History of (with prior L-asparaginase treatment): pancreatitis; hemorrhagic events; serious thrombosis
Cautions:
No more than 2 mL should be administered at any one injection site
Anaphylaxis or serious allergic reactions may occur, monitor patient for 1 hr after administration; discontinue with serious allergic reactions
Glucose intolerance reported (irreversible in some cases); monitor serum glucose
Hepatotoxicity and abnormal liver function, including elevations of AST (SGOT), ALT (SGPT), alkaline phosphatase, bilirubin (direct and indirect), and depression of serum albumin, and plasma fibrinogen may occur; monitor
Discontinue if pancreatitis occurs; evaluate patients with abdominal pain for pancreatitis
Serious thrombotic events, including sagittal sinus thrombosis reported; discontinue if this occurs
Increased prothrombin time, increased PTT and hypofibrinogenemia may occur; monitor for coagulopathy
Pregnancy & Lactation
Pregnancy Category: C
Lactation: not known if excreted in breast milk
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
Pharmacology
Mechanism of Action
Modified version of L-asparaginase depletes asparagine, the aminoacid required for protein synthesis, and in turn kills leukemic cells
Pharmacokinetics
Half-Life: 5-5.6 days
Onset: Asparagine depleted within 4 days (IM)
Duration: 21 days (IM); 2-4 weeks (IV in asparaginase naive adults)
Vd: 1.5 L/m² (IM in children); 2.4 L/m² (IV in adults)
Metabolism: Systemically
Peak plasma time: 3-4 days (IM)
Excretion: Urine (trace amounts)
Storage
Refrigerate
Do not use if cloudy or if precipitate is present
Do not freeze
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Founded in the year 2017, G J Pharmaceuticals LLP is one of the leading Exporters and Traders of Pharmaceutical Injection, Pharmaceutical Tablet, Pharmaceutical Capsules and much more. Besides this, we check these on a variety of grounds before finally shipping them at the destination of our customers. Together with this, our offered facility of customization has earned us huge number of satisfied customers. Due to our moral business dealings and right business policy have assisted us in winning faith of customers. Besides, we work under the guidance of our mentor Mr. Dhiraj Rathod. Under his headship, we have achieved a prominent place in the market. Our "Always Committed to Good Health " is a statement that describes – for our customers, our communities and all of our stakeholders – what we believe in, what we value, and what we strive to deliver in our day-to-day work. Our Promise challenges us to continually improve and inspires us to always aim higher. We are here for the people we serve in their pursuit of healthy lives. This has been the way of G J PHARMACEUTICALS LLP – passionately and thoughtfully translating science into lasting contributions to health. OUR MISSION To make life saving Therapeutic Solutions accessible to Humanity by becoming the most Preferred global partner by joining hands with the medical fraternity VALUES :- Safety We make safety the first priority—the core of all we do. Environment We are committed to protecting the health and well-being of the communities in which we conduct business. Employees We respect every employee, recognizing our mutual need to be safe, healthy, and successful. We value each other for our diverse ideas, experiences, and backgrounds. Empowerment We encourage our people to be innovative, to take action, to make independent decisions, and to be accountable for their actions. Leadership Each of us strives to lead and motivate by example and consistently live these core values. We coach, train, and empower employees to reach their full potential. Teamwork We work as groups and individuals toward our common goal in a spirited and selfless manner. Continuous Improvement We relentlessly pursue doing the right things better. Technology We are committed to providing the resources to develop technology that will build and sustain our businesses. Ethics We are fair, honest, and consistent in our business and personal practices.
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Number of EmployeesBelow 20
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