Animal NDC 86043-1002-2 Sykes 0.9% Sodium Chloride
Sodium Chloride Injection

Animal Product Information

Field Name Field Value
Animal NDC Code 86043-1002-2
Proprietary Name Sykes 0.9% Sodium Chloride What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Sodium Chloride Injection What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Sypharma Pty Ltd
Product Type Prescription Animal Drug
Usage Information
    Sykes 0.9% Sodium Chloride Intravenous Infusion is indicated as a source of water and electrolytes.
Active Ingredient(s)
  • Sodium Chloride
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • WATER (059QF0KO0R)
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Sykes 0.9% Sodium Chloride Images

Sykes 0.9% Sodium Chloride Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Warnings And Precautions



STERILE NONPYROGENIC SOLUTION
For Animal Use Only


Description



Sykes 0.9% Sodium Chloride Intravenous Infusion is a sterile, non-pyrogenic solution intended for water and electrolytes replenishment in single dose containers. May be administered intravenously using aseptic technique. It contains no antimicrobial agents. Discard any unused portion. Composition, osmolarity, pH and ionic concentration are shown in Table 1.

Table 1

The container is free of PVC and phthalates. The container meets the requirements of USP and is registered with US FDA.


Clinical Pharmacology



Sykes 0.9% Sodium Chloride Intravenous Infusion is intended to restore water and electrolytes. It is capable of inducing diuresis, depending on the clinical condition of the patient.


Indications And Usage



Sykes 0.9% Sodium Chloride Intravenous Infusion is indicated as a source of water and electrolytes.


Contraindications



None known.


Warnings



Sykes 0.9% Sodium Chloride Intravenous Infusion 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.

The intravenous administration of Sykes 0.9% Sodium Chloride Intravenous Infusion can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, over-hydration, congested states, or pulmonary edema. The risk of dilutive states is inversely proportional to the electrolyte concentration 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 0.9% Sodium Chloride Intravenous Infusion may result in sodium retention.


Adverse Reactions



Reactions which may occur because of the solution 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



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 0.9% Sodium Chloride Intravenous Infusion to patients receiving corticosteroids or corticotrophin.

Do not administer unless solution is clear and seal is intact.


Dosage And Administration



As directed by a veterinarian. 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 discolouration prior to administration whenever solution and container permit.

All injections in plastic containers are intended for intravenous administration using sterile equipment.

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 0.9% Sodium Chloride Intravenous Infusion in plastic container is available as follows:

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:
[email protected]

Version: US_01


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.