Isoplate
Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Phosphate, Monobasic
Terumo Bct Ltd.
Human Prescription Drug
NDC 14537-408Isoplate also known as Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Phosphate, Monobasic is a human prescription drug labeled by 'Terumo Bct Ltd.'. National Drug Code (NDC) number for Isoplate is 14537-408. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Isoplate drug includes Magnesium Chloride - .03 g/100mL Potassium Chloride - .037 g/100mL Potassium Phosphate, Monobasic - .00082 g/100mL Sodium Acetate - .37 g/100mL Sodium Chloride - .53 g/100mL Sodium Gluconate - .5 g/100mL Sodium Phosphate, Dibasic, Unspecified Form - .008 g/100mL . The currest status of Isoplate drug is Active.
Drug Information:
| Drug NDC: | 14537-408 |
| 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: | Isoplate |
| 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: | Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Phosphate, Monobasic |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Terumo Bct Ltd. |
| 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: | MAGNESIUM CHLORIDE - .03 g/100mL
POTASSIUM CHLORIDE - .037 g/100mL
POTASSIUM PHOSPHATE, MONOBASIC - .00082 g/100mL
SODIUM ACETATE - .37 g/100mL
SODIUM CHLORIDE - .53 g/100mL
SODIUM GLUCONATE - .5 g/100mL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM - .008 g/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| 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: | 05 Mar, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 27 Dec, 2025 |
| 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: | BN090067 |
| 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: | Terumo BCT Ltd.
|
| 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: | 02F3473H9O
660YQ98I10
4J9FJ0HL51
4550K0SC9B
451W47IQ8X
R6Q3791S76
GR686LBA74
|
| 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: | Calculi Dissolution Agent [EPC]
Increased Large Intestinal Motility [PE]
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]
Magnesium Ion Exchange Activity [MoA]
Osmotic Activity [MoA]
Osmotic Laxative [EPC]
Potassium Compounds [CS]
Potassium Salt [EPC]
Stimulation Large Intestine Fluid/Electrolyte Secretion [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 |
|---|
| 14537-408-50 | 18 CONTAINER in 1 CASE (14537-408-50) / 500 mL in 1 CONTAINER | 05 Mar, 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:
Isoplate sodium chloride, sodium gluconate, sodium acetate, potassium chloride, magnesium chloride, sodium phosphate, dibasic, and potassium phosphate, monobasic sodium chloride sodium cation chloride ion sodium gluconate gluconic acid sodium cation sodium acetate acetate ion sodium cation potassium chloride potassium cation chloride ion magnesium chloride magnesium cation chloride ion sodium phosphate, dibasic, unspecified form phosphate ion sodium cation potassium phosphate, monobasic phosphate ion potassium cation water
Indications and Usage:
1 indications and usage isoplate solution - platelet additive solution [pas-f] is an isotonic solution to replace a portion of the plasma to store platelets pheresis platelet additive solution (pas) added leukocytes reduced products collected using a hyperconcentrated collection on terumo bct's trima accel system [see dosage and administration (2) .] platelets pheresis pas added leukocytes reduced products are stored in a mix of 65% isoplate solution and 35% plasma. platelets in the solution can be stored at a concentration range of 0.7 to 2.1 à 10 6 /µl for up to 5 days at 20-24 °c with continuous agitation in the terumo bct elp bag [citrated polyvinyl chloride (pvc)] [see clinical studies (14) .] isoplate solution - platelet additive solution [pas-f] is an isotonic solution to replace a portion of the plasma to store platelets pheresis platelet additive solution (pas) added leukocytes reduced products collected using a hyperconcentrated collection on terumo bct's trima accel
Read more... system. platelets pheresis pas added leukocytes reduced products are stored in a mix of 65% isoplate and 35% plasma. platelets in isoplate solution can be stored at a concentration range of 0.7 to 2.1 à 10 6 /µl for up to 5 days at 20-24 °c with continuous agitation in the terumo bct elp bag [citrated polyvinyl chloride (pvc)]. ( 1 )
Warnings and Cautions:
5 warnings and precautions verify that the solution bag has been securely attached to the platelet additive solution line on the trima accel system tubing set using aseptic technique. do not reuse. discard unused or partially used solution bags. verify that the isoplate solution has been securely attached to the platelet additive solution line on the trima accel system tubing set using aseptic technique. ( 5 )
Dosage and Administration:
2 dosage and administration isoplate solution is added to hyperconcentrated platelets after the apheresis procedure is complete. ( 2 ) isoplate solution may only be used with the trima accel system. for instructions on the use of the solution with the trima accel system, see the trima accel system operator's manual. ( 2.1 ) follow the directions for connecting the isoplate solution bag to the trima accel system. ( 2.2 ) 2.1 general dosing information isoplate solution is added to hyperconcentrated platelets after the apheresis procedure is complete. it is not intended for direct intravenous infusion. isoplate solution may only be used with the trima accel system for automated blood collection. for instructions on the use of the solution with the trima accel system, see the trima accel system operator's manual. 2.2 administration ensure solution is the isoplate solution and is within the expiration date. inspect the bag. do not use if the container is damaged, leaking or if there is any
