Archive for the ‘plasma expanders’ Category

Plasbumin

Plasbumin

Plasbumin is used for:

Treating a variety of conditions, including shock due to blood loss in the body, burns, low protein levels due to surgery or liver failure, and as an additional medicine in bypass surgery. It may be used for certain conditions as determined by your doctor.

Plasbumin is a concentrate of plasma proteins from human blood. It works by increasing plasma volume or serum albumin levels.

Do NOT use Plasbumin if:

Contact your doctor or health care provider right away if any of these apply to you.

Before using Plasbumin :

Some medical conditions may interact with Plasbumin . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Plasbumin . However, no specific interactions with Plasbumin are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Plasbumin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Plasbumin :

Use Plasbumin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Plasbumin .

Important safety information:

Possible side effects of Plasbumin :

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Plasbumin .

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in heart rate or breathing; chills; confusion; excess saliva; fainting; fever; headache; nausea; vomiting; weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (

Store Plasbumin at room temperature at or below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not freeze. Discard unused portion. Do not use after the expiration date. Do not store in the bathroom. Keep Plasbumin out of the reach of children and away from pets.

General information:

This information is a summary only. It does not contain all information about Plasbumin . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Hyskon

Hyskon

Generic Name: dextran, high molecular weight (DEX tran)

What is high-molecular weight dextran?

High-molecular weight dextran is a plasma volume expander derived from natural sources of sugar (glucose). It works by restoring blood plasma lost through severe bleeding.

Severe blood loss can decrease oxygen levels, which can lead to organ failure, brain damage, coma, and possibly death. Plasma is needed to circulate red blood cells that deliver oxygen throughout the body.

Dextran is used to treat hypovolemia (a decrease in the volume of circulating blood plasma), that can result from severe blood loss after surgery, injury, or other causes of bleeding.

Dextran is also used to expand the inside of the uterus, making it easier for a doctor to see with a scope during a diagnostic procedure called hysteroscopy.

Dextran may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about high-molecular weight dextran?

You should not be given this medication if you are allergic to dextran, or if you have severe kidney or heart disease.

If possible before you receive dextran, tell your doctor if you have a bleeding or blood clotting disorder, a blood cell disorder, heart disease or congestive heart failure, kidney disease, a stomach or intestinal disorder, pulmonary edema (fluid in the lungs), urination problems, a food or drug allergy, or if you are on a low-salt diet.

In an emergency situation, it may not be possible before you are treated to tell your caregivers about any health conditions you have or if you are pregnant or breast-feeding. However, make sure any doctor caring for you afterward knows that you have received this medication.

Tell your doctor about all other medications you use, especially a blood thinner, steroid medication, digoxin, or a diuretic.

What should I discuss with my health care provider before I receive high-molecular weight dextran?

You should not be given this medication if you are allergic to dextran, or if you have severe kidney or heart disease.

If you have certain conditions, you may need a dose adjustment or special tests to safely receive this medication. If possible before you receive dextran, tell your doctor if you have:

a bleeding or blood clotting disorder;

a blood cell disorder such as thrombocytopenia (lack of platelets);

heart disease or congestive heart failure;

kidney disease;

a stomach or intestinal disorder;

pulmonary edema (fluid in the lungs);

urination problems not caused by hypovolemia;

a food or drug allergy; or

if you are on a low-salt diet.

In an emergency situation, it may not be possible before you are treated to tell your caregivers about any health conditions you have or if you are pregnant or breast-feeding. However, make sure any doctor caring for you afterward knows that you have received this medication.

How is high-molecular weight dextran given?

Dextran is given as an injection through a needle placed into a vein. For a hysteroscopy procedure, dextran is placed into the uterus using a small tube.

You will receive this injection in a clinic or hospital setting. A doctor, nurse, or other healthcare professional will give you this medication. Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while you are receiving this medication.

To be sure dextran is helping your condition, your blood may need to be tested often. This will help your doctor determine how long to treat you with dextran.

What happens if I miss a dose?

Since dextran is given as needed by a healthcare professional, it is not likely that you will miss a dose.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

An overdose of dextran is not expected to produce life-threatening symptoms.

What should I avoid after receiving high-molecular weight dextran?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity after you are treated with dextran.

