Privacy Policy

At Piramal Group (hereinafter referred to as “Piramal”), we take your privacy very seriously and are committed to protect your personal data. This Privacy Notice sets out the way in which we collect, use, disclose, transfer, and store your personal data when you use our website or other digital platforms.

You are advised to carefully read the Privacy Notice before using this website.

Please note that our website and other digital platforms may contain links to third party websites / digital platforms which are provided for your convenience. We are only responsible for the privacy practices and security of our own digital platforms. We recommend that you check the privacy and security policies and procedures of each and every other website / digital platform that you visit.


COLLECTION AND USE OF PERSONAL DATA

Personal data is data that can be used to identify or contact a single person (including but not limited to name, address, e-mail address, user name, telephone number, age, date of birth, gender, education qualifications, posts and other content you submit to our sites, sensitive information such as information relating to your health life).

All personal data that we collect about you will be recorded, used, and protected by us in accordance with applicable data protection legislation and this Privacy Notice. We may supplement the information that you provide with other information that we obtain from our dealings with you or which we receive from other organisations, for example, our sponsors and partners. Please note, if you don’t choose to provide us with the requested personal data, we will be unable to offer you our products or services.

In broad terms, we use your personal data for the following purposes:

  • to administer and provide products and services you request or have expressed an interest in
  • to communicate with you in the event that any products or services you have requested are unavailable
  • for fraud screening and prevention purposes
  • for record keeping purposes
  • to carry out market research so that we can improve the products and services we offer
  • to track your activity on our digital platforms
  • to create an individual profile for you so that we can understand and respect your preferences
  • to personalise and improve your experience on our digital platforms
  • to personalise and/ tailor any communications that we may send you
  • for profiling purposes to enable us to personalise and/or tailor any marketing communications that you may consent to receive from us

When we provide you with products or services we may collect and store any personal data that you provide to us. We may, for example, keep a record of your name, address, delivery address, email address, telephone number and payment card details. We may also record details of any disability or health needs that you may have.

When you sign up with us for an online account, register to receive marketing communications from us (and/or our sponsors and partners), fill in one of our forms (whether online or offline) or otherwise expressly provide us with your personal data, we may collect and store any personal data that you provide to us and may use it to personalise and improve your experience on our digital platforms, provide products and services you request from us, and carry out profiling and market research.

When you interact with our digital platforms, we may also automatically collect the following information about your visit. This is primarily to help us better understand how you use our digital platforms to enable us create better content and more relevant communications:

  • how you have reached our digital platform and the internet protocol (IP) address you have used
  • your browser type, versions and plug-ins, and your operating system
  • your journey through our digital platform, including which links you click on and any searches you made, how long you stayed on a page, and other page interaction information
  • what content you like or share
  • which adverts you saw and responded to
  • which pop up or push messages you might have seen and responded to
  • your subscription status
  • information collected in any forms you complete

We may also infer your country of location from the IP address you have used to access our digital platforms and we may analyse which marketing activity led to your taking specific action on our digital platforms (e.g. downloading the app).


OFFERS AND OPPORTUNTIES FROM US AND OUR PARTNERS

We want you to be the first to know about new products and services, and occasional offers from our partners. We may share these offers with you only with your prior consent. You can unsubscribe from receiving these offers by emailing us. Please note, if you don ‘t choose to receive this information, we will be unable to keep you informed of new services, products, events or special offers that may interest you and our ability to inform you of ticketing opportunities may be affected.


CHILDREN

We understand the importance of taking extra precautions to protect the privacy and safety of children using Piramal ‘s products and services.

If you are under the age of 16, you must first tell your parent or legal guardian that you wish to register on our digital platforms and get their consent. You must make sure that your parent or legal guardian knows and agrees each time before you:

  • email us, or ask us to email anything to you;
  • send any information to us;
  • enter any competition or game that requires information about you or offers a prize;
  • purchase an official membership; or
  • offer or agree to buy anything online.

Once we receive appropriate authorization or consent from your parents or legal guardian, we may collect your date of birth and retain that with your name and other details you may provide. This is so we can ensure we treat you in an age appropriate way in line with this Privacy Notice.

For so long as you are under the age of 16 we will not send you any marketing communications, allow you to access any of our digital platform message boards, or share your details with our partners. However, if you have signed up to receive a product or service we may contact you about this.


