Adverse Event Reporting
We at PlasmaGen believe that patient safety is our prime concern ahead of commercial or other interests.
The aim of Pharmacovigilance is to protect public health by identifying, evaluating and minimizing safety issues in all possible ways.
So, we encourage consumers, health care professionals, our employees and others to report the following to our Pharmacovigilance department:
Medical occurrence temporally associated with the use of our medicinal product, including an abnormal laboratory finding but not necessarily causally related.
The patient has taken, (accidentally or intentionally) above/below the maximal /minimal recommended dose as stated in the product label/authorized product information or as prescribed
Includes an interaction with another drug, device, disease, food or alcohol
Accidental exposure to Plasmagen product may or may not be a result of one’s occupation
Accidental exposure to PlasmaGen product may or may not be a result of one’s occupation
Drug exposure of embryo or foetus via semen due to father taking PlasmaGen product
Inappropriate use of PlasmaGen product that was not intended. This may be an actual error that occurred, an error that was intercepted (near miss) or an error that could occur (potential).
Medication errors are captured whether or not the product was ingested or administered
Medication errors are captured whether or not it resulted in an adverse event
Examples:- Injection for intravenous use prescribed as intramuscular or subcutaneous.
- Prescribing a drug to which the patient is allergic.
- Wrong drug dispensed, due to illegibility of prescription or drug/brand sounds alike.
Type of medication error involving confusion between PlasmaGen products or confusion between a PlasmaGen product with another manufacturer’s product.
May involve similar packaging, the image of a dosage form, the sound of a product's name, or unclear labelling or instructions for use
May be intentional (e.g., off label use, misuse, or abuse), unintentional (e.g., medication error), or the intention is not known
PlasmaGen drug was ineffective (did not work) or the expected effect was not achieved
Beneficial effect of a product aside from the use for which it has been given
Concern/issue with product quality
Examples:
- Broken in seal of bottle
- Colour change in solution
- Bottle was missing or bottle was empty
- Label is illegible/Font is very small to read
Points to consider
- Provide as many details as possible. This will help us to understand the case better.
- The patient/reporter's identity is held in strict confidence and protected to the fullest extent. The company shall not disclose the patient/reporter’s identity in response to a request from the public.
- The data may be shared with the competent authorities as required to comply with the regulatory requirements.
- Submission of a report does not constitute an admission that medical personnel or manufacturer or the product caused or contributed to the reaction.
If you wish to report by any other means like Telephone, Email, Postal Mail, Etc., you may select one from the following options:
→ 24X7 Medical Information Contact Center: Dial +91 8197761799
→ Simply send an email at: pv@plasmagen.in
→ Download the adverse event reporting form (Click here to download the form for Consumers,Click here to download the form for HCPs), fill and send it to us in any of the following ways:
Send the completed form to:
PlasmaGen BioSciences Pvt Ltd
No.160, KCI Chambers, 2nd Floor, 5th Main Road,
Chamarajpet, Bangalore-560018, Karnataka, India
Scan & email the completed form to pv@plasmagen.in