21cfr pollen raw material expiry dating


This extract is not directly interchangeable with other allergenic extracts.The initial dose must be based on skin testing as described in the “DOSAGE AND ADMINISTRATION” section of this insert.Patients should be observed for at least 20 minutes following allergenic extract injections.Treatment and emergency measures, as well as personnel trained in their use, must be available in the event of a life-threatening reaction.Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v).Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture.Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis.Food extracts made from dried raw material are extracted at 2-10% (- w/v ratio) in extracting fluid containing 50% glycerine.

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The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin.Severe systemic reactions may occur with all allergenic extracts.In certain individuals, especially in steroid-dependent/unstable asthmatics, these life-threatening reactions may result in death.Illo inventore veritatis et quasi architecto beatae vitae dicta sunt explicabo Más info...

Allergenic extract is intended for use by, or under the guidance of, physicians who are experienced in the administration of allergenic extracts for diagnosis and/or immunotherapy and the emergency care of anaphylaxis.

Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators.



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