WHO DO WE SHARE YOUR PERSONAL DATA WITH?

As a global business, Piramal may share your personal data with Piramal Group companies, partners, service providers and other trusted third parties based outside the country in which you live so that they may process that data on our behalf as necessary, in connection with providing our products and services to you, fulfilling contractual arrangements and legal or regulatory requirements. Piramal requires that its service providers and such other third parties keep your personal data confidential and that they only use the personal data in furtherance of the specific purpose for which it was disclosed.

We may share your personal data with:

  • law enforcement or government authorities where they have followed due legal process to request us to disclose the information
  • third party providers of services and web analytics tool providers, if you have any queries about our third party service providers, then you may contact our Data Protection Officer (contact details included in the later part of this notice).


TRANSFERRING YOUR PERSONAL DATA

We may transfer your personal data to servers located outside the country in which you live or to affiliates or other trusted third parties based in other countries so that they may process personal data on our behalf. By using a Piramal site or otherwise providing Piramal with personal data, you agree to us doing so in accordance with the terms of this Privacy Notice and applicable data protection laws and regulations. Piramal will ensure to a reasonable extent that anyone processing your personal data outside your country of origin is required to implement measures to protect it and is only entitled to process it in accordance with Piramal ‘s instructions.

Many countries do not afford the same legal protection to personal data as you might enjoy in your country of origin. While your personal data is in another country, it may be accessed by the courts, law enforcement and national security authorities in that country in accordance with its laws.


RETENTION OF PERSONAL DATA

You are responsible for providing Piramal with accurate and complete personal data. Please notify us of any changes to your personal data. Piramal shall take reasonable steps to ensure that your personal data is kept accurate, complete, and current.

We will retain your personal data for the period necessary to fulfil the purposes outlined in this Privacy Notice unless a longer retention period is required or permitted by law.


COOKIES

In common with many other website operators, we use standard technology called ‘cookies’ on our website. Cookies are small pieces of information that are stored by your browser on your computer’s hard drive and they are used to record how you navigate this website on each visit.

We automatically collect and temporarily store the following information about your visit:

  • the name of the domain you use to access the Internet;
  • the date and time of your visit;
  • the pages you visited; and
  • the address of the web site you came from when you came to visit

We use this information for statistical purposes and to help us make our site more useful to visitors. Unless it is specifically stated otherwise, no additional information will be collected about you.


SAFEGUARDING YOUR PERSONAL DATA

We take all reasonable precautions to keep your personal data secure and require any third parties that handle or process your personal data for us to do the same. Access to your personal data is restricted to prevent unauthorised access, modification or misuse and is only permitted among our employees and agents on a need-to-know basis.


YOUR PRIVACY RIGHTS AND WHO TO CONTACT

We provide you with reasonable access to view and review your personal data and request correction and deletion where appropriate.  In order to protect your privacy, we will take reasonable steps to verify your identity before granting access to your personal data.

If you have any questions, comments or concerns about how we handle your personal data, then you may contact us at dpo.corporate@piramal.com.

You have the right to tell us if you:

  • don’t want to be contacted in the future by us
  • would like a copy of the personal data which we hold about you
  • would like to delete your personal data in our records
  • wish to report any misuse of your personal data
  • would like to correct or update your personal data

To exercise any of the above listed rights you may contact our Data Protection Officer. To assist us in dealing with your request, please provide your full name, address, date of birth and email address.

If you have subscribed to receive marketing communications, you can unsubscribe by contacting our Data Protection Officer.


CHANGES TO OUR PRIVACY NOTICE

We may change our Privacy Notice from time to time and post the updated version of the same. We encourage you to visit frequently to stay informed about how we use your personal data.


HANDLING PRIVACY CONCERNS

If you have any questions about this Privacy Notice or if you believe that your personal data is not handled in accordance with the applicable law or this notice, then you may contact us at dpo.corporate@piramal.com

w.e.f. 25 May 2018

Indications and Usage

  • Gablofen® (baclofen injection) is a gamma-aminobutyric acid (GABA) ergic agonist indicated for use in the management of severe spasticity of cerebral or spinal origin in adult and pediatric patients age 4 years and above.
  • Gablofen should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable central nervous system side effects at effective doses.
  • Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump.
  • Spasticity due to traumatic brain injury: wait at least one year after injury before considering Gablofen therapy.

