Tuberculin and Hylase® safety event report

Our pharmacovigilance program monitors the safety of our drugs. The purpose of this document is to compile all adverse events attributable to the biological products marketed by Advance Scientific Group, which include: TUBERCULIN-PPD and HYLASE®.

General Information Report

Tuberculin and Hylase safety event report (#18)

1. Administrative information

2. Patient information

Information of the patient who presents the adverse event.

Relevant medical history

Note: In case of ADR, indicate the start and end date of therapy.

Exclusive space for fatal adverse events

3. Medication

Exclusive space for Hylase

Exclusive space for Tuberculin – PPD

Concomitant drugs

4. Reacción

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.