SYKES 5% DEXTROSE AND 0.9% SODIUM CHLORIDE (DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE INJECTION) SOLUTION [SYPHARMA PTY LTD]

SYKES 5% DEXTROSE AND 0.9% SODIUM CHLORIDE (DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE INJECTION) SOLUTION [SYPHARMA PTY LTD]
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NDC 86043-1012-1, 86043-1012-2, 86043-1012-3, 86043-1012-4, 86043-1012-5
Set ID b8d421e8-6c23-47d1-a495-dd959246f0b2
Category PRESCRIPTION ANIMAL DRUG LABEL
Packager Sypharma Pty Ltd
Generic Name
Product Class
Product Number
Application Number
  • WARNINGS AND PRECAUTIONS

    STERILE NONPYROGENIC SOLUTION
    For Animal Use Only

  • Description

    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
    Table1

    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

    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

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

  • Contraindications

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

  • Warnings

    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

    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

    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

    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

    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

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

    Table2

    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

    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

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

  • INFORMATION FOR OWNERS/CAREGIVERS

    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

    DextroseNaCl250mL

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

    DextroseNaCl500mL

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

    DextroseNaCl1000mL

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

    DextroseNaCl3000mL

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

    DextroseNaCl5000mL

  • INGREDIENTS AND APPEARANCE
    SYKES 5% DEXTROSE AND 0.9% SODIUM CHLORIDE 
    dextrose monohydrate and sodium chloride injection solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:86043-1012
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE5 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE0.9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86043-1012-1250 mL in 1 CONTAINER
    2NDC:86043-1012-2500 mL in 1 CONTAINER
    3NDC:86043-1012-31000 mL in 1 CONTAINER
    4NDC:86043-1012-43000 mL in 1 CONTAINER
    5NDC:86043-1012-55000 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/09/2016
    Labeler - Sypharma Pty Ltd (753786292)
    Registrant - Sypharma Pty Ltd (753786292)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sypharma Pty Ltd753786292manufacture, pack, sterilize

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