Advanced Acne Wash

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• Elorac, Inc.
  

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  Advanced Acne Wash | Alk-abello, Inc.

  

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  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

  When diluting bulk extracts, use of either Sterile Diluent for Allergenic Extracts or Sterile Diluent for Allergenic Extracts Normal Saline with HSA is recommended. Dilutions should be made with sterile disposable syringes using aseptic technique. Commonly 10 fold dilutions are used to achieve a desired concentration for intradermal testing or initiation and continuation of immunotherapy. For example, transferring 0.5 mL of a 10,000 AU/mL extract into 4.5 mL of diluent will yield 5 mL of extract @ 1,000 AU/mL. Prepare as many additional serial dilutions as necessary to reach the appropriate concentration.

  Care should be exercised to avoid cross contamination of allergens if mixing with other allergenic extracts. The use of separate syringes for each allergen and diluent when compounding patient mixes is recommended.

  Diagnosis - In diagnosing the sensitive individual, the symptom history must be associated with exposure to the allergen. Skin testing is used in conjunction with a definitive history for diagnosing individual sensitivities.

  An excellent method of recording results is to cover the skin reaction with transparent tape, outline the erythema first then the wheal with an indelible pen, then remove the tape and transfer it to the patient's permanent record. For preferred results, it is recommended that the actual measurement of the extent of both responses be recorded. This can be accomplished by measuring the longest erythema diameter, then selecting the mid - point of that line and measuring at a 90° angle to that line to determine the orthogonal diameter. The sum of these two measurements is the sum of erythema (ƩE); the sum of wheal diameters is determined in a similar manner.

  Patient's response is graded on the basis of the size of erythema and/or wheal.

  Percutaneous (prick/scratch/puncture) test:

  Prick, scratch, or puncture skin tests should be performed initially using an extract specially made for this purpose. The usual dose is one drop.

  In a skin test study of 10 patients who were determined to be allergic to mite (D. farinae), the mean puncture test (using a bifurcated needle) to a solution containing 10,000 AU/mL had a sum of erythema of 73 mm (range 43 - 138 mm) and a sum of wheal of 17 mm (range 7 - 31 mm).

  In another skin test study of 11 patients who were determined to be allergic to mite (D. pteronyssinus), the mean puncture test (using a bifurcated needle) to a solution containing 10,000 AU/mL had a sum of erythema of 84 mm (range 56 - 112 mm) and a sum of wheal of 20 mm (range 7 - 33 mm).

  What follows are general guidelines for percutaneous testing. Different devices and/or techniques influence the size of the reaction, therefore it is important to refer to the device manufacturer's or distributor's instructions when grading reactions.

  0       No wheal. Erythema absent or very slight (not more than 1 mm in diameter).

  +       Wheal absent or very slight erythema present (not more than 3 mm diameter).

  ++       Wheal not more than 3 mm diameter, or erythema not more than 5 mm diameter.

  +++       Wheal between 3 mm and 5 mm in diameter with erythema. Possible pseudopodia and itching.

  ++++       Any larger reaction with itching and possible pain.

  Intradermal test:

  On the forearm or upper outer aspect of the arm, using a 26 - 27 gauge, short bevel needle, inject intradermally .05 mL of the intradermal test solution. Skin whealing responses should be observed 10 - 20 minutes after administering the test.

  In a skin test study of the 10 mite puncture reactive patients (D. farinae) described above, the mean intradermal dose for ƩE = 50 mm was 0.01 AU/mL ( range = <0.0003 to 0.4 AU/mL).

  In the skin test study of the 11 mite puncture reactive patients (D. pteronyssinus) described above, the mean intradermal dose for ƩE = 50 mm was 0.006 AU/mL ( range = <0.0007 to 0.05 AU/mL).

  Intradermal testing should start with a dilute solution, usually in the range of 1 AU or less.

  Glycerinated extracts diluted for intradermal testing may be diluted at least 25 fold to less than 2% glycerin (by volume) as glycerin above this level can cause false positive intradermal skin tests.

  A negative skin test is one where the sum of erythema was 0 or equal to the sum of the wheal. As a negative control, the diluent should be tested and included in the interpretation of the skin reactions.

  0       No increase in size of bleb since injection. No erythema.

  +       An increase in size of bleb and a wheal not more than 5 mm diameter with associated erythema.

  ++       Wheal between 5 mm and 8 mm in diameter with erythema.

  +++       Wheal between 8 mm and 12 mm in diameter with erythema and possible pseudopodia, itching or pain.

  ++++       Any larger reaction with itching and pain and possible diffuse blush of the skin surrounding the reaction area.

  Immunotherapy - Starting dose for immunotherapy is related directly to a patient's sensitivity as determined by carefully executed skin testing. Degree of sensitivity can be established by determination of D50 (the intradermal dose, base three, that produces a ƩE = 50 mm).1  

  A general rule is to begin at 1/10 of the dose that produces sum of erythema of 50 mm (approximately a 2+ positive skin test reaction). For example, if a patient exhibits a 2+ intradermal reaction to

  1 AU/mL, the first dose should be no higher than 0.05 mL of 0.1 AU/mL. Dosage may be increased by 0.05 mL each time until 0.5 mL is reached, at which time the next 10-fold more concentrated dilution can be used, beginning with 0.05 mL, if no untoward reaction is observed. (See beginning of DOSAGE AND ADMINISTRATION section for instructions in preparing dilutions of concentrates.)

  If a tolerated dose of allergenic extract has been established, the initial dose from the new extract should be reduced by 75% of the previously well tolerated dose (see also Precautions).

  Interval between doses in the early stages of immunotherapy is no more than once to twice a week, and may gradually be increased to once every two weeks. Generally, maintenance injections may be given as infrequently as once every two weeks to once a month. The progress of patients on immunotherapy should be closely monitored. If improvement is realized a usual course of treatment may be from 3 to 5 years. If progress is unsatisfactory for a year or more, discontinuation of immunotherapy should be considered.

  Injections are given subcutaneously preferably in the arm. It is advantageous to give injections in alternate arms and routinely in the same area. In some patients, a local tolerance to the allergen may develop thus preventing a possible severe local reaction.

  After inserting the needle, but before injecting the dose, pull plunger of the syringe slightly, if blood returns in the syringe, discard the syringe and contents and repeat injection at another site.

  Bulk concentrated extracts must be diluted for initial therapy and intradermal skin testing. For recommended diluent, refer to the beginning of the DOSAGE AND ADMINISTRATION section.

  Use standard aseptic precautions when making dilutions. The first dose of the new extract should be reduced at least 50% - 75% of the amount of the dosage from the previous extract.

  Stability studies for diluted and undiluted forms of this product are not complete. Indications are the undiluted product will retain its potency under recommended storage conditions at least until the expiration date on the vial label is reached. It is recommended that minimal amounts of the concentrate be diluted so that the diluted product is used up within a relatively short period of time, i.e., preferably not more than four weeks.

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