Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 0.9% Sodium Chloride Irrigation USP is supplied sterile and nonpyrogenic in single-dose 2000 mL and 3000 mL plastic containers packaged 4 per case. NDC REF SIZE 0264-7388-50 R8205 2000 mL 0264-7388-60 R8206 3000 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C).; PRINCIPAL DISPLAY PANEL - 2000 mL Container Label 0.9% SODIUM CHLORIDE IRRIGATION USP ISOTONIC SOLUTION FOR IRRIGATION REF R8205 NDC 0264-7388-50 LOT EXP. 2000 mL Each 100 mL contains Sodium Chloride USP 0.9 g Water for Injection USP qs pH adjusted with Hydrochloric Acid NF pH: 5.75 (4.50-7.00) Calc. Osmolarity: 308 mOsmol/liter Electrolytes (mEq/liter): Sodium 154 Chloride 154 Sterile, nonpyrogenic. Single unit container. Discard unused portion. Not for Injection. Use only if solution is clear and container and seal are intact. Warning: Do not warm above 150°F (66°C). Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only Y38-000-060 LD-253-7 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 SET 0.9% Sodium Chloride Irrigation 2L Container Label Recycle-Other set arrow illustration 0.9% Sodium Chloride Irrigation 2L Container Label; PRINCIPAL DISPLAY PANEL - 3000 mL Container Label 0.9% SODIUM CHLORIDE IRRIGATION USP ISOTONIC SOLUTION FOR IRRIGATION REF R8206 NDC 0264-7388-60 LOT EXP. 3000 mL Each 100 mL contains Sodium Chloride USP 0.9 g Water for Injection USP qs pH adjusted with Hydrochloric Acid NF pH: 5.75 (4.50-7.00) Calc. Osmolarity: 308 mOsmol/liter Electrolytes (mEq/liter): Sodium 154 Chloride 154 Sterile, nonpyrogenic. Single unit container. Discard unused portion. Not for Injection. Use only if solution is clear and container and seal are intact. Warning: Do not warm above 150°F (66°C). Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only Y38-000-061 LD-254-6 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 SET 0.9% Sodium Chloride Irrigation 3L Container Label Recycle Other set arrow illustration 0.9% Sodium Chloride Irrigation 3L Container Label
- HOW SUPPLIED 0.9% Sodium Chloride Irrigation USP is supplied sterile and nonpyrogenic in single-dose 2000 mL and 3000 mL plastic containers packaged 4 per case. NDC REF SIZE 0264-7388-50 R8205 2000 mL 0264-7388-60 R8206 3000 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C).
- PRINCIPAL DISPLAY PANEL - 2000 mL Container Label 0.9% SODIUM CHLORIDE IRRIGATION USP ISOTONIC SOLUTION FOR IRRIGATION REF R8205 NDC 0264-7388-50 LOT EXP. 2000 mL Each 100 mL contains Sodium Chloride USP 0.9 g Water for Injection USP qs pH adjusted with Hydrochloric Acid NF pH: 5.75 (4.50-7.00) Calc. Osmolarity: 308 mOsmol/liter Electrolytes (mEq/liter): Sodium 154 Chloride 154 Sterile, nonpyrogenic. Single unit container. Discard unused portion. Not for Injection. Use only if solution is clear and container and seal are intact. Warning: Do not warm above 150°F (66°C). Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only Y38-000-060 LD-253-7 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 SET 0.9% Sodium Chloride Irrigation 2L Container Label Recycle-Other set arrow illustration 0.9% Sodium Chloride Irrigation 2L Container Label
- PRINCIPAL DISPLAY PANEL - 3000 mL Container Label 0.9% SODIUM CHLORIDE IRRIGATION USP ISOTONIC SOLUTION FOR IRRIGATION REF R8206 NDC 0264-7388-60 LOT EXP. 3000 mL Each 100 mL contains Sodium Chloride USP 0.9 g Water for Injection USP qs pH adjusted with Hydrochloric Acid NF pH: 5.75 (4.50-7.00) Calc. Osmolarity: 308 mOsmol/liter Electrolytes (mEq/liter): Sodium 154 Chloride 154 Sterile, nonpyrogenic. Single unit container. Discard unused portion. Not for Injection. Use only if solution is clear and container and seal are intact. Warning: Do not warm above 150°F (66°C). Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only Y38-000-061 LD-254-6 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 SET 0.9% Sodium Chloride Irrigation 3L Container Label Recycle Other set arrow illustration 0.9% Sodium Chloride Irrigation 3L Container Label
Overview
Each 100 mL contains: Sodium Chloride USP 0.9 g; Water for Injection USP qs pH adjusted with Hydrochloric Acid NF pH: 5.75 (4.50-7.00) Calculated Osmolarity: 308 mOsmol/liter Concentration of Electrolytes (mEq/liter): Sodium 154; Chloride 154 0.9% Sodium Chloride Irrigation USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. The formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Sodium Chloride USP NaCl 58.44 The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Not made with natural rubber latex, PVC or DEHP.
Indications & Usage
0.9% Sodium Chloride Irrigation USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
Dosage & Administration
As required for irrigation. When used as a diluent, or vehicle for other drugs, the drug manufacturer's recommendations should be followed. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.
Warnings & Precautions
WARNINGS FOR IRRIGATION ONLY. NOT FOR INJECTION. Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs. Absorption of large amounts can cause fluid and/or solute overload 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 the administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration. Do not warm above 150°F (66°C). After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard unused portion of irrigating solution since it contains no preservatives.
Contraindications
0.9% Sodium Chloride Irrigation USP is not for injection by usual parenteral routes. An electrolyte solution should not be used for irrigation during electrosurgical procedures.
Adverse Reactions
Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes can be minimized when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection. If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.
Drug Interactions
Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic technique. Mix thoroughly. Do not store.
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