Read more... visible sign of deterioration. use only if solution is clear and free of particulate matter. protect from sharp objects. directions for connecting the isoplate solution bag to the trima accel system at the prompt to connect the platelet additive solution to the trima accel system tubing set: remove the overwrap by pulling down at notch, and remove the isoplate solution bag. before use, perform the following checks [see warnings and precautions (5) .] : check for leaks by squeezing the bag. if leaks are found, discard bag. ensure the solution is the isoplate solution and is within the expiration date. inspect the solution in good light. bags showing cloudiness, haze, or particulate matter should not be used. remove the protective cap from the port on the bag. connect the bag to the trima accel system tubing set using aseptic technique and hang the solution. break the frangible connector. when you break frangible connectors, bend them in both directions to ensure that you break them completely. failure to do so may result in restricted flow. proceed per the trima accel system operator's manual. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Dosage Forms and Strength:
3 dosage forms and strengths 500 ml isoplate solution - platelet additive solution [pas-f] is a sterile isotonic solution in a polyolefin bag. each 100 ml contains: sodium chloride 0.53 g; sodium gluconate 0.5 g; sodium acetate trihydrate 0.37 g; potassium chloride 0.037 g; magnesium chloride hexahydrate 0.03 g; dibasic sodium phosphate dihydrate 0.008 g; monobasic potassium phosphate 0.00082 g; in water for injection. 500 ml sterile fluid in polyolefin bag ( 3 )
Contraindications:
4 contraindications do not infuse isoplate solution directly to the patients. do not infuse isoplate solution directly to the patients. ( 4 )
Adverse Reactions:
6 adverse reactions isoplate solution is added to platelets after the apheresis procedure is complete. it is not for direct intravenous infusion. it is expected to cause adverse events that are normally associated with platelet transfusion. isoplate solution is expected to cause adverse events that are seen with platelet transfusion. ( 6 ) to report suspected adverse reactions, contact terumo bct, inc. at 1-877-339-4228 or fda at 1-800-fda-1088 or www.fda.gov/medwatch . 6.1 clinical trials experience no adverse reactions were reported in the subjects infused with < 10 ml of radiolabeled platelets stored for 5 days in 65% isoplate solution, and rinsed prior to infusion [see clinical studies (14) .]
Use in Specific Population:
8 special populations isoplate solution has not been adequately studied in controlled clinical trials with specific populations. isoplate solution has not been studied in controlled clinical trials with specific populations.
Description:
11 description isoplate solution - platelet additive solution [pas-f] is an isotonic solution designed to replace a proportion of the plasma used in the storage of platelet pheresis, leukocytes reduced pas products collected using a hyperconcentrated collection on terumo bct's trima accel system. the solution is sterile, nonpyrogenic and contains no bacteriostatic or antimicrobial agents. the formulas of the active ingredients are provided in table 1. table 1: active ingredients ingredients molecular formula molecular weight sodium chloride usp nacl 58.44 sodium acetate trihydrate usp ch3coonaâ3h2o 136.08 potassium chloride usp kcl 74.55 magnesium chloride hexahydrate usp mgcl2â6h2o 203.30 dibasic sodium phosphate dihydrate usp na2hpo4â2h2o 177.98 monobasic potassium phosphate nf kh2po4 136.09 sodium gluconate usp c6h11nao7 218.14 each 100 ml of isoplate solution contains: sodium chloride usp 0.53 g; sodium gluconate usp 0.5 g; sodium acetate trihydrate usp 0.37 g; potassium chloride usp 0.037 g; magnesium chloride hexahydrate usp 0.03 g; dibasic sodium phosphate dihydrate usp 0.008 g; monobasic potassium phosphate nf 0.00082 g; in water for injection usp. ph may be adjusted with glacial acetic acid usp or sodium hydroxide nf ph: 7.4 (7.0-7.8). concentration of electrolytes (meq/liter): sodium 141; potassium 5; magnesium 3; chloride 98; phosphate (hpo=4 ) 1 (0.5 mmole p/liter); acetate (ch3cooâ) 27; gluconate (hoch2(choh)4cooâ) 23. the polyolefin bag is not made with natural rubber latex or pvc. di(2-ethylhexyl)phthalate (dehp) is present only in sterile dock tube. the bag is made from a multilayered film. it contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. the solution contact layer is an elasticized polyolefin. the bag is nontoxic and biologically inert. the bag-solution unit is a closed system and is not dependent upon entry of external air during administration. the bag is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.
