Powder for suspension for Injection Triptorelin 22.5mg (Prostazar SR) Technical Specification:

Product Name:Powder for suspension for Injection Triptorelin  22.5mg
Brand Name:Prostazar SR
Strength:3.75mg, 11.25mg, 22.5mg
Dosage Form:Lyophilized
Dry Powder for Injection
Packing:SINGLE USE VIAL
Route of Administration:For I.M. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Cancer
Indication: Triptorelin is a hormone drug that you might have as a treatment for prostate cancer that is advanced (spread to other parts of your body) locally advanced with or without radiotherapy or surgery
Storage:Store the vials in the original carton between 2°C to 8°C (36° to 46° F). Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Powder for suspension for Injection Triptorelin 22.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Powder for suspension for Injection Triptorelin 22.5mg
    Each sterile lyophilized vial contains:
    Triptorelin Pamoate
    Equivalent to Triptorelin.….…22.5mg
    (Lyophilized powder for suspension for injection)
    Excipients:
    Anhydrous Citric Acid USP….q.s.
    Mannitol USP……………………..q.s.
    Water for Injection USP……..q.s.

THERAPEUTIC INDICATION:

Triptorelin is a hormone drug that you might have as a treatment for prostate cancer that is advanced (spread to other parts of your body) locally advanced with or without radiotherapy or surgery

PACKING:

  • Powder for suspension for Injection Triptorelin 3.75mg – 1 Month
  • Powder for suspension for Injection Triptorelin 11.25mg – 3 Month
  • Powder for suspension for Injection Triptorelin 22.5mg – 6 Month

DIRECTION OF USE:

For Intramuscular use only.
Reconstitution: Must reconstitute with 2 ml sterile water for injection USP prior to administration and use the preparation immediately.
For further information refer package insert.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
Opening instructions: Open the top and bottom flaps initially and then open the side flap.
TRANSPORT ONLY IN REFRIGERATION CHAIN.
INJECT INSTANTLY AFTER MIXING.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store the vials in the original carton between 2°C to 8°C (36° to 46° F). Protect from light.
Dosage: As directed by an Oncologist.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals stands as a beacon of trust and quality in the realm of pharmaceuticals, including its offering of Triptorelin Powder for Suspension for Injection. With a steadfast commitment to excellence, Taj Pharmaceuticals ensures that patients receive nothing but the highest standards of quality, safety, and effectiveness in their medication. Expertise and Precision: Taj Pharmaceuticals boasts a rich legacy of pharmaceutical expertise and unwavering dedication to precision. Every step in the manufacturing process is executed with meticulous care, adhering to stringent industry standards. This commitment guarantees the consistency and reliability of every vial of Triptorelin medication. Treatment Efficacy: Triptorelin is a well-established therapeutic option for hormonal disorders, including conditions like prostate cancer, endometriosis, and precocious puberty. Taj Pharmaceuticals’ formulations of Triptorelin are carefully designed to deliver the precise dosage required for effective symptom relief and condition management. Quality Assurance: Taj Pharmaceuticals maintains a robust quality control framework that encompasses comprehensive testing and quality checks at every production stage. This rigorous oversight assures patients, healthcare providers, and regulatory bodies that Taj’s medications meet the highest standards of safety and efficacy. Patient-Centered Care: Taj Pharmaceuticals acknowledges the paramount importance of patient-centered care, particularly in complex medical conditions necessitating hormonal management. More than merely offering a product, Taj Pharmaceuticals embodies a comprehensive approach to healthcare, offering unwavering support to patients on their journey toward improved health and well-being. For those seeking Triptorelin Powder for Suspension for Injection, Taj Pharmaceuticals represents a steadfast choice, where commitment to excellence and patient-focused care converge to provide the quality and support that patients deserve in their treatment journey. Trust Taj Pharmaceuticals to be your partner in health.

What is Triptorelin Powder for Suspension for Injection and its uses?

Triptorelin Powder for Suspension for Injection stands out as a versatile medication with a wide range of medical applications, all rooted in its ability to regulate hormones effectively. Its active ingredient, triptorelin, finds diverse uses in the field of healthcare. In the context of advanced prostate cancer, it acts as a gonadotropin-releasing hormone (GnRH) agonist, initiating a temporary surge in testosterone production before sharply reducing it. This hormonal modulation, known as hormonal therapy, is instrumental in slowing down the progression of prostate cancer. Moreover, triptorelin proves its worth in addressing endometriosis, providing relief from pain and restraining the growth of uterine tissue outside the uterus. Triptorelin also plays a pivotal role in pediatric healthcare by delaying the onset of precocious puberty, offering a crucial respite from the early and rapid hormonal changes that can affect children. In the realm of assisted reproductive technologies like in vitro fertilization (IVF), it facilitates precise control over the timing of the menstrual cycle, optimizing fertility treatments. Furthermore, it plays a role in gender transition, aiding in the reduction of testosterone levels, particularly in transgender women. It’s essential to underscore that the administration of Triptorelin Powder for Suspension for Injection should be carried out under the careful guidance of a healthcare provider. Each patient’s unique medical condition and response to treatment require meticulous consideration, and close monitoring is crucial to manage potential side effects effectively. The versatility and efficacy of triptorelin make it a valuable tool in addressing diverse healthcare needs, offering hope and relief in various medical contexts.

