Drug Information for Nonstandardized Allergenic Products (ALK-Abello, Inc.): WARNINGS

  • Patients should always be observed for at least 20 - 30 minutes after any injection. In the event of a marked systemic reaction, application of a tourniquet above the injection site and administration of 0.2 mL to 1 mL (0.01 mg/kg) of Epinephrine Injection (1:1,000) is recommended. Maximal recommended dose for children between 2 and 12 years of age is 0.5 mL. The tourniquet is then gradually released at 15 minute intervals. Patients under treatment with beta-blockers may be refractory to the usual dose of epinephrine.

    Volume expanders and vasopressor agents may be required to reverse hypotension. Inhalation bronchodilators and parenteral aminophylline may be required to reverse bronchospasm. In cases of respiratory obstruction, oxygen and intubation may be necessary. Life-threatening reaction unresponsive to the above may require cardiopulmonary resuscitation.


  • 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.

    Withhold allergenic extracts temporarily or reduce the dose in patients with any one of the following conditions:

    - Severe rhinitis or asthma symptoms;

    - Infection or flu accompanied by fever;

    - Exposure to excessive amounts of clinically relevant allergen prior to therapy.

    Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater risk. See PRECAUTIONS AND ADVERSE REACTIONS.


  • From pyridine extracted alum complexed allergenic extracts to aqueous extracts and glycerinated: In order to avoid untoward reaction, it is recommended that therapy be initiated as though the patients were previously untreated. The first dose should be related to the patient's sensitivity, determined by history and confirmed by skin testing.

    From unstandardized aqueous extracts to standardized aqueous extracts and glycerinated: The physician should establish the potency relationship, perhaps by comparative skin testing at equal concentration, prior to injecting the first standardized dose.

    From aqueous alum precipitated or modified extracts to aqueous extracts and glycerinated: Since this subject has not been studied, it is recommended that therapy be initiated as if the patient were not previously treated.

  • Drug Information Provided by National Library of Medicine (NLM).