Octapharma Usa Inc

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Octapharma Usa Inc Drugs

Albumin

Albumin

2.1 Dosage

General Recommendations

The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patient’s individual requirements.

The dose required depends on the body weight of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required.

The daily dose should not exceed 2 g of ALBUMIN (HUMAN) 20% per kg of body weight.

Hypovolemia

In adults, an intravenous infusion of 25 g should be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.

In spite of limited information about the efficacy in pediatric subjects, an intravenous infusion of 2.5 to 12.5 g or 0.5 to 1 g/kg body weight may be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.

Hemodilution may follow administration of ALBUMIN (HUMAN) 20%. If hemorrhage has occurred, this may result in relative anemia. This condition should be controlled by the supplemental administration of compatible red blood cells or compatible whole blood.

Hypoalbuminemia

In adults, intravenous infusion of 50 to 75 g of ALBUMIN (HUMAN) 20% may be used. Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoalbuminemia.

In burns, therapy usually starts with the administration of large volumes of crystalloid injection to maintain plasma volume. After 24 hours, ALBUMIN (HUMAN) 20% may be added at an initial dose of 25 g with the dose adjusted thereafter to maintain a plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g/100 mL.

Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites

In adults, intravenous infusion of 8 g of ALBUMIN (HUMAN) 20% may be given for every 1,000 mL of ascitic fluid removed.

Ovarian Hyperstimulation Syndrome

In adults, as a guideline, doses of 50 – 100 g of ALBUMIN (HUMAN) 20% should be infused over 4 hours and repeated at 4- to 12-hour intervals as necessary, when infusion of normal saline fails to achieve or maintain hemodynamic stability and urine output. [ 7 ]

Adult Respiratory Distress Syndrome (ARDS)

In adults, a dose of 25 g of ALBUMIN (HUMAN) 20% can be infused over 30 minutes and repeated at 8 hour intervals for 3 days, if necessary. [ 5 ]

Induction of Diuresis in Patients with Acute Nephrosis

In adults, a dose of 25 g of ALBUMIN (HUMAN) 20% can be infused, administered with an appropriate diuretic once a day for 7 to 10 days.

Hemolytic Disease of the Newborn

In newborns, ALBUMIN (HUMAN) 20% may be administered prior to or during exchange transfusion at a dose of 1 g per kilogram body weight. [ 6 ]

2.2 Administration

Intravenous use only.

Prior to administration, parenteral drug products should be inspected visually for turbidity and discoloration, whenever solution and container permit.

Do not dilute with sterile water for injection.

Do not use solutions of ALBUMIN (HUMAN) 20% which are cloudy or have deposits. Once the infusion container has been opened the contents should be used immediately. Discard the unused portion. Filtration of ALBUMIN (HUMAN) 20% is not required.

The infusion rate should be adjusted according to the individual circumstances and the indication. In plasma exchange during paracentesis, the infusion rate may be higher and should be adjusted to the rate of removal.

If large volumes (greater than 1500 ml) are administered, the product should be warmed to room temperature before use.
Albumin

Albumin

2.1 Dosage

General Recommendations

The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patient’s individual requirements.

The dose required depends on the body weight of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required. The daily dose should not exceed 2 g of ALBUMIN (HUMAN) 5% per kg of body weight.

Hypovolemia

In adults, an intravenous infusion of 25 g of ALBUMIN (HUMAN) 5% should be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.

In spite of limited information about the efficacy in pediatric subjects, an intravenous infusion of 2.5 to 12.5 g or 0.5 to 1 g/kg body weight may be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.

Hemodilution may follow administration of ALBUMIN (HUMAN) 5%. If hemorrhage has occurred, this may result in relative anemia. This condition should be controlled by the supplemental administration of compatible red blood cells or compatible whole blood.

Hypoalbuminemia

In adults, intravenous infusion of 50 to 75 g of ALBUMIN (HUMAN) 5% may be used. Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoalbuminemia.

In burns, therapy usually starts with the administration of large volumes of crystalloid injection to maintain plasma volume. After 24 hours, ALBUMIN (HUMAN) 5% may be added at an initial dose of 25 g with the dose adjusted thereafter to maintain a plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g/100 mL.

Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites

In adults, intravenous infusion of 8 g of ALBUMIN (HUMAN) 5% may be given for every 1,000 mL of ascitic fluid removed.

2.2 Administration

Intravenous use only.

Prior to administration, parenteral drug products should be inspected visually for turbidity and discoloration, whenever solution and container permit.

Do not dilute with sterile water for injection.

Do not use solutions of ALBUMIN (HUMAN) 5% which are cloudy or have deposits. Once the infusion container has been opened the contents should be used immediately. Discard the unused portion. Filtration of ALBUMIN (HUMAN) 5% is not required.

