Adverse Event Reporting

ADVERSE EVENT REPORTING

At Prosper Channel Lifescience India, we are steadfastly dedicated to upholding the effectiveness and safety of our products. It's important to acknowledge that while every effort is made to ensure safety, any medication may elicit side effects in certain individuals. Information regarding side effects and associated risks often emerges post-consumption, as a medication is administered to a larger populace. Our paramount concern is to ensure that the therapeutic advantages of our medications far outweigh any potential risks.

We prioritize transparency and accountability in our commitment to safety. Thus, we encourage the prompt reporting of any adverse events experienced by patients following the use of a Prosper Channel Lifescience India medication. This reporting obligation extends to every member of our team; it is mandatory for any Prosper Channel Lifescience India employee who becomes aware of such instances.

Every adverse event report is meticulously documented within our database and subjected to thorough assessment. This rigorous process underscores our unwavering adherence to pertinent regulations, ensuring the continued safety and quality of our products.

Frequently Asked Questions (FAQ)

1. What is an Adverse Event?

An adverse event refers to any undesirable experience linked to the use of a medicinal product in a patient, commonly known as a "side effect". It encompasses:

• Undesirable symptoms and signs such as headache, vomiting, abnormal ECG.
• Medication errors like incorrect dosage or intravenous administration instead of intramuscular.
• Overdose.
• Misuse and abuse.
• Use during pregnancy and breastfeeding.
• Product technical complaints like discolored or deteriorated products, improper labeling.

2. Why Should I Report an Adverse Event?

Reporting adverse events is crucial as it ensures we don't overlook valuable data that could enhance the effective and safe use of our medicines. It aids in identifying rare or unexpected adverse effects, drug/food interactions, unknown risk factors, and the long-term safety profile of medications.

3. What to Report? (Necessary Minimum Information)

• Patient Particulars: This includes the initials, age, gender, etc., of the individual experiencing the adverse event.
• Event Particulars: Describe the symptom/sign, along with additional data such as onset, course, and outcome of the event.
• Reporter Details: Provide your name, address, and phone number as you may be contacted for further information. If you're not a healthcare professional, include details of the prescribing doctor.
• Drug Details: Include the name, batch number, dosage, etc., of the suspected medicinal product causing the adverse event.

4. Who Can I Report To?

You can report adverse events to:

• Any healthcare professional (doctors, dentists, nurses, pharmacists, patients, etc.).
• Non-healthcare professionals (patients, relatives, friends, etc.).

5. How Do I Report?

To report a suspected adverse reaction/side effect related to our drug/vaccine, you can choose any of the following options:

• Call our PV Phone No. +91 011-42564554 , WhatsApp No. +91 9650 7771 59, Monday to Friday, between 10:00 am to 5:30 pm. Or mail us at pv@prosperchannel.in.
• Complete and submit the Adverse Event Reporting (AER) form available on this website.