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K. U. DACTINOMYCIN FOR INJECTION 0.5mg/VIAL

Product Information

Registration Status: Active

SIN10989P

K. U. DACTINOMYCIN FOR INJECTION 0.5mg/VIAL is approved to be sold in Singapore with effective from 1999-06-25. It is marketed by SHOEI UNIVERSAL CORPORATION PTE LTD, with the registration number of SIN10989P.

This product contains Dactinomycin 0.5mg/vial in the form of INJECTION, POWDER, FOR SOLUTION. It is approved for INTRAVENOUS use.

This product is manufactured by KOREA UNITED PHARMACEUTICAL INC in KOREA, and in REPUBLIC OF.

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 compound composed of a two cyclic peptides attached to a phenoxazine that is derived from streptomyces parvullus. It binds to DNA and inhibits RNA synthesis (transcription), with chain elongation more sensitive than initiation, termination, or release. As a result of impaired mRNA production, protein synthesis also declines after dactinomycin therapy. (From AMA Drug Evaluations Annual, 1993, p2015)

Indication

For the treatment of Wilms' tumor, childhood rhabdomyosarcoma, Ewing's sarcoma and metastatic, nonseminomatous testicular cancer as part of a combination chemotherapy and/or multi-modality treatment regimen

Mechanism of Action

Good evidence exists that this drug bind strongly, but reversibly, to DNA, interfering with synthesis of RNA (prevention of RNA polymerase elongation) and, consequently, with protein synthesis.

Pharmacokinetics

Absorption
poorly absorbed from gastrointestinal tract
Distribution
Metabolism
hepatic
Elimination

Toxicity

hepatoxicity

Active Ingredient/Synonyms

2-amino-N,N'-bis(hexadecahydro-2,5,9-trimethyl-6,13-bis(1-methylethyl)-1,4,7,11,14-pentaoxo-1H-pyrrolo(2,1-I)(1,4,7,10,13)oxatetra-azacyclohexadecin-10-yl)-4,6-dimethyl-3-oxo-3H-phenoxazine-1,9-dicarboxamide | ActD | Actinomycin C1 | Actinomycin D | Actinomycin iv | Dactinomicina | Dactinomycin | Dactinomycine | Dactinomycinum | Meractinomycin | Dactinomycin |


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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