Product Information
Registration Status: ActiveSIN09944P
TUBERCULIN PPD RT 23 SSI 2 TU/0.1ml is approved to be sold in Singapore with effective from 1998-08-19. It is marketed by DKSH SINGAPORE PTE LTD, with the registration number of SIN09944P.
This product contains Tuberculin 0.4mcg in the form of INJECTION. It is approved for SUBCUTANEOUS use.
This product is manufactured by STATENS SERUM INSTITUT in DENMARK.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Tuberculin Purified Protein Derivative (PPD) is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis. The diagnostic test is commonly referred to as the Mantoux test which serves to minimize the risk of transmission of infection with *Mycobacterium tuberculosis* through early diagnosis and appropriate therapeutic intervention. The purified protein fraction is isolated from culture media filtrates of a human strain of Mycobacterium tuberculosis. It is included in the World Health Organization's List of Essential Medicines.
Indication
Indicated as a diagnostic agent in Mantoux Test used to detect infection with *Mycobacterium tuberculosis*.
Mechanism of Action
When exposed to *M. tuberculosis* antigen, the sensitization initiates in the regional lymph nodes where T lymphocytes proliferate in response to the antigenic stimulus to give rise to specifically sensitized lymphocytes which may exist in the circulation up to many years. Antigen is presented to T cells by being ingested by antigen presenting cells (APC), which then present it on their surface to lymphocytes in combination with various MHC molecules once they reach local lymph nodes [T28]. Tuberculin PPD most likely interacts with toll-like receptor 2 expressed on APCs that initiates an inflammatory response. Subsequent restimulation of these sensitized lymphocytes with the same or a similar antigen, such as the intradermal injection of tuberculin PPD, evokes a local reaction mediated by these cells. This reaction is referred to as a delayed-type hypersensitivity response that includes vasodilation, edema, and the infiltration of lymphocytes, basophils, monocytes, and neutrophils into the site of antigen injection. The sensitized antigen-specific T lymphocytes proliferate and release lymphokines, which mediate the accumulation of other cells at the site [L806]. In vitro studies show that Tuberculin PPD promotes the upregulation of vascular endothelial growth factor (VEGF) expression in T lymphocytes through major histocompatibility (MHC) class II interaction with CD4+ T lymphocyte interaction [A19537]. The reactions are evident after 5-6 hours following administration.
Toxicity
Some adverse effects at the injection site include pain, discomfort, pyrexia, and erythema, rash, hemorrhage, hematoma and rarely ulcer and necrosis. Other unwanted effects include severe hypersensitivity reactions, dyspnea, generalized rash and syncope.
Active Ingredient/Synonyms
Mycobacterium tuberculosis purified protein derivative | Purified protein derivative of tuberculin | Tuberculin PPD | Tuberculin, purified protein derivative | Tuberculin,purified protein derivative | Tuberculinum | Tuberculin Purified Protein Derivative |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.