High-molecular weight dextran side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have a serious side effect such as:

wheezing or tight feeling in your chest;

urinating less than usual or not at all;

swelling in your hands or feet;

unusual bleeding, or any bleeding that will not stop;

feeling like you might pass out; or

burning, itching, swelling, or pain around the IV needle.

Less serious side effects may include:

nausea, vomiting, stomach pain;

joint pain;

stuffy nose;

mild itching; or

skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect high-molecular weight dextran?

Before you receive dextran, tell your doctor if you are also using:

a blood thinner such as warfarin (Coumadin);

steroids (prednisolone and others);

digoxin (digitalis, Lanoxin); or

a diuretic (water pill) such as amiloride (Midamor, Moduretic), spironolactone (Aldactone, Aldactazide), or triamterene (Dyrenium, Dyazide, Maxzide).

This list is not complete and there may be other drugs that can interact with dextran. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Hextend

Hextend

Generic Name: hetastarch (HET a starch)

What is Hextend (hetastarch)?

Hetastarch (hydroxyethyl) is a plasma volume expander derived from natural sources of starch. It works by restoring blood plasma lost through severe bleeding.

Severe blood loss can decrease oxygen levels, which can lead to organ failure, brain damage, coma, and possibly death. Plasma is needed to circulate red blood cells that deliver oxygen throughout the body.

Hetastarch is used to treat hypovolemia (a decrease in the volume of circulating blood plasma), that can result from severe blood loss after surgery, injury, or other causes of bleeding.

Hetastarch also contains electrolytes (sodium, calcium potassium, magnesium) which are minerals essential for many functions in the body, including the brain and nervous system, heartbeat, and fluid balance.

Hetastarch may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Hextend (hetastarch)?

You should not be given this medication if you are allergic to hetastarch, or if you have a bleeding or blood clotting disorder, congestive heart failure, urination problems not caused by hypovolemia, or lactic acidosis.

Before you receive hetastarch, tell your doctor if you have kidney or liver disease, heart disease, congestive heart failure, diabetes, or an electrolyte imbalance.

Tell your doctor about all other medications you use, especially a blood thinner such as warfarin (Coumadin), steroid medications, digoxin (digitalis, Lanoxin), or a diuretic (water pill).

Tell your caregivers at once if you have a serious side effect such as chest pain, fast or slow heart rate, wheezing or gasping for breath, feeling like you might pass out, weak pulse, slow breathing (breathing may stop), pale skin, easy bruising, blood in your urine or stools, swelling in your hands or feet, unusual bleeding, or any bleeding that will not stop.

Rare but serious side effects may include unusual headache, vision or speech problems, mental changes, drooping eyelids, loss of feeling in your face, tremors, or trouble swallowing, or fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

What should I discuss with my health care provider before I receive Hextend (hetastarch)?

You should not be given this medication if you are allergic to hetastarch, or have certain conditions. Be sure your doctor knows if you have:

a bleeding or blood clotting disorder;

congestive heart failure;

urination problems not caused by hypovolemia; or

lactic acidosis.

Before you receive hetastarch, tell your doctor if you are allergic to any drugs, or if you have:

kidney disease;

liver disease;

heart disease;

congestive heart failure;

diabetes;

high potassium levels in your blood (hyperkalemia), or any other electrolyte imbalance; or

if you are allergic to corn.

If you have any of these conditions, you may need a dose adjustment or special tests to safely receive hetastarch.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether hetastarch passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is hetastarch given?

Hetastarch is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. A doctor, nurse, or other healthcare professional will give you this medication.

To be sure hetastarch is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with hetastarch.

What happens if I miss a dose?

Since hetastarch is given as needed by a healthcare professional, it is not likely that you will miss a dose.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

An overdose of hetastarch is not expected to produce life-threatening symptoms.

What should I avoid while receiving Hextend (hetastarch)?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are receiving hetastarch.

Hextend (hetastarch) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have a serious side effect such as:

chest pain, fast or slow heart rate;

wheezing or gasping for breath, sweating, and anxiety;

feeling like you might pass out;

weak pulse, slow breathing (breathing may stop);

pale skin, easy bruising, weakness, blood in your urine or stools;

unusual bleeding, or any bleeding that will not stop;

unusual headache, vision or speech problems, mental changes, drooping eyelids, loss of feeling in your face, tremors, or trouble swallowing;

swelling in your hands or feet; or

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Rare but serious side effects may include:

unusual headache, vision or speech problems, mental changes;

drooping eyelids, loss of feeling in your face, tremors, or trouble swallowing; or

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

mild itching or skin rash;

cough or sneezing;

warmth, redness, or tingly feeling under your skin;

vomiting;

swollen glands;

headache;

muscle pain; or

flu symptoms.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Hextend (hetastarch)?

