Haemonetics Anticoagulant Citrate Phosphate Double Dextrose Solution (cp2d)
Citric Acid Monohydrate, Trisodium Citrate Dihydrate, Sodium Phosphate, Monobasic, Monohydrate, Anhydrous Dextrose
Haemonetics Corporation
Human Prescription Drug
NDC 57826-455Haemonetics Anticoagulant Citrate Phosphate Double Dextrose Solution (cp2d) also known as Citric Acid Monohydrate, Trisodium Citrate Dihydrate, Sodium Phosphate, Monobasic, Monohydrate, Anhydrous Dextrose is a human prescription drug labeled by 'Haemonetics Corporation'. National Drug Code (NDC) number for Haemonetics Anticoagulant Citrate Phosphate Double Dextrose Solution (cp2d) is 57826-455. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Haemonetics Anticoagulant Citrate Phosphate Double Dextrose Solution (cp2d) drug includes Anhydrous Dextrose - 464 mg/mL Citric Acid Monohydrate - 32.7 mg/mL Sodium Phosphate, Monobasic, Monohydrate - 22.2 mg/mL Trisodium Citrate Dihydrate - 263 mg/mL . The currest status of Haemonetics Anticoagulant Citrate Phosphate Double Dextrose Solution (cp2d) drug is Active.
Drug Information:
| Drug NDC: | 57826-455 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Haemonetics Anticoagulant Citrate Phosphate Double Dextrose Solution (cp2d) |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Citric Acid Monohydrate, Trisodium Citrate Dihydrate, Sodium Phosphate, Monobasic, Monohydrate, Anhydrous Dextrose |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Haemonetics Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ANHYDROUS DEXTROSE - 464 mg/mL
CITRIC ACID MONOHYDRATE - 32.7 mg/mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE - 22.2 mg/mL
TRISODIUM CITRATE DIHYDRATE - 263 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | EXTRACORPOREAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 10 Jan, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | BN000127 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Haemonetics Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 5SL0G7R0OK
2968PHW8QP
593YOG76RN
B22547B95K
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Acidifying Activity [MoA]
Anti-coagulant [EPC]
Calcium Chelating Activity [MoA]
Calculi Dissolution Agent [EPC]
Decreased Coagulation Factor Activity [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 57826-455-02 | 250 mL in 1 BAG (57826-455-02) | 10 Jan, 2013 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Haemonetics anticoagulant citrate phosphate double dextrose solution (cp2d) citric acid monohydrate, trisodium citrate dihydrate, sodium phosphate, monobasic, monohydrate, anhydrous dextrose water citric acid monohydrate anhydrous citric acid trisodium citrate dihydrate anhydrous citric acid sodium phosphate, monobasic, monohydrate phosphate ion anhydrous dextrose anhydrous dextrose
Indications and Usage:
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-
Read more...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.
Warnings and Cautions:
Iv. warnings and cautions contraindications: none known precautions for use: ⢠solutions are not intended for direct infusion. ⢠do not use if particulate matter is present or if the solution is cloudy note: some opacity of the plastic container due to moisture absorbance by the pvc during the sterilization process may be observed. this is normal and does not affect the quality or the safety of the product. this white, hazy appearance will diminish gradually over time. this advice only applies to the plastic container. do not use if the solution itself is cloudy or contains particulate matter. â¢do not use if the container is damaged, leaking or if there is any visible sign of deterioration. note: the over wrap serves as a moisture barrier. upon removing the solution bag, small droplets of condensation may be present in the packaging. this is considered normal. after removing the over wrap gently squeeze the inner bag which protects the sterility of the solution. discard
Read more...if any leaks are observed or if an excessive amount of solution is noted within the over wrap. ⢠do not reuse solution. discard any unused or partially used solutions. ⢠protect from sharp objects. ⢠verify that solutions have been appropriately connected to avoid leaks. ⢠the set should be loaded and primed for use within 8 hours of the start of the collection. ⢠carry out the apheresis procedure in accordance with the detailed instructions of the manufacturer of the apheresis device.
Dosage and Administration:
Dosage and administration: cp2d anticoagulant solution and as-3 solution may be used with haemonetics apheresis devices. see the haemonetics operation manual for full operating instructions. prior to use of the solutions, check the solutions for leaks by squeezing each of the bags firmly. if leaks are found, discard the solution.
