Label: LIQUIVIDA HYDRATION- sodium chloride, chlorhexidine gluconate , isopropyl alcohol kit

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 31, 2020

If you are a consumer or patient please visit this version.

  • SODIUM CHLORIDE INJECTION, USP

    in VIAFLEX Plastic Container

    Baxter Healthcare Corporation

  • DESCRIPTION

    Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The nominal pH is 5.0 (4.5 to 7.0). Composition, osmolarity, and ionic concentration are shown below:

    0.45% Sodium Chloride Injection, USP contains 4.5 g/L Sodium Chloride, USP (NaCl) and is hypotonic with an osmolarity of 154 mOsmol/L (calc). It contains 77 mEq/L sodium and 77 mEq/L chloride.

    0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride.

    The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2- ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of
    the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

  • CLINICAL PHARMACOLOGY

    Sodium Chloride Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient. 

  • INDICATIONS AND USAGE

    Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.

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

  • CONTRAINDICATIONS

    None known.

  • WARNINGS

    Hypersensitivity

    Hypersensitivity and infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash,and pruritus have been reported with 0.9% Sodium Chloride Injection, USP and may occur with 0.45% Sodium Chloride Injection, USP.

    Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

    Electrolyte Imbalances

    Fluid Overload

    Depending on the volume and rate of infusion, and the patient’s underlying clinical condition, the intravenous administration of Sodium Chloride Injection, USP can cause fluid disturbances such as overhydration/hypervolemia and congested states, including pulmonary congestion and edema.

    Avoid 0.9% Sodium Chloride Injection, USP in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, electrolyte concentrations, and acid base balance, as needed and especially during prolonged use.

    Hyponatremia

    Sodium Chloride Injection, USP may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury.

    The risk of hospital-acquired hyponatremia is increased in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH) treated with high volume of Sodium Chloride Injection, USP.

    The risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as diuretics, certain antiepileptic and psychotropic medications). See DRUG INTERACTIONS.

    Patients at increased risk for developing complications of hyponatremia such as hyponatremic encephalopathy, include pediatric patients, women (in particular pre-menopausal women), patients with hypoxemia, and patients with underlying central nervous system disease. Avoid Sodium Chloride
    Injection, USP in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations.

    Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications. Brain adaptations reducing risk of cerebral edema make the brain vulnerable to injury when chronic hyponatremia is too rapidly corrected, which is known as osmotic demyelination syndrome (ODS). To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications.

    Hypernatremia

    Hypernatremia may occur with Sodium Chloride Injection, USP. Conditions that may increase the risk of hypernatremia, fluid overload and edema (central and peripheral), include patients with: primary hyperaldosteronism; secondary hyperaldosteronism associated with, for example, hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis); and pre-eclampsia.

    Certain medications, such as corticosteroids or corticotropin, may also increase risk of sodium and fluid retention, see DRUG INTERACTIONS.

    Avoid Sodium Chloride Injection, USP in patients with, or at risk for, hypernatremia. If use cannot be avoided, monitor serum sodium concentrations.

    Rapid correction of hypernatremia is potentially dangerous with risk of serious neurologic complications. Excessively rapid correction of hypernatremia is also associated with a risk for serious neurologic complications such as osmotic demyelination syndrome (ODS) with risk of seizures and cerebral edema.

  • PRECAUTIONS

    Patients with Severe Renal Impairment

    Administration of Sodium Chloride Injection, USP in patients with or at risk of severe renal impairment, may result in hypernatremia and/or fluid overload (see WARNINGS). Avoid Sodium Chloride Injection, USP in patients with severe renal impairment or conditions that may cause sodium and/or potassium retention, fluid overload, or edema. If use cannot be avoided, monitor patients with severe renal impairment for development of these adverse reactions.

    Drug Interactions

    Other Products that Affect Fluid and/or Electrolyte Balance

    Administration of Sodium Chloride Injection, USP to patients treated concomitantly with drugs associated with sodium and fluid retention may increase the risk of hypernatremia and volume overload. Avoid use of Sodium Chloride Injection, USP in patients receiving such products, such as corticosteroids or corticotropin. If use cannot be avoided, monitor serum electrolytes, fluid balance and acid-base balance.

    Lithium

    Renal sodium and lithium clearance may be decreased during administration of 0.45% Sodium Chloride Injection, USP. Monitor serum lithium concentrations during concomitant use.

    Renal sodium and lithium clearance may be increased during administration of 0.9% Sodium Chloride Injection, USP. Monitor serum lithium concentrations during concomitant use.

    Other Drugs that Increase the Risk of Hyponatremia

    Administration of Sodium Chloride Injection, USP in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia.

    Avoid use of Sodium Chloride Injection, USP in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. If use cannot be avoided, monitor serum sodium concentrations.

    Pregnancy

    There are no adequate and well controlled studies with Sodium Chloride Injection, USP in pregnant women and animal reproduction studies have not been conducted with this drug. Therefore, it is not known whether Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman. Sodium Chloride Injection, USP should be given to a during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    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 Sodium Chloride Injection, USP is administered to a nursing woman.

