OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to clarithromycin citrate (CAS RN 848130-51-8) and clarithromycin lactobionate (CAS RN 135326-55-6). Clarithromycin is a semisynthetic macrolide antibiotic derived from erythromycin used for a wide variety of mild to moderate bacterial infections. Clarithromycin is indicated as an alternative medication for the treatment of acute otitis media caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae in patients with a history of type I penicillin hypersensitivity. It is also indicated for the treatment of pharyngitis and tonsillitis caused by susceptible Streptococcus pyogenes, as well as respiratory tract infections including acute maxillary sinusitis, acute bacterial exacerbations of chronic bronchitis, mild to moderate community-acquired pneumonia, and Legionnaires' disease. Other indications include treatment of uncomplicated skin or skin structure infections, Helicobacter pylori infection, duodenal ulcer disease, Bartonella infections, and encephalitis caused by Toxoplasma gondii (in human immunodeficiency virus (HIV)-infected patients in conjunction with pyrimethamine). Clarithromycin may also decrease the incidence of cryptosporidiosis, may prevent the occurrence of α-hemolytic (viridans group) streptococcal endocarditis, as well as serve as a primary prevention for Mycobacterium avium complex (MAC) bacteremia or disseminated infections (in adults, adolescents, and children with advanced HIV infection). Clarithromycin is also used for the prophylaxis and treatment of nontuberculous mycobacterial infections and has been used as a second-line drug in the treatment of leprosy. It is used in some countries as an alternative to penicillins for the prophylaxis of endocarditis.

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 Clarithromycin, just click the ADD TO CART button.

HBEL

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