Dosage Forms and Strength:
Dosage form the container for all cp2d and as-3 solutions is a flexible polyvinyl chloride (pvc) bag sized for holding the appropriate amount of solution. the bag has a single port that is used for bag filling. the port is sealed after filling with a male luer assembly (cp2d) or female luer assembly (as-3). both the male and female luers are gamma irradiated prior to use. the plastic bag is contained in an overwrap which is added prior to sterilization. the formulations for these products are as follows: citrate phosphate double dextrose solution (cp2d) each 100 ml contains: citric acid (monohydrate), usp 0.327 g sodium citrate (dihydrate), usp 2.630 g monobasic sodium phosphate (monohydrate), usp 0.222 g dextrose (anhydrous), usp 4.640 g additive solution 3 (as-3) each 100ml contains: citric acid (monohydrate), usp 0.042 g monobasic sodium phosphate (monohydrate), usp 0.276 g sodium chloride, usp 0.410 g adenine, usp 0.030 g dextrose (anhydrous), usp 1.000 g sodium citrate (dihydrate), usp 0.588 g containing 15 meq of sodium.
Adverse Reactions:
Adverse reactions: donors being reinfused with citrated blood or blood components may experience side effects due to the presence of citrate. patients being transfused with the blood components could also experience a reaction to the citrated blood components. the major symptom experienced by donors is paraesthesia. should this occur the reinfusion should be stopped or the reinfusion rate decreased. in the event of inadvertent bolus of the product administer calcium gluconate.
Overdosage:
Overdosage: both solutions are intended to be used only with automated apheresis devices for collecting human blood and blood components. cp2d is used as an anticoagulant solution and as-3 is intended for use a nutrient solution. neither solution is intended for direct infusion.
Clinical Studies:
Iii. clinical data studies of the effectiveness of 250ml cp2d and 250ml as-3 made by haemonetics corporation union, south carolina facility included in vivo survival data in healthy subjects at one test site and in vitro characterization of stored red blood cells at three test sites. haemonetics clinical evaluation #95012, involved autologous in vivo recovery and survival studies, and in vitro red blood cell characterization conducted at a single site. rbc results collected with haemonetics cp2d/as-3 were compared to crossover controls of manually collected rbcs from the same donors using cp2d/as-3 made by medsep corporation (crossover manual controls). in addition, results were compared to data from other rbc apheresis donors using cp2d/as-3 solutions manufactured by medsep (unmatched apheresis controls). test parameters included hematocrit, hemoglobin, rbc and wbc counts, atp levels, ph, supernatant potassium, free hemoglobin, supernatant glucose levels, and product weight. the rbc q
Read more...uality of test units after 42-day storage was equivalent or slightly superior to those of the control units. rbcs collected by the two different collection protocols (red blood cells with or without plasma) showed no significant differences in terms of rbc quality and red blood cells from all groups met fda and aabb guidelines for 24-hour recovering at 42 days storage. study #98001 was performed using 250ml cp2d and 250ml as-3 to confirm, in vitro , the results of clinical evaluation #95012. three test sites each performed three rbcp and three 2rbc apheresis procedures using the mcs+ ln8150 and associated collection sets. in addition, each site collected six manual whole blood units as concurrent (unmatched) controls using medsep sets and prepared rbcs according to standard procedures. in vitro tests of red blood cell functional and physical integrity were conducted at days 0 and 42 of storage. all plasma units from the rbcp and manual procedures were evaluated on day 0 for in vitro product characteristics. group t-tests (two tailed) were performed to examine any statistically significant differences between the properties of apheresis and manual rbcs. statistically significant differences (p
