Label: ALFA 0.9% SODIUM CHLORIDE- sodium chloride injection, solution

INTRAVENOUS USE

Sterile and Non pyrogenic

RX ONLY

0.9% SODIUM CHLORIDE ALFA, USP is a sterile, non-pyrogenic solution for fluid replenishment in single-dose containers for intravenous administration. Discard unused portions. It contains no antimicrobial agents.

The Plastic container, 100, 250, 500, 1000mL, Polypropylene (PP) bag with printed literature, injection point, and yellow butterfly port. Protected by a formed, transparent Nylon + PEBDT pouch envelope. Packed in corrugated boxes for 24 units, identified with a white label with the corresponding information.

The Plastic container, 100, 250, 500, 1000mL, Polypropylene (PP) bag with printed literature, SFC port, and a yellow lid. Protected by a formed, transparent Nylon + PEBDT pouch envelope. Packed in corrugated boxes for 24 units, identified with a white label with the corresponding information.

Sodium chloride 0.9% Alfa, USP, for injection is an intravenous solution containing sodium chloride, indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.

Sodium chloride 0.9% Alfa, USP, for injection is contraindicated in patients with clinically significant hypersensitivity to any of its components. Contraindicated in patients with hypernatremia, hyperchloremia, both arterial and intracranial hypertension. Sodium intake should be carefully monitored in patients with heart disease and chronic renal insufficiency.

0.9% Sodium chloride Alfa, USP, for injection, should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.

The intravenous administration of Sodium Chloride Injection, USP, can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations,

overhydration, congested states, or pulmonary edema.

The risk of dilutive states is inversely proportional to the electrolyte concentration of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the

injections.

In patients with diminished renal function, administration of Sodium Chloride Injection, USP may result in sodium retention.

Discard if turbidity or sedimentation is present. Discard if the container is damaged.

Caution must be exercised in the administration of 0.9% Sodium Chloride Alfa, USP solution for Injection to patients receiving corticosteroids or corticotrophin.

When administered intravenously, the solution provides a source of water and electrolytes.

Solutions that provide combinations of hypotonic or isotonic concentrations of sodium chloride are suitable for parenteral maintenance or replacement of water and electrolyte requirements.

Isotonic concentrations of sodium chloride are suitable for parenteral replacement of chloride losses that exceed or equal the sodium loss. Hypotonic concentrations of sodium chloride are suited for parenteral maintenance of water requirements when only small quantities of salt are desired. A hypertonic concentration of sodium chloride may be used to repair severe salt depletion syndrome.

Sodium chloride in water dissociates to provide sodium (Na +) and chloride (Cl -) ions. Sodium (Na +) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl -) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na +) and chloride (Cl -) are largely under the control of the kidney, which maintains a balance between intake and output.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirements range 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.

Reactions that may occur because 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, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures (see WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS).

As directed by a doctor. Dosage is dependent upon the age, weight, and clinical condition of the patient, as well as laboratory determinations.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (see PRECAUTIONS ).

Additives may be incompatible. Consult with a pharmacist if available. When introducing additives, use the aseptic technique, mix thoroughly, and do not store.

Administer intravenously using a strict aseptic technique. Discard the unused portion. Single-use container.

Check for leaks by squeezing the solution container firmly. If leaks are found, discard the solution, as sterility may be impaired. If supplemental medication is desired, follow the directions below before preparing for administration. Check the flexible container solution composition, lot number, and expiry date.

To Open:

1. Turn the solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove the solution container.
2. Check the solution container for leaks by squeezing it firmly. If leaks are found or if the seal is not intact, discard the solution.
3. Do not use it if the solution is cloudy or a precipitate is present.

NOTE: Before use, perform the following checks:

Inspect each container and read the label before use. Ensure the solution is the one ordered and is within the expiration date.

Invert the container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container that fails inspection should not be used. Use only if the solution is clear and the container and seals are intact.

Preparation for Administration:

1. Remove the plastic protector from the sterile set port at the bottom of the container.
2. Attach the administration set. Refer to complete directions accompanying the set.

To Add Medication:

Warning: Some additives may be incompatible.

To Add Medication Before Solution Administration:

Prepare the medication site by removing the additive port closure. Swab the exposed medication site before puncturing.
Using a syringe with 18-22 Ga. needle, puncture medication port and inner diaphragm and inject.
Squeeze and tap ports while ports are upright and mix solution and medication thoroughly.

To Add Medication During Solution Administration:

1. Close the clamp on the set.
2. Prepare the medication site by removing the additive port closure. Swab the exposed medication site before puncturing.
3. Using a syringe with 18-22 Ga. needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject.
4. Remove the container from the IV pole and/or turn to an upright position.
5. Evacuate both ports by tapping and squeezing them while the container is in the upright position.
6. Mix the solution and medication thoroughly.
7. Return the container to the in-use position and continue administration.

NOTE: See full directions accompanying the administration set.

WARNING: Do not use a flexible container in series connections.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

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