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Therapeutic Category
- SOLUTIONS
- Pharmaceutical Form : ٍSolutions
- Composition : ampoule /Sterile water 5 ml
- Active Substance : Sterile water
CLINICAL PHARMACOLOGY
Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).
Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.
The small volume of fluid provided by Sterile Water for Injection, USP when used only as a pharmaceutical aid for diluting or dissolving drugs for parenteral injection, is unlikely to exert a significant effect on fluid balance except possibly in newborns or very small infants.
Indications
This preparation is indicated only for diluting or dissolving drugs intended for parenteral injection, according to instructions of the manufacturer of the drug to be administered.
Contra indications
Sterile Water for Injection, USP must be made approximately isotonic prior to use.
Precautions
Do not use unless the solution is clear and seal intact. Do not reuse single-dose containers, discard unused portion.
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
It is not known whether Sterile Water for Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile Water for Injection, USP with additives should be given to a pregnant woman only if clearly needed.
Warnings
Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis.
Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle. Consult with pharmacist, if available.
The plastic ampule is molded from a specially formulated polyethylene.
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.
ADVERSE REACTIONS
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, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination
Dosage
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 of the drug and be administered.
Storage Conditions
Store at room temperature between (20-25) ˚c.
Packing:
25- 100 single dose units