How does Triptorelin Powder for Suspension for Injection work?

Triptorelin Powder for Suspension for Injection emerges as a pharmaceutical marvel, wielding the power to finely tune hormonal equilibrium in the human body for therapeutic purposes. Its mechanism of action adapts to the specific medical condition being addressed. In the realm of advanced prostate cancer, Triptorelin stands as a formidable gonadotropin-releasing hormone (GnRH) agonist. It commences treatment by orchestrating a temporary surge in testosterone production via the stimulation of the pituitary gland. However, this surge is fleeting, giving way to a profound reduction in testosterone levels—an essential facet of androgen deprivation therapy (ADT). This hormone modulation serves as a potent weapon against prostate cancer, where testosterone is the fuel for tumor growth. In the arena of endometriosis, Triptorelin takes on the role of a GnRH agonist, but its primary mission is to quell estrogen production. By triggering an initial increase in luteinizing hormone (LH) and follicle-stimulating hormone (FSH) and subsequent downregulation of GnRH receptors, it engineers a significant decline in estrogen levels. This pivotal reduction in estrogen brings relief from the agonizing symptoms of endometriosis and hinders the unchecked growth of endometrial tissue outside its usual domain, the uterus. Likewise, in the treatment of precocious puberty, Triptorelin executes its hormone modulation strategy. It kickstarts the process by inducing a surge in sex hormone production via LH and FSH release and then astutely curtails this hormone output. This masterful hormone control ultimately serves to delay the premature onset of puberty in children, providing them with a more age-appropriate trajectory for physical development. Triptorelin Powder for Suspension for Injection thus takes center stage as a therapeutic powerhouse, harnessing the precision of hormone modulation to alleviate symptoms and improve the lives of those affected by these diverse medical conditions.

Benefits of Triptorelin Powder for Suspension for Injection:

Triptorelin Powder for Suspension for Injection offers a spectrum of therapeutic benefits in the realm of healthcare. It stands as a potent weapon in the battle against advanced prostate cancer, effectively curbing the growth of prostate cancer cells by significantly lowering testosterone levels. For individuals grappling with the anguish of endometriosis, Triptorelin provides a lifeline by alleviating the condition’s painful symptoms and addressing fertility concerns. Its ability to suppress estrogen levels proves instrumental in managing endometriosis effectively. Additionally, Triptorelin plays a pivotal role in delaying the onset of precocious puberty, granting affected children the gift of a more age-appropriate pubertal development. Moreover, in the field of assisted reproductive technologies, particularly in vitro fertilization (IVF), Triptorelin enhances the precision of menstrual cycle timing, optimizing the prospects of successful fertility treatments.

Side Effects of Triptorelin Powder for Suspension for Injection:

While Triptorelin bestows a range of therapeutic benefits, it may also introduce certain side effects that warrant consideration. Some individuals undergoing Triptorelin therapy may encounter menopausal-like symptoms, such as hot flashes, night sweats, and vaginal dryness. These symptoms, while potentially bothersome, are generally manageable. Mood swings, irritability, and emotional fluctuations are also possible side effects. Prolonged use of Triptorelin can lead to a reduction in bone density, necessitating vigilant monitoring of bone health. Reduced libido and sexual dysfunction may be experienced by some individuals. Injection site discomfort is another potential side effect, as is weight gain. Allergic reactions to Triptorelin are rare but should be noted, with symptoms like rash, itching, swelling, dizziness, or breathing difficulties. Triptorelin’s hormonal effects can bring about changes in menstrual patterns and fertility, though these are often temporary and reversible upon discontinuation of the medication. The decision to use Triptorelin Powder for Suspension for Injection should be made with careful consideration of its benefits and potential side effects, with the guidance and supervision of a qualified healthcare provider. Regular monitoring during treatment is essential to ensure its safety and efficacy in addressing specific healthcare needs.

Frequently Asked Questions About Triptorelin Powder for Suspension for Injection:

Certainly, here are some frequently asked questions (FAQs) about Triptorelin Powder for Suspension for Injection:

  1. What is Triptorelin Powder for Suspension for Injection used for?

Triptorelin Powder for Suspension for Injection is used in the treatment of various medical conditions, including advanced prostate cancer, endometriosis, precocious puberty, and as part of assisted reproductive technologies like in vitro fertilization (IVF).

