Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/232
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
Sterile Water (Injection, Solution)
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| dailymed-instance:dosage |
Following suitable admixture of prescribed additive,
the dose is usually dependent upon the age, weight and clinical condition
of the patient.
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| dailymed-instance:descripti... |
Sterile Water for Injection, USP is a sterile, nonpyrogenic,
solute-free preparation of distilled water for injection. It is for
use only as a sterile solvent or diluent vehicle for drugs or solutions
suitable for parenteral administration. The pH is 5.5 (5.0 to 7.0). 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. Water for Injection, USP is chemically
designated HO. The flexible
plastic container is fabricated from a specially formulated polyvinylchloride.
Water can permeate from inside the container into the overwrap but
not in amounts sufficient to affect the solution significantly. Solutions
inside the plastic container also can leach out certain chemical components
of the plastic in very small amounts before the expiration period
is attained. However, the safety of the plastic has been confirmed
by tests in animals according to USP biological standards for plastic
containers.
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| dailymed-instance:clinicalP... |
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 112 mOsmol or more per liter. 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.
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| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
Do not administer without the addition of a solute.
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| dailymed-instance:supply |
Sterile Water for Injection, USP is supplied in a
single-dose 1000 mL flexible plastic container (List No. 7990).
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| dailymed-instance:activeMoi... | |
| dailymed-instance:precautio... |
Do not use for intravenous injection unless the osmolar
concentration of additives totals at least 112 mOsmol/liter (two-fifths
of the normal osmolarity of the extracellular fluid���280 mOsmol/liter). Do not administer unless solution is clear and container
is undamaged. Discard unused portion.<br/>Pregnancy Category C.: 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.<br/>Pediatric Use:: 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. This product contains no more than 25 mcg/L of aluminum.
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| dailymed-instance:overdosag... |
In the event of overhydration or solute overload,
re-evaluate the patient and institute appropriate corrective measures.
See WARNINGS.
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| dailymed-instance:genericMe... |
Water
|
| dailymed-instance:fullName |
Sterile Water (Injection, Solution)
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| dailymed-instance:adverseRe... |
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.
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| dailymed-instance:warning |
FOR DRUG DILUENT USE ONLY. Intravenous administration of Sterile Water for Injection, USP
without additives may result in hemolysis. The
intravenous administration of sterile water for injection with additives
can cause fluid and/or solute overloading resulting in dilution of
serum electrolyte concentrations, overhydration, congested states
or pulmonary edema. 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. WARNING: 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.
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| dailymed-instance:indicatio... |
Sterile Water for Injection, USP 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 (0.4) of the normal osmolarity of the extracellular fluid
(280 mOsmol/liter) is essential to avoid intravascular hemolysis.
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| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Sterile Water
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