Sterile Bacteriostatic Water 30 ml Multiple Dose Vial
Bacteriostatic Water (modified sterile water) for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for injection. The pH is 5.7 (4.5 to 7.0).
Bacteriostatic Water for Injection, USP is chemically designated H2O.
The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper labeled volume.Sterile Bacteriostatic water is a multi-dose sterile water for injection used for diluting medications prior to injection. Bacteriostatic water is packaged in a multiple dose plastic vial that can be reused several times before needing to discard. Bacteriostatic water for injection contains 0.9% of benzyl alcohol as a bacteriostatic preservative. Benzyl alcohol suppresses or stops the growth of most potentially contaminating bacteria. Benzyl alcohol, is safe to us and is naturally made by many plants and is commonly found in fruits, teas and essential oils like jasmine. This bacteriostatic water has a pH level is 5.7 (4.5 to 7.0) and is safely packaged in a fabricated semi-rigid vial specially formulated with copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper label volume. This product is not to be used in neonates.
What is Bacteriostatic Water?
Bacteriostatic Water for Injection is sterile non-pyrogenic water that contains 0.9% benzyl alcohol (9mg/mL), which is added as a bacteriostatic preservative. This preparation of sterile water and benzyl alcohol (BnOH) allows repeated withdrawals to be made from a single 30mL plastic vial. Hospira, the world’s leading manufacturer and supplier of bacteriostatic and sterile water, recommends that once a vial of bacteriostatic water is open the preservatives will prolong its life for up to 28 days and that after this period of time the vial should to be discarded. Other sterile waters for injection without the bacteriostatic agent (single-dose vials) should be discarded after a single use. Visit our page to purchase online at wholesale supply prices.
Do not use Bacteriostatic Water for Injection, USP for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture.
Consult the manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection.
Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration.
Pregnancy Category C. Animal reproduction studies have not been conducted with Bacteriostatic Water for Injection. It is also not known whether Bacteriostatic Water for Injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bacteriostatic Water for Injection, USP containing additives should be given to a pregnant woman only if clearly needed.
The safety and effectiveness of Bacteriostatic Water for Injection, USP have not been established in pediatric patients. Due to the potential for toxicity, solutions containing benzyl alcohol should not be used in neonates.
Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available.
Use aseptic technique for single or multiple entry and withdrawal from all containers.
When diluting or dissolving drugs, mix thoroughly and use promptly.
Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute.
Do not use unless the solution is clear and seal intact.
Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.
Although adverse reactions to intravenous, intramuscular or subcutaneous injection of 0.9% benzyl alcohol are not known to occur in man, experimental studies of small volume parenteral preparations containing 0.9% benzyl alcohol in several species of animals have indicated that an estimated intravenous dose up to 30 mL may be safely given to an adult without toxic effects. Administration of an estimated 9 mL to a 6 kg infant or neonate is potentially capable of producing blood pressure changes.
DOSAGE AND ADMINISTRATION
The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit
- First examine vial appearance. Make sure sterile bacteriostatic water inside is clear and seal is intact and undamaged. Purple plastic flip top helps protect rubber injection entry site.
- Swab top of rubber injection site with antiseptic wipe containing 70% isopropyl alcohol or higher to reduce any existing bacteria growth. Wait until alcohol is dry before continuing.
- Next, using a sterile syringe and wearing sterile examination gloves, draw the exact dose of sterile water from the vial and carefully injected it into an empty vial to prepare for mixing. Mix thoroughly with desired drug and use promptly after mixing.
- After the first time the water is used, label the vial with date and time to ensure preservative integrity (25-28 days once opened). Store at 20 to 25 Celsius (68 to 77 degrees Fahrenheit).
How long does it last once it's opened?