indication of the return of coordinated bowel motility following surgery is the passage of flatus • Flatus: 5-80% CO 2 - Carbon dioxide analyzer to note the time to first flatus (TFF) • Nalbuphine, Placebo (NS), morphine • The median TFF: - Bain vs. Placebo: 212 min: 64 min (3 times) - IM Bain vs. morphine: 5.65 h: 11.84 h • Nalbuphine will have considerably less adverse effect on recovery of bowel function than morphine.
  • 19. Bain包裝規格 中文品名:芯奔 英文品名:Bain Injection 10Amps/box 劑型 :注射液 成分 :nalbuphine HCl 10mg/ml 適應症: 解除中度到嚴重疼痛,也可作為平衡 麻醉的輔助劑。如手術前後之止痛, 及在分娩陣痛過程中的產科止痛 健保價: 52元/Amp
  • 20. Thanks for your kindness