    Pediatric Use

    The use of Sodium Chloride Injection, USP in pediatric patients is based on clinical practice. (See DOSAGE AND ADMINISTRATION).

    Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of Sodium Chloride Injection, USP may result in increased serum osmolality and risk of intracerebral
    hemorrhage.

    Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy.

    Geriatric Use

    Geriatric patients are at increased risk of developing electrolyte imbalances. Sodium Chloride Injection, USP 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. Therefore, 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. Consider monitoring renal function in elderly patients.

  • ADVERSE REACTIONS

    Post-Marketing Adverse Reactions

    The following adverse reactions have been identified during post approval use of Sodium Chloride Injection, USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

    The following adverse reactions have been reported in the post-marketing experience during use of Sodium Chloride Injection, USP and include the following:

    General disorders and administration site conditions: Infusion site erythema, injection site streaking, burning sensation, and infusion site urticaria

    Hypersensitivity reactions: Hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus.

    Metabolism and nutrition disorders: Hypernatremia*, hyponatremia, hyperchloremic metabolic acidosis.

    Nervous System Disorders: Hyponatremic encephalopathy

    * Adverse reaction of hyponatremia is only related to 0.9% Sodium Chloride Injection, USP

    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.

  • OVERDOSAGE

    Excessive administration of:

    • 0.45% Sodium Chloride Injection, USP can cause hyponatremia and hypernatremia. Both hypo- and hypernatremia can lead to CNS manifestations, including seizures, coma, cerebral edema and death.
    • 0.9% Sodium Chloride Injection, USP can cause hypernatremia.
    • Sodium Chloride Injection, USP can cause fluid overload (which can lead to pulmonary and/or peripheral edema). See WARNINGS and ADVERSE REACTIONS.

    When assessing an overdose, any additives in the solution must also be considered. The effects of an overdose may require immediate medical attention and treatment.

    Interventions include discontinuation of Sodium Chloride Injection, USP administration, dose reduction, and other measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations and acid base balance).

  • DOSAGE AND ADMINISTRATION

    Important Administration Instructions

    • Sodium Chloride Injection, USP is intended for intravenous administration using sterile equipment.
    • Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container.
    • Set the vent to the closed position on a vented intravenous administration set to prevent air embolism.
    • Use a dedicated line without any connections to avoid air embolism.
    • Do not pressurize intravenous solutions contained in flexible plastic containers to increase flow rates in order to avoid air embolism due to incomplete evacuation of residual air in the container.
    • Prior to infusion, visually inspect the solution for particulate matter and discoloration. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear, and container is undamaged.
    • Do not mix or administer 0.45% Sodium Chloride Injection, USP through the same administration set with whole blood or cellular blood components.

    Dosing Information

    The choice of product, dosage, volume, rate, and duration of administration is dependent upon the age, weight and clinical condition of the patient and concomitant therapy, and administration should be determined by a physician experienced in intravenous fluid therapy.

    Introduction of Additives

    Additives may be incompatible.

    Evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with a 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. After addition, if there is a discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. Do not
    store solutions containing additives. Discard any unused portion.

  • HOW SUPPLIED

    The available sizes of each injection in VIAFLEX plastic containers are shown below:

    Code Size (mL)  NDC Product Name 
    2B1313500 0338-0043-03  0.45% Sodium Chloride
    Injection, USP
    2B13141000 0338-0043-04 
    2B130025 Quad Pack 0338-0049-100.9% Sodium Chloride Injection,
    USP
     
     

    50

      
    2B1306Single Pack 0338-0049-41 
    2B1301Quad Pack 0338-049-11 
    2B1308Multi Pack 0338-0049-31 
     

    100

      
    2B1307Single Pack 0338-0049-48 
    2B1302Quad Pack 0338-0049-18 
    2B1309Multi Pack 0338-0049-38 
    2B1321150 0338-0049-01 
    2B1322250 0338-0049-02 
    2B1323500 0338-0049-03 
    2B13241000 0338-0049-04 

    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 VIAFLEX PLASTIC CONTAINER

    For Information on Risk of Air Embolism – see DOSAGE AND ADMINISTRATION.

    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 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
    Additives may be incompatible

    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 6  015 USA
    Printed in USA

    Distributed in Canada by: Mississauga, ON L5N 0C2

    07-19- 00-1174

    Rev. May 2019

    Baxter and Viaflex are trademarks of Baxter International Inc.

  • PREVANTICS SWAB

    PREVANTICS SWAB- chlorhexidine gluconate and isopropyl alcohol solution

    Professional Disposables International, Inc.