IMPORTANT RISK INFORMATION

WARNING: DO NOT DISCONTINUE ABRUPTLY

See full prescribing information for complete boxed warning

Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional post-implant clinician and patient information.

CONTRAINDICATIONS

  • Hypersensitivity to baclofen.
  • Do not use Gablofen for intravenous, intramuscular, subcutaneous or epidural administration.

WARNINGS AND PRECAUTIONS

  • Risk of life-threatening overdose during pump refills. Use extreme caution when filling the Medtronic SynchroMed® II Programmable Pump which is equipped with an injection port that allows direct access to the intrathecal catheter. Direct injection into the catheter through the catheter access port may cause a life-threatening overdose.
  • Use only with Medtronic SynchroMed® II Programmable Pump (or other pumps labeled for intrathecal administration of Gablofen (baclofen injection)).
  • Potential for contamination due to non-sterile external surface of prefilled syringe. Although the drug solution and pathway in the Gablofen prefilled syringes are sterile, the external surface of the prefilled syringes (all strengths, including the 50 mcg/mL strength) are non-sterile and have the potential to lead to contamination and consequent adverse reactions. The use of Gablofen prefilled syringe in an aseptic setting (e.g., operating room) to fill sterile intrathecal pumps prior to implantation in patients is not recommended, unless the external surface of the prefilled syringe is treated to ensure sterility. Gablofen supplied in vials may be used with conventional aseptic technique to fill intrathecal pumps prior to implantation.
  • Resuscitative equipment and trained staff must be available during screening dose, dose titration, and refills due to the potential life-threatening CNS depression, cardiovascular collapse, and/or respiratory failure.
  • Overdose may cause drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.
  • Use with caution in patients with psychotic disorders, schizophrenia or confusional states as it may exacerbate condition(s).
  • Fatalities have been reported with intrathecal baclofen use.
  • Caution should be used in patients with a history of autonomic dysreflexia.
  • Presence of infection may increase the risk of surgical complication and complicate dosing of Gablofen.
  • May cause drowsiness: use caution in operation of automobiles, dangerous machinery and activity that may be hazardous by decreased alertness. Other CNS depressants and alcohol may add to this effect.
  • Potential development of intrathecal mass formation. Clinicians should monitor for signs and symptoms of new neurologic symptoms including the use of imaging diagnostic modalities.
  • Oral baclofen use has been associated with a dose-related increase in incidence of ovarian cysts.

ADVERSE REACTIONS

  • Serious Adverse Reactions
    • Sudden withdrawal of Gablofen can result in serious complications that include high fever, confusion, muscle stiffness, multiple organ-system failure, and death. Inform patients that early symptoms of Gablofen withdrawal may include increased spasticity, itching, and tingling of extremities. If Gablofen withdrawal or a pump malfunction is suspected, patients should be brought immediately to a hospital for assessment and treatment.
    • Gablofen overdose may occur suddenly or insidiously, and symptoms may include confusion, drowsiness, lightheadedness, dizziness, slow or shallow breathing, seizures, loss of muscle tone, loss of consciousness, and coma.
    • Other serious adverse events may include: potential development of intrathecal mass formation, drainage, infection, meningitis, unmanageable trunk control, CSF leakage, coma and death.
  • Common Adverse Reactions
    • The most common adverse reactions in patients with spasticity of spinal origin were hypotonia (25.3%), somnolence (20.9%), dizziness, nausea/vomiting, hypotension, headache, and convulsions.
    • The most common adverse reactions in patients with spasticity of cerebral origin were hypotonia (34.7%), somnolence (18.7%), headache (10.7%), agitation, constipation, leukocytosis, chills, and urinary retention.
    • Other common adverse events may include hypoventilation, hypertonia, paresthesia, increased salivation, back pain, pruritus, diarrhea, peripheral edema, asthenia, pain, confusion, speech disorder, amblyopia, accidental injury, and dry mouth.

USE IN SPECIFIC POPULATIONS

  • Pregnancy Category C. The effect of baclofen in labor and delivery is unknown.
  • Breastfeeding: Baclofen is excreted into breast milk at oral therapeutic doses.
  • Pediatric use: Safety and effectiveness in pediatric patients below the age of 4 years have not been established.
Important Risk Information View Full