Before you receive hetastarch, tell your doctor if you are also using:

a blood thinner such as warfarin (Coumadin);

steroids (prednisolone and others);

corticotropin (Acthar, ACTH);

digoxin (digitalis, Lanoxin); or

a diuretic (water pill) such as amiloride (Midamor, Moduretic), spironolactone (Aldactone, Aldactazide), or triamterene (Dyrenium, Dyazide, Maxzide).

This list is not complete and there may be other drugs that can interact with hetastarch. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Hespan

Hespan

Hespan is used for:

Increasing plasma volume during shock caused by bleeding, burns, surgery, or other trauma. It is not a substitute for blood or plasma. It may also be used for other conditions as determined by your doctor.

Hespan is a synthetic plasma expander. It works by producing expansion of plasma blood volume.

Do NOT use Hespan if:

Contact your doctor or health care provider right away if any of these apply to you.

Before using Hespan :

Some medical conditions may interact with Hespan . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Hespan . However, no specific interactions with Hespan are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hespan may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hespan :

Use Hespan as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Hespan .

Important safety information:

Possible side effects of Hespan :

All medicines may cause side effects, but many people have no, or minor, side effects.

Coughing; flu-like symptoms (chills, headache, mild fever); flushing; lightheadedness; muscle pains; restlessness; sneezing; swelling of ankles or feet; swollen glands in the jaw area; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast or irregular heartbeat; unusual bleeding or bruising.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (

Hespan is usually handled and stored by a health care provider. If you are using Hespan at home, store Hespan as directed by your pharmacist or health care provider. Keep Hespan out of the reach of children and away from pets.

General information:

This information is a summary only. It does not contain all information about Hespan . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

More Hespan resources

User reviews

Gentran 70

Gentran 70

Generic Name: dextran, high molecular weight (DEX tran)

What is high-molecular weight dextran?

High-molecular weight dextran is a plasma volume expander derived from natural sources of sugar (glucose). It works by restoring blood plasma lost through severe bleeding.

Severe blood loss can decrease oxygen levels, which can lead to organ failure, brain damage, coma, and possibly death. Plasma is needed to circulate red blood cells that deliver oxygen throughout the body.

Dextran is used to treat hypovolemia (a decrease in the volume of circulating blood plasma), that can result from severe blood loss after surgery, injury, or other causes of bleeding.

Dextran is also used to expand the inside of the uterus, making it easier for a doctor to see with a scope during a diagnostic procedure called hysteroscopy.

Dextran may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about high-molecular weight dextran?

You should not be given this medication if you are allergic to dextran, or if you have severe kidney or heart disease.

If possible before you receive dextran, tell your doctor if you have a bleeding or blood clotting disorder, a blood cell disorder, heart disease or congestive heart failure, kidney disease, a stomach or intestinal disorder, pulmonary edema (fluid in the lungs), urination problems, a food or drug allergy, or if you are on a low-salt diet.

In an emergency situation, it may not be possible before you are treated to tell your caregivers about any health conditions you have or if you are pregnant or breast-feeding. However, make sure any doctor caring for you afterward knows that you have received this medication.

Tell your doctor about all other medications you use, especially a blood thinner, steroid medication, digoxin, or a diuretic.

What should I discuss with my health care provider before I receive high-molecular weight dextran?

You should not be given this medication if you are allergic to dextran, or if you have severe kidney or heart disease.

If you have certain conditions, you may need a dose adjustment or special tests to safely receive this medication. If possible before you receive dextran, tell your doctor if you have:

a bleeding or blood clotting disorder;

a blood cell disorder such as thrombocytopenia (lack of platelets);

heart disease or congestive heart failure;

kidney disease;

a stomach or intestinal disorder;

pulmonary edema (fluid in the lungs);

urination problems not caused by hypovolemia;

a food or drug allergy; or

if you are on a low-salt diet.