The infusion rate should be adjusted according to the individual circumstances and the indication. In plasma exchange during paracentesis, the infusion rate may be higher and should be adjusted to the rate of removal.

If large volumes (greater than 1500 ml) are administered, the product should be warmed to room temperature before use.
Albumin

Albumin

2.1 Dosage

General Recommendations

The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patient’s individual requirements.

The dose required depends on the body weight of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required.

The daily dose should not exceed 2 g of ALBUMIN (HUMAN) 25% per kg of body weight.

Hypovolemia

In adults, an intravenous infusion of 25 g should be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.

In spite of limited information about the efficacy in pediatric subjects, an intravenous infusion of 2.5 to 12.5 g or 0.5 to 1 g/kg body weight may be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.

Hemodilution may follow administration of ALBUMIN (HUMAN) 25%. If hemorrhage has occurred, this may result in relative anemia. This condition should be controlled by the supplemental administration of compatible red blood cells or compatible whole blood.

Hypoalbuminemia

In adults, intravenous infusion of 50 to 75 g of ALBUMIN (HUMAN) 25% may be used. Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoalbuminemia.

In burns, therapy usually starts with the administration of large volumes of crystalloid injection to maintain plasma volume. After 24 hours, ALBUMIN (HUMAN) 25% may be added at an initial dose of 25 g with the dose adjusted thereafter to maintain a plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g/100 mL.

Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites

In adults, intravenous infusion of 8 g of ALBUMIN (HUMAN) 25% may be given for every 1,000 mL of ascitic fluid removed.

Ovarian Hyperstimulation Syndrome

In adults, as a guideline, doses of 50 – 100 g of ALBUMIN (HUMAN) 25% should be infused over 4 hours and repeated at 4- to 12-hour intervals as necessary, when infusion of normal saline fails to achieve or maintain hemodynamic stability and urine output. [ 7 ]

Adult Respiratory Distress Syndrome (ARDS)

In adults, a dose of 25 g of ALBUMIN (HUMAN) 25% can be infused over 30 minutes and repeated at 8 hour intervals for 3 days, if necessary. [ 5 ]

Induction of Diuresis in Patients with Acute Nephrosis

In adults, a dose of 25 g of ALBUMIN (HUMAN) 25% can be infused, administered with an appropriate diuretic once a day for 7 to 10 days.

Hemolytic Disease of the Newborn

ALBUMIN (HUMAN) 25% may be administered prior to or during exchange transfusion at a dose of 1 g per kilogram body weight. [ 6 ]

2.2 Administration

Intravenous use only.

Prior to administration, parenteral drug products should be inspected visually for turbidity and discoloration, whenever solution and container permit.

Do not dilute with sterile water for injection.

Do not use solutions of ALBUMIN (HUMAN) 25% which are cloudy or have deposits. Once the infusion container has been opened the contents should be used immediately. Discard the unused portion. Filtration of ALBUMIN (HUMAN) 25% is not required.

The infusion rate should be adjusted according to the individual circumstances and the indication. In plasma exchange during paracentesis, the infusion rate may be higher and should be adjusted to the rate of removal.

If large volumes (greater than or equal to 1500 ml) are administered, the product should be warmed to room temperature before use.
Cold

Cold

For intravenous use only

Administer Octaplas based on AB0-blood group compatibility.

2.1 Dose

Replacement of coagulation factors in patients with acquired deficiencies due to liver disease or undergoing cardiac surgery or liver transplant

Initially infuse of 10 to 15 mL Octaplas per kilogram body weight. This should increase the patient’s plasma coagulation factor levels by approximately 15-25%. If hemostasis is not achieved, use higher doses.

Adjust dose based on desired clinical response.

Monitor response, including measurement of activated partial thromboplastin time (aPTT), prothrombin time (PT), and/or specific coagulation factors.

Plasma exchange in patients with TTP

Completely replace plasma volume removed during plasmapheresis with Octaplas. Generally, 1 to 1.5 plasma volumes corresponds to 40 to 60 milliliters per kg. [ 1,2 ]

2.2 Administration

Administer Octaplas after thawing using an infusion set with a filter.

Octaplas should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if turbid.

Avoid shaking.

