Product Monograph - Sterile Water for Injection USP (B. Braun Medical, PM 00058021)
Serious Warnings and Precautions
PHARMACY BULK PACKAGE, NOT FOR DIRECT INFUSION (see Dosage and
Administration);
- Hypotonic and Hemolytic: Do not inject until made isotonic by addition of an appropriate solute; due to possibility of hemolysis (see Warnings and Precautions);
- This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired (see Warnings and Precautions).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration and final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration. Use of a final filter is recommended during administration of all parenteral solutions.
Sterile Water for Injection USP in the Pharmacy Bulk Package is intended for use in the preparation of sterile, intravenous admixtures. Additives may be incompatible with the fluid withdrawn from this container. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist.
When compounding admixtures, use aseptic technique. Mix thoroughly. Discard any unused portion of Sterile Water for Injection USP.
Preparation:
- Inspect overwrap and primary bag.
- Do not use if overwrap has been damaged.
- Do not use unless solution is clear and closure is intact.
To open:
- Tear overwrap starting from the tear notches (see Figure 1).
For Pharmacy Bulk Packages:
The Pharmacy Bulk Package is to be used only in a suitable
work area such as a laminar air flow hood (or an equivalent
clean air compounding area).
- For compounding only. Do not use for direct infusion.
- Do not use/penetrate blocked port (see Figure 2, left upper corner).
- Suspend container.
Remove aluminum foil of set port at the bottom of container
(see Figure 3).
Attach suitable transfer device or compounding set (Figure 2).
Refer to complete directions accompanying device.
- Hang bag on suitable fixture (Figure 4).
Once container closure has been penetrated, withdrawal of content
should be completed within 4 hours. Discard any unused portion.
Important Admixing Instructions
The contents are intended for use in a pharmacy admixture
program and are restricted to the preparation of admixtures for infusion or, through a sterile transfer device, for the filling of
empty sterile syringes.
Additives may be incompatible with the fluid withdrawn from
this container. Consult with pharmacist.
When compounding admixtures, use aseptic technique, mix
thoroughly and discard unused portion.
Parenteral drug products should be inspected visually for particulate
matter and discoloration prior to administration (See Warnings and Precautions, General).
5 OVERDOSAGE
Overdosage (hypotonic expansion) is a function of an increase in fluid intake over fluid output, and occurs when the increase in the volume of body fluids is due to water alone. Overdosage may occur in patients who receive large quantities of electrolyte-free water to replace abnormal excessive fluid losses, in patients whose renal tolerance to water loads is exceeded, or in patients who retain water postoperatively in response to stress.
Manifestations of water intoxication are behavioral changes (confusion, apathy, disorientation and attendant hyponatremia), central nervous system disturbances (weakness, muscle twitching, headaches, nausea, vomiting, convulsions) and weight gain.
Treatment consists of withholding fluids until excessive water is excreted. In severe hyponatremia it may be necessary to cautiously administer hypertonic saline to increase extracellular osmotic pressure and excretion of excess water by the kidneys.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
Sterile Water for Injection USP is a clear, colorless, odorless liquid.
It is sterile, hypotonic, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Sterile Water for Injection USP is a diluent suitable for intravascular injection after first having been made isotonic by the addition of suitable solute. pH: 5.5 (5.0-7.0). The osmolarity is 0 mOsmol / L.
Flexible Plastic Container not made with natural rubber latex, PVC or DEHP.
The plastic container is made from a multilayered film specifically developed for parenteral drugs. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during use. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.
Sterile Water for Injection USP is supplied in 2000 mL and 3000 mL Pharmacy Bulk Package containers packaged 4 per case.
7 WARNINGS AND PRECAUTIONS
Please see the Serious Warnings and Precautions Box at the beginning of Part I: Health Professional Information.
| Route of Administration | Dosage Form / Strength/Composition | Non-medicinal Ingredients |
| For Intravenous Use Only after Admixture or Dilution | Liquid, 100% | There are no non-medicinal ingredients. |
For management of a suspected drug overdose, contact your regional poison control centre.
General
This solution is for compounding only, not for direct infusion.
The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration.
To minimize the risk of possible incompatibilities arising from the mixing of additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration and periodically during administration.
Do not use plastic container in series connection.
If administration of Sterile Water for Injection USP after admixture or dilution is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container.
This solution is intended for intravenous administration after admixture or dilution using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.
Use only if solution is clear and container and seals are intact.
Carcinogenesis and Mutagenesis
Refer to the product monograph, prescribing information or package insert of the solute used.
Renal
This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg / kg / day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
The drug product contains no more than 25 mcg / L of aluminum.
Sexual Health
Reproduction
Refer to the product monograph, prescribing information or package insert of the solute used.
7.1 Special Populations
7.1.1 Pregnant Women
Refer to the product monograph, prescribing information or package insert of the solute used.
7.1.2 Breast-feeding
Refer to the product monograph, prescribing information or package insert of the solute used.
7.1.3 Pediatrics
See WARNINGS AND PRECAUTIONS, Renal.
Refer to the product monograph, prescribing information or package insert of the solute used.
7.1.4 Geriatrics
See WARNINGS AND PRECAUTIONS, Renal.
Refer to the product monograph, prescribing information or package insert of the solute used.
8 ADVERSE REACTIONS
Refer to the product monograph, prescribing information or package insert of the solute used.
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.
The physician should also be alert to the possibility of adverse reactions to drug additives. The product monograph, prescribing information or package insert for drug additives to be administered in this manner should be consulted.
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.
9 DRUG INTERACTIONS
Refer to the product monograph, prescribing information or package insert of the solute used.
Some additives may be incompatible. Consult with pharmacist. When performing admixture or dilution, use aseptic techniques. Mix thoroughly. Discard unused portion.
10 ACTION AND CLINICAL PHARMACOLOGY
Sterile Water for Injection USP is used as a diluent for other parenteral drugs. As such, Sterile Water for Injection USP contributes to the water for hydration when provided in parenteral drug and fluid therapy, after the introduction of suitable additives and/or mixture with suitable solutes to isotonicity.
11 STORAGE, STABILITY AND DISPOSAL
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.
PART II: SCIENTIFIC INFORMATION
13 PHARMACEUTICAL INFORMATION
Drug Substance
Proper name: Water
Chemical name: Water
Molecular formula and molecular mass: H2O; 18.01 g/mol
Structural formula:
B. Braun Medical Inc.
824 Twelfth Avenue
Bethlehem, PA 18018-3524 USA
Questions / Concerns: 1-800-539-0801
Date of Revision: August 18, 2020