Dextrose 100 mg/mL Injection, Solution
Other active recalls for Dextrose Monohydrate (different manufacturers) — 3 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Other irrigating solutions class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Dextrose is essentially glucose — sugar — given directly into a vein. In an emergency, it's used to quickly raise dangerously low blood sugar, which can happen with too much insuli...
- Specific formulations — Infant Dextrose (25%) and Dextrose (25% injection) — are FDA-approved to treat low blood sugar in newborns and infants up to 2 years old. That said, prematu...
- Is dextrose safe for my baby or newborn?
- The most common issues are high blood sugar, vein irritation or clotting at the IV site, low sodium in the blood, and infection. More serious — but less common — reactions include...
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.0200 | $150.00 / 7500 ml |
| Medicare Part B allowsASP · J7799 | No ASP payment limit on file for J7799 this quarter. | |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dextrose 100 mg/mLthis 63323-0824-74 | Fresenius | 250 ml | — | AP | FDA listed | — |
| Dextrose 100 mg/mL 17271-0721-05 | Becton | 250 ml | — | AP | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63323-0824-74 You're viewing this | 30 BAG in 1 CASE (63323-824-74) / 250 mL in 1 BAG (63323-824-24) | 2019-03-29 | Active |
| 63323-0824-75 | 20 BAG in 1 CASE (63323-824-75) / 500 mL in 1 BAG (63323-824-25) | 2019-03-29 | Active |
| 63323-0824-76 | 10 BAG in 1 CASE (63323-824-76) / 1000 mL in 1 BAG (63323-824-26) | 2019-03-29 | Active |
Pack size FAQ
What quantity is in NDC 63323-0824-74?
What NDC number is used to bill for this package of Dextrose 100 mg/mL Injection, Solution?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
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Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Does this product have a billing J-code?
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Dextrose Injection is indicated as source of water and calories. Dextrose Injection is indicated as a source of water and calories. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Only for intravenous infusion. ( 2.1 ) See full prescribing information for information on preparation, administration, dosing considerations and instructions for use. ( 2.1 , 2.2 , 2.3 )
2.1Important Administration Instructions Dextrose Injection is intended for intravenous use. Peripheral administration of 5% dextrose is generally acceptable, however, consider central vein when administering more than 5% dextrose or with an osmolarity of at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain [see Warnings and Precautions ( 5.3 )] . Do not administer Dextrose Injection simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis.
To prevent air embolism, use a non-vented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by a pumping device, turn off pump before the container runs dry. Prior to infusion, visually inspect the diluted dextrose solution for particulate matter. The solution should be clear and there should be no precipitates.
Do not administer unless solution is clear and container is undamaged. Use of a final filter is recommended during administration of parenteral solutions, where possible.
2.2Recommended Dosage The choice of dextrose concentration, rate and volume depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy. Electrolyte supplementation may be indicated according to the clinical needs of the patient. The administration rate should be governed, especially for premature infants with low birth weight, during the first few days of therapy, by the patient's tolerance to dextrose.
Increase the infusion rate gradually as indicated by frequent monitoring of blood glucose concentrations [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )] .
2.3Instructions for Use Check flexible container solution composition, lot number, and expiry date. Prior to administration, visually inspect for particulate matter and discoloration. The intact port caps provides visual tamper evidence.
Do not use if a port cap is prematurely removed. Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique.
To Open Place the solution container on a clean, flat surface. Using the pre-cut corner tabs, peel open the overwrap and remove solution container. Check the solution container for leaks by squeezing firmly.
If leaks are found, or if the seal is not intact, discard the solution. Do not use if the solution is cloudy or a precipitate is present. To Add Medication Identify WHITE Additive Port with arrow pointing toward container.
Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container. Hold base of WHITE Additive Port horizontally. Insert needle (18 to 23 gauge) horizontally through the center of WHITE Additive Port's septum and inject additives.
Mix container contents thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly. Preparation for Administration Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from container.
Use a non-vented infusion set or close the air-inlet on a vented set. Close the roller clamp of the infusion set. Hold the base of BLUE Infusion Port.
Insert spike through BLUE Infusion Port by rotating wrist slightly until the spike is inserted. Suspend solution container from hanger hole For Single Use Only. Discard unused portion.
