Should Remaining Saline Be Left Uncapped and Used Again

What is Hypertonic Saline and how is it used?

Hypertonic Saline is a prescription medicine used to care for the symptoms of electrolyte and fluid replenisher used every bit a source of h2o and electrolytes. Hypertonic Saline may be used alone or with other medications.

Hypertonic Saline belongs to a class of drugs called Mucolytics.

It is not known if Hypertonic Saline is rubber and constructive in children younger than two years of age.

What are the possible side effects of Hypertonic Saline?

Hypertonic Saline may cause serious side effects including:

headache,
lack of energy,
nausea,
vomiting,
stupor,
coma,
hurting or discomfort in the upper torso, including artillery, left shoulder, back, cervix, jaw or stomach,
trouble animate,
shortness of breath,
sweating,
indigestion,
heartburn,
nausea,
vomiting,
middle assail,
defoliation,
loss of energy,
drowsiness,
fatigue,
restlessness,
irritability,
muscle cramps, and
convulsions (seizures)

Get medical help right abroad, if you take any of the symptoms listed higher up.

The most common side furnishings of Hypertonic Saline include:

fever,
infections at the site of injection,
claret clot or inflammation surround the site of injection,
leakage of fluid into the surrounding tissues (extravasation), and
besides much fluid in the blood (hypervolemia)

Tell the medico if you accept any side consequence that bothers you or that does not go abroad.

These are not all the possible side furnishings of Hypertonic Saline. For more than information, ask your dr. or pharmacist.

Call your medico for medical advice about side furnishings. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

3% and v% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic solution for fluid and electrolyte replenishment in single dose containers for intravenous assistants. The pH may accept been adjusted with hydrochloric acid. It contains no antimicrobial agents. Composition, ionic concentration, osmolarity, and pH are shown in Tabular array 1.

Tabular array i

	size (mL)	Composition (g/L)	Ionic Concentration (mEq/Fifty)		*Osmolarity (mOsmol/50) (calc)	pH
	size (mL)	Sodium Chloride USP (NaCl)	Sodium	Chloride	*Osmolarity (mOsmol/50) (calc)	pH
3% Sodium Chloride Injection, USP	500	30	513	513	1027	v.0 (4.v to vii.0)
five% Sodium Chloride Injection, USP	500	50	856	856	1711	5.0 (iv.5 to 7.0)
*Normal physiological osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions ( ≥ 600 mOsmol/L) may crusade vein damage.

The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is bereft to affect the solution significantly. Solutions in contact with the plastic container tin leach out certain of its chemical components in very minor amounts within the expiration period, e.k., di-two-ethylhexyl phthalate (DEHP), upward to five parts per one thousand thousand. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers also every bit by tissue culture toxicity studies.

INDICATIONS

three% and 5% Sodium Chloride Injection, USP is indicated every bit a source of h2o and electrolytes.

DOSAGE AND ADMINISTRATION

Equally directed by a doc. Dosage is dependent upon the historic period, weight, and clinical condition of the patient as well as laboratory determinations.

Parenteral drug products should exist inspected visually for particulate thing and discoloration prior to administration whenever solution and container allow. Employ of a last filter is recommended during administration of all parenteral solutions, where possible.

All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile equipment.

Additives may be incompatible. Complete information is not bachelor. Those additives known to be incompatible should non be used. Consult with chemist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

HOW SUPPLIED

3% and five% Sodium Chloride Injection,USP in VIAFLEX plastic container is available equally follows:

Code	Size (mL)	NDC	Product Name
2B1353	500	0338-0054-03	three% Sodium Chloride Injection, USP
2B1373	500	0338-0056-03	5% Sodium Chloride Injection, USP

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25^oC); brief exposure up to 40^oC does not adversely affect the product.

Directions for Use of VIAFLEX Plastic Container

Alarm: Do not use plastic containers in series connections. Such use could outcome in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

To Open

Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may exist observed. This is normal and does non affect the solution quality or safety. The opacity volition diminish gradually. Check for minute leaks past squeezing inner bag firmly. If leaks are constitute, discard solution every bit sterility may exist dumb. If supplemental medication is desired, follow directions below.

Training for Administration

Suspend container from eyelet support.
Remove plastic protector from outlet port at bottom of container.
Attach administration gear up. Refer to consummate directions accompanying set up.

To Add Medication

Warning: Additives may be incompatible.

To add medication before solution administration

Prepare medication site.
Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.

To add medication during solution administration

Close clamp on the set.
Prepare medication site.
Using syringe with 19 to 22 estimate needle, puncture resealable medication port and inject.
Remove container from 4 pole and/or turn to an upright position.
Evacuate both ports past squeezing them while container is in the upright position.
Mix solution and medication thoroughly.
Return container to in utilize position and proceed administration.

Baxter Healthcare Corporation, Deerfield, IL 60015, USA. March 2005. FDA Rev date: northward/a

QUESTION

According to the USDA, at that place is no difference between a "portion" and a "serving." Come across Answer

Side Effects & Drug Interactions

SIDE Effects

Reactions which may occur considering of the solution or 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, plant appropriate therapeutic countermeasures, and save the balance of the fluid for examination if deemed necessary.

DRUG INTERACTIONS

No data provided.

WARNINGS

three% and 5% Sodium Chloride Injection, USP is strongly hypertonic and may cause vein impairment.

iii% and v% Sodium Chloride Injection, USP should be used with peachy care, if at all, in patients with congestive eye failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retentivity.

In patients with diminished renal function, administration of 3% and 5% Sodium Chloride Injection, USP may consequence in sodium retentiveness.

PRECAUTIONS

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid residual, electrolyte concentrations, and acid base residual during prolonged parenteral therapy or whenever the status of the patient warrants such evaluation.

Caution must be exercised in the administration of 3% and 5% Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin.

Pregnancy: Teratogenic Effects

Pregnancy Category C. Animate being reproduction studies have non been conducted with 3% and 5% Sodium Chloride Injection, USP. It is also not known whether 3% and v% Sodium Chloride Injection, USP can crusade fetal harm when administered to a pregnant adult female or can bear upon reproduction chapters. 3% and 5% Sodium Chloride Injection, USP should be given to a significant woman only if clearly needed.

Pediatric Use

Safety and effectiveness of 3% and 5% Sodium Chloride Injection, USP in pediatric patients accept not been established past adequate and well controlled trials, nevertheless, the use of sodium chloride solutions in the pediatric population is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population.

Geriatric Use

Clinical studies of 3% and 5% Sodium Chloride Injection, USP, did not include sufficient numbers of subjects aged 65 and over to decide whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses betwixt the elderly and younger patients. In general, dose option for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.

This drug is known to exist substantially excreted past the kidney, and the chance of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more than probable to accept decreased renal function, care should be taken in dose pick, and it may be useful to monitor renal function.

Do non administrate unless solution is clear and seal is intact.

Overdosage & Contraindications

OVERDOSE

No information provided.

CONTRAINDICATIONS

None known

CLINICAL PHARMACOLOGY

3% and five% Sodium Chloride Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.

PATIENT Information

No information provided. Delight refer to the WARNINGS and PRECAUTIONS sections.

From

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Report Issues to the Food and Drug Administration

You are encouraged to study negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call ane-800-FDA-1088.

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