Label: ALFA VETERINARY 0.9% SODIUM CHLORIDE- sodium chloride injection, solution injection, solution

  • NDC Code(s): 72483-203-01, 72483-203-05, 72483-203-10, 72483-203-25
  • Packager: Laboratorios Alfa, S.R.L.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL

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Drug Label Information

Updated December 9, 2019

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  • DESCRIPTION

    Veterinary 0.9% Sodium Chloride Injection, USP is a sterile, non-pyrogenic solution for fluid replenishment in single dose containers for intravenous administration. Discard unused portion. It contains no antimicrobial agents.

    Table 1: Veterinary 0.9% Sodium Chloride Injection, USP
     Size (mL)

    Compostion(mg/100 mL)

    pHIonic Concentration (mEq/L)

     Sodium Chloride,

    USP (NaCl)

     Osmolarity (mOsmol/L)
    (Calculated)
    SodiumChloride
     100900    308    4.5-7.0        154     154 
     250
     500
     1000

    The Plastic container, a semi-rigid bottle, is made of a low density polyethylene which is a flexible and resistant material that provides an excellent compatibility with a maximum number of pharmaceuticals, reducing the risk of interactions. No venting is necessary during infusion.

    OTHER SAFETY INFORMATION

    CAUTION: Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.

  • INDICATIONS AND USAGE

    Veterinary 0.9% Sodium Chloride is indicated as a source of water and electrolytes.


    Veterinary 0.9% Sodium Chloride injection, USP is also indicated for use as a priming solution in hemodialysis procedures.

  • CONTRAINDICATIONS

    None known

  • WARNINGS

    None known

  • 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 veterinary 0.9% Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotrophin.

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

  • DOSAGE & 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 discolorations 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 judgment 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. Discard unused portion.

    Overdosage

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

    Packaging NDC 72483-203-10 1000 mL in Plastic Bottle; NDC 72483-203-05 500 mL in Plastic Bottle; NDC 72483-203-25 250 mL in Plastic Bottle; NDC 72483-203-01 100 mL in Plastic Bottle

    NDC 72483-203-10 1000 mL in Plastic Bottle

    NDC 72483-203-05 500 mL in Plastic Bottle

    NDC 72483-203-25 250 mL in Plastic Bottle

    NDC 72483-203-01 100 mL in Plastic Bottle

    Storage

    Store below 30​0C (86​0​F).

    DIRECTIONS FOR USE PLASTIC CONTAINER

    Preparation and administration (Use Aspetic Technique):

    1. Check for minute leaks by squeezing the container firmly. If leaks are found discard solutions as sterility may be impaired.
    2. Suspend container from eyelet support. 
    3. Remove Plastic protector from port area at bottom of container. 
    4. Hold bottle in vertical position and insert IV administration set in outlet port.

    To add Medication: 

    WARNING: Additives may be incompatible.

    1. Prepare medication site. 
    2. Using syringe with 19 to 22 gauge needle, puncture inlet port and inject. 
    3. Mix solution and medication thoroughly. Return container to in-use position and continue administration.

    Caution

    Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.

  • OVERDOSAGE

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

    See Warnings, Precautions and Adverse Reactions.

  • STORAGE

    Store below 30ºC (86ºF)

  • PRECAUTION FOR USE OF THE BOTTLE

    This is a single dose container and does not contain preservatives.

    Use the solution immediately after the bottle is opened, discard the remaining one.
    Squeeze and inspect the bottle, discard if leaks are found or if the solution contains visible and solid particles.

    Do not administer simultaneously with blood.
    Do not use it unless solution is clear and seal is intact, the solution containing dextrose may be contraindicated in patients with a known allergy to corn or corn products.

    DIRECTIONS FOR USE PLASTIC CONTAINER

    Preparation and administration

    1. Check for minute leaks by squeezing the container firmly. If leaks are found, discard solution as sterility may be impaired.
    2. Suspend container from eyelet support.
    3. Remove Plastic protector from ports area at the bottom of container.
    4. Hold the bottle in vertical position and inset pyrogen free IV administration set in the outlet port. Use aseptic technique.

    To Add Medication
    WARNING:Additives may be incompatible.
    To add medication before solution administration.

    1. Prepare medication site.
    2. Using syringe with 19 to 22 gauge needle, puncture inlet port and inject.
    3. Mix solution and medication thoroughly. Return container to in-use position and continue administration. 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 inlet port and inject.
    4. Remove container from IV pole and/or turn to an upright position.
    5. Mix solution and medication thoroughly.
    6. Return container to in use position and continue administration.
  • PACKAGE INSERT

    For Animal Use Only

    Veterinary 0.9% Sodium Chloride Injection (1)Veterinary 0.9% Sodium Chloride Injection (2)Veterinary 0.9% Sodium Chloride Injection (3)Veterinary 0.9% Sodium Chloride Injection (4)

  • PRINCIPAL DISPLAY PANEL

    0.9% Sodium Chloride Injection, USP 

    Veterinary Use

    Sterile and NonProgenic Solution

    Keep out of reach of Children.

    For Animal Use Only.

    Take Time - Observe label directions

    Manufactured by:

    Laboratorios Alfa, SRL

    Santo Domingo

    Domincan Republic

    www.laboratoriosalfa.com

    +1-809-544-0222

    Veterinary 0.9% Sodium Chloride Injection (1000mL)Veterinary 0.9% Sodium Chloride Injection (500mL)Veterinary 0.9% Sodium Chloride Injection (250mL)Veterinary 0.9% Sodium Chloride Injection (100mL) description

  • INGREDIENTS AND APPEARANCE
    ALFA VETERINARY 0.9% SODIUM CHLORIDE 
    sodium chloride injection, solution injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:72483-203
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE900 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72483-203-101000 mL in 1 BOTTLE, PLASTIC
    2NDC:72483-203-05500 mL in 1 BOTTLE, PLASTIC
    3NDC:72483-203-25250 mL in 1 BOTTLE, PLASTIC
    4NDC:72483-203-01100 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/04/2019
    Labeler - Laboratorios Alfa, S.R.L. (815941244)