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RAPAMUNE ORAL SOLUTION 1mg/ML

Product Information

Registration Status: Active

SIN11964P

RAPAMUNE ORAL SOLUTION 1mg/ML is approved to be sold in Singapore with effective from 2002-05-28. It is marketed by PFIZER PTE LTD, with the registration number of SIN11964P.

This product contains Sirolimus 1mg/mL in the form of SOLUTION. It is approved for ORAL use.

This product is manufactured by Patheon Inc. in CANADA.

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
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Description

A macrolide compound obtained from Streptomyces hygroscopicus that acts by selectively blocking the transcriptional activation of cytokines thereby inhibiting cytokine production. It is bioactive only when bound to immunophilins. Sirolimus is a potent immunosuppressant and possesses both antifungal and antineoplastic properties.

Indication

For the prophylaxis of organ rejection in patients receiving renal transplants.

Mechanism of Action

Sirolimus inhibits T lymphocyte activation and proliferation that occurs in response to antigenic and cytokine (Interleukin IL-2, IL-4, and IL-15) stimulation by a mechanism that is distinct from that of other immunosuppressants. Sirolimus also inhibits antibody production. In cells, sirolimus binds to the immunophilin, FK Binding Protein-12 (FKBP-12), to generate an immunosuppressive complex. The sirolimus:FKBP-12 complex has no effect on calcineurin activity. This complex binds to and inhibits the activation of the mammalian Target Of Rapamycin (mTOR), a key regulatory kinase. This inhibition suppresses cytokine-driven T-cell proliferation, inhibiting the progression from the G1 to the S phase of the cell cycle.

Active Ingredient/Synonyms

(-)-Rapamycin | Rapamycin | sirolimús | sirolimus | sirolimusum | Sirolimus |


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.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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