Adverse Drug Reactions

To report the Adverse Events related to CSL Behring Medicinal products

This page is created to reporting the Adverse Events that may occur with a patient who uses a drug from the CSL Behring products marketed in Middle East and Africa.

Below you will find all the information you need to complete the reporting process successfully!

First: What is the Adverse Event?

An Adverse Event is any unwanted medical occurrence in a patient who has been given a pharmaceutical product that may or may not has been caused by treatment with the product. An adverse event can therefore be any unfavorable and unintended sign, symptom, or disease associated with the use of the product.

But ... why should you report side effects?

Understanding patients' experiences of treatment, and especially the harm they may suffer, is an important aspect of patient care and public health. Recognising, recording, and reporting adverse effects will help us improve treatment and prevent harm for other patients in the future.

In addition to reporting the adverse events, you can also report the product's ineffectiveness and even the unexpected benefits that may happen to you!

Second: If you or the person you are reporting on behalf of are currently suffering from a severe adverse event, you should contact your doctor or other medical health professionals before reporting the adverse event.

Third: When you are communicating through the available communication channels for reporting; Please provide the following information to ensure that it is dealt with in a manner consistent with applicable local laws. To learn more about the privacy policy followed, please click on the link.

Product name: including the concentration of the drug and the number of daily doses (the amount and number of times the drug is used, for example, 40 mg twice daily.)

The batch number of the medicinal product used

The indication of use the medicinal product: the intended reason behind prescribing this medication to you by your doctor.

When did you start using the medication and when stopped by What is meant here is the periods of time during which you began to use the medicine and terminate it, for example: began to use the drug on/ 1/1 2013 And it stopped it on 1/1/2020

Start Date

Date of Suspension

Have you changed the method of taking the medication ( for example, reduce the dose or discontinue use of the medicinal product.) and the impact of that action on the adverse event that you want to report.

For the required information about the Adverse Event/s are as follows :

What is the Adverse Event/s resulting?

When did you experience this Adverse Event/s? Was it treated? Have any other treatments been prescribed to reduce this Adverse Event?

The patient's name, age, gender: Please write the initial letters of the patient's name; for example, Ahmed Suleiman writes the initials as (A.S.)

Name

Age

Gender

Country

Patient information: Any other medical conditions the patient is suffering from at the moment, any other medicinal product/s that he is currently taking (name of the medicine, the concentration of the medicinal product, number of daily doses, and the date

The name of the treating physician and his contacts, we may need to contact your doctor to follow up on the adverse event/s that you have included in this report

Doctor's Name

The doctor's contact details

By checking this box, I give my consent to CSL Behring and its agents to communicate with the doctor through the above-mentioned communication methods.

Name of the person reporting( optional ) : Please note that personally identifiable information ( such as name and email address) will not be shared with health authorities and agencies. We may communicate with you by the company or its agents to get more information about the adverse event that you have reported it. If you do not wish to be contacted, this should be mentioned in this email.

Reporter Name

Contact Information

By checking this box, I give my consent to CSL Behring and its agents to contact me through the above-mentioned communication methods

Thank You

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Fourth: Communication channels for reporting Adverse Event to CSL Behring: Please contact the Pharmaceutical Safety Officer in our company :
Mobile: +966 (56) 155 3055
Email: PhV-ECI@cslbehring.com