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Haemonetics Anticoagulant Citrate Phosphate Double Dextrose Solution Recall
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Uses
The Haemonetics 250mL Anticoagulant Citrate Phosphate Double Dextrose (CP2D)
and 250mL Additive Solution Formula 3 (AS-3) nutrient solution are intended to be
used only with automated apheresis devices for collecting human blood and blood
components. The anticoagulant solution is metered by the apheresis machine into
the collected whole blood. It is not to be infused directly into the donor. After the
anticoagulant is used, the bag in which it was contained is discarded. When
collecting plasma in the RBCP protocol, the plasma is collected into an empty plasma
collection bag. One hundred milliliters (100ml) of AS-3 is transferred into one RBC
collection bag when using the RBCP protocol or 2 separate bags when using the
2RBC protocol. AS-3 solution provides nutrients to keep the red blood cells viable for
42 days when refrigerated.
CP2D is also indicated for the collection of FFP and PF24 plasma, collected and
stored plasma collected using the 822, 822-2P and 822F-2P disposable sets may be
frozen within 8 hours (FFP) or within 24 hours which includes 8 hours room
temperature storage and 16 hours refrigeration storage (PF24).
The 300mL AS-3 is used in conjunction with automated red blood cell washing
devices. AS-3 serves as the nutrient solution for storage of the red blood cell product
after deglycerolization. The red blood cells are washed using the Model 215 System.
AS-3 is used for priming the disposable and for the last wash of the red blood cells.
The washed cells are then re-suspended in 100mL of the AS-3 before transfer into a
product collection bag or storage bag. Additive Solution Formula 3 (AS-3) provides
nutrients to keep the washed red blood cells viable for up to 14 days after washing
when refrigerated.
Neither the CP2D nor the AS-3 container is used for the storage of blood or blood
components.
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Haemonetics Anticoagulant Citrate Phosphate Double Dextrose Solution Manufacturers
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Haemonetics Corporation
Haemonetics Anticoagulant Citrate Phosphate Double Dextrose Solution | Taro Pharmaceuticals U.s.a., Inc
When given in equal doses, phenytoin chewable tablets, USP yield higher plasma levels than extended phenytoin sodium capsules, USP. For this reason serum concentrations should be monitored and care should be taken when switching a patient from the sodium salt to the free acid form.
Extended phenytoin sodium capsules, USP is formulated with the sodium salt of phenytoin. The free acid form of phenytoin is used in phenytoin oral suspensions and phenytoin chewable tablets, USP. Because there is approximately an 8% increase in drug content with the free acid form over that of the sodium salt, dosage adjustments and serum level monitoring may be necessary when switching from a product formulated with the free acid to a product formulated with the sodium salt and vice versa.
GeneralNot for once-a-day dosing.
Dosage should be individualized to provide maximum benefit. In some cases, serum blood level determinations may be necessary for optimal dosage adjustments—the clinically effective serum level is usually 10–20 mcg/mL. With recommended dosage, a period of seven to ten days may be required to achieve steady-state blood levels with phenytoin and changes in dosage (increase or decrease) should not be carried out at intervals shorter than seven to ten days.
Phenytoin chewable tablets, USP can be either chewed thoroughly before being swallowed or swallowed whole.
Adult DosagePatients who have received no previous treatment may be started on two chewable tablets three times daily, and the dose is then adjusted to suit individual requirements. For most adults, the satisfactory maintenance dosage will be six to eight chewable tablets daily; an increase to twelve chewable tablets daily may be made, if necessary.
Dosing in Special Populations Patients with Renal or Hepatic DiseaseDue to an increased fraction of unbound phenytoin in patients with renal or hepatic disease, or in those with hypoalbuminemia, the interpretation of total phenytoin plasma concentrations should be made with caution.
Unbound phenytoin concentrations may be more useful in these patient populations.
Elderly PatientsPhenytoin clearance is decreased slightly in elderly patients and lower or less frequent dosing may be required.
PediatricInitially, 5 mg/kg/day in two or three equally divided doses, with subsequent dosage individualized to a maximum 300 mg daily. A recommended daily maintenance dosage is usually 4 to 8 mg/kg. Children over 6 years old and adolescents may require the minimum adult dose (300 mg/day). If the daily dosage cannot be divided equally, the larger dose should be given before retiring.
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