Hepatitis-sode

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• Synergy Formulas, Inc.
  

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  Hepatitis-sode | Methapharm Inc.

  

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  Before Provocholine® (methacholine chloride powder for inhalation) Inhalation challenge is begun, baseline pulmonary function tests must be performed. A subject to be challenged must have an FEV1 of at least 70% of the predicted value.

  
  The target level for a positive challenge is a 20% reduction in the FEV1 compared with the baseline value after inhalation of the control sodium chloride solution (Note: Use the same diluent that the Provocholine® powder has been reconstituted with for the baseline spirometry). This target value should be calculated and recorded before Provocholine® challenge is started.

  
  Dilutions: (Note: Do not inhale powder. Do not handle this material if you have asthma or hay fever.) All dilutions should be made with 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0) using sterile, empty USP Type I borosilcate glass vials. After adding the sodium chloride solution, shake each vial to obtain a clear solution (Note: When preparing dilutions, use only the same kind of diluent to prepare all concentrations).

  Multiple Patient Dilution Sequence

  Multiple Patient Testing (2 5 patients), requires 2 vials of Provocholine® 100 mg  Vials  Instructions  Concentrations

   A 1 & A2

   Add 4 mL of 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0) to each of two 20 mL vials containing 100 mg of Provocholine® (methacholine chloride powder for inhalation). These will be designated vials A1 and A2.  25 mg/mL  B  Remove 3 mL from vial A1, transfer to another vial and add 4.5 mL of 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0). This is vial B.  10 mg/mL  C  Remove 1 mL from vial A2, transfer to another vial and add 9 mL of 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0). This is vial C.  2.5 mg/mL  D  Remove 1 mL from vial C, transfer to another vial and add 9 mL of 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0). This is vial D  0.25 mg/mL  E  Remove 1 mL from vial D, transfer to another vial and add 9 mL of 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0). This is vial E. Vial E must be prepared on the day of challenge.  0.025 mg/mL   Multiple Patient Testing (16 - 40 patients), requires 1 vial of Provocholine® 1600mg  Vials  Instructions  Concentration  Stock Solution  Add 40 mL of 00.9% saline or 0.9% saline with 0.4% phenol to the 50 mL vial containing 1600 mg of Provocholine®. This vial of 40 mg/mL will be designated as the stock solution to obtain the balance of the dilutions needed to perform the test.

  DO NOT ADMINISTER TO PATIENTS

   40 mg/mL

  DO NOT ADMINISTER TO PATIENTS

   A  Remove 25 mL from the vial labeled stock solution and transfer to another vial and add 15 mL of 0.9% saline or 0.9% saline with 0.4% phenol. This is vial A. 25 mg/mL  B  Remove 10 mL from the vial labeled stock solution and transfer to another vial add 30 mL of 0.9% saline or 0.9% saline with 0.4% phenol. This is vial B  10 mg/mL  C  Remove 3 mL from the vial labeled stock solution and transfer to another vial add 45 mL of 0.9% saline or 0.9% saline with 0.4% phenol. This is vial C.  2.5 mg/mL  D  Remove 5 mL from vial C and transfer to another vial add 45 mL of 0.9% saline or 0.9% saline with 0.4% phenol. This is vial D.  0.25 mg/mL  E  Remove 1 mL from vial D and transfer to another vial add 9 mL of 00.9% saline or 0.9% saline with 0.4% phenol. This is vial E. Vial E must be prepared on the day of the challenge.  0.025 mg/mL

  Single Patient Dilution Sequence

  Single Patient Testing, requires 1 vial of Provocholine® 100 mg  Vials  Instructions  Concentration  A  Add 4 mL of 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0) to the 20 mL vial containing 100 mg of Provocholine®(methacholine chloride powder for inhalation). This is vial A.  25 mg/mL  B  Remove 1 mL from vial A, transfer to another vial and add 1.5 mL of 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0). This is vial B.  10 mg/mL  C  Remove 1 mL from vial A, transfer to another vial and add 9 mL of 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0). This is vial C.  2.5 mg/mL  D  Remove 1 mL from vial C, transfer to another vial and add 9 mL of 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0). This is vial D.  0.25 mg/mL  E  Remove 1 mL from vial D, transfer to another vial and add 9 mL of 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0). This is vial E. Vial E must be prepared on the day of the challenge.  0.025 mg/mL

  Dilutions A through D should be stored at 36° to 46°F (2° to 8°C) in a refrigerator and can be stored for not more than 2 weeks. [The unreconstituted powder should be stored at 59°F to 86°F (15° to 30°C)]. After this time, discard the vials and prepare new dilutions.  Freezing does not affect the stability of dilutions A through D.  Vial E must be prepared on the day of challenge.

  A Sterile bacterial-retentive filter (porosity 0.22µm) should be used when transferring a solution from each vial (at least 2mL) to a nebulizer.

  Procedure:  A standardized procedure for inhalation has been developed.

  The challenge is performed by giving a subject ascending serial concentrations of Provocholine®.  At each concentration, five breaths are administered by a nebulizer that permits intermittent delivery time of 0.6 seconds by a breath-actuated timing device (dosimeter).

  At each of five inhalations of a serial concentration, the subject begins at functional residual capacity (FRC) and slowly and completely inhales the dose delivered.  Within 5 minutes, FEV1 values are determined.  The procedure ends either when there is a 20% or greater reduction in FEV1 compared with the baseline sodium chloride solution value (i.e., a positive response) or if 188.88 total cumulative units has been administered (see table below) and the FEV1 has been reduced by 14% or less (i.e., a negative response).  If there is a reduction of 15% to 19% in the FEV1 compared with baseline, either the challenge may be repeated at that concentration or a higher concentration may be given as long as the dosage administered does not result in total cumulative units exceeding 188.88.

  The following is a suggested schedule for the administration of Provocholine® (methacholine chloride powder for inhalation) challenge.  Cumulative units are calculated by multiplying the number of breaths by the concentration administered.

  Total cumulative units are the sum of cumulative units for each concentration administered.

   Serial Concentration  Number of Breaths  Cumulative Units per Concentration  Total Cumulative Units  0.025 mg/mL  5  0.125  0.125  0.25 mg/mL  5  1.25  1.375  2.5 mg/mL  5  12.5  13.88  10 mg/mL  5  50.0  63.88  25 mg/mL  5  125.0  188.88

  An inhaled beta-agonist may be administered after Provocholine® challenge to expedite the return of the FEV1 to baseline and to relieve the discomfort of the subject.  Most patients revert to normal pulmonary function within 5 minutes following bronchodilators or within 30 to 45 minutes without any bronchodilator.

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