Safety event report oncological chemical synthesis drugs

Our pharmacovigilance program is responsible for monitoring the safety of our medications. The purpose of this document is to compile all adverse events attributable to the chemical synthesis products marketed by Advance Scientific Group, which include: MYELKILAN®, PHENASEN®, TEPACITOX® (Tiotepa 100 mg, lyophilized powder) and TEPACITOX® (Tiotepa 15 mg, lyophilized powder).

General Information Report

Safety event report oncological chemical synthesis drugs (#20)

1. Administrative information

2. Patient information

Information of the patient who presents the adverse event.

Diagnostic support

Note: Please attach any paraclinical findings that you consider relevant to the imputability analysis.

Relevant medical history

Note: in the case of RAM, indicate the start and end date of therapy.

3. Medication

Therapeutic protocol

Premedication

Concomitant drugs

4. Reaction

Note: Please indicate the type of paraclinic, its magnitude and units of measurement, which was used to identify the safety novelty.

Event Result

Check an option

Temporality criterion

In case of re-exposure, what was the outcome?

5. Additional information

Note: Feel free to enter any type of information, everything you attach will be thoroughly evaluated to deepen the information on the products immersed in the novelty.

From Advance Scientific de Colombia SAS, we appreciate the information provided that will be used to build evidence that promotes the more rational use of pharmaceutical products in the Colombian scenario.