Sykes 5% Dextrose and 0.9% Sodium Chloride

Manufacturer
Sypharma Pty Ltd
Effective date
2017-12-19
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:06:25

Label at a glance#

ProductSykes 5% Dextrose and 0.9% Sodium Chloride
Active ingredientDEXTROSE MONOHYDRATE, SODIUM CHLORIDE
Label structure19 sections

Dosage and administration

To be used as directed by a licensed veterinarian. The dosage of the Sykes 5% Dextrose and 0.9% Sodium Chloride Injection is dependent upon the age, weight and clinical conditions of the patient as well as laboratory determinations. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. For use in one patient on one occasion only. Discard any unused ...

Label contents#

Full prescribing information#

WARNINGS AND PRECAUTIONS SECTION

STERILE NONPYROGENIC SOLUTION
For Animal Use Only

Description

DESCRIPTION SECTION

Sykes 5% Dextrose and 0.9% Sodium Chloride Injection is a sterile, non-pyrogenic solution intended for fluid and electrolyte replenishment and caloric supply in single dose containers. May be administered intravenously using aseptic technique. It contains no antimicrobial agents. Discard any unused portion. Composition, osmolarity, pH and caloric content are shown in Table 1. 

Table 1
Table1Table1

Normal physiologic osmolarity range is approximately 560 to 620 mOsmol/L.
Administration of substantially hypertonic solutions (≥600 mOsmol/L) may cause vein damage.
The container is free of PVC and phthalates. The container meets the requirements of USP and is registered with US FDA.

Clinical Pharmacology

CLINICAL PHARMACOLOGY SECTION

Sykes 5% Dextrose and 0.9% Sodium Chloride Injection has value as a source of water, electrolytes and calories. It will induce diuresis depending on the clinical condition of the patient.

Indications

INDICATIONS & USAGE SECTION

Sykes 5% Dextrose and 0.9% Sodium Chloride Injection is indicated as a source of water and calories for all species. 

Contraindications

CONTRAINDICATIONS SECTION

Sykes 5% Dextrose and 0.9% Sodium Chloride Injection is contraindicated in patients with a known allergy to corn or corn products.

Warnings

WARNINGS SECTION

Excessive administration of Sykes 5% Dextrose and 0.9% Sodium Chloride Injection may result in significant hypokalemia.

Sykes 5% Dextrose and 0.9% Sodium Chloride Injection should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.

Sykes 5% Dextrose and 0.9% Sodium Chloride Injection should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.

The intravenous administration of Sykes 5% Dextrose and 0.9% Sodium Chloride Injection 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.

In patients with diminished renal function, administration of Sykes 5% Dextrose and 0.9% Sodium Chloride Injection may result in sodium retention.

Adverse Reactions

ADVERSE REACTIONS SECTION

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.

Precautions

PRECAUTIONS SECTION

This is a single dose unit. It contains no preservatives. Use entire contents when first opened.

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.

Caution must be exercised in the administration of Sykes 5% Dextrose and 0.9% Sodium Chloride Injection to patients receiving corticosteroids or corticotropin.

Sykes 5% Dextrose and 0.9% Sodium Chloride Injection should be used with caution in patients with known subclinical or overt diabetes mellitus.
Do not administer unless solution is clear and both seal and container are intact.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

To be used as directed by a licensed veterinarian. The dosage of the Sykes 5% Dextrose and 0.9% Sodium Chloride Injection is dependent upon the age, weight and clinical conditions of the patient as well as laboratory determinations. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

For use in one patient on one occasion only. Discard any unused portion. Care should be taken with administration technique to avoid administration site reactions and infection.

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 judgement of the veterinarian, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

Over-dosage

OVERDOSAGE SECTION

In an event of over-hydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See Warnings, Precautions and Adverse Events.

Packs Supplied

HOW SUPPLIED SECTION

Sykes 5% Dextrose and 0.9% Sodium Chloride Injection is available in containers in various sizes as follows:

Table2Table2

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (86°F/30°C). Protect from freezing.

Directions for use of plastic container

INSTRUCTIONS FOR USE SECTION

To Open
Tear overwrap at slit and remove solution container. 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 solution container firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below:

Preparation for Administration
1. Suspend container from eyelet support.
2. Remove plastic protector from inlet/outlet port at bottom of container.
3. Attach administration set.

To Add Medication
WARNING: Additives may be incompatible.

To add medication before solution administration
1. Prepare medication site.
2. Using syringe with 0.63mm to 0.80mm needle, puncture 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 the clamp on the administration set.
2. Prepare medication site.
3. Using syringe with 0.63mm to 0.80mm needle, puncture 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.