20% when ffp and pf24 were compared. table 1, summary of ffp and pfz4 plasma product assays (n=59) assay mean (sd) median (min, max) mean difference (pf24, ffp) (95% confidence interval) ffp pf24 ffp pf24 ffp pf24 prothrombin time (sec) 12.0 (0.50) 12.1 (0.59) 11.9 12.1 (11.2, 13.8) (10.5, 14.0) 015 (0.09,0.20) activated partial thromboplastin time (sec) 29.4 (3.32) 30.3 (3.34) 28.8 29.8 (23.1, 38.5) (24.1, 39.5) 0.86 (0.64, 1.08) favtor v (%) 120.1 (23.93) 120.0 (23.88) 120.0 120.0 (61.0, 181.0) (59.0, 182.0) -0.14 (-2.03, 1.76) factor vlla (mu/ml)* 60.5 (26.95) 45.0 (24.72) 54.0 41.5 (21.0, 131.0) (12.0, 159.0) -15 .50 (-19 .23, -11.77) factor viii:c (%)* 94.3 (34.24) 81.7 (27.31) 88.5 82.5 (33.0, 194.0) (34.0, 152.0) -12.67 (-15.97, -9.38) at-iii (%) 97.8 (12.24) 94.7 (15.97) 98.0 95.0 (71.0, 126.0) (19.0, 134.0) -3.05 (-6.30, 0.20) factor xi (%) 112.2 (17.42) 112.8 (18.46) 113.0 113.0 (81.0,151.0) (82.0, 155.0) 0.63 (-0.70,1.95) vwf (r:co) (% function) 89.5 (35.65) 89.4 (35.58) 85.0 87.0 (35.0, 179.0) (37.0, 185.0) -0.15 (-2.21, 1.91) protein s (% activity) 74.9 (19.61) 73.4 (20.76) 72.0 71.0 (33.0, 125.0) (39.0, 126.0) -1.49 (-3.81, 0.83) protein c (% activity) 117.1 (17.59) 117.7 (17.49) 115.0 118.0 (65.0,157.0) (68.0, 162.0) 0.53 (-0.54,1.59) fibrinopeptide f 1.2 (pmol/l)* 136.4 (63.34) 133.1 (55.15) 113.0 114.0 (80.0, 344.0) (80.0,331.0) -3.29 (-8.37,1.78) thrombln-anti- thrombin complex (ng/ml) 2.3 (1.38) 2.1 (0.40) 2.0 2.0 (2.0, 12.4) (2.0,4.8) -0.17 (-0 .53, 0.18) *sample size = 58. the outlier pair was excluded from the analysis based on the statistical criteria or laboratory errors. one sample (plasma sample a) showed significantly increased levels for factor viia and f1.2. another sample (plasma sample b) showed significantly decreased level of factor viii:c for the ffp sample (table 2). these data were excluded from table 1 since the values for viia and f1.2 were more than 4 sd from the mean. the factor viii:c was not more than 4 sd from the mean but was significantly lower in ffp as compared to pf24. while other parameters in this sample did not show significant differences when compared to the control ffp, the fda could not exclude the possibility that the activation found in the pf24 sample was related to the preparation procedure. the rate of such event occurrence was unknown and, based on review of published values for pf24 products, is most likely very rare. the clinical significance of the elevated markers of clotting activation for transfusion recipients is undetermined. table 2, three outlier pairs in plasma measurements subject # measurement ffp pf24 range without the outliers ffp min ffp max pf24 min pf24 max rbcp16 factor fviia (mu/ml) 220 767 21 131 12 159 rbcp16 f1.2 (pmol/l) 702 1940 80 344 80 331 rbcp01 factor viii: c(%) 2 63 33 194 34 152 table 3, proportion of paired sample:pf24 is greater than or less than ffp by more than 20% assay pfz4>ffp by more than 20% pf24
How Supplied:
How supplied: 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.
Package Label Principal Display Panel:
Package label haemonetics® anticoagulant citrate phosphate double dextrose solution (cp2d) intended for use only with automated red cell apheresis devices to collect red blood cells and plasma (ffp and pf24). see the appropriate operatorâs manual for additional information and complete usage instructions. each 100 ml contains: citric acid (monohydrate), usp 0.327 g sodium citrate (dihydrate), usp 2.630 g monobasic sodium phosphate (monohydrate), usp 0.222 g dextrose (anhydrous), usp 4.640 g caution: not for direct intravenous infusion. the pouch is a moisture barrier. do not use unless solution is clear and no leaks detected. single use container. discard unused portion. sterile, nonpyrogenic fluid path. rx only recomended storage: room temperature (25°c / 77°f) avoid excessive heat. protect from freezing. l065 da product code 455a haemonetics corporation lot no. braintree, ma 02184 usa exp date
Product label - package label
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