In an emergency situation, it may not be possible before you are treated to tell your caregivers about any health conditions you have or if you are pregnant or breast-feeding. However, make sure any doctor caring for you afterward knows that you have received this medication.

How is high-molecular weight dextran given?

Dextran is given as an injection through a needle placed into a vein. For a hysteroscopy procedure, dextran is placed into the uterus using a small tube.

You will receive this injection in a clinic or hospital setting. A doctor, nurse, or other healthcare professional will give you this medication. Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while you are receiving this medication.

To be sure dextran is helping your condition, your blood may need to be tested often. This will help your doctor determine how long to treat you with dextran.

What happens if I miss a dose?

Since dextran is given as needed by a healthcare professional, it is not likely that you will miss a dose.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

An overdose of dextran is not expected to produce life-threatening symptoms.

What should I avoid after receiving high-molecular weight dextran?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity after you are treated with dextran.

High-molecular weight dextran side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have a serious side effect such as:

wheezing or tight feeling in your chest;

urinating less than usual or not at all;

swelling in your hands or feet;

unusual bleeding, or any bleeding that will not stop;

feeling like you might pass out; or

burning, itching, swelling, or pain around the IV needle.

Less serious side effects may include:

nausea, vomiting, stomach pain;

joint pain;

stuffy nose;

mild itching; or

skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect high-molecular weight dextran?

Before you receive dextran, tell your doctor if you are also using:

a blood thinner such as warfarin (Coumadin);

steroids (prednisolone and others);

digoxin (digitalis, Lanoxin); or

a diuretic (water pill) such as amiloride (Midamor, Moduretic), spironolactone (Aldactone, Aldactazide), or triamterene (Dyrenium, Dyazide, Maxzide).

This list is not complete and there may be other drugs that can interact with dextran. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Flexbumin

Flexbumin

Generic Name:

FDA approves Flexbumin

The company plans to launch Flexbumin by early 2006.

Baxter’s current

Flexbumin has the same indications and provides the same stability as albumin in glass bottles, but provides improved convenience for healthcare professionals as its flexible packaging provides less risk of breakage and is more compatible with hospital inventory storage systems. The flexible containers are lighter and require less space, which may ultimately save hospitals money on disposal.

Historically, albumin has been packaged in glass bottles as a result of technical requirements related to manufacturing, including inertness, sturdiness and a high water vapor and oxygen barrier that no single plastic material has been able to fulfill.

Flexbumin uses Baxter’s Galaxy(R) flexible container system, a proprietary multi-layer system that helps maintain albumin quality and allows the solution to be stored at room temperature. Galaxy, which employs barrier technology and a continuous aseptic filling process, has been used in the United States for more than 16 years to package pharmaceutical products.

Flexbumin has the same indications and provides the same stability as Buminate, and can be stored for up to two years at room temperature. The solution will be available in both 50 mL and 100 mL flexible containers. All components of Flexbumin are latex-free.

About Flexbumin

Flexbumin is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. Flexbumin is indicated in hypovolemia, hypoalbuminemia due to inadequate reproduction, excessive catabolism, hemorrhage, major surgery or burns, and for use during cardiopulmonary bypass surgery.

Flexbumin is contraindicated in patients with a history of allergic reactions to albumin, in severely anemic patients, and in patients with cardiac failure.

Flexbumin is made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, such as viruses, that can cause disease.

The potential risks and benefits of albumin should be weighed against those of alternative therapies for all patients for whom albumin administration is being considered.

Source:

More Flexbumin resources

Compare Flexbumin with other medications for the treatment of:

Dextran 70 6% in 5% Dextrose

Dextran 70 6% in 5% Dextrose

Generic Name: dextran, high molecular weight (DEX tran)

What is high-molecular weight dextran?

High-molecular weight dextran is a plasma volume expander derived from natural sources of sugar (glucose). It works by restoring blood plasma lost through severe bleeding.

Severe blood loss can decrease oxygen levels, which can lead to organ failure, brain damage, coma, and possibly death. Plasma is needed to circulate red blood cells that deliver oxygen throughout the body.

Dextran is used to treat hypovolemia (a decrease in the volume of circulating blood plasma), that can result from severe blood loss after surgery, injury, or other causes of bleeding.

Dextran is also used to expand the inside of the uterus, making it easier for a doctor to see with a scope during a diagnostic procedure called hysteroscopy.

Dextran may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about high-molecular weight dextran?

