sterile water for injection, USP, bacteriostatic vial Warnings and Precautions

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WARNINGS

Benzyl alcohol, a preservative in Bacteriostatic Water for Injection, USP has been associated with toxicity in neonates. Data are unavailable on the toxicity of other preservatives in this age group. Where water is required for preparing or diluting medications for use in neonates, only preservative-free Sterile Water for Injection should be used.

Intravenous administration of Bacteriostatic Water for Injection without a solute may result in hemolysis.

PRECAUTIONS

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: 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.

Pediatric Use

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.

Drug Interactions

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.

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Warnings and Precautions

WARNINGS

Benzyl alcohol, a preservative in Bacteriostatic Water for Injection, USP has been associated with toxicity in neonates. Data are unavailable on the toxicity of other preservatives in this age group. Where water is required for preparing or diluting medications for use in neonates, only preservative-free Sterile Water for Injection should be used.

Intravenous administration of Bacteriostatic Water for Injection without a solute may result in hemolysis.

PRECAUTIONS

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: 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.

Pediatric Use

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.

Drug Interactions

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.

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