The small volume of fluid provided by Sterile Water for Injection, USP when used only as a pharmaceutic aid for diluting or dissolving drugs for parenteral injection, is unlikely to exert a significant effect on fluid balance except possibly in neonates or very small infants.
This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis. Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture. Inspect reconstituted diluted or dissolved drugs for clarity if soluble and freedom from unexpected precipitation or discoloration prior to administration.
Animal reproduction studies have not been conducted with Sterile Water for Injection. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed.
Safety and effectiveness have been established in pediatric patients. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. 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. 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. Do not reuse single-dose containers. Discard unused portion. 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.
Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures.
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. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The pH is 5. Sterile Water for Injection contains no bacteriostat, antimicrobial agent or added buffer and is intended only for single dose injection after admixture with an appropriate solute or solution.
When smaller amounts are required, the unused portion should be discarded. Sterile Water for Injection is a pharmaceutic aid vehicle and parenteral fluid replenisher after addition of an appropriate solute. The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.
When administered intravenously as a vehicle for drugs, sterile water for injection provides a source of water for parenteral fluid replenishment after sufficient solute is introduced to achieve an osmolarity of mOsmol or more per liter. Average normal adult daily requirement ranges from two to three liters 1. Water balance is maintained by various regulatory mechanisms. Sterile Water for Injection is indicated for use only as a solvent or diluent vehicle for parenterally administered drugs or solutions and as a source of water for parenteral fluid replenishment after suitable additives are introduced.
For intravenous administration, an osmolar concentration not less than two-fifths 0. Intravenous administration of Sterile Water for Injection without additives may result in hemolysis. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions.
The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions. 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.
Tissue loading may occur at even lower rates of administration. Animal reproduction studies have not been conducted with sterile water for injection. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Sterile water for injection with additives should be given to a pregnant woman only if clearly needed. The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.
Reactions which may occur because of 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.
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.
Following suitable admixture of prescribed additive, the dose is usually dependent upon the age, weight and clinical condition of the patient. Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.
0コメント