NOTE: See full directions accompanying administration set. WARNING: Do not use flexible…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 10% Dextrose Injection, USP is a clear, sterile, non-pyrogenic solution of dextrose in single-dose flexible plastic containers 10% (0.1 grams/mL): 10 grams of dextrose hydrous per 100 mL in flexible plastic containers: 250 mL, 500 mL, and 1000 mL Injection: 10% (0.1 grams/mL): 10 grams of dextrose hydrous per 100 mL in flexible containers: 250 mL, 500 mL, and 1000 mL. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS The use of Dextrose Injection is contraindicated in patients with: Clinically significant hyperglycemia [see Warnings and Precautions ( 5.1 )] . Known hypersensitivity to dextrose [see Warnings and Precautions ( 5.2 )] . Clinically significant hyperglycemia. ( 4 ) Known hypersensitivity to dextrose. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hyperglycemia or Hyperosmolar Hyperglycemic State : Monitor blood glucose and administer insulin as needed. ( 5.1 ) Hypersensitivity Reactions : Monitor for signs and symptoms and discontinue infusion if reactions occur. ( 5.2 ) Vein Damage and Thrombosis : Consider central vein when administering more than 5% dextrose or with an osmolarity of at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain.
( 2.2 , 5.3 ) Hyponatremia : Avoid in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations. ( 5.4 ) Electrolyte Imbalance and Fluid Overload : Avoid in patients with or at risk for fluid and/or solute overloading.
If use cannot be avoided, monitor daily fluid balance, electrolyte concentrations, and acid-base balance, as needed and especially during prolonged use. ( 5.5 ) Refeeding Syndrome : Monitor severely undernourished patients and slowly increase nutrient intake. ( 5.6 )
5.1Hyperglycemia and Hyperosmolar Hyperglycemic State The use of dextrose infusions in patients with impaired glucose tolerance may worsen hyperglycemia. Administration of dextrose at a rate exceeding the patient's utilization rate may lead to hyperglycemia, coma, and death. Hyperglycemia is associated with an increase in serum osmolality, resulting in osmotic diuresis, dehydration and electrolyte losses [see Warnings and Precautions ( 5.5 )] .
Patients with underlying CNS disease and renal impairment who receive dextrose infusions, may be at greater risk of developing hyperosmolar hyperglycemic state. Monitor blood glucose levels and treat hyperglycemia to maintain levels within normal limits while administering Dextrose Injection. Insulin may be administered or adjusted to maintain optimal blood glucose levels during Dextrose Injection administration.
5.2Hypersensitivity Reactions Hypersensitivity and infusion reactions, including anaphylaxis, have been reported with Dextrose Injection [see Adverse Reactions ( 6 )] . Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated.
5.3Vein Damage and Thrombosis Peripheral administration of 5% Dextrose Injection is generally acceptable, however, consider central vein when administering more than 5% dextrose or with an osmolarity of ≥ at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain [see Dosage and Administration ( 2.1 )] .The infusion of hypertonic solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis. The primary complication of peripheral access is venous thrombophlebitis, which manifests as pain, erythema, tenderness or a palpable cord.
Remove the catheter as soon as possible, if thrombophlebitis develops.
5.4Hyponatremia Dextrose Injection is a hypertonic solution [see Description, Table 1 ( 11 )] . In the body, however, glucose containing fluids can become extremely physiologically hypotonic due to rapid glucose metabolization. Monitoring of serum sodium is particularly important for hypotonic fluids.
Depending on the tonicity of the solution, the volume and rate of infusion, and depending on a patient's underlying clinical condition and capability to metabolize glucose, intravenous administration of glucose can cause electrolyte disturbances, most importantly hypo- or hyperosmotic hyponatremia. Monitor serum sodium to minimize the risk of hyponatremia. The risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as diuretics, certain antiepileptic and psychotropic medications).
Close clinical monitoring may be warranted. Acute hyponatremia can lead to acute hyponatremic encephalopathy characteriz…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions associated with the use of dextrose injection were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. The following clinically significant adverse reactions are described elsewhere in the labeling: Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions : anaphylaxis, pruritus, bronchospasm, cyanosis, angioedema, hypotension, pyrexia, chills, and rash [see Warnings and Precautions ( 5.2 )] Infusion Site Reactions : infusion site phlebitis, infusion site erythema, vein damage and thrombosis, and infusion site thrombophlebitis [see Warnings and Precautions ( 5.3 )] Hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions ( 5.4 )] Electrolyte imbalance, fluid overload and hypervolemia [see Warnings and Precautions ( 5.5 )] Refeeding syndrome [see Warnings and Precautions ( 5.6 )] Pulmonary vascular precipitates The most common adverse reactions are, hyperglycemia, hypersensitivity reactions, hyponatremia, infection both systemic and at the injection site, vein thrombosis or phlebitis, and electrolyte imbalance.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance : Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance. ( 7.1 )
7.1Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance Dextrose Injection can affect glycemic control, vasopressin and fluid and/or electrolyte balance [see Warnings and Precautions ( 5.1 , 5.4 , 5.5 )] . Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance when using Dextrose Injection in patients treated with other substances that affect glycemic control, vasopressin or fluid and/or electrolyte balance.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pediatric Use : Increased risk of hypoglycemia/hyperglycemia; monitor serum glucose concentrations. ( 8.4 )
8.1Pregnancy Risk Summary Appropriate administration of Dextrose Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with injectable dextrose solutions. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
8.2Lactation Risk Summary There are no data on the presence of dextrose in human milk, the effects on a breastfed infant, or the effects on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of Dextrose Injection to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Dextrose Injection and any potential adverse effects on the breastfed infant from Dextrose Injection or from the underlying maternal condition.