You should not be given this medication if you are allergic to dextran, or if you have severe kidney or heart disease.

If possible before you receive dextran, tell your doctor if you have a bleeding or blood clotting disorder, a blood cell disorder, heart disease or congestive heart failure, kidney disease, a stomach or intestinal disorder, pulmonary edema (fluid in the lungs), urination problems, a food or drug allergy, or if you are on a low-salt diet.

In an emergency situation, it may not be possible before you are treated to tell your caregivers about any health conditions you have or if you are pregnant or breast-feeding. However, make sure any doctor caring for you afterward knows that you have received this medication.

Tell your doctor about all other medications you use, especially a blood thinner, steroid medication, digoxin, or a diuretic.

What should I discuss with my health care provider before I receive high-molecular weight dextran?

You should not be given this medication if you are allergic to dextran, or if you have severe kidney or heart disease.

If you have certain conditions, you may need a dose adjustment or special tests to safely receive this medication. If possible before you receive dextran, tell your doctor if you have:

a bleeding or blood clotting disorder;

a blood cell disorder such as thrombocytopenia (lack of platelets);

heart disease or congestive heart failure;

kidney disease;

a stomach or intestinal disorder;

pulmonary edema (fluid in the lungs);

urination problems not caused by hypovolemia;

a food or drug allergy; or

if you are on a low-salt diet.

In an emergency situation, it may not be possible before you are treated to tell your caregivers about any health conditions you have or if you are pregnant or breast-feeding. However, make sure any doctor caring for you afterward knows that you have received this medication.

How is high-molecular weight dextran given?

Dextran is given as an injection through a needle placed into a vein. For a hysteroscopy procedure, dextran is placed into the uterus using a small tube.

You will receive this injection in a clinic or hospital setting. A doctor, nurse, or other healthcare professional will give you this medication. Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while you are receiving this medication.

To be sure dextran is helping your condition, your blood may need to be tested often. This will help your doctor determine how long to treat you with dextran.

What happens if I miss a dose?

Since dextran is given as needed by a healthcare professional, it is not likely that you will miss a dose.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

An overdose of dextran is not expected to produce life-threatening symptoms.

What should I avoid after receiving high-molecular weight dextran?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity after you are treated with dextran.

High-molecular weight dextran side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have a serious side effect such as:

wheezing or tight feeling in your chest;

urinating less than usual or not at all;

swelling in your hands or feet;

unusual bleeding, or any bleeding that will not stop;

feeling like you might pass out; or

burning, itching, swelling, or pain around the IV needle.

Less serious side effects may include:

nausea, vomiting, stomach pain;

joint pain;

stuffy nose;

mild itching; or

skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect high-molecular weight dextran?

Before you receive dextran, tell your doctor if you are also using:

a blood thinner such as warfarin (Coumadin);

steroids (prednisolone and others);

digoxin (digitalis, Lanoxin); or

a diuretic (water pill) such as amiloride (Midamor, Moduretic), spironolactone (Aldactone, Aldactazide), or triamterene (Dyrenium, Dyazide, Maxzide).

This list is not complete and there may be other drugs that can interact with dextran. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Dextran 70 6% in 0.9% Sodium Chloride

Dextran 70 6% in 0.9% Sodium Chloride

Generic Name: dextran, high molecular weight (DEX tran)

What is high-molecular weight dextran?

High-molecular weight dextran is a plasma volume expander derived from natural sources of sugar (glucose). It works by restoring blood plasma lost through severe bleeding.

Severe blood loss can decrease oxygen levels, which can lead to organ failure, brain damage, coma, and possibly death. Plasma is needed to circulate red blood cells that deliver oxygen throughout the body.

Dextran is used to treat hypovolemia (a decrease in the volume of circulating blood plasma), that can result from severe blood loss after surgery, injury, or other causes of bleeding.

Dextran is also used to expand the inside of the uterus, making it easier for a doctor to see with a scope during a diagnostic procedure called hysteroscopy.

Dextran may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about high-molecular weight dextran?

You should not be given this medication if you are allergic to dextran, or if you have severe kidney or heart disease.

If possible before you receive dextran, tell your doctor if you have a bleeding or blood clotting disorder, a blood cell disorder, heart disease or congestive heart failure, kidney disease, a stomach or intestinal disorder, pulmonary edema (fluid in the lungs), urination problems, a food or drug allergy, or if you are on a low-salt diet.

