STERILE WATER- water injection, solution

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)

Հասանելի է:

ICU Medical Inc.

Կառավարման երթուղին:

INTRAVENOUS

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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. Do not administer without the addition of a solute.

Ապրանքի ամփոփագիր:

Sterile Water for Injection, USP is supplied in a single-dose 1000 mL flexible plastic container (NDC 0409-7990-091, 2 and 0990-7990-091, 2). ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. INSTRUCTIONS FOR USE To Open Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. To Add Medication Prepare additive port. Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication. The additive port may be protected by covering with an additive cap. Mix container contents thoroughly. Preparation for Administration (Use aseptic technique) Close flow control clamp of administration set. Remove cover from outlet port at bottom of container. Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: See full directions on administration set carton. Suspend container from hanger. Squeeze and release drip chamber to establish proper fluid level in chamber. Open flow control clamp and clear air from set. Close clamp. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture. Regulate rate of administration with flow control clamp. WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: September, 2018   ICU Medical, Inc., Lake Forest, Illinois, 60045, USA                            EN-4689

Լիազորման կարգավիճակը:

New Drug Application

Ապրանքի հատկությունները

STERILE WATER- WATER INJECTION, SOLUTION
ICU MEDICAL INC.
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STERILE WATER FOR INJECTION, USP
FOR DRUG DILUENT USE ONLY
FLEXIBLE PLASTIC CONTAINER
Rx only
DESCRIPTION
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 H O.
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.
CLINICAL PHARMACOLOGY
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