  1. How does Triptorelin work in the treatment of prostate cancer?

Triptorelin lowers testosterone levels in the body, which is essential for slowing the growth of prostate cancer cells. It initially causes a surge in testosterone production before dramatically reducing it, a mechanism known as androgen deprivation therapy (ADT).

  1. What are the common side effects of Triptorelin Powder for Suspension for Injection?

Common side effects may include menopausal like symptoms (hot flashes, night sweats, vaginal dryness), mood changes, bone density loss, decreased libido, injection site discomfort, weight gain, and changes in menstrual patterns or fertility.

  1. How is Triptorelin administered?

Triptorelin is administered as an injection. The frequency and dosage of injections may vary depending on the specific condition being treated and the healthcare provider’s recommendations.

  1. Can Triptorelin be used during pregnancy or breastfeeding?

Triptorelin is not typically used during pregnancy or breastfeeding, and its use in such situations should be discussed thoroughly with a healthcare provider due to potential risks.

  1. Are there any interactions with other medications or substances?

Triptorelin may interact with certain medications, so it’s important to inform your healthcare provider about all the medications, including over-the-counter drugs and supplements, that you are taking to avoid potential interactions.

  1. How long is Triptorelin treatment typically prescribed for?

The duration of Triptorelin treatment varies depending on the individual’s condition and response to the medication. It may be prescribed for a specific period or as long-term therapy, and the treatment plan is determined by a healthcare provider.

  1. What should I do if I experience side effects or have concerns during Triptorelin treatment?

If you experience side effects or have any concerns about your Triptorelin treatment, it’s important to communicate with your healthcare provider promptly. They can assess your situation, provide guidance, and make any necessary adjustments to your treatment plan.

  1. Can Triptorelin be used in children?

Triptorelin can be used in children, especially for the treatment of precocious puberty, but its use should be carefully monitored and managed by a pediatrician or healthcare specialist with expertise in pediatric endocrinology.

  1. Is Triptorelin a cure for prostate cancer or endometriosis?

Triptorelin is not a cure for these conditions, but it is a valuable treatment that helps manage symptoms and slow disease progression, allowing individuals to lead a better quality of life. The duration and effectiveness of treatment can vary from person to person.

Patients are encouraged to discuss their specific questions and concerns about Triptorelin Powder for Suspension for Injection with their healthcare provider to receive personalized information and guidance.

As Triptorelin Powder for Suspension for Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Triptorelin Powder for Suspension for Injection product in Following Countries:

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Triptorelin Powder for Suspension for Injection Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Triptorelin Powder for Suspension for Injection, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Powder for suspension for Injection Triptorelin 3.75mg
b) Powder for suspension for Injection Triptorelin 11.25mg
c) Powder for suspension for Injection Triptorelin 22.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Powder for suspension for Injection Triptorelin 3.75mg
Each sterile lyophilized vial contains:
Triptorelin Pamoate
Equivalent to Triptorelin.….…3.75mg
(Lyophilized powder for suspension for injection)
Excipients:
Anhydrous Citric Acid USP….q.s.
Mannitol USP……………………..q.s.
Water for Injection USP……..q.s.

b) Powder for suspension for Injection Triptorelin 11.25mg
Each sterile lyophilized vial contains:
Triptorelin Pamoate
Equivalent to Triptorelin.….…11.25mg
(Lyophilized powder for suspension for injection)
Excipients:
Anhydrous Citric Acid USP….q.s.
Mannitol USP……………………..q.s.
Water for Injection USP……..q.s.

c) Powder for suspension for Injection Triptorelin 22.5mg
Each sterile lyophilized vial contains:
Triptorelin Pamoate
Equivalent to Triptorelin.….…22.5mg
(Lyophilized powder for suspension for injection)
Excipients:
Anhydrous Citric Acid USP….q.s.
Mannitol USP……………………..q.s.
Water for Injection USP……..q.s.


THERAPEUTIC INDICATIONS:

Triptorelin is a hormone drug that you might have as a treatment for prostate cancer that is advanced (spread to other parts of your body) locally advanced with or without radiotherapy or surgery

PACKING:

1) Powder for suspension for Injection Triptorelin 3.75mg – 1 Month
2) Powder for suspension for Injection Triptorelin 11.25mg – 3 Month
3) Powder for suspension for Injection Triptorelin 22.5mg – 6 Month

DIRECTION OF USE:

For Intramuscular use only.
Reconstitution: Must reconstitute with 2 ml sterile water for injection USP prior to administration and use the preparation immediately.
For further information refer package insert.

CAUTION AND WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
Opening instructions: Open the top and bottom flaps initially and then open the side flap.
TRANSPORT ONLY IN REFRIGERATION CHAIN.
INJECT INSTANTLY AFTER MIXING.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.

STORAGE AND DOSAGE:

Storage: Store the vials in the original carton between 2°C to 8°C (36° to 46° F).
Protect from light.
Dosage: As directed by an Oncologist.