8.4Pediatric Use The safety profile of Dextrose Injection in pediatric patients is similar to adults. Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long-term adverse effects. Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes.
In very low birth weight infants, excessive or rapid administration of Dextrose Injection may result in increased serum osmolality and risk of intracerebral hemorrhage. Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions ( 5.4 )] .
8.5Geriatric Use Clinical studies of Dextrose Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions ( 5.4 )] . Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Dextrose is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Appropriate administration of Dextrose Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with injectable dextrose solutions. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety profile of Dextrose Injection in pediatric patients is similar to adults. Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long-term adverse effects. Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes.
In very low birth weight infants, excessive or rapid administration of Dextrose Injection may result in increased serum osmolality and risk of intracerebral hemorrhage. Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions ( 5.4 )] .
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of Dextrose Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions ( 5.4 )] . Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Dextrose is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
🆘 Overdosage ▾
10 OVERDOSAGE An increased infusion rate of Dextrose Injection or administration of dextrose solutions can cause hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance [see Warnings and Precautions ( 5.1 , 5.5 )]. Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. Discontinue infusion, reduce dose and institute appropriate corrective measures such as administration of exogenous insulin.
Discontinue infusion and institute appropriate corrective measures in the event of overhydration or solute overload during therapy, with particular attention to CNS, respiratory and cardiovascular systems. If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Dextrose is oxidized to carbon dioxide and water, yielding energy.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Dextrose is oxidized to carbon dioxide and water, yielding energy.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING 10% Dextrose Injection, USP is supplied in single dose flexible plastic containers as follows: Product Number Unit of Sale Strength Each 824174 63323-824-74 Package of 30 free flex ® bag 25 grams per 250 mL (100 mg per mL) NDC 63323-824-24 One 250 mL free flex ® bag 824175 63323-824-75 Package of 20 free flex ® bag 50 grams per 500 mL (100 mg per mL) NDC 63323-824-25 One 500 mL free flex ® bag 824176 63323-824-76 Package of 10 free flex ® bag 100 grams per 1,000 mL (100 mg per mL) NDC 63323-824-26 One 1000 mL free flex ® bag Exposure of pharmaceutical products to heat should be minimized.
Avoid excessive heat. STORE AT: 20° to 25 °C ( 68° to 77° F) [see USP Controlled Room Temperature]; brief exposure up to 40°C/104°F does not adversely affect the product. The container closure is not made with natural rubber latex.
Non-PVC, Non-DEHP, Sterile.
📦 Storage and Handling ▾
STORE AT: 20° to 25 °C ( 68° to 77° F) [see USP Controlled Room Temperature]; brief exposure up to 40°C/104°F does not adversely affect the product. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.
📋 Description ▾
11 DESCRIPTION 10% Dextrose Injection, USP is a sterile, non-pyrogenic solution for fluid replenishment and caloric supply in single dose containers for intravenous administration. The solution contains no bacteriostatic, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. The pH range is 4.0 (3.2 to 6.5) Table 1.
Contents and Characteristics of Dextrose Injection 10%, USP *Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous Strength Fill Volume Amount of Dextrose Hydrous per Container kcal* per Container Osmolarity (mOsmol per liter) Dextrose Injection 10%, USP (0.1 grams/mL) 250 mL 25 grams 85 505 500 mL 50 grams 170 505 1000 mL 100 grams 340 505 Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17.
It has the following structural formula: Water for Injection, USP is chemically designated H 2 O. Dextrose is derived from corn. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag).
The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.
The flexible container is a closed system, and air is prefilled in the container to facilitate drainage. The container does not require entry of external air during administration. The container has two ports: one is the administration outlet port for attachment of an intravenous administration set and the other port has a medication site for addition of supplemental medication ([see Instructions for Use ( 2.3 )] ).
The primary function of the overwrap is to protect the container from the physical environment. Structural Formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Inform patients, caregivers, or home healthcare providers of the following risks of Dextrose Injection: Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions ( 5.1 )] Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] Vein damage and thrombosis [see Warnings and Precautions ( 5.3 )] Hyponatremia [see Warnings and Precautions ( 5.4 )] Electrolyte imbalance and fluid overload [see Warnings and Precautions ( 5.5 )] Refeeding syndrome [see Warnings and Precautions ( 5.6 )] Lake Zurich, IL 60047 www.fresenius-kabi.com/us Fresenius Kabi Logo