In an emergency situation, it may not be possible before you are treated to tell your caregivers about any health conditions you have or if you are pregnant or breast-feeding. However, make sure any doctor caring for you afterward knows that you have received this medication.

Tell your doctor about all other medications you use, especially a blood thinner, steroid medication, digoxin, or a diuretic.

What should I discuss with my health care provider before I receive high-molecular weight dextran?

You should not be given this medication if you are allergic to dextran, or if you have severe kidney or heart disease.

If you have certain conditions, you may need a dose adjustment or special tests to safely receive this medication. If possible before you receive dextran, tell your doctor if you have:

a bleeding or blood clotting disorder;

a blood cell disorder such as thrombocytopenia (lack of platelets);

heart disease or congestive heart failure;

kidney disease;

a stomach or intestinal disorder;

pulmonary edema (fluid in the lungs);

urination problems not caused by hypovolemia;

a food or drug allergy; or

if you are on a low-salt diet.

In an emergency situation, it may not be possible before you are treated to tell your caregivers about any health conditions you have or if you are pregnant or breast-feeding. However, make sure any doctor caring for you afterward knows that you have received this medication.

How is high-molecular weight dextran given?

Dextran is given as an injection through a needle placed into a vein. For a hysteroscopy procedure, dextran is placed into the uterus using a small tube.

You will receive this injection in a clinic or hospital setting. A doctor, nurse, or other healthcare professional will give you this medication. Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while you are receiving this medication.

To be sure dextran is helping your condition, your blood may need to be tested often. This will help your doctor determine how long to treat you with dextran.

What happens if I miss a dose?

Since dextran is given as needed by a healthcare professional, it is not likely that you will miss a dose.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

An overdose of dextran is not expected to produce life-threatening symptoms.

What should I avoid after receiving high-molecular weight dextran?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity after you are treated with dextran.

High-molecular weight dextran side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have a serious side effect such as:

wheezing or tight feeling in your chest;

urinating less than usual or not at all;

swelling in your hands or feet;

unusual bleeding, or any bleeding that will not stop;

feeling like you might pass out; or

burning, itching, swelling, or pain around the IV needle.

Less serious side effects may include:

nausea, vomiting, stomach pain;

joint pain;

stuffy nose;

mild itching; or

skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect high-molecular weight dextran?

Before you receive dextran, tell your doctor if you are also using:

a blood thinner such as warfarin (Coumadin);

steroids (prednisolone and others);

digoxin (digitalis, Lanoxin); or

a diuretic (water pill) such as amiloride (Midamor, Moduretic), spironolactone (Aldactone, Aldactazide), or triamterene (Dyrenium, Dyazide, Maxzide).

This list is not complete and there may be other drugs that can interact with dextran. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Albutein

Albutein

Albutein is used for:

Treating a variety of conditions, including shock due to blood loss in the body, burns, low protein levels due to surgery or liver failure, and as an additional medicine in bypass surgery. It may be used for certain conditions as determined by your doctor.

Albutein is a concentrate of plasma proteins from human blood. It works by increasing plasma volume or serum albumin levels.

Do NOT use Albutein if:

Contact your doctor or health care provider right away if any of these apply to you.

Before using Albutein :

Some medical conditions may interact with Albutein . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Albutein . However, no specific interactions with Albutein are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Albutein may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Albutein :

Use Albutein as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Albutein .

Important safety information:

Possible side effects of Albutein :

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Albutein .

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in heart rate or breathing; chills; confusion; excess saliva; fainting; fever; headache; nausea; vomiting; weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (

Store Albutein at room temperature at or below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not freeze. Discard unused portion. Do not use after the expiration date. Do not store in the bathroom. Keep Albutein out of the reach of children and away from pets.

General information:

This information is a summary only. It does not contain all information about Albutein . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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Alburx

AlbuRx

R

1. DESCRIPTION

AlbuRx

This product is prepared from the plasma of US donors. The product has been produced by alcohol fractionation and has been heated for 10 hours at 60°C for inactivation of infectious agents. The results of virus validation studies have shown that the manufacturing process, particularly alcohol fractionation, eliminates enveloped and non-enveloped viruses. Additionally, heat treatment at 60°C for a period of 10 hours efficiently inactivates viruses. The solution contains 130–160 milliequivalents of sodium per liter (mEq/L) and the potassium content is not over 2 mEq/L. The aluminum content does not exceed 200 µg/L. The solution is stabilized with 0.08 millimole of sodium acetyltryptophanate plus 0.08 millimole of sodium caprylate per gram of albumin. The solution contains no preservative.

