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Defitelio 80 Mg/ML

Jazz Pharmaceuticals

Generic Name : Defibrotide

 

What is Defitelio Used For and Defitelio Cost

Defitelio defibrotide sodium is indicated for treatment of adults and children with venous occlusive hepatitis known as sinusoidal obstructive syndrome. In other words kidney or lung dysfunction after hematopoietic stem cell transplantation. Defitelio cost is low in India. Buy defibrotide price in india online at Yourmedikart.

Description

Defibrotide sodium is a mixture of oligonucleotides with plasminogen properties. Therefore The chemical name of Defibrotide sodium is polydeoxyribonucleotide sodium salt. In Addition Defibrotide sodium is a polydisperse mixture of single-stranded polydeoxyribonucleotide sodium salt mainly derived from porcine intestine tissue, After that weight average molecular weight of 13-20 kDa, and potency of 27-39 and 28 per mg -38 biological units are determined by two independent assays measuring the release of products formed by contact between defibrotide sodium, plasmin and plasmin substrate.

DEFITELIO (defibrotide sodium) injection is a clear, pale yellow to brown, sterile, non-vaccine, single dose medication contained in a single vial. Each milliliter of injection contains 80 mg of defibrotide sodium and 10 mg of sodium citrate (USP) in water for injection (USP). The pH can adjusted to 6.8-7.8 using hydrochloric acid NF and/or sodium hydroxide NF.

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Indications

DEFITELIO is indicated for treat of adults and children with hepatic venous occlusive disease (VOD), Similarly Therefore known sinusoidal obstruction syndrome (SOS), which has kidney or lung dysfunction after hematopoietic stem cell transplantation (HSCT).Buy Defitelio defibrotide price in india online at Yourmedikart.

Subjective and quantitative composition

One mL of concentrate contains defibrotide 80 mg comparing to an amount of 200 mg in 2.5 mL in a vial, and relating to a concentration in the scope of 4 mg/mL to 20 mg/mL after weakening.

Created from porcine intestinal mucosa.

Excipient with known impact

Every vial contains 0.89 mmol (comparable to 20.4 mg) sodium.

Clinical particulars

Therapeutic signs

Defitelio is indicated for the treatment of serious hepatic veno-occlusive disease (VOD) also called sinusoidal obstruction syndrome (SOS) in hematopoietic stem-cell transplantation (HSCT) treatment.

Indicated in grown-ups and in adolescents, children and babies more than multi month old enough.

Posology and method for organization

Defitelio Injection should recommended and managed to patients by specialized doctors experienced in the diagnosis and treatment of complications of HSCT.

Posology

The suggested dose is 6.25 mg/kg body weight at regular intervals (25 mg/kg/day).

There is restricted adequacy and safety information on dosages over this level and subsequently it is not prescribed to build the dose over 25 mg/kg/day.

The treatment should administered for at least 21 days and proceeded until the indications and indications of extreme VOD resolve.

Hepatic impairment

Therefore No formal pharmacokinetic studies have performed in patients with hepatic impairment; however, the medicinal product has used in clinical trials of patients developing hepatic impairment without dose adjustment with no safety issues identified. Defitelio defibrotide price in india online at Yourmedikart.

Pediatric populace

The suggested dose for youngsters matured a month to 18 years is a similar mg/kg dose concerning adults for example 6.25 mg/kg body weight at regular intervals.

The safety and efficacy of defibrotide in youngsters matured under a month has not yet established. No information are available. Defitelio use in youngsters matured short of what one month isn’t suggested.

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Renal Impairment

Dose adjustment is not required for patients with renal impairment or who are on intermittent hemodialysis.

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Precautions You Must Know

Hypersensitivity Reactions

Hypersensitivity reactions in urticarial, urticarial and angioedema occur in less than 2% of NO patients. Anaphylactic reactions have reported recently in patients receiving defilio. In other words Evaluate the patient for hypersensitivity reactions, Therefore especially if there is a history of previous exposure. For instance If adverse effects occur, the drug is discontinued, administered with initial care, and its effects monitored until resolution.

Hemorrhage

Defitelio injection may increase the risk of bleeding in patients with VOD after HSCT. Do not give this medication to patients with high blood pressure. After that Defitelio monitors the patient for signs of bleeding. Continue or stop Defitelio if bleeding occurs.