GENERAL PRECAUTIONS SECTION

CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF A LICENSED VETERINARIAN.

INFORMATION FOR OWNERS/CAREGIVERS SECTION

Made in Australia

Manufactured and distributed by:
Sypharma Pty Ltd
27 Healey Road Dandenong
Victoria 3175 Australia

For customer service email:
customerservice@sypharma.com.au

Version: US_01

Sykes 5% Dextrose and 0.9% Sodium Chloride Injection 250mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DextroseNaCl250mLDextroseNaCl250mL

Sykes 5% Dextrose and 0.9% Sodium Chloride Injection 500mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DextroseNaCl500mLDextroseNaCl500mL

Sykes 5% Dextrose and 0.9% Sodium Chloride Injection 1000mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DextroseNaCl1000mLDextroseNaCl1000mL

Sykes 5% Dextrose and 0.9% Sodium Chloride Injection 3000mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DextroseNaCl3000mLDextroseNaCl3000mL

Sykes 5% Dextrose and 0.9% Sodium Chloride Injection 5000mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DextroseNaCl5000mLDextroseNaCl5000mL

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-139317643192643GTIN-13: 9317643192643
EAN-13: 9317643192643
GTIN storage (14 digits): 09317643192643
DextroseNaCl500mL.jpg
BarcodeEAN-139317643192650GTIN-13: 9317643192650
EAN-13: 9317643192650
GTIN storage (14 digits): 09317643192650
DextroseNaCl1000mL.jpg
BarcodeEAN-139317643192667GTIN-13: 9317643192667
EAN-13: 9317643192667
GTIN storage (14 digits): 09317643192667
DextroseNaCl3000mL.jpg
BarcodeEAN-139317643192674GTIN-13: 9317643192674
EAN-13: 9317643192674
GTIN storage (14 digits): 09317643192674
DextroseNaCl5000mL.jpg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86043-1012SYKES 5% DEXTROSE AND 0.9% SODIUM CHLORIDE (DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE INJECTION) SOLUTION [SYPHARMA PTY LTD]2Unmatched20171219_b8d421e8-6c23-47d1-a495-dd959246f0b2.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86043-101286043-1012-1, 86043-1012-2, 86043-1012-3, 86043-1012-4, 86043-1012-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROSE MONOHYDRATELX22YL083GACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DextroseDEXTROSE MONOHYDRATEHenry Schein, Inc.8cf6943f-16e8-4521-863c-09bb0b55e2a92026-09-09Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEREMEDYREPACK INC.b8b77421-d687-45aa-82f6-d49bce644c102026-08-31Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEHospira, Inc.4ed365da-4e62-4329-c1b9-c197ab4fb6e12026-07-13Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEHospira, Inc.672264e3-9709-4bba-2a9d-12bf70c7396a2026-06-24Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare Corporation3bb406a9-f5cb-403a-b1bb-5c4facbea3d52026-06-11Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEHospira, Inc.10e98cb0-31a5-4ad1-3eaa-aa4af387a42d2026-06-02Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEHenry Schein, Inc.40fd1ac4-39bb-45fb-ba99-4fb65481f2312026-04-09Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEBecton Dickinson and Company8e7046f8-841e-465a-af69-af9fb3d6799d2026-03-17Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEFresenius Kabi USA, LLC3b8f2692-4371-4f1a-95af-b41842131fdd2026-03-13Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEBECTON DICKINSON AND COMPANY32132016-1870-481b-9816-e11beb03ca0b2026-01-08Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEFresenius Kabi USA, LLCbd250a46-d229-4e80-b5a1-b34169ccecc42025-12-17Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEICU Medical, Inc.8b25b7e0-703e-4b43-a4eb-52863511602d2025-11-02Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEICU Medical, Inc.cb578dba-094c-4787-951d-763d12fd06e12025-11-01Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEICU Medical Inc.cdf35d11-fbc8-4f8e-85a8-33220312c0b42025-10-17Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEProPharma Distribution3eff8bcd-6a33-428f-e063-6394a90afa682025-09-17Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEBaxter Healthcare Companybfc4224a-2fc9-4137-b4c6-9d2d6d9484132025-07-30Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEProPharma Distribution3842a9c0-8b15-1c94-e063-6394a90ae1202025-07-18Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare Corporation36e9478c-5df0-4b47-b97d-de3626d7cb292025-06-30Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEFRESENIUS KABI USA, LLC576a22d8-5f2f-497e-80ad-1842ca74bb532024-08-22Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
DextroseDEXTROSE MONOHYDRATEBecton Dickinson and Companyc1f72bce-4bef-49db-a8da-f26a703d67482024-08-15Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.