Clinical Pharmacology:
12 clinical pharmacology 12.1 mechanism of action isoplate solution contains the following key components to maintain platelet function: sodium chloride for osmolarity acetate to fuel platelet metabolism gluconate or phosphate for buffering magnesium and potassium to reduce platelet activation 1,2 this solution has no pharmacological effect; the solution provides the appropriate components for platelet function while allowing for a lower volume of plasma in the platelet product during storage.
Mechanism of Action:
12.1 mechanism of action isoplate solution contains the following key components to maintain platelet function: sodium chloride for osmolarity acetate to fuel platelet metabolism gluconate or phosphate for buffering magnesium and potassium to reduce platelet activation 1,2 this solution has no pharmacological effect; the solution provides the appropriate components for platelet function while allowing for a lower volume of plasma in the platelet product during storage.
Clinical Studies:
14 clinical studies in vivo radiolabeled recovery and survival a paired study was completed to verify that in vivo radiolabeled recovery and survival of hyperconcentrated leukocyte reduced platelets collected by apheresis on the trima accel system, diluted in isoplate solution, and stored for five days (test) meet fda acceptance criteria in comparison with fresh autologous platelets (control). table 2 summarizes the in vivo radiolabeled platelet recovery and survival data. table 2 â in vivo radiolabeled platelet recovery and survival data (n = 23) recovery survival test control test/control test control test/control % % % days days % average 51.1 60.2 85 6.6 8.7 76 st. dev. 10.9 10.2 10 1.2 0.9 12 min 32.6 40.4 66 4.5 6.4 52 max 84.1 82.8 102 8.8 10.0 104 the primary outcomes for this study were: recovery: test minus 66% control is equal to or greater than zero with one-sided 97.5% confidence limit survival: test minus 58% control is equal to or greater than zero with one-sided 97
Read more....5% confidence limit both primary outcomes were met for hyperconcentrated leukocyte reduced platelets collected on the trima accel system and stored in isoplate solution. in vitro platelet quality study a paired study was completed to verify that in vitro platelet quality (functional assays) of hyperconcentrated leukocyte reduced platelets collected by apheresis on the trima accel system, diluted in isoplate solution, and stored for five days (test) meet fda acceptance criteria in comparison to plasma-stored platelets (control). table 3 summarizes the in vitro platelet quality data. table 3 â in vitro platelet quality data (n = 66) functional assay isoplate stored apheresis platelets (test) average (standard deviation) plasma stored apheresis platelets (control) average (standard deviation) ph 7.4 (0.2) 7.5 (0.1) cd62 expression; p-selectin (%) 22.8 (15.6) 15.0 (9.8) morphology score (max score 400) 289 (49) 292 (47) hypotonic shock response (%) 53.3 (12.4) 55.9 (10.9) extent of shape change (%) 23.2 (5.0) 25.0 (6.0) the primary outcome for this study was: ph: 95% or more of test units will have a ph (22 °c) greater than 6.2 with a one-sided confidence interval of 95% all 66 platelet products collected in this study had ph > 6.2 therefore the primary outcome for ph was met for hyperconcetrated platelets collected on the trima accel system and stored in isoplate solution.
How Supplied:
16 how supplied/storage and handling isoplate solution - platelet additive solution [pas-f] is a clear solution supplied in sterile and nonpyrogenic polyolefin bags. the isoplate solution bags are packaged 18 bags per case. size catalog number ndc number 500 ml 40850 14537-408-50 storage store up to 25 °c [see usp controlled room temperature]. platelets pheresis pas added leukocytes reduced products are stored in a mix of 65% isoplate solution and 35% plasma. platelets in the solution can be stored at a concentration range of 0.7 to 2.1 à 106/µl for up to 5 days at 20-24 °c with continuous agitation in the terumo bct elp bag [citrated polyvinyl chloride (pvc)].
Package Label Principal Display Panel:
Principal display panel - 500 ml bag label isoplate solution platelet additive solution [pas-f] catalog # 40850 polyolefin bag 500 ml ndc 14537-408-50 sterile. non-pyrogenic. do not use unless the solution is clear and the container is intact. rx only. single use container. caution: not for direct intravenous infusion. recommended storage: store up to 25 °c (see usp controlled room temperature). each 100 ml contains: sodium chloride usp 0.53 g sodium gluconate usp 0.5 g sodium acetate trihydrate usp 0.37 g potassium chloride usp 0.037 g magnesium chloride hexahydrate usp 0.03 g dibasic sodium phosphate dihydrate usp 0.008 g monobasic potassium phosphate nf 0.00082 g in water for injection usp manufactured by terumo bct, inc. 10811 w. collins ave., lakewood co 80215, usa 777969-551 terumo bct lot expiry date principal display panel - 500 ml bag label