DEXTROSE- dextrose monohydrate injection, solution
Baxter Healthcare Corporation
----------
Dextrose Injection, USP
in AVIVA Plastic Container
DESCRIPTION
Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid replenishment and caloric supply in single dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, and caloric content are shown in Table 1.
|
|
Size |
*Dextrose Hydrous, USP |
Osmolarity |
pH nominal |
Caloric Content |
|
5% Dextrose Injection, USP |
250 |
50 |
252 |
4.5 |
170 |
The flexible container is made with non-latex plastic materials specially designed for a wide range of parenteral drugs including those requiring delivery in containers made of polyolefins or polypropylene. For example, the AVIVA container system is compatible with and appropriate for use in the admixture and administration of paclitaxel. In addition, the AVIVA container system is compatible with and appropriate for use in the admixture and administration of all drugs deemed compatible with existing polyvinyl chloride container systems. The solution contact materials do not contain PVC, DEHP, or other plasticizers.
The suitability of the container materials has been established through biological evaluations, which have shown the container passes Class VI U.S. Pharmacopeia (USP) testing for plastic containers. These tests confirm the biological safety of the container system.
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 DIRECTIONS FOR USE). The primary function of the overwrap is to protect the container from the physical environment.
CLINICAL PHARMACOLOGY
Dextrose Injection, USP has value as a source of water and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.
CONTRAINDICATIONS
Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.
WARNINGS
Dextrose Injection, USP should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or hemolysis.
The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutive states is inversely proportional to the electrolyte concentrations of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections.
Excessive administration of dextrose injections may result in significant hypokalemia.
In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.
Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.
PRECAUTIONS
General
Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from a secondary container is completed.
Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.
Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.
Dextrose Injection, USP should be used with caution in patients with overt or subclinical diabetes mellitus.
Pregnancy
There are no adequate and well controlled studies with Dextrose Injection, USP in pregnant women and animal reproduction studies have not been conducted with this drug. Therefore, it is not known whether Dextrose Injection, USP can cause fetal harm when administered to a pregnant woman. Dextrose Injection, USP should be given during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Labor and Delivery
Intrapartum maternal intravenous infusion of glucose-containing solutions may produce maternal hyperglycemia with subsequent fetal hyperglycemia and fetal metabolic acidosis. Fetal hyperglycemia can result in increased fetal insulin levels which may result in neonatal hypoglycemia following delivery. Consider the potential risks and benefits for each specific patient before administering Dextrose Injection, USP.
Nursing Mothers
It is not known whether this drug is present in human milk. Because many drugs are present in human milk, caution should be exercised when Dextrose Injection, USP is administered to a nursing woman.
Pediatric Use
The use of Dextrose Injection, USP in pediatric patients is based on clinical practice (see DOSAGE AND ADMINISTRATION).
Newborns – especially those born premature and with low birth weight - are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death.
Geriatric Use
Clinical studies of Dextrose Injection, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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.
This drug 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.
ADVERSE REACTIONS
Hypersensitivity reactions, including anaphylaxis and chills.
Reactions which may occur because of the injection or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
DOSAGE AND ADMINISTRATION
As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible.
Do not administer unless solution is clear and seal is intact.
All injections in AVIVA plastic containers are intended for intravenous administration using sterile equipment.
The dosage selection and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/ hypoglycemia. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in pediatric intravenous fluid therapy.
Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.
HOW SUPPLIED
Dextrose Injection, USP in AVIVA plastic container is available as follows:
|
Code |
Size (mL) |
NDC |
Product Name |
|
6E0062 |
250 |
0338-6346-02 |
5% Dextrose Injection, USP |
|
6E0063 |
500 |
0338-6346-03 |
|
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25° C/ 77° F); brief exposure up to 40° C/ 104° F does not adversely affect the product.
DIRECTIONS FOR USE OF AVIVA PLASTIC CONTAINER
For Information on Risk of Air Embolism – see PRECAUTIONS
To Open
Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow “To Add Medication” directions below.
Preparation for Administration
- 1.
- Suspend container from eyelet support.
- 2.
- Remove protector from outlet port at bottom of container.
- 3.
- Attach administration set. Refer to complete directions accompanying set.
To add medication before solution administration
- 1.
- Prepare medication site.
- 2.
- Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
- 3.
- Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.
To add medication during solution administration
- 1.
- Close clamp on the set.
- 2.
- Prepare medication site.
- 3.
- Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
- 4.
- Remove container from IV pole and/or turn to an upright position.
- 5.
- Evacuate both ports by squeezing them while container is in the upright position.
- 6.
- Mix solution and medication thoroughly.
- 7.
- Return container to in-use position and continue administration.
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Printed in USA
07-19-00-0283 Rev. April 2018
Baxter and Aviva are trademarks of Baxter International Inc.
PRINCIPAL DISPLAY PANEL - PACKAGING LABELING
Container Label
LOT
EXP
250 mL
6E0062
NDC 0338-6346-02
5% Dextrose
Injection USP
Each 100 mL contains 5 g Dextrose
Hydrous USP pH 4.5 (3.2 to
6.5) Osmolarity 252 mOsmol/L
(calc) Sterile Nonpyrogenic Single
dose container Additives may be
incompatible Consult with pharmacist
if available When introducing
additives use aseptic technique Mix
thoroughly Do not store Dosage
Intravenously as directed by a
physician See directions Cautions
Squeeze and inspect inner bag which
maintains product sterility Discard if
leaks are found Must not be used in
series connections Do not administer
simultaneously with blood Do not
use unless solution is clear
Rx OnlyStore at room temperature
(25oC/77oF) until ready to use Avoid
excessive heat See insert
Baxter Logo
Baxter Healthcare Corporation
Deerfield IL 60015 USA
Made in USA
Baxter AVIVA and the AVIVA
crescent design are trademarks of
Baxter International Inc
For product information
1-800-933-0303
AVIVA CONTAINER
| DEXTROSE
dextrose monohydrate injection, solution |
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| Labeler - Baxter Healthcare Corporation (005083209) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Baxter Healthcare Corporation | 059140764 | ANALYSIS(0338-6346) , LABEL(0338-6346) , MANUFACTURE(0338-6346) , PACK(0338-6346) , STERILIZE(0338-6346) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Baxter Healthcare Corporation | 189326168 | ANALYSIS(0338-6346) , LABEL(0338-6346) , MANUFACTURE(0338-6346) , PACK(0338-6346) , STERILIZE(0338-6346) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Baxter Healthcare Corporation | 194684502 | ANALYSIS(0338-6346) | |