2. CLINICAL PHARMACOLOGY

2.1 AlbuRx

2.2 The binding properties of albumin may, in special circumstances, provide an indication for its clinical use. For such purposes, however, an Albumin (Human) 25% solution should be used.

2.3 The colloid osmotic or oncotic properties of albumin constitute the predominant reason for its clinical use. The rationale for this is the Starling concept of the capillary balance of hydrostatic and oncotic pressure gradients across the capillary walls as the determinant of the fluid – i.e. volume – distribution between the intravascular and the interstitial compartment

3. INDICATIONS AND USAGE

3.1 Shock

The definitive treatment of major hemorrhage is the transfusion of red blood cells restoring a normal oxygen transport capacity of the blood. Since, however, the life-threatening event in major hemorrhage is the loss of blood volume and not the erythrocyte deficit, the blood volume can, as an emergency measure, be supported by AlbuRx

3.2 Burns

Apart from damage to the respiratory tract, the development of burn shock is the most life-threatening event in the immediate care of the burned patient. Therapy during the first 24 hours is directed at the administration of large volumes of crystalloid solutions and lesser amounts of AlbuRx

3.3 Pancreatitis and peritonitis

AlbuRx

3.4 Postoperative albumin loss

It is now recognized that intra-operative damage to capillary walls by blunt handling and sharp dissection of tissues leads to substantial postoperative losses of circulating albumin, over and above those due to bleeding. Forty to eighty percent of the intravascular albumin mass may thus be lost after radical dissections for malignant disease, surgery of the colon and rectum, and reconstructive procedures involving the aorta and major iliac vessels.

3.5 Hypoproteinemia with an oncotic deficit

In subacute or chronic hypoproteinemia, efforts should always be made to determine the underlying cause and to improve circulating protein levels by dietary means. Most commonly, such states are due to protein-calorie malnutrition, defective absorption in gastrointestinal disorders, faulty albumin synthesis in chronic hepatic failure, increased protein catabolism postoperatively or with sepsis, and abnormal renal losses of albumin with chronic kidney disease. In all these situations, the circulating plasma volume is usually maintained by the renal retention of sodium and water, but this is associated with tissue edema due to the hypoalbuminemia with an oncotic deficit. The cutaneous edema lowers the oxygen tension of wounds and may thus impair the healing process

4. CONTRAINDICATIONS

The use of AlbuRx

5. WARNINGS

AlbuRx

The physician should discuss the risks and benefits of this product with the patient.

Turbid solutions must not be used. Do not begin administration more than 4 hours after introduction of the administration set. Partially used bottles must be discarded.

6. PRECAUTIONS

Adequate precautions should be taken against circulatory overload (see

PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with AlbuRx

Use an intravenous infusion set suitable for the infusion of blood and blood products.

7. ADVERSE REACTIONS

Since AlbuRx

Though very rare, non-septic incompatibility reactions including nausea, chills, fever, urticaria, headache and hypotension following the administration of albumin-containing preparations have occasionally been observed.

8. DOSAGE AND ADMINISTRATION

AlbuRx

Upon administration of AlbuRx

During resuscitation, constant monitoring of the patient provides the guidelines for treatment.

For children, a dose of 10 to 15 mL per pound body weight is usually adequate and close surveillance of the young patient is essential. Since patients – notably those with sepsis or severe multiple injuries – often need a circulating blood volume exceeding the prediction derived from their body weight, treatment should always be guided by the hemodynamic response and not by blood volume calculations or measurements.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

9. HOW SUPPLIED

AlbuRx

10. STORAGE

AlbuRx

REFERENCES

Manufactured by:

Distributed by:

Revised: June 2007

Package Label – Principal Display Panel – 250 mL

NDC 44206-310-25

5%

AlbuRx

250 mL

For intravenous

Rx only

CSL Behring

Package Label – Principal Display Panel – 500 mL

NDC 44206-310-50

5%

AlbuRx

500 mL

For intravenous

Rx only

CSL Behring

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