    B11400

    NDC 10819-1080-2

  • ACTIVE INGREDIENTS

    • Chlorhexidine gluconate 3.15% w/v
    • Isopropyl alcohol 70% v/v
  • PURPOSE

    • Antiseptic
    • Antiseptic
  • USE

    For the preparation of the patient's skin prior to an injection

  • WARNINGS

    • For external use only

    • Flammable, keep away from fire or flame

    • Do not use with electrocautery procedures

    Allergy Alert 
    This product may cause a severe allergic reaction. Symptoms may include:
    • wheezing/difficulty breathing
    • shock
    • facial swelling
    • hives
    • rash
    If an allergic reaction occurs, stop use and seek medical help right away.
    Do not use 
    • on patients allergic to chlorhexidine gluconate or any other ingredients in this product
    • for lumbar puncture or in contact with the meninges
    • on open skin wounds or as a general skin cleanser
    • under occlusive patch
    When using this product 
    keep out of eyes, ears, mouth and mucous membranes. May causer serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.
    Stop use and ask a doctor if
     irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
     
     Keep out of reach of children.
     If swallowed, get medical help or contact a Poison Control Center right away.
  • DIRECTIONS

    • use with care in premature infants or infants under  2 months of age. These products may cause irritation or chemical burns.

    • maximum treatment area for one swab is approximately  2.5 by 2.5 inches (6 by 6 cm)

    • tear open packet and remove swab. Do not unfold swab.

    • prior to injection, apply swab to the procedure site by holding swab between thumb and index finger. Apply swab to skin  using repeated back-and-forth strokes for 15 seconds.

    • allow the prepped area to air dry for 30 seconds

    • do not blot or wipe dry

    • discard after a single use

  • INACTIVE INGREDIENT

    • USP purified water
  • OTHER INFORMATION

    • Store between 68-77°F (20-25°C)
    • Avoid freezing and excessive heat above 104°F (40°C)

    • For hospital and professional use only

    For Questions:

    Call 1-800-999-6423

    M-F (9:00 am - 5:00 pm EST)

    Professional Disposables International, Inc

    Orangeburg, NY 10962-1376 USA

    www.pdihc.com

    Revised 8/2019

  • PRINCIPAL DISPLAY PANEL: LIQUIVIDA HYDRATION KIT

    NDC 49836-032-05

    Rx Only

    LIQUIVIDATM 
    HYDRATION KIT

    Kit Contains:

    1 Sodium Chloride , USP 0.9% IV Bag (500mL)
    1 Sterile IV Administration Set
    1 Sterile IV Start Kit
    1 Sterile Safety IV Catheter Jelco ViaValve†     (22 gauge x 1")
    1 Sterile Pair Nitrile Powder-Free Gloves (Size 7.5)

    1 Dose

    1 ONE NEEDLE,
       ONESYRINGE,
       ONLY ONETIME.
    Safe Injection Practices Coalition
    www.ONEandONLYcampaign.org

    Members of One & Only Campaign

    LIQUIVIDATM  HYDRATION KIT

    DISTRIBUTED BY:
    SCHMIGS
    HAUPPAUGE, NY 11788
    NDC 49836-032-05

    MANUFACTURED BY:
    Rx Pharma Pack
    HAUPPAUGE, NY 11788

    Questions/Comments 1-844-632-7898

    Kit Contents:

    Sodium Chloride , USP 0.9% IV Bag (500mL)* (Baxter Healthcare Corp.)

    Sterile IV Administration Set* (Dynarex)

    Sterile IV Start Kit* (CovidienTM)

    Sterile Safety IV Catheter Jelco ViaValve†   (22 gauge x 1")* (Smiths Medical)

    Sterile Nitrile Powder-Free Gloves* (Dynarex)- Size 7.5

     

    † All trademarks and registered trademarks noted herein are the property of their respective owners.
    * Internal package components remain sterile when stated as long as items are unopened and undamaged.

    WARNING: KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
    IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONALASSISTANCE OR
    CONTACT A POISON CONTROL CENTER IMMEDIATELY.

    PROTECT FROM LIGHT/AVOID FREEZING

    STORE AT CONTROLLED ROOM TEMPERATURE
    15°-30°C (59°-86°F) [SEE USP CONTROLLED
    ROOM TEMPERATURE]

    DO NOT REFRIGERATE

    For Single use Only.

    Directions for Use: See enclosed inserts.

    SUSTAINABLE           Certified Sourcing
    FORESTRY                www.sfiprogram.org
    INITIATIVE                 SFI-01376

    ORG 11/2018

    This product is not eligible for Medicare or Medicaid reimbursement.

    LIQUIVIDA HYDRATION KIT

    LIQUIVIDA HYDRATION KIT

  • INGREDIENTS AND APPEARANCE
    LIQUIVIDA HYDRATION 
    sodium chloride, chlorhexidine gluconate , isopropyl alcohol kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49836-032
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49836-032-051 in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package11/20/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BAG 500 mL
    Part 21 POUCH 1 mL
    Part 1 of 2
    SODIUM CHLORIDE 
    sodium chloride injection, solution
    Product Information
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE9 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1500 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01667712/09/1970
    Part 2 of 2
    PREVANTICS 
    chlorhexidine gluconate , isopropyl alcohol solution
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE31.5 mg  in 1 mL
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02152401/15/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01667711/20/2018
    Labeler - RX PHARMA-PACK, INC. (962149634)