Use of oral coagulants or fibrinolytic may increase the risk of bleeding and should discontinued prior to administration. Consider delaying administration of Defitelio until the effects of coagulants have subsided.

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How is Defibrotide given?

  • Defibrotide is injected in vein intravenously. These drugs should take slowly, and IV infusions can take up to 2 hours.
  • Most Importantly Do not give this medicine if you do not understand how to use the vaccine and how to dispose of needles, IV tubing, and other supplies.
  • Secondly Defibrotide given for 21 days up to 60 days, if symptoms persist. Follow all directions on your prescription. Do not use this medication in higher doses, lower doses, or for longer than the recommended dose.
  • In other words Defibrotide must mixed with diluent before use. If you use home remedies, understand the ingredients and store your medications properly.
  • Do not mix Defibrotide with other drugs in the same intravenous line. For instance Follow your doctor’s instructions for cleaning your IV line after each injection.
  • After that Do not use if solution has changed color or contains particles. Ask your pharmacist about new medications.
  • After mixing the Defibrotide with the diluent, store it in the refrigerator and use it within 24 hours. The mixture should used within 4 hours if stored at room temperature.
  • For instance Each person uses only one vial (bottle) of this medicine for one person. Discard after one use, even if medication remains after injection.
  • Above all Detail Information about injection.

Before Taking This Medicine

You should not use defibrotide if you are allergic to it, or if:

  • Firstly you have active bleeding;
  • Similarly also take blood thinner such as warfarin (Coumadin, Jantoven); or
  • Thirdly you use any medication to treat or dissolve blood clots such as streptokinase or urokinase.

To make sure defibrotide is safe for you, tell your doctor if you have:

  • bleeding or blood clotting disorder.

defibrotide will harm an unborn baby. After that Tell your doctor if you are pregnant or plan to become pregnant.

For instance defibrotide passes into breast milk or if it could harm nursing baby. Tell your doctor if you are breast-feeding baby.

Dosage

The recommended dose of defibrotide for pediatric or adult patients is 6.25 mg/kg every 6 hours, intravenously for 2 hours. The dose of defibrotide should based on the patient’s initial weight. In other words This medicine must taken for at least 21 days. However the signs/symptoms of hepatic venous occlusion disease have not resolved after 21 days, defibrotide should  continued until the venous occlusive disease resolves or up to 60 days. Defitelio defibrotide price in india online at Yourmedikart.

Warnings and Precautions

  • Firstly Patients should monitored for bleeding. Withhold or discontinue defibrotide sodium injection in case significant bleeding occurs.
  • Secondly Patients with Defitelio dose should monitored for the hypersensitivity reactions, especially in case there is history of the previous exposure.
  • Use of Defitelio (defibrotide sodium) should avoided by women with childbearing potential.
  • Most Importantly The defibrotide 80 mg should not used in individuals with bleeding complications or who are taking blood thinners.
  • After that Patients should informed that breastfeeding  not recommended during defibrotide sodium injection treatment. Above all are warning and Precautions we should take care.

 

FAQ

What is the use of Defitelio Injection ?

Defitelio is treat severe venous occlusive disease (VOD) in adults and children receiving chemotherapy and stem cell transplantation. VOD occurs when blood vessels in liver are blocked, blood flow is reduced, and liver damage may occur.

What type of drug is defibrotide?

Defibinide injection belongs to a class of drugs called antithrombotic agents. Its role is to prevent the formation of blood clots.

What is sinusoidal obstruction syndrome?

Listen to the pronunciation. (SINE-yoo-SOY-dul ub-STRUK-shun SIN-drome) Some venous obstruction in the liver. This causes a decrease in blood flow in the liver and may cause liver damage.

How do you treat VOD?

Defibrotide only drug registered for treatment of moderate/severe VOD/SOS; it is a mixture of polydeoxyribonucleotides, mainly single-stranded, derived from porcine intestinal mucosa.

How is VOD diagnosed?

However, unexplained weight gain and fluid retention only occur in VOD. There are two techniques that can used to confirm the diagnosis of VOD. The first is a procedure using ultrasound, In other words which shows reversal of blood flow through the liver.

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