Steps for Thawing:
For water bath: Thaw in the outer wrapper for up to 30 minutes in a circulating water bath at +30°C to +37°C (86°F to 98.6°F).An overwrap bag may be used to provide further protection of contents if appropriate. Prevent water from contaminating the entry port. The minimum thawing time is 30 minutes at 37°C (98.6°F). The thawing time depends on the number of bags in the water bath. If more than one plasma bag is thawed in the same water bath, then the thawing time can be prolonged, but should not exceed 60 minutes. For dry tempering system: Place the Octaplas bags between the heating plates according to the manufacturer´s instructions. Thaw plasma following manufacturer directions between +30°C to +37°C (86°F to 98.6°F). Remove the product when the thawing process is completed. The thawing process may be monitored and recorded using the thawing device printer or barcode scanner recommended by the device manufacturer. Monitor the thawing process and record using the thawing device printer or barcode scanner recommended by the device manufacturer.
Do not freeze Octaplas. Discard unused product.
Nadh Plus

Nadh Plus

For intravenous use only

Administer Octaplas based on AB0-blood group compatibility.

2.1 Dose

Replacement of coagulation factors in patients with acquired deficiencies due to liver disease or undergoing cardiac surgery or liver transplant

Initially infuse of 10 to 15 mL Octaplas per kilogram body weight. This should increase the patient’s plasma coagulation factor levels by approximately 15-25%. If hemostasis is not achieved, use higher doses.

Adjust dose based on desired clinical response.

Monitor response, including measurement of activated partial thromboplastin time (aPTT), prothrombin time (PT), and/or specific coagulation factors.

Plasma exchange in patients with TTP

Completely replace plasma volume removed during plasmapheresis with Octaplas. Generally, 1 to 1.5 plasma volumes corresponds to 40 to 60 milliliters per kg. [ 1,2 ]

2.2 Administration

Administer Octaplas after thawing using an infusion set with a filter.

Octaplas should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if turbid.

Avoid shaking.

Steps for Thawing:
For water bath: Thaw in the outer wrapper for up to 30 minutes in a circulating water bath at +30°C to +37°C (86°F to 98.6°F).An overwrap bag may be used to provide further protection of contents if appropriate. Prevent water from contaminating the entry port. The minimum thawing time is 30 minutes at 37°C (98.6°F). The thawing time depends on the number of bags in the water bath. If more than one plasma bag is thawed in the same water bath, then the thawing time can be prolonged, but should not exceed 60 minutes. For dry tempering system: Place the Octaplas bags between the heating plates according to the manufacturer´s instructions. Thaw plasma following manufacturer directions between +30°C to +37°C (86°F to 98.6°F). Remove the product when the thawing process is completed. The thawing process may be monitored and recorded using the thawing device printer or barcode scanner recommended by the device manufacturer. Monitor the thawing process and record using the thawing device printer or barcode scanner recommended by the device manufacturer.
Do not freeze Octaplas. Discard unused product.
Methocarbamol

Methocarbamol

For intravenous use only

Administer Octaplas based on AB0-blood group compatibility.

2.1 Dose

Replacement of coagulation factors in patients with acquired deficiencies due to liver disease or undergoing cardiac surgery or liver transplant

Initially infuse of 10 to 15 mL Octaplas per kilogram body weight. This should increase the patient’s plasma coagulation factor levels by approximately 15-25%. If hemostasis is not achieved, use higher doses.

Adjust dose based on desired clinical response.

Monitor response, including measurement of activated partial thromboplastin time (aPTT), prothrombin time (PT), and/or specific coagulation factors.

Plasma exchange in patients with TTP

Completely replace plasma volume removed during plasmapheresis with Octaplas. Generally, 1 to 1.5 plasma volumes corresponds to 40 to 60 milliliters per kg. [ 1,2 ]

2.2 Administration

Administer Octaplas after thawing using an infusion set with a filter.

Octaplas should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if turbid.

Avoid shaking.

Steps for Thawing:
For water bath: Thaw in the outer wrapper for up to 30 minutes in a circulating water bath at +30°C to +37°C (86°F to 98.6°F).An overwrap bag may be used to provide further protection of contents if appropriate. Prevent water from contaminating the entry port. The minimum thawing time is 30 minutes at 37°C (98.6°F). The thawing time depends on the number of bags in the water bath. If more than one plasma bag is thawed in the same water bath, then the thawing time can be prolonged, but should not exceed 60 minutes. For dry tempering system: Place the Octaplas bags between the heating plates according to the manufacturer´s instructions. Thaw plasma following manufacturer directions between +30°C to +37°C (86°F to 98.6°F). Remove the product when the thawing process is completed. The thawing process may be monitored and recorded using the thawing device printer or barcode scanner recommended by the device manufacturer. Monitor the thawing process and record using the thawing device printer or barcode scanner recommended by the device manufacturer.
Do not freeze Octaplas. Discard unused product.

Octapharma Usa Inc

Manufacturer Details

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Octapharma Usa Inc Drugs