HAEMONETICS ADDITIVE SOLUTION FORMULA 3 (AS-3)- citric acid monohydrate, sodium phosphate, monobasic, monohydrate, sodium chlori

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL), SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), ADENINE (UNII: JAC85A2161) (ADENINE - UNII:JAC85A2161), ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)

Disponível em:

Haemonetics Corporation

DCI (Denominação Comum Internacional):

CITRIC ACID MONOHYDRATE

Composição:

ANHYDROUS CITRIC ACID 4.2 mg in 1 mL

Via de administração:

EXTRACORPOREAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

250mL CP2D Anticoagulant Solution is supplied in flexible PVC containers with a sterile, non-pyrogenic fluid path. 250mL and 300mL AS-3 Nutrient Solution is supplied in flexible PVC containers with a sterile, non-pyrogenic fluid path.

Status de autorização:

New Drug Application

Características técnicas

HAEMONETICS ADDITIVE SOLUTION FORMULA 3 (AS-3)- CITRIC ACID
MONOHYDRATE,
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM CHLORIDE, ADENINE,
ANHYDROUS DEXTROSE,
TRISODIUM CITRATE DIHYDRATE SOLUTION
HAEMONETICS CORPORATION
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HAEMONETICS ADDITIVE SOLUTION FORMULA 3 (AS-3)
HAEMONETICS®
CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION (CP2D) AND ADDITIVE
SOLUTION FORMULA 3 (AS-3)
INSTRUCTIONS FOR USE
FOR USE WITH HAEMONETICS APHERESIS DEVICES
RX ONLY
PRODUCTS: Anticoagulant Citrate Phosphate Double Dextrose (CP2D)
and Additive Solution Formula 3 (AS-3)
COMPANY: Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
I. INDICATIONS FOR USE
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 us