OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to acepromazine maleate (CAS RN 3598-37-6), and acepromazine hydrochloride (CAS RN 973-12-6). Acepromazine maleate is a phenothiazine derivative that is used as a neuroleptic agent in veterinary medicine. Acepromazine injection in dogs and cats can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures, to alleviate itching as a result of skin irritation and as an antiemetic to control vomiting associated with motion sickness. It is particularly useful as a preanesthetic agent to enhance and prolong the effects of barbiturates, thus reducing the requirements for general anesthesia and as an adjunct to surgery under local anesthesia. In horses, acepromazine injection can be used as an aid in controlling fractious animals during examination, treatment, loading and transportation. Particularly useful when used in conjunction with local anesthesia for firing, castration, neurectomy, removal of skin tumors, ocular surgery and applying casts.

Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.

Why do you need this OEL Fastrac monograph?

OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Acepromazine, just click the ADD TO CART button.

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